Boost training for doctors prescribing acne drug: researcher

A Canadian researcher says doctors aren't giving women critical information they need about a potentially dangerous prescription acne medication that can cause severe birth defects.

The popular drug Accutane was approved in 1982 to treat only the worst forms of acne. Over the years, it's increasingly been used to treat milder cases.

• INDEPTH: Adverse Drug Reactions

Dawn Paxton of Newmarket says her breakouts were not that severe, but she felt insecure about the acne and asked her doctor for Accutane.

Paxton's family doctor told her not to get pregnant on the medication but she wasn't too worried.

"My husband had a vasectomy, we weren't having any children so I never really thought about it," said Paxton.

Six weeks after starting the drug, Paxton was pregnant with her fourth child. Her daughter Jaime was born with cranial and facial deformities, including a missing ear and hearing and vision problems.

Paxton said her doctor never gave her the educational material that is supposed to come with every Accutane prescription.

"He did not give it to me," said Paxton. "The prescription itself did have an information package, but I didn't look at it."

At Toronto's Hospital for Sick Children, Dr. Gideon Koren is tracking babies born to women taking Accutane. He says none of the 11 women in his study received the complete educational package required by Health Canada.

• FROM NOV. 1, 2001: U.S. restricts use of popular acne drug

"Most women tell us that they knew it's not good to conceive while on Accutane," said Koren. "But most of them have not seen either the whole program or even part of it."

U.S. weighs new limits on Accutane

Some U.S. officials want manufacturers to beef up educational materials warning women that Accutane can cause severe birth defects. A panel of experts is meeting at the U.S. Food and Drug Administration on Thursday and Friday to review data showing women continue to get pregnant while on the drug, despite recommended safety measures such as using two forms of birth control. One consumer group is calling for the drug to be pulled from the market. Source: Food and Drug Administration

Koren would like to see doctors who prescribe Accutane take a short course of the drug's risk and the proper way to counsel patients.

Toronto dermatologist Dr. Neil Shearer hopes health regulators in the U.S. and Canada will come up with a solution.

"This is a drug that's too important to lose and birth defects are too important to ignore," said Shearer of Sunnybrook and Women's Health Science Centre.

Paxton says she doesn't regret her decision to have Jaime, who is now 15 months old, despite the challenges.

"It's an extreme guilt and you think because of your own vanity, you've caused somebody else all that trouble," Paxton said.

She's sorry no one explained the high risks of becoming pregnant while on the drug.