FDA Set to Put Heavier Restrictions on Acne Treatment Drug for Pregnant Women

Even after 30 years, the acne treatment drug, Accutane, has been responsible for causing birth defects, despite efforts to educate the public.  In response to the increased number of total birth defects, the FDA requires both the doctor prescribing the drug and users to register in a national database which keeps track of the drugs usage.  Government advisors also recommend that women be required to have pregnancy tests and the administration of the drug be limited to 30 days.  The drug, originally designed to treat sever nodular and cystic acne that could not be treated using any topical creams, has been criticized for being prescribed too freely.  Despite the harsh side effects that come with using the oral drug, it is still available to doctors to give to patients who suffer from acne that leaves severe scars that mutilate the skin and can lead to psychological and emotion stress if left alone.
The first wave of reaction from government advisors came after around 2,000 cases of pregnancies were reported while female patients were on Accutane.  The alarming issue with these reports is the well documented number of birth defects that occurred, since the pregnancies resulted in 383 live births and a little over 40% of the infants had a birth defect, meanwhile, another 40% ended up in miscarriage.  Another often overlooked statistic is the infants who may be physically normal, but have psychological and mental defects, such as learning disabilities.

Since its approval, the drug has been used by about 2.5 million women, of whom approximately 75% were of childbearing age. This demonstrates that although pregnancies continue to occur, the dimension and challenges of this undesirable outcome has at least been minimized, adds Russell Ellison, MD, vice president of medical affairs at Hoffmann-La Roche.

The company has tried to reduce the number of defects by trying to educate the public and discourage women from getting pregnant while on the oral acne treatment.  Most notably, the company created a Pregnancy Prevention Program, also known as PPP along with sending letters out to doctors warning them of the potential issue.  However, the attempts have not been successful, as the impact these initiatives had in reducing in birth defects has been minimal.  In fact, in a survey conducted in 2000, which involved around 500,000 females, 25% of the women who had taken Accutane did not have a pregnancy test prior to using the drug, and 33% did not have to wait for the results of the tests before starting the acne treatment.  In addition, millions of women have taken the drug and of those prescribed, around 75% are of childbearing age, making the scope of the project quite large.  Despite the difficulties, the company continues attempting to improve their PPP program, as it is in the company’s interest to prevent pregnant women from using the drug.

However, not everyone is in favor of supporting stricter regulations, as some doctors argue that requiring certain documents, along with a tedious legal procedure limits the number of professionals that can prescribe Accutane and creates a larger black market, in which people purchase from in order to bypass mandatory procedures.  Instead, some propose that educating the public of the potential risks involved is a better method than required registration.