Roche drug slapped with caveats

US regulators have enforced tighter regulations on the prescription and administration of Roche's acne treatment, Accutane, in a bid to shore up safeguards to prevent pregnant women using the drug after it was linked with birth defects.

The Food and Drug Administration (FDA) said it had approved a strengthened distribution programme for Accutane, also known under its generic name isotretinoin, requiring doctors and patients to register and accept specific responsibilities before receiving authorisation to prescribe or use the drug.

Under the new plan, women of child-bearing potential must sign consent forms, be counselled about risks, have monthly pregnancy tests and promise to use two forms of birth control.

Doctors must pledge to inform patients of potential side effects and check that pregnancy tests are negative.

Manufacturers of the drug, which along with Roche include generic firms Genpharm, Mylan, Barr and Ranbaxy, will implement the computer and telephone-based registry, called iPledge. Wholesalers and pharmacies that do not register to the scheme will no longer have supplies of the pills shipped to them.

ìWe've been working on making the use of Accutane safe now for 22 years,î said FDA Commissioner Lester Crawford. ìThis programme is about as tight as we can legally make it. If a pharmacist, a wholesale drug company or a physician does not wish to participate in this programme, then they will not have access to the drug.î

However, the March of Dimes, a health advocacy group that works to prevent birth defects, said it would closely monitor the scheme to see if it worked.

ìIf this does not prevent pregnancy exposures, we would consider calling for a withdrawal of the drug from the market,î said March of Dimes medical director, Nancy Green.

Since Accutane began selling in 1982, the FDA has had reports of more than 160 babies born with drug-related defects. The agency estimates that 100,000 US prescriptions of Accutane are filled each month.

Accutane is one of five drugs that long-time FDA drug reviewer David Graham said should be subject to closer scrutiny, during his controversial testimony at a hearing over Merck's withdrawal of painkiller Vioxx.

At the meeting in November 2004, he told the Senate Finance Committee that the FDA's failure to prevent women from taking Accutane while pregnant was a ìtragedyî.

Analysts said the requirements would have little impact on Accutane sales, which have seen a steady decline since the drug was exposed to generic competition.