FDA Re-evaluates Qnexa over Topamirate Side Effects

Recently it was reported that the weight loss drug Qnexa was under fire after the pill’s main ingredient, topamirate (brand name Topamax) caused some serious adverse side effects. This news has caused the U.S. Food and Drug Administration to decide to take a new look at the drug’s side effects.

The side effects that have been linked to topamirate include birth defects to babies whose mothers take the pills while pregnant as well as heart complications. Even though topamirate has been proven to be an effective tool at losing weight, it is most commonly known as Topamax, which is an epilepsy drug. Research has proven that Topamax causes birth defects, though one of the drug’s other side effects is weight loss. This is why Qnexa was created as a weight loss drug with topamirate as one of its main ingredients.

While effective at reducing weight, the drug was originally refused when Vivus Inc. sought to get it on the market in 2010 because of the side effects that may come up. Now the FDA has scheduled a panel meeting to look at at least two years of information and weigh the risks-to-benefits ratio again since there are more data available now than there was before. That meeting took place on Wednesday February 15. Qnexa is formulated with phentermine, which is an appetite suppressant, and topamirate (Topamax). Phentermine was once a part of the notorious “fen-Phen” diet pills that were recalled years ago after patients started dying while taking the drug. Indeed, the dangers of topamirate have many experts worried about the future of Qnexa; still, not all believe that the FDA will spur the pills.

Dr. Louis Aronne, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center in New York City, is remaining optimistic (although cautious) that the FDA will approve Qnexa, but he does think that there will be some conditions that will apply. If Qnexa is approved, lawsuits may start to arise once the side effects of the drug begin to occur and it is expected that those side effects caused by topamirate (Topamax) will certainly come about.

Studies have shown that Topamax, when taken during pregnancy, can cause babies to be born with serious birth defects, including PPHN, cleft palate, neural tube defects and heart, lung and brain defects.

UPDATE: The FDA’s panel decision has since been reported and they overwhelmingly recommended Qnexa’s approval despite the drug’s links to birth defects. While the final FDA decision hasn’t been made yet, the recommendation is an astounding yes. The vote by the panel was 20-2.

If your baby was born with birth defects after being exposed to Topamax, contact Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to get you compensated for your baby’s injuries.

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