Doctors call for better warning with acne drug
An acne drug that carries risks for pregnant women may not be clear enough with its warnings. Doctors at Toronto's Hospital for Sick Children say women on the drug are getting pregnant even though there are strict programs in place to prevent this from happening.
In the last six months the hospital's Mother Risk Program, a group that monitors pregnant women for birth defects, found four women taking the drug had become pregnant unexpectedly.
Two of the babies were born with defects while one was born healthy and the other pregnancy was terminated.
Accutane, prescribed by dermatologists for cystic acne, is manufactured by Hoffmann-La Roche. The drug has been approved for use since 1983.
If taken during pregnancy, Accutane increases the risk of severe birth defects including mental disabilities, missing ears and heart problems.
By 1988 doctors had reported over 500 children worldwide had been born with such defects, despite warning labels on the package.
That prompted calls for the FDA and Health Canada to ban the drug. Instead, with the regulators' approval, the manufacturer set up a detailed education system which it called the Pregnancy Prevention Program.
The program says that doctors can only prescribe Accutane once they've informed women of the risk in detail. And the women must:
- take two approved methods of birth control
- undergo a pregnancy test within two weeks of starting treatment
- sign a consent form
In the four cases at the Toronto hospital all of the women, who were less than 22 years of age, only used only one method of birth control instead of two. All had been warned of the risk, but only one had been been given the company's Pregnancy Prevention Program.
Dr. Gideon Koren at the Hospital for Sick Children says these four cases show the current education program isn't good enough and someone should step in.
Hoffmann-La Roche said in a statement, this the first time they'd heard of these cases and they called for increased education of doctors.
Health Canada says current warnings are adequate. Should cases continue to rise, though, doctors predict there'll be renewed calls to ban the drug.