U.S. FDA approves Qnexa, now called Qsymia, in spite of side effects | DENENA | POINTS

Posted on Jul 18, 2012

The Houston drug injury lawyers at Denena & Points note that controversy has swirled around the diet drug Qsymia and its side effects, as well as its approval process, for months. We have written several articles regarding the products potential dangers and apparent gaps in the FDA safety assurance process for new drugs. One scientist on the FDA advisory panel that reviewed the diet drug recommended very strongly against its approval and continues to point out the drug’s potential dangers.

Interestingly enough, the FDA asked the drug’s maker Vivus to change the product’s name from Qnexa at the time it approved the drug. The FDA says it wants to avoid confusion with another product on the market.

In clinical trials, many patients taking Qsymia did experience weight loss, with patients reducing from an average of 227 pounds to an average of 204 pounds. But potentially dangerous side effects also manifested themselves. The side effects included an increased heart rate and a condition known as metabolic acidosis, which can lead to fatigue, hyperventilation, and anorexia.

One of the major concerns with Qsymia (formerly known as Qnexa) is its ingredient of topiramate. Topiramate is an anti-convulsant tied to birth defects like cleft lip and cleft palate in the babies of women who became pregnant while taking the drug for migraines or seizures. The risk of birth defects stands at about 5 in every 1,000 births. (Source: William Hudson and Elizabeth Cohen, CNN, 7/17/2012)

Our Houston drug injury lawyers point out that technically the FDA approved Qsymia only for overweight or obese patients having a body mass index of 27 or higher and who also have weight-related health risks like diabetes and hypertension. Nonetheless, physicians remain completely free to prescribe the drug to anyone now that it has been approved.

Despite the evident side effect risks of Qsymia, Vivus has allayed FDA concerns by proposing a risk management program designed to minimize the possibility of “pill mills” and massive over-prescribing of the drug such as occurred with the dangerous diet drug fen-phen in the 1990s.

Vivus was up front in acknowledging that the clinical trials for Qsymia (Qnexa) did not try to assess cardiovascular risks regarding the drug. The company says that a study on Qsymia’s cardiovascular risks, such as from elevated heart rate, will be conducted now that the drug has been approved.

Our Houston drug injury lawyers understand that there are many people who’d like to lose some weight. Many of us are willing to try almost anything to shed those stubborn pounds. But we urge you to think twice before rushing into your doctor’s office asking for a Qsymia prescription. Your safety and heart health could be at high risk. And if you’re a woman who becomes pregnant while taking the drug, your baby could be at risk.

If you receive an injury or experience negative side effects from a prescription drug, feel free to contact our experienced Houston drug injury lawyers for a case evaluation regarding the problem. Your initial case evaluation consultation is entirely free and could help you understand whether you’re eligible to claim just financial compensation from the drug’s manufacturer for your needless injury.

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