Washington, D.C.The US Food and Drug Administration (FDA) has rejected two diet drugs seeking to fill a vacuum in the anti-obesity medication market after Meridia was pulled from the market in October, according to the San Francisco Chronicle.
The rejected drugs are lorcaserin, manufactured by San Diego drugmaker Arena, and Qnexa, made by Mountain View, California, pharmaceutical company Vivus. Lorcaserin was rejected by the FDA on October 22nd, with rejection of Qnexa occurring six days later.
A clinical study of lorcaserin found that diabetic patients who took the drug over the course of a year lost more weight than those taking a placebo but were also more likely to develop valvulopathy, a disorder affecting the valves of the heart. Earlier studies of the drug's effect on rats also raised concerns over a potential link between lorcaserin and cancer.
Qnexa was rejected due to concerns regarding its impact on pregnancy and potential to cause birth defects.
Only one new diet drug, manufactured by San Diego's Orexigen, remains before the FDA for approval. According to the source, no new diet drug has passed the agency's testing in more than a decade, in which time three other well-known medications—fen-phen, rimonabant and Meridia—have been recalled.
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