Qnexa Endorsed by FDA, First Approved Weight Loss Pill in 13 Years

By Brittney R. Villalva, Christian Post Reporter Thursday, February 23, 2012

The Food and Drug Administration has approved a new prescription diet pill by reversing a decision that had previously banned the drug. Some remain skeptical about the negative aspects of the drug.

In 2010 the FDA had rejected Qnexa due to concerns over its connection with heart issues and birth defects. However, the most recent vote has overturned that decision making Qnexa the first new prescription diet pill in 13 years.

The vote was concluded with 20-2 in favor of the new drug, which is a combination of two other drugs that have long been FDA approved. Qnexa contains both phentermine and topiramate, which are considered appetite suppressants.

Qnexa was originally voted against due to a lack of data confirming the safety of the drug. Qnexa was linked to birth defects with women who took the drug while pregnant. New safety warnings will warn women who are pregnant to not take the drug. The drug will also be marketed to people who meet the government definition of obesity, which is equivalent to a BMI of 30 or greater.

New labels will also advise people who do not lose at least three percent of their body weight in three months to stop taking the drug. The drug has been linked to increasing the likelihood of birth defects, most specifically cleft lip and palate.

The drug has also been linked to increased heart rate, which could also lead to increased heart attack risk. The drug does however have other positive effects on certain heart health issues including weight loss, lower blood pressure, and good cholesterol.

Some remained skeptical about the drug's approval. "I remember the cases of the anti-arrhythmic drugs. They were supposed to save lives, but they ended up killing people," said Michael Lauer, MD, director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute.

Approval of Qnexa at this stage, he said, would be based on "hopes and suppositions." Lauer was one of two to vote against passing the drug.