FDA Panel Rejects Ban on Anti-Acne Drug Accutane
An advisory panel of the Food and Drug Administration Tuesday rejected calls for an all-out ban on the anti-acne drug Accutane, urging instead that the government toughen warnings about the risk of birth defects caused by the controversial drug and consider limiting its distribution.
Accutane, first marketed in 1982, is considered the only effective drug available for the treatment of the type of severe cystic acne that can lead to serious skin disfigurement. But it has been the target of growing scrutiny since an FDA study, disclosed last week, linked the drug to as many as 1,369 birth malformations in five years--a risk far greater than had previously been thought.
At a combative, daylong FDA hearing, the drug’s manufacturers and supporters from the scientific community attacked the validity of the new federal data. And, while acknowledging some risk of birth defects to offspring of users, they succeeded in persuading the FDA’s dermatologic advisory committee not to pull the product from the market.
‘Cannot Deny Our Patients’
“The lack of (Accutane’s) availability will set back the treatment of acne by 20 years,” testified Dr. John S. Strauss, a University of Iowa professor who is considered a leader in the field of dermatology. “We cannot deny our patients a cure.”
In the end, FDA panel members--bombarded with graphic slide shows and eloquent appeals from both sides--were forced to weigh two competing and gruesome prospects: the physical and emotional scarring suffered by thousands of severe acne victims, for whom Accutane may be the only hope, and the facial disfigurement, heart ailments and other birth defects experienced by an estimated one in four babies born to women who ignore warnings and take the drug around the time of pregnancy.
The federal panel, made up of 11 dermatology experts from around the country, ultimately settled on a compromise designed to reduce the risks but maintain the drug’s availability.
The recommendation brought favorable reactions from officials with Accutane’s manufacturer, Hoffman-La Roche Inc. of New Jersey, and their supporters.
But a glum Dr. David Graham, an FDA epidemiological researcher who headed the preliminary study that was released last week, predicted after the vote: “Those (recommendations) are simply not going to successfully eliminate pregnancy exposure for Accutane users.” But he promised, “this issue isn’t over.”
Public Reassured on Drug
The panel’s recommendations now go for a final decision to FDA Commissioner Frank E. Young, who promised a ruling within several months. “This is one we’re going to bring to closure fast,” Young said, adding that in the meantime he sees no reason for the public to “feel ill at ease” over the drug.
In rejecting calls for a total ban on the use of Accutane despite the new birth defects study, panel members argued repeatedly that proscribing the drug would be unfair to two large groups: the 60% to 70% of the drug’s 250,000 annual users who are either men, or women unable to have children, and the women of child-bearing age who use Accutane responsibly for severe acne problems and follow warnings to avoid pregnancy.
The panel did, however, recommend by a split vote that the FDA consider several general means of restricting Accutane’s use and distribution in an attempt to curtail the risk of birth defects.
Still in the exploratory stages, these suggestions included: banning the drug for high-risk groups, perhaps by requiring pregnancy tests and regular check-ups; making Accutane a “controlled substance” like codeine or morphine, subjecting it to much tighter regulation; limiting the number of physicians authorized to prescribe the drug, and requiring them to show familiarity with its risks and acquire a second opinion.
This last recommendation reflects the recent FDA study’s assertion that Accutane, approved by the FDA six years ago for cases untreatable through conventional means, is grossly overprescribed for less severe acne--perhaps by as much as 15 times. The drug’s manufacturer disputed the charge, saying virtually all users have severe problems with no alternative treatment.
Stronger Warnings Urged
The advisory panel also recommended strengthening the existing warning on Accutane packages, which now read: “You should not take Accutane if you are or may become pregnant during therapy. Severe human birth defects are known to occur in women taking Accutane during pregnancy. . . .”
Strengthening the warning was suggested and endorsed by Hoffman-LaRoche officials. They promised to beef up the drug’s warning language, display the warning more prominently and enclose additional information on risks.
But critics said it is not enough.
“We were naive to believe (in 1982) fetal exposure would be prevented” through public information and warnings, said Dr. J. David Erickson of the Centers for Disease Control in Atlanta. “The approach has failed to prevent the birth of babies with major handicapping defects,” he argued in pushing for vastly reduced distribution of the drug.
The FDA’s epidemiological branch study, which extrapolated national figures on birth defect risk based on small-scale Medicaid studies in three cities, estimated that between 3,876 and 21,060 Accutane users were pregnant between 1982 and 1986, producing between 2,325 and 12,600 induced abortions and as many as 1,369 birth defects.
Subject of Lawsuits
Just over 60 such cases of Accutane-related birth defects have been reported to the government, with several now the subject of lawsuits.
Accutane’s manufacturers, supported by several FDA panel members, blasted the recent FDA study as biased and invalid because of its methodology, but opponents of the drug dismissed these objections as technical quibbles.
Reflecting this view, Dr. Robert L. Brent of the American Academy of Pediatrics complained: “We’re worrying about orders of magnitude and where the decimal point is. . . . It’s irrelevant. The fact is children are being born with defects (caused by Accutane) every year.”
