MEDDESKTOP

Monday, May 19, 2008

Recallr: Medicis Recalls Solodyn® (minocycline HCL, USP) 90 Mg Tablets

Medicis today announced that the Company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30).
Recallr: Medicis Recalls Solodyn® (minocycline HCL, USP) 90 Mg Tablets
FDA Recall, Drug Recall, Medicis Recalls, Solodyn Recall, AAIPharma, AZASAN

"MORREALE MEAT", Beef Recall: JSM Meat Holdings Company Recalls Beef Products.

Another beef recall! Due to E. coli O157:H7 contamination.
Recallr: Beef Recall: JSM Meat Holdings Company Recalls "MORREALE MEAT" An Undetermined Amount Of Beef Products.

Tags: USDA Recall, FSIS Recall, Beef Recall, JSM Meat Holdings Company Recall, E. coli O157:H7, MORREALE MEAT

Get Jump On Your Blog Traffic With Entrecard.

Warning, this post may not help with your health but your blogs health if you are a blogger. One can have all the good information on a blog but it is of no use if people do not see read them. That is the exact reason we joined Entrecard, to attract mo readers, to increase trafic.
If you are a regular visitor to our blog, you have seen the Entrecard widget advertising that we have selected from thousands of other blogs in Entrecard system who wished to advertise on out blog.
But I did not get paid for those ads in money. I got paid in Entrecard credits that I could use to advertise in other blogs I see fit. Another factor is the widget itself is a visiting card. If you happen to visit a Entrecard enabled site, you can drop your card and you will be paid points for that as well.
But why I am today is to let you know that Entrecard is going places and has upgraded the system.
Now all Entrecard members could add more than one blog. You can add all your blogs to Entrecard simply by going to your Dashboard and clicking "Linked Blogs" in your Dashboard navigation. You will be able to choose whether to link your account with another EXISTING account, or to register a NEW BLOG with Entrecard, and automatically link it to your account. You will find all the information about this on this blog post about new features.

The other best thing is the Entrecard Ebook, this ebook will guide you along the way from beginner to expert, to make the best use of Entrecard to increase the traffic to your blog.

Thursday, May 15, 2008

Trasylol and the Publication of the BART Study, Health Canada Comments

In USA,Bayer HealthCare Pharmaceuticals Inc. Removes Remaining Stocks of Trasylol From US Market

OTTAWA - In light of the May 14, 2008 publication in the New England Journal of Medicine of the BART study on the use of Trasylol (the brand name for aprotinin) during high-risk cardiac surgery, Health Canada would like to update Canadians on the status of Trasylol in Canada.

Trasylol is authorized for use during coronary artery bypass grafting (CABG) surgery to help reduce bleeding and the need for blood transfusions. The BART clinical trial included use of Trasylol during higher-risk cardiac surgeries for which Trasylol has not been authorized in Canada. The trial was stopped in October 2007 due to an increased number of patient deaths in the Trasylol group.

On November 5, 2007, Health Canada asked Bayer Inc., the manufacturer of Trasylol, to suspend the marketing of the product in Canada. No other product is authorized in Canada for a similar use. A limited access program was put in place by Bayer, in consultation with Health Canada, to make Trasylol available to physicians who conclude that the benefits outweigh the risks for patients undergoing CABG surgery. The use of Trasylol has significantly declined and no adverse events from this limited access program have been reported to Health Canada since the program was initiated. This program will remain in effect until Health Canada's ongoing safety review is completed.

Health Canada continues to review available safety information on Trasylol and will include the findings of the BART study as part of the review. The Department will convey new safety information to Canadians and health care professionals as necessary.

Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709

Information And Safety Issues On Asthma Medications,

Click On The Image To Down Load Printable PDF Version Of the Document

Asthma is a chronic, life-threatening disease that causes the airways to become inflamed or swollen. When people with asthma react to various triggers, such as upper respiratory infections, dust, pollen, or smoke, their airways become narrow. This can cause difficulty breathing, wheezing, chest tightness, or coughing. The two main types of asthma drugs are quick-relief medications that immediately treat sudden symptoms and long-term control medications that are taken regularly to prevent symptoms.

Here is a Food and Drug Administration (FDA) update on recent safety issues with asthma medications.

Incorrect use of Foradil Aerolizer

In February 2008, FDA issued a Public Health Advisory to highlight the correct use of Foradil capsules. Foradil Aerolizer (formoterol fumarate inhalation powder) is approved to prevent wheezing and breathing problems caused by asthma and chronic obstructive pulmonary disease (COPD).

The medication in Foradil capsules is specifically designed to be inhaled through the Foradil Aerolizer inhalation device to deliver the medicine to the lungs. FDA and the American Association of Poison Control Center's National Poison Data System have received reports of people swallowing the capsules rather than placing them in the inhalation device.

Few patients have experienced side effects from swallowing the capsules. But the medication won't work if the capsules are swallowed rather than inhaled. FDA's Public Health Advisory on Foradil also addresses similar incorrect use of Spiriva HandiHaler (tiotropium) capsules, which is approved by FDA to treat COPD.

Advice for patients …
Patients should not swallow the Foradil or Spiriva capsules as the capsules are only to be used with the inhalation device provided with the product. Patients should follow the instructions in the patient information leaflet provided with the product.

The Public Health Advisory: Important Information on the Correct Use of Spiriva and Foradil Capsules, may be found at: www.fda.gov/cder/drug/advisory/tiopropium_formoterol.htm

Suicidality and Behavior/Mood Changes with Singulair

Singulair (montelukast sodium) is approved to treat asthma and symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of nose), and to prevent exercise-induced asthma. Singulair is part of a class of "anti-leukotriene" drugs. These drugs act by blocking the activity of leukotrienes, chemicals that are involved in airway inflammation.

In the past year, Merck & Company, Inc. has updated the patient information for Singulair to include these postmarketing adverse events: tremor, depression, suicidal thinking and behavior (including suicide), and anxiousness.

In March 2008, FDA issued an early communication about an ongoing safety review of Singulair. The agency is investigating a possible association between the use of Singulair and behavior/mood changes, suicidal thinking and behavior, and suicide.

Early communications are in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. An early communication does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue. It means that FDA is considering the information but has not yet reached a conclusion.

FDA is working with Merck to perform a complex analysis of Singulair data and will communicate the conclusions and recommendations to the public. The agency is also reviewing postmarketing reports it has received of behavior/mood changes, suicidal thinking, and suicide in patients who have taken Singulair as well as other leukotriene modifying medications, such as Accolate (zafirlukast) and Zyflo (zileuton) and Zyflo CR.

Advice for patients …
Patients should not stop taking these medications before talking to their health care professional about this information. FDA urges patients to report side effects from use of these medications to FDA's MedWatch Adverse Event Reporting Program at: http://www.fda.gov/medwatch/report/consumer/consumer.htm

The Early Communication About an Ongoing Safety Review of Montelukast (Singulair) may be found at: www.fda.gov/cder/drug/early_comm/montelukast.htm

Safety of Long-Acting Beta Agonists (LABAs)

Bronchodilators are medications that help open up the breathing tubes, but they do not treat the underlying inflammation of asthma. Short-acting bronchodilators are quick-relief medications used for treatment of asthma symptoms. One example is Albuterol. Long-acting beta2 adrenergic agonists (LABAs) are bronchodilators used to provide long-term control of asthma. Examples of medications that contain LABAs and that are approved for use in asthma patients include Advair Diskus (fluticasone propionate; salmeterol xinafoate), Symbicort (budesonide; formoterol fumarate dihydrate), Serevent Diskus (salmeterol xinafoate), and Foradil.

In 2005, FDA issued a Public Health Advisory that alerted health care professionals and patients that LABA medicines may increase the chance of severe asthma episodes and death when the episodes occur. In this advisory, FDA highlighted several recommendations about LABA drugs. For example, LABAs should not be the first medicine used to treat asthma.

In 2006, the manufacturers of Advair Diskus, Foradil Aerolizer, and Serevent Diskus updated product labels with these warnings. Since that time, several additional products containing LABAs have been approved, including Symbicort, Perforomist (formoterol fumarate), and Brovana (arformoterol tartrate). The labels for these products contain similar warnings regarding severe asthma episodes and death.

At a November 2007 Pediatric Advisory Committee meeting, FDA raised concerns about the safety of LABAs in children with asthma. In January 2008, FDA requested manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution, Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and Symbicort Inhalation Aerosol to provide information regarding controlled clinical studies conducted with these products to further evaluate their safety. Following the analysis of this data, FDA plans to discuss the benefit and risk of LABAs at a public advisory committee meeting later this year.

Advice for patients …
Patients should understand the risks of LABAs and talk with their health care professional about their concerns.

The FDA Public Health Advisory: Advair Diskus, Advair HFA, Brovana, Foradil, Perforomist, Serevent Diskus, and Symbicort Information, may be found at: www.fda.gov/cder/drug/infopage/LABA/default.htm

Anaphylaxis and Xolair

Xolair (omalizumab) is approved for treating moderate to severe persistent asthma related to allergies in patients whose symptoms are not controlled with inhaled corticosteroids. In February 2007, FDA requested that Genentech add a boxed warning to the Xolair product label. The boxed warning emphasizes that Xolair may cause anaphylaxis, an allergic reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.

Advice for patients …
It's important to know that patients may develop this reaction after any dose of Xolair, even if there was no reaction to the first dose. Also, anaphylaxis after administration of Xolair may be delayed up to 24 hours or more after the dose is given.

Patients who take Xolair should know the symptoms of anaphylaxis, and should also know how to initiate emergency self-treatment.

The FDA Health Care Professional Alert: Stronger Warning Proposed for Xolair, may be found at: www.fda.gov/cder/drug/infopage/omalizumab/default.htm

7 Ways to Prevent Foodborne Illness, Start At The Store.

Click On The Image To Down Load The PDF Version (printable book) Of This Circular.

Safeguarding your home against foodborne illnesses begins not at home, but at the supermarket, grocery store, or any other place where you buy food that you plan to store and serve.

Combating foodborne illnesses is a top priority at the Food and Drug Administration (FDA). That's because, according to the Centers for Disease Control and Prevention (CDC), foodborne ailments cause about 325,000 hospitalizations and 5,200 deaths nationwide each year.

You as a consumer can play a key role in preventing these illnesses. While shopping for food, you should:

1. Check for cleanliness.

Buying from a retailer who follows proper food handling practices helps assure that the food is safe. Ask yourself: What is the general impression of this facility? Does it look and smell clean?

2. Keep certain foods separated.

Separate raw meat, poultry, and seafood from other foods in your grocery shopping cart. Place these foods in plastic bags to prevent their juices from dripping on other foods. It is also best to separate these foods from other foods at checkout and in your grocery bags.

3. Inspect cans and jars.

Don't buy food in cans that are bulging or dented. Also, don't buy food in jars that are cracked or have loose or bulging lids.

Since foods sold in cans or jars are processed to be sterile, they can "keep" for a long time if the can or jar is intact. A bulging can or jar lid may mean the food was under-processed and is contaminated. A dent in a can, especially if the dent affects a seam, may cause an opening in the seam which may allow contamination, as would a crack in a jar. A loose lid on a jar means the vacuum has been lost and the product may be contaminated. Don't buy a food product whose seal seems tampered with or damaged.

4. Inspect frozen food packaging.

Don't buy frozen food if the package is damaged. Packages should not be open, torn or crushed on the edges. Also, avoid packages that are above the frost line in the store's freezer. If the package cover is transparent, look for signs of frost or ice crystals. This could mean that the food in the package has either been stored for a long time or thawed and refrozen. In such cases, choose another package.

5. Select frozen foods and perishables last.

Meat, poultry, fish and eggs should be the last items placed in your shopping cart. Always put these products in separate plastic bags so that drippings don't contaminate other foods.

6. Choose fresh eggs carefully.

Before putting eggs in your cart, open the carton and make sure that the eggs are clean and none is cracked. Buy only refrigerated eggs and follow the "Safe Handling Instructions" on the carton.

7. Be mindful of time and temperature.

It's important to refrigerate perishable products as soon as possible after grocery shopping. Food safety experts stress the "2-hour rule"—because harmful bacteria can multiply in the "danger zone" (between 40° and 140° F), perishable foods should not be left at room temperature longer than 2 hours. Modify that rule to 1 hour when temperatures are above 90° F, as they often are in cars that have been parked in the sun.

If it will take more than an hour to get your groceries home, use an ice chest to keep frozen and perishable foods cold. Also, when the weather is warm and you are using your car's air conditioner, keep your groceries in the passenger compartment, not the trunk.

Bayer HealthCare Pharmaceuticals Inc. Removes Trasylol From US Market

On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.

Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.

Recallr: Bayer HealthCare Pharmaceuticals Inc. Removes Remaining Stocks of Trasylol From US Market

Tags: FDA Recall, Drug Recall, Trasylol recall, Trasylol marketing suspension, Bayer Recall , Trasylol, FDA, Antifibrinolytic drugs, Bayer Pharmaceuticals Corp