February 20, 2012
Diet pill manufacturer Vivus Inc. is preparing to make a second attempt to persuade the Food and Drug Administration (FDA) to approve one of their products later this week. According to reports from KATV 7 News, FDA officials still have concerns over the safety of the weight-loss medication the company is seeking approval for.
In October 2010, the FDA rejected the company’s proposal for approval of the diet pill Qnexa, saying they needed more information regarding the drug’s safety. Among the risks the FDA was concerned with were potential heart problems and birth defects in the children of women who became pregnant while taking the drug.
Qnexa is a combination of two other drugs that have a long history of complications and abuse potential. One of the main active ingredients in the drug is phentermine, a stimulant that acts as an appetite suppressant and was part of the dangerous fen-phen weight loss combination associated with serious heart complications.
On Wednesday, Vivus will resubmit their proposal by offering to conduct a follow-up study to monitor patients for heart problems after short-term use of the drug.
The Arkansas Drug Injury Lawyers with Rainwater, Holt & Sexton would like to remind you to discuss the risks of taking a medication with your doctor and pharmacist before starting a drug regimen. If you feel it may be unsafe to take a drug, do not hesitate to seek a second opinion from another qualified physician.