FDA to approve obesity drug with significant safety risks, scant benefits

Tuesday, March 27, 2012 by: Jonathan Benson, staff writer
Tags: FDA, obesity drugs, safety risks

(NaturalNews) After first denying approval for the obesity drug Qnexa (phentermine and topiramate) back in 2010 because of its harrowing side effects, the U.S. Food and Drug Administration (FDA) is now under intense pressure by Big Pharma-backed lawmakers, institutionalized drug pushers, and even its own advisory panel to approve the medication anyway. According to reports, taking Qnexa can cause some very serious heart problems and birth defects, and may not even provide any legitimate, long-term weight loss benefits -- and yet an FDA advisory panel recently voted 20 - 2 to approve the drug.

On July 15, 2010, an FDA advisory panel voted 10 - 6 to reject approval for VIVUS Inc.'s Qnexa concoction, which is a blend of appetite-suppressing amphetamines and an anti-convulsion medication, because the drug is linked to a significant uptick in depression symptoms, heart issues, memory problems, and birth defects. And later in the year on October 28, the FDA formally rejected approval for Qnexa based on these and other concerns (http://www.tesofensine-information.com/qnexa.html).

But nearly two years later, the FDA now appears poised to cave to industry pressures demanding approval of the drug, which is made from the some of the same chemical components used in the formerly-popular weight loss drug "Fen-Phen." The FDA pulled Fen-Phen from the market back in 1997 because of the billions of dollars worth of lawsuits filed by patients whose cardiovascular systems were destroyed as a result of taking it.

Anxious to take advantage of the billions of dollars in new revenues that are expected to result from the approval of Qnexa and potentially several other weight-loss drugs, the drug industry is chomping at the bit to convince the FDA to ignore the drug's side effects and approve it for use as soon as possible. And because Qnexa is made from two drugs that are already approved for use independent of one another -- phentermine and topiramate -- the agency may not even require further safety studies as a prerequisite for approval.

According to Reuters, a trial involving Qnexa allegedly showed a ten percent average weight reduction in patients after one year of taking the drug. But the same study found that after ceasing the medication, most patients regained the weight they had lost, while also acquiring new heart conditions and various other health problems (http://www.reuters.com).

The FDA is expected to make its final decision about Qnexa in April, which is expected to align with its advisory panel's recommendations. Should this occur, Qnexa is anticipated to be the next blockbuster drug, with annual sales raking in $1 to $3 billion.

Sources for this article include:

http://www.forbes.com

http://www.npr.org