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Heart Risks Major Cause of Recent Drug Recalls

Posted Sep 28 2010 10:04pm
It seems that the majority of drug recalls by the Food and Drug Administration (FDA) over the past 15 years have involved cardiac complications.   At least one-half of the 21 drugs pulled from the market in the U.S. for safety reasons since 1995 involved heart complications.   Some of the most notable examples of drug recalls and advisories in recent time have been Vioxx, Avandia and Meridia.

Vioxx was used to treat arthritis.   Merck recalled Vioxx after 5 years of marketing when a study suggested the drug doubled the risk of heart attacks after 18 months of treatment. An earlier study published in 2000 suggested the medicine posed heart risks and led to calls for further research into the drug’s side effects.

Avandia, at one time the world’s best-selling diabetes drug, was linked to a 43% higher risk of heart attacks in an analysis released in 2007, eight years after its approval. Glaxo, of London, said last week that it would stop promoting the drug as a result of new FDA restrictions and European regulators’ decision to withdraw the product completely.

Meridia, a 13-year-old diet pill, was tied to 16% more major cardiovascular complications in a 6 year study of 10,000 patients released this month. Abbott Park, Illinois-based Abbott no longer promotes the drug in the U.S.

This finding has resulted in calls from legislators and doctors for closer government review of side effects. FDA has used administrative and insurance claims databases to investigate safety questions about FDA regulated products.   For the most part, FDA has worked with one particular health care system at a time to evaluate a given safety issue.   FDA as set as it's goal creation of fully integrated, linked, sustainable system.   The conceptual system which FDA is striving for has been termed their "Sentinel System".   This ideal system will draw on existing automated health care data from multiple sources to actively monitor the safety of medical products continuously and in real-time.   FDA has implemented the Adverse Event Reporting System (AERS).   This system is a a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Clearly, on going data collection after approval of new medications is essential in order to fully understand the potential medium and long term side-effects which may occur with new drugs.   FDA is taking a step in the right direction in utilizing modern forms of data collection and inter-connectivity in order to properly monitor adverse medication effects.   It will be interesting to see how technology impacts these efforts by FDA.

Heart Risk Major Cause of Recent Drug Recalls -

Heart Risks Cause of Most Drug Recalls -

Recalled Drugs Tied to Heart Risk Spurs Call for FDA Review -

Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs -

FDA's Sentinel Initiative -

Guidance for Industry Diabetes Mellitus -Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes -

Adverse Event Reporting System (AERS) -

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