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Dangerous Drug Warnings

FDA Recommends Against Use of Propoxyphene (Darvocet/Darvon)

November 19, 2010 - The FDA issued a Drug Safety Communication recommending against continued prescribing and use of the pain reliever propoxyphene (Darvocet & Darvon) because data shows that the drug can cause serious toxicity to the heart, even when used at therapeutic doses.  The FDA has requested that companies voluntarily withdraw propoxyphene from the U.S. market.  

Propoxyphene is a pain reliever used to treat mild to moderate pain.  FDA's new recommendation is based on a new study that looked at the effects increasing doses of propoxyphene have on the heart.  The study showed that propoxyphene caused significant changes to the electrical activity of the heart, even when taken in therapeutic doses.  The serious damage to the heart included prolonged PR interval, widened QRS complex and prolonged QT interval.  Based on the results of this study, the FDA determined that the health risks of propoxyphene outweighed its benefits.  Accordingly, the FDA recommended that healthcare professionals stop prescribing propoxyphene (Darvon & Darvocet) immediately; contact patients currently taking the drug and advising them to cease using it; and inform patients of the risks associated with propoxyphene.

FDA Recommends Against Continued Use of Meridia

October 8, 2010 - Today the FDA issued a Drug Safety Communication recommending against continued prescribing and use of Meridia, or sibutramine, because the cardiovascular risks outweigh the drug's benefits.  The FDA has requested that the manufacturer of Meridia, Abbott Laboratories, voluntarily withdraw this product from the United States market.

Approved by the FDA in November 1997 for weight loss and maintenance of weight loss in patients considered obese.  FDA's recommendation to pull the drug from the market follows the results of a new study, the SCOUT trial, which showed a 16% increase in risk of major adverse cardiovascular events including, non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and cardiovascular death in patients treated with Meridia compared to those taking a placebo.

The FDA recommends that doctors stop prescribing Meridia, contact patients currently taking Meridia and asking them to stop taking the medication and informing patients of the known risks associated with Meridia.

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