Accutane Maker Will Devise New Safeguards On Use
WASHINGTON (AP) _ The maker of a popular anti-acne medication that can cause birth defects says it will try once again to devise a way to keep women from taking the prescription drug if they are pregnant or likely to become pregnant.
The Food and Drug Administration said Friday it has convened an advisory panel next Tuesday to consider reports that more pregnant women than previously believed are taking the drug Accutane despite strict warnings that it is likely to cause birth defects.
Short of an outright ban, the agency has no way to guarantee the drug will not be used by women who are pregnant or become pregnant while taking it. And there was no indication whether the FDA was actively considering ordering it off the market.
The New Jersey-based maker - Roche Laboratories - issued a statement late Friday saying it will propose a new series of safeguards at the Tuesday meeting.
It said it will propose tighter restrictions on use of the drug in women of childbearing potential and offer to provide ″innovative blister-packaging to ensure that female patients receive the pregnancy warning with every prescription.″
The statement did not detail what type of restrictions the company will propose for the drug in the United States. The drug is marketed in 40 countries worldwide.
The warnings accompanying the drug since its introduction in the United States in 1982 are explicit: Don’t take the drug if you are pregnant and don’t get pregnant while you are taking it.
FDA spokesman Don McLearn said Friday the agency’s dermatologic drugs advisory committee has been asked to review use of Accutrane because ″we’re concerned that a drug is not being used as the labeling indicates.″
″The drug has all sorts of warnings that people who are pregnant should not be using it and that the drug is only for a very severe form of acne,″ said McLearn. ″It’s clear that it’s being used for a larger group than that.″
Dr. Robert Stern, a dermatologist from Beth Israel Hospital in Boston and a member of the advisory panel, emphasized that concern about the drug does not involve any new scientific discoveries, but rather new indications that some people are ignoring long-standing warnings of those effects.
He said in a telephone interview Friday that the newly raised concern flows from a study of Michigan Medicaid figures that suggests the frequency of people getting pregnant while on Accutane may be ″much higher than anybody thought it was.″
However, Stern said he has substantial questions about the accuracy of the projected pregnancy rate, since it was based on a ″very specialized population, namely people who are already on Aid to Families With Dependent Children because of prior unintended pregnancies.″
The question, he said, is not whether there is a problem, but how great the problem is for the estimated 1 million people - a majority of them men - who benefit from the drug.
The Michigan statistical projection says Accutane may have caused more than 1,000 babies to be born with birth defects in the past six years.
The FDA has received reports of 62 birth defects associated with the drug from the time it came on the market in 1982, but scientists believe that may understate the problem simply because many side effects from any drug often are unrecognized and under-reported.
Accutane is specifically intended for treatment of severe cystic acne, a type that often causes severe disfiguring and deep pitting scars and sometimes can be treated only with Accutane.
Since the drug was approved in 1982, the FDA and Roche - a division of Hoffmann-La Roche Inc. - have strengthened the warning label, made repeated mailings of special letters to doctors and pharmacists emphasizing the risks and discussed the risks twice in the FDA Drug Bulletin that is sent to more than 1 million health professionals.
They also have distributed red warning stickers to pharmacists to be placed on each prescription bottle.