Roche’s acne drug Accutane and its generic versions will face tighter prescription controls to prevent harm to unborn children, U.S. health regulators said on Tuesday. The measures include a new joint database shared by all manufacturers of the drug to monitor patients, doctors and pharmacies, the Food and Drug Administration said. Accutane, or isotretinoin, is already restricted to prevent use by pregnant women because it can cause fetuses to die or develop birth defects. But FDA officials are concerned about women who get pregnant while taking the drug. Under the new monitoring program, manufacturers must keep track of doctors who prescribe the drug, pharmacies that distribute it and patients who take it. The database will use codes instead of names to maintain privacy, the FDA said. Doctors and pharmacies must inform patients about the drug’s risks and get their informed consent and must obtain proof of negative pregnancy tests before giving the drug to women, the FDA said. Accutane treats severe acne that causes inflamed, cystic-like pimples and can prevent scarring, but some critics say it is overprescribed for milder cases. The three generic makers are Barr Pharmaceuticals Inc., Ranbaxy Laboratories Ltd. and Mylan Laboratories Inc.
