FDA Approves New Weight Loss Drug Qsymia
The FDA recently announced its approval of the weight-loss drug, Qsymia, manufactured by Vivus, Inc. The drug, originally submitted under the name Qnexa, was previously rejected by the FDA in 2010 citing safety concerns such as heart problems and birth defects. Vivus provided the FDA with additional safety data and is required to do a long-term follow-up study of the drug’s safety as conditions for the drug’s approval. The drug is a combination of two drugs: phentermine (an amphetamine and half of the now-recalled drug combo fen-phen) and topiramate (an anti-seizure medication currently marketed under the brand-name Topamax).
Qsymia’s approval marks the second FDA approval of a weight-loss drug this year. In June 2012, the FDA approved Belviq, manufactured by Arena Pharmaceuticals. Similar to Qsymia, Belviq is approved for obese people with at least one weight-related medical condition like high blood pressure, Type 2 diabetes, or high cholesterol. Belviq was also previously rejected by the FDA in 2010 because of its marginal effectiveness and concerns about heart problems and tumors that developed in laboratory animals who were given the drug. Arena pharmaceuticals is required to conduct several post-market studies including one assessing the long-term risk for cardiovascular problems.
Most people recall the controversy surrounding fen-phen, which was linked to serious heart and lung problems in the 90s, prompting its recall in 1997. Both Qsymia and Belviq cite potential side-effects of increased heart rate or heart palpitations, however, there is some concern that long-term use could lead to serious heart problems. Both manufacturers are required to do post-market data, however, the drugs are planned for release prior to those study results being completed.
Pharmaceutical drugs can improve quality of life for people who suffer from a variety of ailments. Consumers rely on the manufacturers who create these drugs to have patient safety in mind and conduct thorough testing before putting its products in pharmacies. Failure to perform careful testing of products can increase a patient’s risk for serious injury.
Our product liability attorneys are experienced in litigating cases against drug manufacturers who have failed to warn patients about the risk of serious injury associated with its products. If you or someone you know has been injured by a defective drug, contact us to talk with a personal injury/product liability lawyer about your legal rights and options.