Accutane® is a controversial acne medication that has been on the market since 1983. Intended to treat severe cases of cystic acne, Accutane® is supposed to be a last resort when all other treatment options have failed. Accutane® alternatives should first be tried because of the serious side effects that have been linked to the acne medication, but estimates show it is prescribed to 26 times more women than it should be.

FDA Tighter Accutane® Restrictions

The FDA is currently debating on having tighter restrictions on the medication that could inadvertently force Accutane® alternatives to be sought. Accutane® was immediately linked to serious side effects, especially in pregnant women after its arrival to the market. The high incidence of birth defects to occur when becoming pregnant while using Accutane has resulted in the majority of women to choosing abortions to avoid risks such as severe brain and heart defects, mental retardation, and other complications.

Sales of Accutane® soared through the years and despite the dangers associated with the drug, Accutane® alternatives were not always used. The widespread use of the acne medication for cases of mild to moderate problems were being prescribed, and Accutane® alternatives sought less. Public Citizen consumer group first petitioned the FDA a year after Accutane® became available in 1983, asking the agency to give patients warning information along with the drug.

Accutane® Birth Defects

In 1988, Public Citizen petitioned for a ban on Accutane® after the high rate of birth defects associated from the use of Accutane® failed to decline. The FDA did not act on the group's urges. Recently, though, the FDA acknowledged that part of the problem with Accutane® is that it is over prescribed and women are being treated without first trying alternatives to Accutane®. The FDA also acknowledged that perhaps women were being treated with Accutane® for cases less serious than the drug was intended for.

In 2001, the FDA's advisory committee recommended a registry, which resulted in less prescriptions and perhaps a greater number of doctors to first recommend alternatives to Accutane®. The number of pregnancies in Accutane® users remained the same, however. Statistics have also shown the registry has failed to work effectively so consumers and groups are demanding implementation more than voluntary restrictions. The Public Citizen told the FDA panel in February 2004 that it would again petition the agency for an Accutane® ban.

When to Obtain an Accutane Prescription

The consumer group believes that only after Accutane® alternatives are found to be ineffective, and with photographic proof of severe cystic acne, should one obtain a prescription for Accutane®. A written statement detailing the patient's contraceptive practices and negative pregnancy tests should also be required according to Public Citizen. Some worry that tighter restrictions on Accutane® may force otherwise good candidates to suffer more, but safety groups are hoping it will narrow down ideal candidates for Accutane® and direct non-ideal Accutane® candidates to try alternative drugs. Public Citizen thinks Accutane® should be prescribed under limited and controlled conditions and up to now, its wide availability has been reckless.

Talks of a registry system that would mandate requirements in order to fill Accutane® prescriptions are still being considered in hopes of reducing the number of pregnancies that occur and to encourage Accutane® alternatives first.

If you are someone you love has experienced an injury from using Accutane®, please contact our experienced Accutane® lawyers now!