Drug maker Hoffmann-La Roche on January 7 began distributing to physicians and pharmacists updated requirements aimed at preventing pregnancy in women who take the company's acne drug Accutane.

Accutane is known to cause birth defects, and for 13 of the last 20 years the drug has been on the market, Roche has continually instituted and revised restrictions on its use. Despite the company's efforts, 2,000 pregnancies occurred in women taking Accutane between 1982 and 2000, according to the Centers for Disease Control and Prevention.

Roche and the US Food and Drug Administration worked together to come up with a new plan, and the System to Manage Accutane-Related Teratogenicity (SMART) program was approved by the federal agency in October.

Under SMART, which was mailed to 375,000 dermatologists, primary physicians and pharmacists beginning Monday, female patients will now be required to submit to a pregnancy test every month before receiving a 30-day refill of the medication. Before, the test was optional.

Also before receiving an initial prescription, women must have two negative pregnancy tests, one as a screen and the second during the first 5 days of the next menstrual period. They also must select and commit to using two forms of birth control simultaneously for one month before treatment, continue use during treatment, and for a month afterwards.

Patients also have to read and sign an informed consent about the risk of birth defects, and participate in the Accutane Survey, a questionnaire about their use of the drug.
If a woman has complied with these criteria, the physician places a yellow sticker on the paper prescription. The sticker acts as a certification, and pharmacists will be warned to only fill prescriptions with a sticker.

Women will not be allowed to request refills by phone -- they must return to the physician for the pregnancy test and certification.

Despite increasing numbers of prescriptions for Accutane, the numbers of pregnancies were declining. About 550,000 prescriptions are written for Accutane each year, and some 15 million have been issued since the drug came on the market, she said.

Reuters January 8, 2001

Dr. Mercola's Comments:

Another example of a drug-based solution gone bad. This is especially sad as changing one's eating choices seems to resolve most cases of acne. Severe cases might require some additional, more sophisticated natural medical therapies, but rarely, if ever is Accutane needed. I have no problems with topical Retin A, which is most likely beneficial and probably prevents and even reverses several types of skin cancers. However, Accutane should be used with great caution and only if one has not seen improvement with the eating plan and consulting with a natural medical clinician. In addition to Accutane, it would be best to avoid ALL medications, even over-the-counter ones, if there is any chance of pregnancy. No drug has been proven to be completely safe during pregnancy. As I said in December when I reviewed the evidence that Accutane is also associated depression and suicide: Accutane is not the miracle cure-all for acne that it is promoted to be. It has a category X for pregnancy which means that it causes birth defects in nearly 100% of pregnant women. The key to eliminating acne is to stop drinking soft drinks, juice, and milk and to drink one quart of pure water for every fifty pounds of body weight. It is also necessary to eliminate ALL sugar and chocolate. This strategy works in the majority of people, but some have elevated testosterone levels, which can promote acne. In this case, non-synthetic vitamin A (the real McCoy-my favorite is emulsified vitamin A from Biotics Research) is very helpful. It is likely not toxic in pregnancy, but nonetheless should be avoided. To be effective one must use a high dose of 100-200,000 IU per day. The dose should not be used for longer than several months as toxicity could be an issue (as detailed above) if taken much longer. Related Articles: Plane Crash Reinforces That Accutane Can Cause Suicide