On behalf of Brown & Crouppen, P.C. posted in Defective Medications on Wednesday, February 29, 2012
A number of diet drugs have been rejected by federal regulators due to potentially dangerous side effects. But with the market of people looking to lose weight in the U.S. still tempting to drug makers, three medications that the Food and Drug Administration has previously turned down are being resubmitted. At least two of the medications will probably have to have a patient safety study conducted before they will be allowed to be sold.
The drug that may be the first approved by the FDA is called Qnexa. It is a combination of an amphetamine called phentermine that is already approved for use in short-term weight loss and topiramate, currently sold as an anti-convulsant under the name Topamax. The amphetamine is meant to reduce appetite, while topiramate is supposed to make users feel more “satisfied,” according to MSNBC.
The FDA first rejected Qnexa in October 2010 due to data suggesting the drug can cause birth defects and elevated heart rate. Vivus Inc., the drug’s developer, resubmitted it, and an FDA advisory panel voted to approve it if a follow-up study by the company shows no risk of heart problems.
Another drug, called lorcaserin, has been developed by Arena Pharmaceutical. The company says that lorcaserin affects user’s brain chemistry to trick them into believing they are full. But the FDA is being very cautious after studies found that lorcaserin caused an increase in tumors in lab rats. Arena has submitted new data on the link between the drug and tumors, and the FDA is scheduled to rule on approval by June 27.
Another combination diet drug, Contrave, contains an anti-smoking drug with an antidepressant. Like with Qnexa, the FDA is concerned about Contrave’s effects on the heart, given its manufacturer’s history of creating diet pills that caused heart problems. That is why the drug maker, Orexigen Therapeutics Inc., is being required to conduct a 10,000 patient study before the FDA will consider approving Contrave.
Source: MSNBC, “3 weight loss drugs make 2nd bid for approval,” Feb. 24, 2012