Articles Tagged with FDA

The New York Times reports that Topamax, manufactured by Johnson & Johnson, has been linked to birth defects, such as a higher risk of developing cleft lips and palates, genital malformations and cranial malformations.

Topamax is an anti-seizure and migraine drug used in the treatment of migraines and epilepsy. It is also used in the weight-loss drug Qnexa.

Infants exposed to the dangerous drug during their mother’s first trimester of pregnancy had a 3 times higher rate of mouth defects than those whose mothers took other seizure medications.

If you or a loved one has been harmed by taking Topamax, contact an experienced New Mexico Topamax attorney to discuss your options.

The FDA notes “doctors should think carefully before prescribing the drug to women of childbearing age and ‘alternative medications that have a lower risk of birth defects should be considered.'”
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The U.S. Supreme Court has agreed to hear argument over whether generic drug makers can be sued for the failure to warn about dangerous side effects on their drug label even when they follow federal rules.

In PLIVA, Inc. v. Mensing a woman took metoclopramide – the generic equivalent of Reglan – for four years to fight diabetic gastroparesis. She claims that the drug caused a severe neurological movement disorder – tardive dyskinesia – not warned about by the drug’s manufacturers and distributors.

The 8th U.S. Circuit Court of Appeals found in favor of the woman, noting that more should have been done to warn consumers about possible risks. The court reasoned, “If they realized their label was insufficient but did not believe they could propose a label change, they could have simply stopped selling the product. Instead they …placed a drug with inadequate labeling on the market and profited from its sale.”

The FDA has now required Reglan to add warnings about tardive dyskinesia in February 2009.

The Supreme Court will hear argument in the spring.
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Last week, the FDA finally pulled propoxyphene – sold as Darvon and Darvocet – from the U.S. market. For nearly 50 years concerns have been raised over the side effects of Darvon/Darvocet usage, including its toxicity even at low levels and its highly addictive properties. Additionally, it has not been shown to be very effective as a painkiller – its intended use.

According to reports, its toxicity and risk of causing abnormal heart rhythms have caused thousands of deaths in patients who took these medications.

As recently reported, the FDA now concludes, even the recommended dose caused “significant changes to the electrical activity of the heart” which can “increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death.”

Although last week’s FDA actions in removing the drug, as well as its generic equivalents, is a positive step, it comes several decades too late, after thousands of consumers may have died as a result.
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