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New Diet Drug Rejected by FDA

By Editor, March 22, 2012

Another investigational weight loss pill was again rejected by the FDA to become the second diet drug rejected in the same week. The diet pill, Qnexa, was developed and manufactured by Vivus and was submitted to the FDA for approval following a number of clinical trials conducted by the company. People with weight problems shed off between 6 to 10 percent of their weight, according to the results from clinical trials. In fact, at a previous meeting of outside experts convened to vote on the drug, one of the panelists at the meeting appraised the drug being superior to every other weight-loss pill on the market. The panel eventually voted 10-6 against the drug.

The drug itself is a combination of two FDA approved drugs in low doses, which are phentamine and topiramate, an appetite suppressant and anti-seizure drug respectively. The makers of the drug argued that while each of these drugs is known to have its own set of health risks, the fact that they were combined in very low doses in the new drug reduced those risks considerably.

 

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The FDA cited the following health concerns as its reasons for rejecting Qnexa:

- Psychiatric concerns: Psychiatric adverse effects such as depression, anxiety and sleep disorders were witnessed in 21% of patients taking the drug.

- Cardiovascular concerns: Some of the drugs components, phentermine, have been associated with heart valve problems and while data from the clinical trials did not show the same exact problems, the fact that it increased heart rates in patients indicates it may have the same effects.

- Birth defects: The data provided by Vivus did not provide comprehensive information regarding birth defects resulting when expectant mothers consumed the drug. This was a concern since topiramate, a component of Qnexa, has been found to cause birth defects according to U.K studies. The rejection of the new diet loss drug as well as the withdrawal of Meridia, another obesity drug, from the market indicate just how risky a wrong choice of drugs can be for a person trying to lose weight through pills.

 

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