Product Liability

FDA advises diet drug makers to assess heart risks

bathroom scale iStock CROPPED FDA advises diet drug makers to assess heart risksPharmaceutical companies who develop weight loss drugs need to study their medications to determine heart risks before seeking approval from health regulators, the Food and Drug Administration (FDA) said in a report released this week.

Three drug companies are vying to get approval for what would be the first diet pills to hit the market in 13 years. Vivus’s drug Qnexa will be reviewed by an FDA panel in April, and Arena’s medication lorcasserin will be reviewed in May. Drug company Orexigen agreed in September to conduct safety studies on its diet pill, Contrave.

Contrave hit a snag with FDA approval because the agency felt larger studies were necessary to properly assess heart risks. The drug is currently involved in a two-year study. Lorcaserin was previously rejected because of concerns over brain and breast cancer. Qnexa was denied because drug regulators wanted more information about how the drug will affect the heart and the potential for causing birth defects.

Drugs to treat obesity have hit a rocky patch over the past 15 years, starting with the withdrawal of fen-phen after the drug was linked to heart-valve abnormalities. The last weight loss drug to be approved by the FDA was Roche Holding AG’s Xenical. That drug, which includes the active ingredient orlistat, is also sold over-the-counter under the brand name Alli. Orlistat carries unpleasant side effects, such as oily spotting on underwear or on clothing and gas with oily spotting. It has also been linked to severe liver injury. In 2010, the FDA ordered the removal of the weight loss drug Meridia (sibutramine) because studies showed it increases the risk for serious cardiovascular events.

Source: Bloomberg