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.
The previous safeguards were mostly voluntary.
Women were supposed to have two negative pregnancy tests before starting therapy and more pregnancy tests during each month of Accutane therapy -- typically four to six months.
The testing was tracked using stickers that went on prescriptions and there were several different programs, which the FDA said “created confusion.”
In a one-year period, even after safety measures were strengthened in 2002, 120 pregnancies were reported in women taking the drug, compared with 127 in a similar period with looser restrictions, the FDA said.
Covance Inc. will develop and run the new monitoring system for the manufacturers after an agreement was reached with Celgene Corp., which held patents over a similar safety program.
The new measures come on the heels of a congressional hearing last week, when a veteran FDA scientist called for closer scrutiny of five drugs -- including Accutane, which has been sold for 22 years. FDA officials immediately disagreed, saying the five were not a specific concern.
David Graham, associate director for science in the FDA’s Office of Drug Safety, told Senators on Nov. 18 that the older measures “did nothing to stop the expansive use of the drug.”
An FDA panel of outside experts called for the tighter restrictions in February.
