Acne-Drug Campaign Aimed at Preventing Birth Defects

Starting last week, patients filling prescriptions for the acne drug Accutane have to follow unusually strict rules imposed by the U.S. Food and Drug Administration and Roche Pharmaceuticals aimed at preventing pregnant women from taking the drug, which is known to cause miscarriages and severe birth defects.

The program, known as SMART--an acronym for System to Manage Accutane-Related Teratogenicity (birth defects caused by a drug)--enlists doctors, pharmacists and patients to stop women who are already pregnant from taking Accutane and to keep women who are taking the drug from becoming pregnant while on it.

Women who want to start taking the oral medication will have to show their doctor they’ve had two recent negative pregnancy tests before being issued a prescription. Each month before refilling their prescription, they will have to get another pregnancy test. They will also need to agree to use two forms of birth control or completely avoid sexual intercourse while taking the drug and for a month after stopping. Women and men must sign consent forms indicating that they are aware of the drug’s risks, which also include depression and suicidal thoughts.

Physicians will have to register with Roche and sign an agreement saying they understand the drug’s risks and agree to follow the new guidelines for prescribing it. They will also be required to provide patient counseling or referrals about effective pregnancy prevention; write prescriptions for no more than a one-month supply; get a negative pregnancy test from female patients before writing another prescription; and apply a bright yellow qualification sticker--the cornerstone of the SMART program--on all Accutane prescriptions they write.

Pharmacists will be expected to fill only prescriptions bearing a yellow sticker, dispense only a one-month supply at a time and refuse to fill prescriptions more than seven days old.

Pharmacist Joe Smith, owner of the Medicine Shoppe in Falls Church, Va., called the new safety measures extraordinary. Accutane, he said, now carries more instructions and warnings than any drug he’s ever seen. Besides the warnings printed on the package, he has to hand out a large medication guide with each prescription. “It’s almost a matter of overkill,” Smith said.

However, the Public Citizen Health Research Group, a consumer advocacy group, complained that the program doesn’t go far enough and that the controversial drug is over-prescribed.

There are two facts about Accutane on which physicians, pharmacists, the FDA and Roche agree. The first is that Accutane works. Within four to six months, it clears up the nasty kind of acne that lodges painful red lumps deep under the skin and leaves inflamed, pus-filled lesions that often cause permanent scars. The second is that, for women who get pregnant while taking Accutane or who begin taking the drug when they are already pregnant, the drug carries significant risk of miscarriage, premature birth or severe birth defects. Exactly how many women have become pregnant while taking the drug is not known. FDA reports between 1982 and Dec. 31, 2001, show 2,261 pregnancies for women who had been exposed to Accutane. Of these, 1,349 chose to abort, 252 had spontaneous abortions, 195 had normal babies and 167 had babies with birth defects.

In 1988, in response to even more pregnancies, the FDA and Roche launched the “Pregnancy Prevention Program for Accutane,” a voluntary program aimed at educating patients to avoid pregnancy.

The program recommended many of the same measures required by SMART including pregnancy tests before starting the drug and two forms of birth control while on it, but it had no method like the yellow qualification sticker to ensure compliance. It recommended but didn’t require monthly pregnancy tests.

The new SMART program mandates these tests and prohibits call-in prescriptions.

But Sidney Wolfe, director of the Public Citizen Health Research Group, wants more. His organization has petitioned the FDA repeatedly since 1982 to permit only dermatologists to write Accutane prescriptions--any doctor can now write them--and only for patients who exhibit severe forms of acne and have had no success with other acne medications.

Jonathan Wilkin, director of the FDA’s Division of Dermatologic and Dental Drug Products, said that if the SMART program does not succeed in reducing birth defects tied to Accutane, the agency will institute an even stricter program.