Qnexa Approved by FDA Panel After Re-evaluation over Topamirate Side Effects

The weight loss pill Qnexa has won FDA approval after previously being denied in 2010 after it was discovered that one of the pill’s main ingredients, topamirate (Topamax), causes severe adverse side effects including birth defects.

Vivus Inc., the makers of Qnexa, is hoping to produce the first new weight loss medication to hit the American marketplace in a decade. However, that effort was almost derailed over the side effects linked to the new drug’s formula. Topamirate (also known by the brand name Topamax) is used as an epilepsy drug and has been proven to cause birth defects in babies born to mothers who take the drug while pregnant.

The FDA has rejected three different weight loss pills in the past two years and Qnexa was one of them. Weight loss drugs have been deemed too dangerous by the regulators. But when the FDA recently met on February 15, 2012, a panel of doctors voted on Qnexa’s future and they decided in a 20-2 vote to approve the drug. Qnexa faces similar side effect dangers as other weight loss pills in that it is known to cause patients to experience a raised heart rate and causes heart palpitations. This is not a new side effect as most previous weight loss medications do the same thing.

“The potential benefits of this medication seem to trump the side effects, but in truth, only time will tell,” said Dr. Kenneth Burman of the Washington Hospital Center.

The FDA can choose to ignore the panel’s advice, although regulators rarely do this. The end result is not to be released until the middle of April. If Qnexa is approved, lawsuits may start to arise once the side effects of the drug begin to occur — and with a main ingredient like topamirate (Topamax), such serious side effects will certainly come about.

Studies have shown that topamirate (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. 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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