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Thursday, May 27, 2010

Baxter International Inc Recalls Hylenex recombinant (hyaluronidase human injection)

Baxter International Inc Hylenex recombinant (hyaluronidase human injection): Recall

Audience: Risk Manager, Emergency Medicine

[Posted 05/26/2010] Baxter International Inc. announced a voluntary recall of all manufactured lots of Hylenex recombinant (hyaluronidase human injection) has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing. To date, no medical events or customer complaints associated with this issue have been reported. As part of this stability testing for Hylenex recombinant, a limited number of vials were observed to contain small, flake-like particles, identified as glass. The company estimates that there are approximately 3,500 vials in the marketplace.
Baxter is working with the product's NDA-holder, Halozyme Therapeutics, to investigate the root cause of the issue and appropriately address the situation.

[05/17/2010- Firm Press Release1- Baxter International Inc.]
   

Tuesday, May 25, 2010

Label Change of Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen)

Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.
Audience: Pain management healthcare professionals
[Posted 05/25/2010] Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.
[April 2010 - Dear Healthcare Professional Letter1: Ultram - Ortho-McNeil-Janssen]
[April 2010 - Dear Healthcare Professional Letter2: Ultracet - Ortho-McNeil-Janssen]
    
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Proton Pump Inhibitors (PPI): Class Labeling Change1


Audience: Family Practice, consumers
[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the "Drug Facts" label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication.
[05/25/2010 - Drug Safety Communication1 - FDA]
[05/25/2010 - Possible Increased Risk of Bone Fractures With Certain Antacid Drugs2 - FDA Consumer Health Update]
    

Kanec USA Recalls Stud Capsule For Men Due To Undeclared Drug Ingredient

Audience: Consumers, Pharmacists
[Posted 04/06/2010] Kanec USA and FDA notified healthcare professionals of a nationwide recall of Stud Capsule For Men [Lot #060607-01/060108-01, Exp 6-2013], after being informed by FDA that laboratory analysis of a sample found the product to be adulterated with sildenafil, an FDA approved drug.
Use of this product may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
The products are sold as a blister pack containing one capsule per unit of use 24-packs in a Box. Lot number and expiration date appears on the seal. Consumers who have this recalled product in their possession should stop using them immediately.
[04/02/2010 - Press Release1 - Kanec USA]

Thursday, May 13, 2010

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease : Report By INSTITUTE OF MEDICINE.

In 2008, the Food and Drug Administration (FDA) assigned the INSTITUTE OF MEDICINE (IOM) to conduct a study on the evaluation process for biomark­ers, focusing on biomarkers and surrogate endpoints in chronic disease.
The FDA’s Center for Food Safety and Applied Nutrition initiated this study at a time when it was faced with hundreds of applications for review of food health claims based on stated effects on biomarkers.
In the report presented by the INSTITUTE OF MEDICINE, it recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process. The biomarker evaluation framework should consist of three steps:
Press Release and links for obtaining the complete report.

Date:  May 12, 2010
Contacts:  Christine Stencel, Senior Media Relations Officer
Alison Burnette, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail

for immediate release

IOM Report Recommends Framework to Evaluate Science Behind Health Claims for Foods and Drugs; Calls for Equal Rigor in Assessing Food Claims and Drug Approvals

WASHINGTON -- The U.S. Food and Drug Administration (FDA) should apply the same rigor to evaluating the science behind claims of foods' and nutritional supplements' health benefits as it devotes to assessing medication and medical technology approvals, says a new report from the Institute of Medicine.  There are no scientific grounds for using different standards of evidence when evaluating the health benefits of food ingredients and drugs given that both can have significant impacts on people's well-being, said the committee that wrote the report.  It recommended a new framework the agency can use to consistently and transparently judge the appropriateness and validity of the scientific benchmarks used in studies that companies provide to support health and safety claims for their products. 

Because it can be time-consuming and difficult to test products against actual clinical outcomes -- such as whether they cure or reduce the risk of a disease -- companies often conduct studies measuring effects on biomarkers, which are used as biological yardsticks or substitutes for clinical outcomes.  For example, tumor size is used as a way to measure a cancer drug's effectiveness.  Blood level of harmful cholesterol is often used as a biomarker for the risk of heart disease, and drug and food companies make claims about the heart health benefits of their products based on their ability to lower cholesterol levels, even if the products have not been shown to actually decrease heart disease. 

FDA has been hampered in its ability to assess the proliferation of health claims being made by food and supplement manufacturers in part because it lacks a process broadly accepted across the regulatory, food, and medical communities to evaluate biomarkers as valid and appropriate measurements to substitute for clinical outcomes.  The committee's proposed three-part framework gives the agency a way to consistently and rigorously assess the selection and use of biomarke rs across the food, device, and drug areas.    

In addition, the report calls on Congress to boost the agency's authority to require further studies of drugs and devices after they are approved if their approval is based on studies using biomarkers as surrogate clinical outcomes.  And Congress should give FDA the authority to conduct studies of how well consumers understand food and supplement health claims and require manufacturers to make changes if needed to promote greater clarity.

"Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medications, and this committee thinks that should in fact be the case," said committee chair John Ball, executive vice president, American Society for Clinical Pathology, Chicago.  "Without changes in the way biomarkers are used and assessed, however, health care providers, regulators, and consumers will not be able to reliably collect or judge information to support claims."

The proposed framework entails validating that a biomarker can be accurately measured, ensuring that it is associated with the clinical outcome of concern, and confirming that it is appropriate for the proposed use.  Committee members demonstrated the kinds of information and lessons the framework can provide by doing several case studies, looking at tumor size as a biomarker for cancer, blood level of beta-carotene as a surrogate for cancer and cardiovascular disease risk, and cholesterol level as an indicator of heart disease, among others.

The report calls for Congress to enhance FDA's abilities to study how health-related information can be communicated more effectively to consumers to help them better understand the science behind claims they see on packaging.  The typical consumer is not aware that claims for food ingredients and supplements are often made based on studies using biomarkers instead of actual health outcomes, and that this introduces a measure of uncertainty.

FDA also needs the resources and authority to act on claims when they are found to cause confusion or to exceed regulatory limits.  A report issued by Rep. Henry Waxman's office noted that FDA enforcement of food and supplement health claims declined by more than 50 percent from 2000 to 2005.  However, recent actions by the FDA indicate it is engaging in heightened enforcement of food labeling, including health claims.

The report was sponsored by the U.S. Food and Drug Administration.  Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public.  The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.  A committee roster follows.

Copies of Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu.  Reporters may obtain a copy from the Office of News and Public Information (contacts listed above). 

Saturday, May 08, 2010

Rivastigmine Transdermal Patch (EXELON* PATCH) Serious Adverse Events Related to Medication Errors/Misuse Including Death

Novartis Pharmaceuticals Canada Inc. ("Novartis"), in consultation with Health Canada, would like to inform you that serious adverse events including death, have occurred following rivastigmine overdose due to medication errors /misuse of EXELON* PATCH. Therefore, Novartis would like to remind you of the importance of the proper use and application of EXELON* PATCH (rivastigmine transdermal patch) and the need to instruct patients and caregivers on correct application techniques for the use of EXELON* PATCH1.


The EXELON* PATCH Product Monograph, including the Consumer Information section (Part III of the Product Monograph), is being revised to further emphasize the following safety information:
  • Healthcare providers should inform patients and caregivers on the proper use of rivastigmine patch prior to initiating therapy, and advise them to strictly follow instructions on patch usage;
  • Only one transdermal patch should be applied per day to healthy skin on one of the recommended locations: the upper or lower back, or upper arm or chest;
  • The previous day's patch must be removed before applying a new patch to a different skin location after 24 hours of use;
  • The patch should not be cut into pieces;
  • In case of overdose, all EXELON* transdermal patches should be immediately removed and the patient should be evaluated by a physician

Overdose with rivastigmine resulting from medication errors and misuse of EXELON* PATCH has been reported in the post-marketing setting. As of July 31, 2009, a total of 129 cases of medication errors/misuse, including 2 cases with fatal outcomes, have been reported with EXELON* PATCH worldwide. Three Canadian cases of medication errors/misuse have been associated with EXELON* PATCH up to February 28, 2010. The most frequently reported causes of overdose are failure to remove the patch before applying a new patch and application of more than one patch at the same time. Healthcare professionals, caregivers, or the patients themselves have been involved in these errors.
The typical symptoms reported in association with overdose include nausea, vomiting, diarrhea, hypertension, hallucinations, salivation, sweating, respiratory depression and convulsions. Bradycardia and/or syncope may also occur. As with medication errors and misuse in general, serious medical outcomes, possibly including death, may occur if the medication errors and misuse are not corrected in a timely manner and properly managed. In case of overdose, all EXELON* transdermal patches should be immediately removed and no further patch should be applied for the next 24 hours.
Please refer to the Overdosage section of the Canadian Product Monograph for EXELON* PATCH for additional details concerning the proper management of rivastigmine overdose.

Wednesday, May 05, 2010

FDA Finds Dust And Contaminated Ingredients at Johnson & Johnson Plant, Where Recalled Childrens Medications Were Made.

 "Consumers should not use these products," Deborah Autor, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research told reporters in a conference call, even though the chance of getting sick from the recalled products (Johnson And Johnson Recalls Infant Tylenol, Mocrin And Zyrtec Medications) was "remote."A Food and Drug Administration report released on Tuesday said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled last Friday.
Inspectors also found raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30.
The findings were a further blow to J&J's reputation, as the FDA later on Tuesday urged parents to choose private label alternatives for the over-the-counter medications and said it was weighing possible further regulatory action.

Via Reuters.

Using Bar-Code Technology With eMAR Reduces Medication Administration and Transcription Errors, Agency for Healthcare Research and Quality.

ROCKVILLE, Md., May 5 /PRNewswire-USNewswire/ -- Using bar-code technology with an electronic medication administration record (eMAR) substantially reduces transcription and medication administration errors, as well as potential drug-related adverse events, says a new study funded by HHS' Agency for Healthcare Research and Quality. The study is published in the May 6 issue of the New England Journal of Medicine.
Bar-code eMAR is a combination of technologies that ensures that the correct medication is administered in the correct dose at the correct time to the correct patient.  When nurses use this combination of technologies, medication orders appear electronically in a patient's chart after pharmacist approval.  Alerts are sent to nurses electronically if a patient's medication is overdue.  Before administering medication, nurses are required to scan the bar codes on the patient's wristband and then on the medication.  If the two don't match the approved medication order, or it is not time for the patient's next dose, a warning is issued.
Researchers at Brigham and Women's Hospital in Boston compared 6,723 medication administrations on hospital units before bar-code eMAR was introduced with 7,318 medication administrations after bar-code eMAR was introduced. Having bar-code eMAR technologies in place was associated with reductions in errors related to the timing of medications, such as giving a medicine at the wrong time, and non-timing medication administration, such as giving a patient the wrong dose.
The researchers documented a 41 percent reduction in non-timing administration errors and a 51 percent reduction in potential drug-related adverse events associated with this type of error.  Errors in the timing of medication administration, meaning a patient was given medication an hour or more off schedule, fell by 27 percent.  No transcription errors or potential drug-related adverse events related to this type of error occurred.
"Medication errors in hospitals are a very serious issue and can often lead to patient harm," said AHRQ Director Carolyn M. Clancy, M.D.  "The good news from this study is that using bar-code technology and an electronic medication administration record together can be an important intervention to help achieve medication safety."
The findings have important implications because bar-code eMAR technology is being considered as a 2013 criterion for meaningful use of health information technology under the American Recovery and Reinvestment Act of 2009.
"Our study shows that this combination of technologies can make the delivery of hospital care safer. However, hospitals need the right set of resources and human talent to deploy these technologies successfully, so more research is needed to identify ways to implement them in the most cost-effective way," said lead study author Eric G. Poon, M.D., M.P.H., of Brigham and Women's Hospital.
Editor's Note: AHRQ's health information technology initiative is part of the nation's strategy to use health IT to improve health care.  Since 2004, AHRQ has invested more than $300 million in contracts and grants to more than 150 communities, hospitals, providers, and health care systems in 48 states to develop knowledge about and encourage the adoption of health IT practices that improve quality and safety.
SOURCE Agency for Healthcare Research & Quality

Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients

Audience: Substance Abuse healthcare providers, patients
[Posted 05/04/2010] Alkermes and FDA notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009.
FDA requires that a Medication Guide, which communicates this and other important information about treatment be provided to all patients. Healthcare professionals should also counsel patients about the risks and benefits of Vivitrol before an initial prescription, including those risks and benefits set forth in the new Medication Guide and Prescribing Information, and should ensure that patients understand these risks.
[05/04/2010 - Dear Healthcare Professional Letter1 - Alkermes]
[03/2010 - Prescribing Information2 - Alkermes]
[12/2009 - Medication Guide3 - Alkermes]
    

Vita Breath Dietary Supplement, Do Not Consume, FDA Advisory

Vita Breath Dietary Supplement, Do Not Consume, FDA Advisory
Audience: Consumers, healthcare professionals
[Posted 05/03/2010] FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.
People with high blood levels of lead may show no symptoms, but the condition may cause damage to the nervous system and internal organs. Acute lead poisoning may cause a wide range of symptoms, including abdominal pain, muscle weakness, nausea, vomiting, diarrhea, weight loss, and bloody or decreased urinary output. Children are particularly vulnerable to lead poisoning.
The FDA is working with state officials in New York and California to further investigate Vita Breath. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Online: www.fda.gov/MedWatch/report.htm1
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms2" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178
[05/01/2010 - News Release3 - FDA]

Orlando Greco & Son Imports Recalls Prosciutto Products Due To Listeria monocytogenes,

Recall Release CLASS I RECALL
FSIS-RC-028-2010 HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
Adrian Gianforti

WASHINGTON, May 4, 2010 - Orlando Greco & Son Imports, a Carol Stream, Ill., establishment, is recalling approximately 822 pounds of prosciutto products that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today.

The problem was discovered by FSIS microbiological testing of imported product resulting in a positive sample for Listeria monocytogenes. FSIS was notified by the Canadian Food Inspection Agency that the implicated product was also distributed to an Importer of Record and further distributed, thus resulting in this recall. FSIS has received no reports of illness as a result of consuming this product.

The following products are subject to recall
  • Various pound cases of "Prosciutto Boneless Casa Italia"

The products were distributed to restaurants and retailers in Illinois and Indiana.

Consumers and media with questions about the recall should contact company Office Manager, Maria Spano, at (708) 436-0070.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. If available, the retail distribution list(s) will be posted on the FSIS Web site at http://www.fsis.usda.gov/FSIS_Recalls/ Open_Federal_Cases/index.asp.
Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, an uncommon but potentially fatal disease. Healthy people rarely contract listeriosis. However, listeriosis can cause high fever, severe headache, neck stiffness and nausea. Listeriosis can also cause miscarriages and stillbirths, as well as serious and sometimes fatal infections in those with weakened immune systems, such as infants, the elderly and persons with HIV infection or undergoing chemotherapy.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Tuesday, May 04, 2010

Flat Feet And The High Cost Of The Arch Correction.


I have a friend who is flat footed and I used to joke around him, until today when I read a post on New York Times. "My Left Foot: The High Costs of Fallen Arches" by Gbenga Akinnagbe, (an actor, appears in a one-man play, “The Thin Place,” at the Intiman Theater in Seattle, and the movie “Lottery Ticket,” opening in August.)
The man has lived with flat feet or pes planus for 31 years and had to correct the defect one foot at a time. He has done the left foot and awaiting the right time for the right foot. The story is not easy to listen to and he healed fast because he was young and a non smoker / non drinker.
But it look like flat feet is no laughing matter, if you or a loved one has it, better ask about it from you Doctor, before the pain hits. I alread called and forwarded the article to my friend.

FDA Orders Baxter Healthcare Corp. To Recall & Destroy All Colleague Volumetric Infusion Pumps (Colleague pumps)

The U.S. Food and Drug Administration sent a letter to Baxter Healthcare Corp. on April 30 ordering the company to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use in the United States. This action is based on a longstanding failure to correct many serious problems with the pumps. The FDA believes there may be as many as 200,000 of those pumps currently in use.

Additionally, the FDA is ordering the company to provide refunds to customers or replace pumps at no cost to customers help defray the cost of replacement.

Infusion pumps are devices that deliver fluids, including nutrients and medications, into a patient’s body in a controlled manner. They are widely used in hospitals, other clinical settings and, increasingly, in the home because they allow a greater level of accuracy in fluid delivery.

Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.

The FDA has been working with Baxter since 1999 to correct numerous device flaws. Since then, Colleague pumps have been the subject of several Class I recalls for battery swelling, inadvertent power off, service data errors, and other issues.
In June 2006, the FDA was obtained a consent decree of permanent injunction in which Baxter agreed to stop manufacturing and distributing all models of the Colleague pump until the company corrected manufacturing deficiencies and until devices in use were brought into compliance. Since then, Baxter has made numerous changes to the Colleague pumps but these changes have not corrected the product defect leading to the permanent injunction.

On April 8, 2010, Baxter submitted a proposed correction schedule to the FDA that stated that Baxter did not plan to begin the latest round of corrections to the adulterated and misbranded pumps until May 2012. The proposal also stated that Baxter does not anticipate completion of the proposed corrections until 2013. On that schedule, a device with known safety concerns would remain in use on patients needing specialized care until 2013. FDA found this proposal unacceptable. The 2006 consent decree gave FDA authority to take any action it deemed appropriate. The FDA has determined that this action is necessary, as Baxter has failed to adequately correct, within a reasonable timeframe, the deficiencies in the Colleague infusion pumps still in use.

Therefore the FDA is now ordering Baxter to:

  • Recall and destroy all Colleague infusion pumps.
  • Reimburse customers for the value of the recalled device
  • Assist in finding a replacement for these customers.

Infusion pumps, including the Baxter Colleague models, have been the source of persistent safety problems. In the past five years, the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps. Those events have included serious injuries and more than 500 deaths. Between 2005 and 2009, 87 infusion pump recalls were conducted to address identified safety concerns, according to FDA data.

An FDA analysis of these adverse events has uncovered software defects, user interface problems and mechanical and electrical failures. Problems with infusion pumps are not confined to one manufacturer or one type of device.
In response, last month the FDA announced a new initiative to address safety problems associated with infusion pumps. As part of its initiative, the FDA is moving to establish additional premarket requirements manufacturers will be expected to meet, in part through static testing in FDA’s facilities before device submissions. The FDA is also holding a May public workshop on infusion pump design, and the agency is raising public awareness of the issue among health care workers and patients.

FDA NEWS RELEASE

For Immediate Release: May 3, 2010
Media Inquiries: Dick Thompson, 240-753-3049, dick.thompson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Johnson And Johnson Recalls Infant Tylenol, Mocrin And Zyrtec Medications

Johnson And Johnson Recall, Infant Tylenol Recall, Mocrin Recall, Zyrtec Recall,

Even though we posted this recall of Infant Tylenol, Mocrin And Zyrtec Medications five days ago, we would like to repost the matter as it is related to infant health in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

Please read carefully and follow the instructions to safeguard yourselves. Click here to request a refund or high value coupon.

Johnson & Johnson's McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also atwww.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

###

CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS' TYLENOL® AND CHILDREN'S TYLENOL® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS' MOTRIN® AND CHILDREN'S MOTRIN® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN'S ZYRTEC® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN'S BENADRYL® PRODUCTS

CLICK HERE FOR INFORMATION ON ALL RECALLED PRODUCTS FROM APRIL 30, 2010

Saturday, May 01, 2010

Implantable Diagnostic Device For Noninvasive Repeat Cancer Monitoring.

 Photograph of sensing devices filled with a solution. The polydimethylsiloxane (PDMS) substrate contains reservoirs which are covered by a semi-permeable polycarbonate (10nm pore) membrane. The membrane will allow analyte to diffuse into the reservoir and induce nanoparticles aggregation, which is measured by MRI.
Continuous Monitoring Of Cancer With Implantable Diagnostic Device
Rapid monitoring of chemotherapy delivery and tumor growth would provide clinicians with a valuable tool for personalized medicine says Michael J. Cima, Ph.D., who has developed this implantable device . The advent of nanotechnology affords such a tool. Drs. Michael Cima and Robert Langer have designed an implantable microfluidic device which can determine the local concentrations of various substances. This device could be utilized for real time and noninvasive repeat monitoring for cancer. For instance, this device could survey the amounts of chemotherapy which has reached the tumor following systemic administration of drug.

These microfluidic devices are composed of silicone and contain nanoparticles composed of dextran-coated iron oxide. These groups have shown that the silicone casing acts as a protective barrier for the nanoparticles. Moreover, the device can be implanted into a tumor and used for implanted magnetic sensing. For this technique, antibodies to any cancer biomarker are then attached to the surface of the nanoparticles. Clumping occurs when the target molecule is present, and magnetic resonance imaging is utilized to detect the clumping. This will allow researchers to observe the tumor directly over time. The design facilitates molecules smaller than 10 nm to enter the device; however, the nanoparticles are trapped by a porous membrane. This device boasts several advantages in that it can simultaneously measure several biomarkers and evaluate the amount of chemotherapy. The device can also determine if the tumor is shrinking or if has spread to new locations
A paper “Implantable diagnostic device for cancer monitoring,” was supported by the NCI Alliance for Nanotechnology in Cancer, an initiative designed to accelerate the application of nanotechnology to the prevention, diagnosis, and treatment of cancer. An abstract is available at the Science Direct.

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