Topamax-Based Diet Pill’s Approval Delayed Pending Safety Plan

The FDA has decided that it will delay its decision on the new diet pill Qnexa, which contains the epileptic drug Topamax as its active ingredient. The final decision from the FDA was expected to take place this month; however, the regulators are now thinking that their final choice may not be made until July 17.

Qnexa was recently recommended for approval by an FDA panel despite the fact that one of its active ingredients is Topamax. The pill is also made up of phentermine, an amphetamine. Phentermine was once the “phen” part of the now banned “Fen-Phen” diet pill. Those pills were banned after it was discovered that they were causing patients to suffer from heart problems. The Topamax additive wasn’t helpful in getting Qnexa off the ground, either, as it is known to cause birth defects in babies whose mothers took the drug while pregnant. Some of those side effects caused by Topamax include oral clefts, neural tube defects and spina bifida. Additional side effects of taking Topamax included weight loss, which is why Qnexa added the drug to its active ingredients in the first place.

Qnexa was rejected the first time its makers sought FDA approval, but this February an FDA advisory panel voted 20-2 to approve the drug. The panel defended its position by stating that the drug’s ability to help patients lose weight and improve their overall health justified the risks involved in taking the drug. If the drug is approved, it will be the first new diet pill to be approved in 10 years. The new three-month delay from the FDA is common when the regulators are reviewing a risk management plan. One thing that the FDA may be looking for from Vivus, the makers of Qnexa, is proof that the phentermine in the pills won’t cause heart problems like they did in the Fen-Phen pills.

If your baby was born with any of these birth defects after being exposed to Topamax during gestation, contact Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your baby’s injuries.

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