Concerns Raised Over New Weight Loss Drug

For the first time in more than a decade, the Food and Drug Administration (FDA) approved a new diet pill in a move that has raised the concerns of consumer advocacy groups and some physicians.

Consumer group Public Citizen urged the FDA not to approve Arena Pharmaceutical’s diet pill lorcaserin due to concerns that it may increase a patient’s risk of heart valve damage, according to Reuters. Although an FDA advisory panel voted to recommend approval of the drug, some of the panel’s doctors had voiced concerns about risk of valve damage.

Diet drug fen-phen was pulled from the market in 1997 over heart-valve damage as well as other serious medical issues such as PPH, a deadly lung disorder that can lead to heart failure.

Other companies also trying to gain approval for their diet drugs are Orexigen Therapeutics Inc. and Vivus Inc.

The same panel that voted in favor of lorcaserin also backed Vivus’ diet pill Qnexa. The FDA will review the company’s risk valuation plan before making its final decision next month on Qnexa, according to Reuters.

However, physicians still are pushing for weight loss counseling including the stand-bys of healthy diet and exercise for obese patients even as new weight-loss drugs move toward regulatory approval.

One expert panel recommended that doctors consider telling healthy adults willing to make changes in their lives to incorporate an exercise and diet regimen rather than turning to pills, according to the Boston Globe.

“One of the problems with drugs is that the clinical trials just show short-term outcomes,” said Dr. David Grossman, a Seattle pediatrician who led the US Preventive Services Task Force panel that issued the recommendations. He told the Globe: “Once a person stops taking the drug, we don’t know what happens with long-term weight gain.”

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you. For legal help, call (800) 581-6358.

Tags: