FDA Issues Draft Guidelines To Eliminate Microbial Contamination In Tomatoes, Leafy Greens, And Melons.

The U.S. Food and Drug Administration has published three draft guidances designed to help growers and others across the entire supply chain minimize or eliminate microbial contamination in tomatoes, leafy greens, and melons.

The guidances are, in part, based on those originally developed by the produce industry with assistance from FDA. They represent the first step in a fundamental shift in strategy for the agency in the prevention of foodborne hazards associated with fresh fruits and vegetables.

“These guidances embody the Obama Administration’s and FDA’s prevention-oriented food safety strategy,” said FDA Commissioner Margaret A. Hamburg, M.D. “They will be made final as soon as possible after public comment, and will be followed within two years by enforceable standards for fresh produce.”

These commodity-specific guidances were called for by the President’s Food Safety Working Group, which recommends a new, public-health focused approach to food safety. In a report issued earlier this month, the working group made recommendations aimed at creating a stronger food safety system. The recommendations stem from three core food safety principles:

• Prevent harm to consumers
• Use good data and analysis to ensure effective food safety inspections and enforcement of the law
• Identify outbreaks of foodborne illness quickly and stop them

Key elements of the draft guidances related to the working group’s strategies include:

• An acceptable baseline standard of industry practices that help both domestic and foreign firms minimize the risk for microbial contamination of their products throughout the entire supply chain
• Recommendations regarding growing, harvesting, packing, processing, transportation, and distribution of the product
• Recommendations for recordkeeping, including some that will help the FDA determine more quickly the source of outbreaks that do occur.

Comments on FDA’s guidance documents may be submitted at any time. However, to ensure that comments are received in time for consideration in drafting final versions of these guidance documents, written or electronic comments should be submitted within 90 days of publication in the Federal Register. See http://www.regulations.gov for information.

• News Release: HHS Secretary Sebelius, Agriculture Secretary Vilsack Announce New Strategies to Keep America's Food Supply Safe
• Questions and Answers on FDA’s Proposed Commodity-Specific Guidances (CSGs)
• The Draft Guidances
  • Guide to Minimize Microbial Food Safety Hazards of Tomatoes
  • Guide to Minimize Microbial Food Safety Hazards of Melons
  • Guide to Minimize Microbial Food Safety Hazards of Leafy Greens

Tags: Microbial Contamination, FDA Guidance, foodborne hazards

Guidance for Industry, Drug-Induced Liver Injury

FDA has released a guidance to assist the pharmaceutical industry and other investigators who are conducting new drug development in assessing the potential for a drug or a product to cause severe liver injury (i.e., irreversible liver failure that is fatal or requires liver transplantation).

In particular, the guidance addresses how laboratory measurements that signal the potential for such drug-induced liver injury (DILI) can be obtained and evaluated during drug development.

This evaluation is important because most drugs that cause severe DILI do so infrequently; typical drug development databases with up to a few thousand subjects exposed to a new drug will not show any cases. Databases may, however, show evidence or signals of a drug’s potential for severe DILI if the clinical and laboratory data are properly evaluated for evidence of lesser injury that may not be severe, but may predict the ability to cause more severe injuries. This guidance describes an approach that can be used to distinguish signals of DILI that identify drugs likely to cause severe liver injury from signals that do not suggest such a potential. This guidance does not address issues of preclinical evaluation for signals of DILI, nor the detection and assessment of DILI after drug approval and marketing.
The guidance is available from FDA.
Follow the link below for a PDF file;
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf

Tags: drug-induced liver injury, DILI, drug development databases, FDA Guidance, pharmaceutical industry

Dietary Supplements 101 Form FDA

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The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.

Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements and include among others

• vitamin and mineral products
• "botanical" or herbal products—These come in many forms and may include plant materials, algae, macroscopic fungi, or a combination of these materials.
• amino acid products—Amino acids are known as the building blocks of proteins and play a role in metabolism.
• enzyme supplements—Enzymes are complex proteins that speed up biochemical reactions.

People use dietary supplements for a wide assortment of reasons. Some seek to compensate for diets, medical conditions, or eating habits that limit the intake of essential vitamins and nutrients. Other people look to them to boost energy or to get a good night's sleep. Postmenopausal women consider using them to counter a sudden drop in estrogen levels.

Talk with a Health Care Professional

The Food and Drug Administration (FDA) suggests that you consult with a health care professional before using any dietary supplement. Many supplements contain ingredients that have strong biological effects, and such products may not be safe in all people.

If you have certain health conditions and take these products, you may be putting yourself at risk. Your health care professional can discuss with you whether it is safe for you to take a particular product and whether the product is appropriate for your needs. Here is some general advice:

• Dietary supplements are not intended to treat, diagnose, cure, or alleviate the effects of diseases. They cannot completely prevent diseases, as some vaccines can. However, some supplements are useful in reducing the risk of certain diseases and are authorized to make label claims about these uses. For example, folic acid supplements may make a claim about reducing the risk of birth defects of the brain and spinal cord.
• Using supplements improperly can be harmful. Taking a combination of supplements, using these products together with medicine, or substituting them in place of prescribed medicines could lead to harmful, even life-threatening, results.
• Some supplements can have unwanted effects before, during, or after surgery. For example, bleeding is a potential side effect risk of garlic, ginkgo biloba, ginseng, and Vitamin E. In addition, kava and valerian act as sedatives and can increase the effects of anesthetics and other medications used during surgery. Before surgery, you should inform your health care professional about all the supplements you use.

How Are Supplements Regulated?

You should know the following if you are considering using a dietary supplement.

• Federal law requires that every dietary supplement be labeled as such, either with the term "dietary supplement" or with a term that substitutes a description of the product's dietary ingredient(s) for the word "dietary" (e.g., "herbal supplement" or "calcium supplement").
• Federal law does not require dietary supplements to be proven safe to FDA's satisfaction before they are marketed.
• For most claims made in the labeling of dietary supplements, the law does not require the manufacturer or seller to prove to FDA's satisfaction that the claim is accurate or truthful before it appears on the product.
• In general, FDA's role with a dietary supplement product begins after the product enters the marketplace. That is usually the agency's first opportunity to take action against a product that presents a significant or unreasonable risk of illness or injury, or that is otherwise adulterated or misbranded.
• Dietary supplement advertising, including ads broadcast on radio and television, falls under the jurisdiction of the Federal Trade Commission.
• Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion.
• Dietary supplement firms must report to FDA any serious adverse events that are reported to them by consumers or health care professionals.
• Dietary supplement manufacturers do not have to get the agency's approval before producing or selling these products.
• It is not legal to market a dietary supplement product as a treatment or cure for a specific disease, or to alleviate the symptoms of a disease.
• There are limitations to FDA oversight of claims in dietary supplement labeling. For example, FDA reviews substantiation for claims as resources permit.

Are Supplements Safe?

Many dietary supplements have clean safety histories. For example, millions of Americans responsibly consume multi-vitamins and experience no ill effects.

Some dietary supplements have been shown to be beneficial for certain health conditions. For example, the use of folic acid supplements by women of childbearing age who may become pregnant reduces the risk of some birth defects.

Another example is the crystalline form of vitamin B12, which is beneficial in people over age 50 who often have a reduced ability to absorb naturally occurring vitamin B12. But further study is needed for some other dietary supplements.

Some supplements have had to be recalled because of proven or potential harmful effects. Reasons for these recalls include

• microbiological, pesticide, and heavy metal contamination
• absence of a dietary ingredient claimed to be in the product
• the presence of more or less than the amount of the dietary ingredient claimed on the label

In addition, unscrupulous manufacturers have tried to sell bogus products that should not be on the market at all.
Before taking a dietary supplement, make sure that the supplement is safe for you and appropriate for the intended purpose.

Be a Safe and Informed Consumer

• Let your health care professional advise you on sorting reliable information from questionable information.
• Contact the manufacturer for information about the product you intend to use.
• Be aware that some supplement ingredients, including nutrients and plant components, can be toxic. Also, some ingredients and products can be harmful when consumed in high amounts, when taken for a long time, or when used in combination with certain other drugs, substances, or foods.
• Do not self-diagnose any health condition. Work with health care professionals to determine how best to achieve optimal health.
• Do not substitute a dietary supplement for a prescription medicine or therapy, or for the variety of foods important to a healthful diet.
• Do not assume that the term "natural" in relation to a product ensures that the product is wholesome or safe.
• Be wary of hype and headlines. Sound health advice is generally based upon research over time, not a single study.
• Learn to spot false claims. If something sounds too good to be true, it probably is.

Report Problems

Adverse effects with dietary supplements should be reported to FDA as soon as possible. If you experience such an adverse effect, contact or see your health care professional immediately. Both of you are then encouraged to report this problem to FDA. For information on how to do this, go to www.cfsan.fda.gov/~dms/ds-rept.html.

Adverse effects can also be reported to the product's manufacturer or distributor through the address or phone number listed on the product's label. Dietary supplement firms are required to forward reports they receive about serious adverse effects to FDA within 15 days.

For a general, nonserious complaint or concern about dietary supplements, contact your local FDA District Office (www.cfsan.fda.gov/~dms/district.html).

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

Tags: FDA Guidance, FDA Health Advisory, dietary ingredient, vitamins, minerals, amino acids, Dietary supplements, enzyme supplements

Are You Prepared for Hurricanes and Floods?

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Prepare for Hurricanes and Floods: Advice From FDA

Here are resources from the Food and Drug Administration on how to keep food, medical products, and pets safe during an emergency such as Hurricanes and Floods.

FOOD

Food that has been exposed to flood waters or that hasn't been properly refrigerated can cause illness.

• When in doubt, throw it out. Don't eat food that may have been exposed to flood water.


• Use bottled water if it is available. Don't drink water that may have been exposed to flood water. If you don't have bottled water, boil water at a rolling boil for one minute to make it safe.
  
  
  • Follow these steps if you can't boil water.
    
    
    • If the water is cloudy, filter it through clean cloths or allow it to settle, and draw off the clear water for disinfection.
    
    
    • Add 1/8 teaspoon (or 8 drops) of regular, unscented, liquid household bleach per each gallon of water. Stir it well and let it stand for at least 30 minutes before you use it.
    
    
    • Store disinfected water in clean containers with covers.
    
    
  
  


• Keep refrigerator and freezer doors closed. If the power goes out, keep refrigerator and freezer doors closed as much as possible. Your refrigerator will keep food cold for about 4 hours if it's unopened. A full freezer will keep an adequate temperature for about 48 hours if the door remains closed.


• Use appliance thermometers. Thermometers should be in your refrigerator and freezer. When power is restored, check your freezer thermometer. If it reads 40°Fahrenheit, the food is safe and may be refrozen. Refrigerated food should be safe as long as the power was out no more than 4 hours and the door has remained closed.


• Be prepared - have coolers and ice or frozen gel packs. Coolers can help keep refrigerator food cold. If the power will be out for more than 4 hours, store foods that require refrigeration so they are in contact with ice or frozen gel packs. Purchase or make ice cubes and store in the freezer for use in the refrigerator or in a cooler. Freeze gel packs ahead of time for use in coolers.


• Throw out spoiled food. Discard any perishable foods—such as meat, poultry, seafood, eggs, or leftovers—that have been above 40°Fahrenheit for 2 hours or more.

Returning Home After a Hurricane or Flood

www.cfsan.fda.gov/~dms/fsdisas5.html

Food and Water Safety

www.cfsan.fda.gov/~dms/fsdisas.html

MEDICINE

If you are in an area that may flood …

• Keep your medication containers in zippered plastic bags. Store them in your home in a place less likely to flood.


• Keep a list of your medications. Be sure to include:
  
  
  • the name of the medicine
  
  
  • the dose of the medicine
  
  
  • how frequently you take the medicine
  
  
  • your doctor's name and phone number
  
  


• Take the bags and medications with you if you must evacuate.

If a medication container falls into flood water …

• Replace the medication. That's the safest approach.

But during an emergency, replacing your medicines may not be easy.

• If the container gets wet but it appears that flood water did not touch the medicine, then use the medication, but only until a replacement can be obtained.


• Do not use the medication if any pills were touched by flood water.


• Save the original containers.


• Contact your physician or local public health provider for guidance.

Safe Drug Use After a Natural Disaster

www.fda.gov/cder/emergency/water-refrig.htm

INSULIN

If a hurricane strikes, people with diabetes may not be able to refrigerate their insulin.

• Replace the medication with a new supply. Temperature sensitive drugs, like insulin, lose potency if not refrigerated, so they should be replaced with a new supply as soon as possible.


• Insulin products may be left unrefrigerated (between 59 and 86°F) for up to 28 days and still maintain potency.


• Contact a hospital or other health care provider for guidance.

Insulin Storage and Switching Between Products in an Emergency

www.fda.gov/cder/emergency/insulin.htm

MEDICAL DEVICES

In an emergency, follow these tips for safe use of medical devices and equipment.

• Keep your medical device and supplies clean and dry.


• Seek emergency services immediately if you depend on your device to keep you alive.


• Request evacuation. If possible, notify your local public health authority to request evacuation before bad weather occurs.


• Use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use. This lowers the risk of fire.


• Contact your distributor or device manufacturer if your device appears to be damaged or you need a back-up device.


• Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power at the main breaker.


• Never run a generator inside your home or garage unless the equipment has been professionally installed and vented.

Medical Devices and Hurricanes

www.fda.gov/cdrh/emergency/hurricane.html

Medical Devices Requiring Refrigeration

www.fda.gov/cdrh/emergency/refrigeration.html

VACCINES AND OTHER BIOLOGICS

Most biological products, including bacterial and viral vaccines, allergenic extracts (e.g. for allergy shots and tests), and blood products, require specific storage conditions to maintain their safety, purity, and potency. This type of information is indicated in the product labeling.

These products may often be found in health clinics, physicians' offices and patients' homes where emergency back up power may not be available.

Here are some suggested actions to preserve cold or frozen storage conditions during a power outage:

Vaccines and Non-Blood Biologicals

• Note the time of the power outage and do not open freezers and refrigerators until power is restored. This will help conserve the cold mass of the products.


• Do not open units to check temperatures during a power outage, as many products will maintain their potency for a few days in a closed refrigerator.


• For vaccines requiring freezer storage, you may consider removing them from the freezer after one day (if the power outage continues) and packing them in dry ice. But if the vaccines are not cold to the touch upon removal from the freezer, you may wish to consider not using them.

Blood Products and Plasma Derivatives

Blood banks and plasma centers typically have back up generators and emergency procedures in place for storing products in the event of a power outage. For those facilities and in-home users that may not have emergency back up power, the following may be helpful:

• There is some evidence that lyophilized coagulation products such as Factor VIII and Factor IX may be stored at room temperature for a fairly long period of time without loss of factor potency. If you are concerned about the exposure or efficacy of a particular product, please contact the supplier or the manufacturer.


• Many immune globulin products are licensed for storage at 36 to 46 degrees Fahrenheit, and some products may be stored at room temperature for all or part of the time before expiration. Because storage temperatures and times are specific to each product, you should follow the package insert recommendations for Immune Globulin Intravenous (IGIV), intramuscular IG (IG), and subcutaneous IG (IGSC) products. Products requiring lower temperatures can be stored on wet ice. All of these products should not be frozen.

Severe Weather Conditions and Biological Products

www.fda.gov/cber/weatherimpact.htm

TAKING CARE OF PETS

When a hurricane strikes, it's a dangerous situation for people AND pets.

• Try to take your pets with you if you leave home during an emergency.


• Plan in advance. Find out which motels or hotels accept pets in an emergency. Or, plan to go to the home of a friend or relative who will allow you to bring your pet.


• Prepare a disaster kit that you can grab as you leave home. The kit should include pet food, medicines, vaccination records, and pet insurance information.


• Make arrangements for a neighbor or nearby friend to take care of your pets in case you get trapped away from home.


• Make sure your pets have identification tags (including rabies and license tags, if applicable.) This may help reunite you with your pets if you get separated. Identification tags should provide your name, home address, a phone number where you can be reached, and an out-of-state phone number of someone with whom you will be in contact during or soon after the disaster/evacuation.


• Have a leash, collar or harness for your pets (cats and dogs) and pet carriers or transport kennels/cages for each pet.

Taking Care of Pets

www.fda.gov/cvm/disaster.htm

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer)

Tags: INSULIN, MEDICINE, FOOD, Hurricanes, Floods, medical products, FDA Advisory, FDA Guidance, Disaster preparedness

What is an FDA advisory committee?

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As technology changes, so do the tools we use to combat disease in the United States. Many companies use new technologies and scientific innovations to develop new generations of drugs, medical devices, and biological products such as vaccines. Some of these new medical products hold great promise. But some pose great risk.

Part of the Food and Drug Administration’s (FDA) mission is to evaluate new therapies and determine which are safe and effective for their intended use. This is a complex job, often involving many areas of expertise, and sometimes FDA turns to outside experts for counsel.

FDA's advisory committees provide independent, expert advice to the agency on a range of complex scientific, technical, and policy issues. This includes questions related to the development and evaluation of products regulated by FDA. The agency currently has 49 technical and scientific advisory committees and panels. They are a valuable resource and make an important contribution to the agency’s decision-making processes. Although advisory committees provide recommendations to the agency, FDA makes the final decisions.

What is an FDA advisory committee?

An advisory committee lends credibility to the product review process and provides a forum for public discussion of certain controversial issues. The process helps air issues that do not have simple answers. For specific products, advisory committees consider the available evidence and provide scientific and medical advice on safety, effectiveness, and appropriate use. Committees might also advise the agency on broader regulatory and scientific issues.

Who serves on advisory committees and panels?

In general, each committee includes a chairperson, several members, a consumer representative, an industry representative, and often a patient representative. Additional experts may be added for specific meetings, as needed.

Committee membership typically includes ethnic, gender, and geographic diversity. Members have recognized expertise and judgment in a specific field. Typical members include

• Physician-scientists
• Statisticians
• Epidemiologists
• Pharmacologists
• Nutritionists
• Nurses
• Experts in animal (preclinical) studies

Representatives for industry, patients, and consumers add different perspectives and expertise that give balance to the discussions and final recommendations.

What does a consumer representative do?

Consumer representatives are technically qualified professionals who have specific links with consumer advocacy groups or community based organizations.

Consumer representatives

• facilitate dialogue with the committees on scientific issues that affect consumers
• must be able to analyze scientific data
• must understand research design
• must discuss benefits and risks
• must evaluate the safety and effectiveness of products under review

How often do advisory committee meetings occur?

Advisory committee meetings can occur during any stage of a product's review process, or if appropriate, once a product is marketed. Typically, an individual committee may convene on average one to four times per year. The decision to involve an advisory committee is usually at the discretion of the Division Director of one of FDA's five product centers.

How does a person become a member of an advisory committee?

Nominations for scientific members and consumer, industry, and patient representatives typically come from professional societies, industry, consumer and patient advocacy groups, the interested individual, or from other interested people. Candidates must be willing to provide detailed information about financial holdings, employment, research grants and contracts, and other potential conflicts of interest. FDA is committed to finding qualified individuals who represent a variety of points of view to serve on advisory committees. Applications are now available on line.

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer)

Tags: FDA Guidance, FDA News, FDA advisory committees

Changes In Albuterol Delivery System, Albuterol Inhaler With HFA.

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Albuterol is a quick-relief medication that's used to open up the airways so that it's easier to breathe. The medication is used by people with certain airway diseases, such as asthma and chronic obstructive pulmonary disease (COPD), a group of lung diseases that includes chronic bronchitis and emphysema.

One method of delivering albuterol is the metered dose inhaler, a hand-held device that delivers a specific amount of medication directly into the lungs. Traditionally, inhalers have contained chlorofluorocarbons (CFCs), a type of propellant that helps the albuterol reach the lungs. But inhalers with CFCs are being phased out because they are harmful to the environment.

Here are facts you should know about switching from your CFC-propelled albuterol inhaler to inhalers that contain propellants called hydrofluoroalkanes (HFAs).

CFCs deplete the ozone layer.

CFCs deplete ozone high up in the stratosphere--the part of the earth's atmosphere that protects us from the sun's harmful ultraviolet radiation. In the stratosphere, the ozone layer serves as a shield that absorbs ultraviolet radiation and keeps it from reaching the earth's surface. CFCs are among the substances that damage the ozone layer. This leads to higher levels of ultraviolet B radiation, which has negative effects, including increases in skin cancers and cataracts. Under an international agreement, the United States, along with almost all countries of the world, agreed to phase out CFCs and other ozone-depleting substances.

CFC-propelled albuterol inhalers will no longer be available after Dec. 31, 2008.

In accordance with an FDA Final Rule and under the authority of the Clean Air Act of the U.S. Environmental Protection Agency, no CFC-propelled albuterol inhalers can be produced, marketed, or sold in the United States after Dec. 31, 2008. Manufacturers have been increasing production of HFA-propelled albuterol inhalers so that sufficient supplies exist to replace the CFC-containing inhalers. If you haven't done so already, you should talk with your health care professional about switching to an HFA-propelled albuterol inhaler.

Albuterol inhalers containing HFAs deliver the same medicine, but there are some differences.

The HFA-propelled albuterol inhalers are still convenient and have been shown to be safe and effective in studies with patients. But you may find that the spray from an HFA inhaler tastes and feels different than the spray from the CFC-propelled albuterol inhalers. The spray from an HFA inhaler may feel less forceful, but this does not mean that the medication is not working.

Cleaning and priming your HFA inhaler are especially important.

Cleaning and priming helps prevent medication build-up and blockages, and ensures that the inhaler works properly. Priming an inhaler involves shaking it well and then releasing test sprays into the air. Be sure to hold the inhaler away from your face so that you don't get medication in your eyes. Each inhaler has specific instructions for cleaning and priming that you should follow. Refer to the patient information that accompanies the product.

Four alternative HFA-propelled inhalers are approved by FDA.

There are four products available that can be used to replace your CFC-propelled albuterol inhaler:

• Proair HFA Inhalation Aerosol (Ivax Corp.)
• Proventil HFA Inhalation Aerosol (Schering-Plough)
• Ventolin HFA Inhalation Aerosol (GlaxoSmithKline)
• Xopenex HFA Inhalation Aerosol (Sepracor)

While they have all been shown to be effective, there are some differences between the products. You may need to talk with your health care professional and try different inhalers to find the product that is right for you.

For More Information

Metered Dose Inhalers (MDIs)
www.fda.gov/cder/mdi/default.htm

FDA Safety Update: Asthma Medications
www.fda.gov/consumer/updates/asthmameds051308.html

FDA's Web Page on Eliminating Ozone-depleting Substances from Metered-Dose Inhalers
www.fda.gov/cder/mdi/albuterol.htm

Tags: FDA Guidance, FDA Action, Asthma Medication, COPD Medication, Albuterol, Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, Ventolin HFA Inhalation Aerosol, Xopenex HFA Inhalation Aerosol

Pregnancy and Lactation Labeling

The U.S. Food and Drug Administration today proposed major revisions to the physician labeling for prescription drugs (including biological products) to provide better information about the effects of medicines used during pregnancy and breast-feeding.

The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Although physician labeling is directed to health care professionals, it is sometimes adapted for use in consumer-directed labeling such as patient package inserts or medication guides when such labeling is approved for a prescription drug.

"With this proposal, FDA's goal is to help women, their physicians and their pharmacists have better information about the effects of prescription medicines so that pregnant women, nursing mothers, and breast-feeding infants will benefit," said Rear Admiral Sandra Kweder, M.D., Center for Drug Evaluation and Research, FDA. "This proposal would help make drug labeling a better communication tool, and would potentially have a huge impact on public health and well being for women."

There are about six million pregnancies in the United States every year, and pregnant women take an average of three to five prescription drugs during pregnancy. Additionally, women with pre-existing medical conditions, such as asthma or high blood pressure, may need to continue to use prescription drugs to treat those conditions during pregnancy.

The proposed rule outlines what important information about the use of medicines during pregnancy and breast-feeding would be required to be added to product labeling for newly approved drugs. Under the proposal, drug labeling would explain, based on available information, the potential benefits and risks for the mother and the fetus, and how these risks may change during the course of pregnancy.

In the 1990s, the FDA recognized the shortcomings of pregnancy and breastfeeding information in prescription drug labeling and began reviewing ways to improve the information. The agency held public meetings and focus groups to obtain comment on the current labeling from health care professionals and scientific experts. Current labeling uses a letter category system to describe the risks of drug use during pregnancy. Stakeholders have said the letter category system leads to an inaccurate and overly simplified view of these risks, and does not facilitate updating of labeling as new information becomes available.

The proposed rule would remove the letter categories from the pregnancy section of prescription drug labeling. The newly designed format, for the pregnancy section of the labeling would have three sections:

• The first section, called the "Fetal Risk Summary," would describe what is known about the effects of the drug on the fetus, and if there is a risk, whether this risk is based on information from animals or humans. The proposal calls for a risk conclusion based on the available data and provides a number of examples depending on the quality and quantity of that data. For example, one risk conclusion might be: "Human data indicate that (name of drug) increases the risk of cardiac abnormalities." This would be followed by a summary of the most important data on the drug’s effects.
• Another section, called "Clinical Considerations," would include information about the effects of the use of the drug if it is taken before a woman knows she is pregnant. This section also would feature discussions about the risks of the disease to the mother and the baby, dosing information, and tell how to address complications.
• The third section, under the heading "Data," would describe in more detail the available data regarding use of the drug in humans and from animal studies that were used to develop the Fetal Risk Summary.

The pregnancy section would also include information about whether there is a pregnancy exposure registry for the drug. Pregnancy exposure registries collect and maintain data on the effects of approved drugs that are prescribed to and used by pregnant women.

The lactation (breastfeeding) section of prescription drug labeling would use the same format as the pregnancy section. The lactation section would provide information about using the drug while breastfeeding, such as the amount of drug in breast milk and potential effects on the breastfed infant.

Certain newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs will be phased in gradually under FDA’s recent Physician Labeling Rulemaking.

Electronic comments can be submitted within 90 days via the Federal Documents Management System/eRulemaking portal at www.regulations.gov. The FDA will carefully consider the comments in preparing a final rule.

For more information, visit: http://www.fda.gov/cder/regulatory/pregnancy_labeling/default.htm

Tags: Pregnancy, Lactation, prescription drugs Labeling, biological products Labeling

Control Your Cholestrol With Statins.

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When it comes to keeping your heart healthy, what foods you eat and the genes you inherit matter. Good heart health also may depend on the drugs you take. Several medicines are effective at lowering blood cholesterol levels—a key factor in good heart health. Chief among them are the statins.

Statins (HMG-CoA reductase inhibitors) are one class of many drugs used to lower the level of cholesterol in the blood by reducing the production of cholesterol by the liver. Statins block the enzyme in the liver that is responsible for making cholesterol. Too much cholesterol can increase a person's chance of getting heart disease. According to the Centers for Disease Control and Prevention, heart disease is the leading cause of death for both women and men in the United States.

Understanding Cholesterol

Cholesterol is a waxy substance found in all parts of the body. It is critical to the normal function of all cells. The body needs cholesterol for making hormones, digesting dietary fats, building cell walls, and other important processes. Your body makes all the cholesterol it needs, but cholesterol is also in some of the foods you eat.

When there is too much cholesterol in your blood, it can build up on the walls of the arteries (blood vessels that carry blood from the heart to other parts of the body). This buildup is called plaque. Over time, plaques can cause narrowing or hardening of the arteries—a condition called atherosclerosis. In short, too much cholesterol can clog your arteries and keep your heart from getting the blood it needs.

Cholesterol Numbers That Matter

There are no warning symptoms of high cholesterol. But a simple blood test by your doctor will measure the different kinds of cholesterol.

Low-density lipoprotein (LDL) or "bad" cholesterol can clog the arteries. Lower numbers of LDL are best. The higher the LDL level, the greater the risk for heart disease.

High-density lipoprotein (HDL) or "good" cholesterol carries bad cholesterol out of your blood, back to the liver, where it can be eliminated, to keep it from building up in the arteries. The higher the HDL level, the lower the risk for heart disease.

For information on what your cholesterol numbers mean, visit FDA. (We will also have an article about it soone.)

What Affects Cholesterol?

The following factors affect blood cholesterol levels:

* Certain foods - eating too much saturated fat, found mostly in animal products, and too much cholesterol, found only in animal products
* Heredity - genes play a role in influencing the levels
* Weight - excess weight tends to increase the levels
* Exercise - regular physical activity may not only lower LDL cholesterol, but it may increase the level of desirable HDL cholesterol
* Smoking - cigarette smoking lowers HDL cholesterol
* Age and gender - cholesterol levels naturally rise as men and women age. Menopause is often associated with increased LDL cholesterol in women.

State of the Statins

The main goal of cholesterol treatment is to lower LDL to levels that will not lead to or worsen heart disease. When a patient without heart disease is first diagnosed with elevated blood cholesterol, the National Cholesterol Education Program guidelines advise a six-month program of reduced dietary saturated fat and cholesterol, together with physical activity and weight control, as the primary treatment to bring levels down.

When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe medication—the most prominent being the statins. By interfering with the production of cholesterol, statin medications can slow the formation of plaques in the arteries.

Statins are relatively safe for most people, but some can respond differently to the drugs. Certain people may have fewer side effects with one statin drug than another. Some statins, in particular Lovastatin and Simvastatin, also are known to interact adversely with other drugs. This information, coupled with the degree of cholesterol-lowering desired, will help guide the decision about which statin to use, or whether another type of drug should be used.

Statin medications (HMG-CoA reductase inhibitors)

* work in the liver to prevent formation of cholesterol
* are effective in lowering bad cholesterol levels and raising good cholesterol
* are not recommended for pregnant patients or those with active or chronic liver disease
* can cause serious muscle problems

Currently available statins

* Lovastatin (Mevacor, Altoprev)
* Pravastatin (Pravachol)
* Simvastatin (Zocor)
* Fluvastatin (Lescol)
* Atorvastatin (Lipitor)
* Rosuvastatin (Crestor)

Tips for Consumers

* Have your blood cholesterol levels checked at least once every 5 years if you are an adult 20 years or older.
* Check with your doctor. You may be able to lower your cholesterol levels by eating better and exercising more.
* Maintain a healthy weight. Being overweight increases your risk for heart disease.
* Stay active every day.
* Use the food label to choose foods lower in saturated fat, including trans fats, and calories.
* Eat more fruits and vegetables.
* Don't stop taking any cholesterol-lowering medications you may be on without first talking to your doctor.

For More Information

National Heart, Lung, and Blood Institute Health Information Center

FDA's Center for Drug Evaluation and Research

Tags: cholesterol control, FDA Guidance, statins, HMG-CoA reductase inhibitors, plaque, atherosclerosis, Low-density lipoprotein, LDL, High-density lipoprotein, HDL, Lovastatin, Mevacor, Altoprev, Pravastatin, Pravachol, Simvastatin, Zocor, Fluvastatin, Lescol, Atorvastatin, Lipitor, Rosuvastatin, Crestor

How To Combat Antibiotic Resistance

PDF Version of this Document could be down loaded directly from FDA by clicking on the above image or Here

Antibiotics are drugs used for treating infections caused by bacteria. Also known as antimicrobial drugs, antibiotics have saved countless lives.

Misuse and overuse of these drugs, however, have contributed to a phenomenon known as antibiotic resistance. This resistance develops when potentially harmful bacteria change in a way that reduces or eliminates the effectiveness of antibiotics.

A Public Health Issue

Antibiotic resistance is a growing public health concern worldwide. When a person is infected with an antibiotic-resistant bacterium, not only is treatment of that patient more difficult, but the antibiotic-resistant bacterium may spread to other people.

When antibiotics don't work, the result can be

• longer illnesses
• more complicated illnesses
• more doctor visits
• the use of stronger and more expensive drugs
• more deaths caused by bacterial infections

Examples of the types of bacteria that have become resistant to antibiotics include the species that cause skin infections, meningitis, sexually transmitted diseases and respiratory tract infections such as pneumonia.

In cooperation with other government agencies, the Food and Drug Administration (FDA) has launched several initiatives to address antibiotic resistance.

The agency has issued drug labeling regulations, emphasizing the prudent use of antibiotics. The regulations encourage health care professionals to prescribe antibiotics only when clinically necessary, and to counsel patients about the proper use of such drugs and the importance of taking them as directed. FDA has also encouraged the development of new drugs, vaccines, and improved tests for infectious diseases.

Antibiotics Fight Bacteria, Not Viruses

Antibiotics are meant to be used against bacterial infections. For example, they are used to treat strep throat, which is caused by streptococcal bacteria, and skin infections caused by staphylococcal bacteria.

Although antibiotics kill bacteria, they are not effective against viruses. Therefore, they will not be effective against viral infections such as colds, most coughs, many types of sore throat, and influenza (flu).

Using antibiotics against viral infections

• will not cure the infection
• will not keep other individuals from catching the virus
• will not help a person feel better
• may cause unnecessary, harmful side effects
• may contribute to the development of antibiotic-resistant bacteria

Patients and health care professionals alike can play an important role in combating antibiotic resistance. Patients should not demand antibiotics when a health care professional says the drugs are not needed. Health care professionals should prescribe antibiotics only for infections they believe to be caused by bacteria.

As a patient, your best approach is to ask your health care professional whether an antibiotic is likely to be effective for your condition. Also, ask what else you can do to relieve your symptoms.

Follow Directions for Proper Use

When you are prescribed an antibiotic to treat a bacterial infection, it's important to take the medication exactly as directed. Here are more tips to promote proper use of antibiotics.

• Complete the full course of the drug. It's important to take all of the medication, even if you are feeling better. If treatment stops too soon, the drug may not kill all the bacteria. You may become sick again, and the remaining bacteria may become resistant to the antibiotic that you've taken.
• Do not skip doses. Antibiotics are most effective when they are taken regularly.
• Do not save antibiotics. You might think that you can save an antibiotic for the next time you get sick, but an antibiotic is meant for your particular infection at the time. Never take leftover medicine. Taking the wrong medicine can delay getting the appropriate treatment and may allow your condition to worsen.
• Do not take antibiotics prescribed for someone else. These may not be appropriate for your illness, may delay correct treatment, and may allow your condition to worsen.
• Talk with your health care professional. Ask questions, especially if you are uncertain about when an antibiotic is appropriate or how to take it.

It's important that you let your health care professional know of any troublesome side effects. Consumers and health care professionals can also report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.

What FDA is Doing

Efforts to combat antibiotic resistance include agency-wide cooperation and development of an FDA Task Force on Antimicrobial Resistance. FDA activities include

• Labeling regulations addressing proper use of antibiotics. Antibiotic labeling contains required statements in several places advising health care professionals that these drugs should be used only to treat infections that are believed to be caused by bacteria. Labeling also encourages health care professionals to counsel patients about proper use.
• Partnering to promote public awareness. FDA is partnering with the Centers for Disease Control and Prevention (CDC) on "Get Smart: Know When Antibiotics Work," a campaign that offers Web pages, brochures, fact sheets, and other information sources aimed at helping the public learn about preventing antibiotic-resistant infections.
• Encouraging the development of new antibiotics. FDA is actively engaged in developing guidance for industry on the types of clinical studies that could be performed to evaluate how an antibacterial drug works for the treatment of different types of infections.

For More Information

FDA: Antibiotic Resistance
www.fda.gov/oc/opacom/hottopics/anti_resist.html

FDA Center for Drug Evaluation and Research (CDER): Antimicrobial Resistance
www.fda.gov/cder/drug/antimicrobial/default.htm

FDA Task Force on Antimicrobial Resistance
www.fda.gov/cder/drug/antimicrobial/documents/TFREPORT12052000.pdf

CDC: Get Smart: Know When Antibiotics Work
www.cdc.gov/drugresistance/community/

Tags: FDA Guidance, Antibiotics, skin infections, meningitis, sexually transmitted diseases, pneumonia

Medication Errors Are Preventable

FDA 101: Medication Errors

A medication error is any preventable event that may cause or lead to inappropriate medication use or harm to a patient. Since 2000, the Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. FDA reviews reports that come to MedWatch, the agency's adverse event reporting program.

"These reports are voluntary, so the number of actual medication errors is believed to be higher," says Carol Holquist, R.Ph., Director of the Division of Medication Error Prevention in FDA's Center for Drug Evaluation and Research.

FDA works with many partners to track medication errors, including the U.S. Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). "Every report received through the USP/ISMP Voluntary Medication Error Reporting Program (MERP) automatically gets sent to FDA's MedWatch program," says Mike Cohen, R.Ph., Sc.D., President of ISMP. "It takes a cooperative approach to monitor errors, evaluate them, and educate the public about strategies to keep errors from happening again."

Medication errors occur for a variety of reasons. For example, miscommunication of drug orders can involve poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units.

"Medication errors usually occur because of multiple, complex factors," says Holquist. "All parts of the health care system—including health professionals and patients—have a role to play in preventing medication errors."

FDA's Role

• Drug Name Review:
  To minimize drug name confusion, FDA reviews about 400 drug names a year that companies submit as proposed brand names. The agency rejects about one-third of the names that drug companies propose.
• Drug Labels:
  FDA regulations require all over-the-counter (OTC) drug products (more than 100,000) to have a standardized "drug facts label." FDA has also improved prescription drug package inserts for health care professionals.
• Drug Labeling and Packaging:
  FDA works with drug companies to reduce the risk of errors that may result from similar-looking labeling and packaging, or from poor product design.
• Bar Code Label Rule:
  In accordance with an FDA rule that went into effect in 2004, bar codes are required on product labels for certain drugs and biologics such as blood. When used with bar code scanner and computerized patient information systems, bar code technology can help ensure that the right dose of the right drug is given to the right patient at the right time.
• Error Analyses:
  FDA reviews about 1,400 reports of medication errors per month and analyzes them to determine the cause and type of error.
• Guidances for Industry:
  FDA is working on three new guidances—one on complete submission requirements for anaylsis of trade names, one about the pitfalls of drug labeling, and another on best test practices for naming drugs.
• Public Education:
  FDA spreads the message about medication error prevention through public health advisories, medication guides, and outreach partnerships with other organizations.

Examples of Medication Errors

Misuse of Tussionex Prescription Cough Medicine:
On March 11, 2008, FDA informed health care professionals about adverse events and deaths in children and adults who have taken Tussionex Pennkinetic Extended-Release Suspension (Tussionex). Tussionex is a long-acting prescription cough medicine.

Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems when too much medicine is given at one time or when the medicine is given more frequently than recommended. Tussionex should not be used in children less than 6 years old.

Reports indicate that health care professionals have prescribed Tussionex for patients younger than the approved aged group of 6 years old and older, more frequently than the labeled dosing interval of every 12 hours ("extended release"), and that patients have administered the incorrect dose due to misinterpretation of the dosing directions and the use of inappropriate measuring devices. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal breathing problems.

For more information, see FDA Issues Alert on Tussionex at www.fda.gov/bbs/topics/NEWS/2008/NEW01805.html

and the FDA Public Health Advisory at www.fda.gov/cder/drug/advisory/hydrocodone.htm

Overdoses of Cough and Cold Products in Children:
Roughly 7,000 children ages 11 and younger are treated in hospital emergency rooms each year because of overdoses of OTC cough and cold medication, according to a recent study by the Centers for Disease Control and Prevention. About two-thirds of those incidents occurred when children took medication without a parent's knowledge. Parents should keep medication out of children's reach and should never describe medication as "candy."

OTC cough and cold products can be harmful if more than the recommended amount is used, if they are given too often, or if more than one product containing the same active ingredient is used. In January 2008, FDA issued a public health advisory recommending that OTC cough and cold products not be used in infants and children under 2.

Serious injuries and deaths have resulted from such errors as misunderstanding directions and failing to use the measuring devices that come with the medicine. For more information, see OTC Cough and Cold Products: Not for Infants and Children Under 2 Years of Age. www.fda.gov/consumer/updates/coughcold011708.html

Overdoses of Acetaminophen:
Taking too much of the pain reliever acetaminophen can lead to serious liver damage. The drug is sold under brand names such as Tylenol and Datril, and is also available in many cough and cold products, prescription pain relievers, and sleep aids.

To avoid accidental overdosing, consumers should not take more than the recommended dose on the label. Also, acetaminophen should not be taken for more days than recommended, and should not be taken with other drug products that also contain acetaminophen without direction from a health care provider.

Parents should be cautious when giving acetaminophen to children. For example, the infant drop formula is three times more concentrated than the children's liquid. So parents need to be sure to give the appropriate dose.

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Misuse of Fentanyl Patches:
FDA has issued warnings about the fentanyl transdermal system, an adhesive patch that delivers an opioid called fentanyl through the skin. An opioid is a potent pain medicine. It is also sometimes called a narcotic drug. Other examples of opioids include hydrocodone, morphine, and oxycodone.

The directions on the product label and package insert of the fentanyl transdermal system should be followed exactly in order to avoid overdose. Fentanyl patches should not be used for short-term acute pain, pain that is not constant, or for pain after an operation. The patch is only for moderate-to-severe chronic pain that is expected to last for any number of weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.

Fentanyl patches are mostly prescribed for patients with cancer. Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant.

In other cases, patients have used the patch incorrectly. The patients replaced the patch more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch. All of these cases resulted in dangerously high fentanyl levels in the blood.

For more information, see FDA Issues Second Safety Warning on Fentanyl Skin Patch www.fda.gov/bbs/topics/NEWS/2007/NEW01762.html

FDA Public Health Advisory www.fda.gov/cder/drug/advisory/fentanyl_2007.htm

Overdoses with Methadone:
FDA has issued a public health advisory cautioning practitioners to avoid overdoses when they are prescribing methadone or managing patients taking the drug.

Since the 1970s, methadone has been primarily used in treating drug abuse, but it is increasingly being used to treat pain. FDA issued the advisory because of reports of life-threatening adverse events and death in patients receiving methadone for pain control. Like other opioids, methadone causes slowed breathing, affects heart rate, and can also interact with other drugs. An overdose can occur because methadone stays in the body longer than the pain relief lasts.

For more information, see FDA's Public Health Advisory on methadone www.fda.gov/cder/drug/advisory/methadone.htm

Mix-ups Between Edetate Disodium and Edetate Calcium Disodium:
Both edetate disodium and edetate calcium disodium work by binding with heavy metals or minerals in the body, allowing them to be passed out of the body through the urine. Edetate calcium disodium was approved to treat severe lead poisoning. Edetate disodium was approved as an emergency treatment for certain patients with very high levels of calcium in the blood or certain patients with heart rhythm problems resulting from high amounts of the medication digoxin in the blood.

But a number of uses that are not approved by FDA have emerged. These include the removal of other heavy metals from the blood and the treatment of heart disease, commonly referred to as "chelation therapies."

In January 2008, FDA issued a public health advisory, warning that some children and adults have died when they were mistakenly given edetate disodium instead of edetate calcium disodium (calcium disodium versenate), or when edetate disodium was used for chelation therapies and other uses not approved by FDA.

The drugs are easily mistaken for each other because they have very similar names and are both commonly referred to only as "EDTA." One of FDA's recommendations is that the abbreviation not be used.

For more information, see FDA's Public Health Advisory on Edetate Disodium (marketed as Endrate and generic products) www.fda.gov/cder/drug/advisory/edetate_disodium.htm

For More Information

6 Tips to Avoid Medication Mistakes
www.fda.gov/consumer/updates/medtips062107.html

Medication Errors (FDA)
www.fda.gov/cder/drug/MedErrors/default.htm

Reporting Adverse Experiences to FDA
www.fda.gov/medwatch/how.htm

Institute for Safe Medication Practices
www.ismp.org

U.S. Pharmacopeia
www.usp.org

tag: FDA Guidance, medication errors, Medication Error Prevention, Pharmacopeia, Safe Medication Practices, Tussionex Prescription Cough Medicine, Hydrocodone,

FDA Issues Recommendations And Draft Guidance on Medical Devices That Treat Blocked Heart Arteries, And Requests Public Comments.

FOR IMMEDIATE RELEASE March 26, 2008

Media Inquiries: Peper Long, 301-827-0599 Consumer Inquiries: 888-INFO-FDA

FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries

U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach today announced that the agency has issued draft guidelines to aid the development, testing and manufacture of coronary drug-eluting stents, devices used to treat blocked heart arteries.

Over the past few years, FDA and the clinical community have been closely monitoring these devices, including concerns over clot formation in some patients several years after implantation. The draft guidelines issued today—called an FDA guidance document—outline the agency's recommendations for pre-market clinical evaluation and post-market studies, which may provide data to better address this and other potential safety concerns.

Each year in the United States, approximately one million patients undergo procedures to treat coronary atherosclerosis, also known as hardening or blockages of the heart arteries, a condition that can cause angina and heart attacks.

Some 650,000 of these patients are treated with drug-eluting stents, a scaffolding device that is placed into the arteries to prop them open. Drug-eluting stents have a coating that slowly releases a drug to prevent the growth of scar tissue that may accumulate after the initial procedure opens the artery. Re-accumulation of scar tissue can mean additional procedures to keep arteries open and preserve adequate blood flow.

"This draft guidance is part of FDA's ongoing effort to provide regulated industry with recommendations on measures that can minimize the risks while preserving for patients the benefits of drug-eluting stents," said Daniel G. Schultz, M.D., director of FDA's Center for Devices and Radiological Health.

This draft guidance, announced in today's Federal Register, http://www.gpoaccess.gov/fr/index.html, discusses the development pathway for new drug-eluting stents and provides recommendations on information necessary for a complete marketing submission. It also provides guidance on assessing the toxicity of the drug used to coat the stent, both on its own and as part of the complete product. Because these stents combine device and drug technology, this guidance contains expertise and input from two agency centers—the Center for Devices and Radiological Health and the Center for Drug Evaluation and Research.

Also included are draft recommendations for engineering tests, biocompatibility tests, and animal studies to assess the device's overall safety.

"This guidance demonstrates how FDA will need to work across traditional product boundaries to guide the development of innovative new products," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

Currently, FDA has approved three coronary drug-eluting stents.

A copy of the guidance, "Draft Guidance for Industry on Developing Coronary Drug Eluting Stents," can be found at http://www.fda.gov/cdrh/ode/guidance/6255.html.

FDA is planning a public workshop on drug-eluting stents, in part as one means of soliciting comments on this guidance. The date, location and method for comment for this workshop will be announced in the Federal Register and on FDA's Web site, www.fda.gov.

FDA invites public comment on this draft guidance for 120 days from today's publication in the Federal Register.

Typed comments should include the docket number (CD6255), and be sent to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

tag: FDA Guidance, FDA Recommendations, coronary drug-eluting stents, engineering tests, biocompatibility tests, CDER, Blocked Heart Arteries, medical Devices