Accutane is a prescription drug used to treat serious forms of cystic acne, one of the most common forms of skin disease. Manufactured in the U.S. by a division of Hoffmann-La Roche, Inc., and approved by the U.S. Food and Drug Administration in 1982, Accutane is the brand name for the generic drug isotretinoin. While there are clear benefits to the use of Accutane, for decades the drug has been known to cause birth defects when used by pregnant women. In addition, a number of recent lawsuits have claimed a link between the acne drug and depressive or suicidal behavior.

Birth Defects

Even before Accutane was approved by the FDA, studies showed that it could cause birth defects in animals. It was designated as "Category X pregnancy drug," meaning that it must be avoided by women under all circumstances during their pregnancy. On its label, Roche warned against use of Accutane by pregnant women, but pregnancies resulting in birth defects caused by Accutane still occurred. So in 1988, the company instituted a voluntary program designed to prevent pregnancies during Accutane treatment, called the Accutane Pregnancy Prevention Program (PPP).

Roche sent PPP kits to physicians, and encouraged them to review them with patients before prescribing Accutane. Materials in the kit included a booklet about contraception, and consent forms for patients to sign, acknowledging their understanding of the risk of birth defects associated with Accutane use. Roche also sponsored a survey to assess compliance with the program. To further reinforce pregnancy prevention, Roche began packaging Accutane in blister packs that included warnings set in red and black, a drawing of a malformed baby, and an "Avoid Pregnancy" symbol. Roche also set up a toll-free telephone line, made contraceptive information available in 13 languages, and offered to pay for contraceptive counseling and pregnancy testing performed by a specialist. Still, a 1999 survey showed that of 500,000 women who took Accutane from 1989 to 1998, about 3 in 1,000 became pregnant. As a result, the FDA required Roche to undertake more labeling changes.

On April 10, 2002, Roche announced the implementation of a new program, called SMART (System to Manage Accutane Related Teratogenicity), aimed at women who failed to comply with pregnancy prevention provisions that were previously in place. Roche also began shipping pregnancy tests to physicians. Now, in order to get an Accutane prescription, a female patient must have two negative pregnancy tests, and must commit to using two forms of birth control from one month before treatment through at least one month after treatment ceases. She also must read and sign a consent agreement that explains the risk of birth defects associated with the drug. Yellow Accutane qualification stickers then will be placed on the prescription, and only prescriptions with stickers attached are to be accepted.

As of April 2004, the FDA was examining the need for further safeguards surrounding Accutane use and potential birth defects. One proposal would allow Accutane prescriptions only for those patients whose use is tracked on a national registry.

Depression and Suicidal Behavior

Another serious potential side effect of Accutane treatment is the tendency of some patients to become depressed and to exhibit suicidal behavior. From 1982 to May 2000, the FDA received reports of 37 Accutane patients in the U.S. who committed suicide, 24 while on the drug and 13 after ceasing use of the drug. In addition, the FDA received reports of 110 U.S. Accutane users hospitalized for depression, suicidal ideation, and suicide attempts. There were also reports of 284 Accutane users with non-hospitalized depression.

Studies seem to suggest a link between vitamin A and depression. Since Accutane is chemically similar to vitamin A, there may also be reason to suspect a link between taking Accutane and developing depression. But despite numerous studies, there has been no scientific evidence indicating that Accutane causes depression. Nevertheless, in 1998, the FDA sent a letter to physicians warning them that use of Accutane may be linked to a higher risk of depression and suicide.

The issue attracted national attention in May 2000, when the son of Rep. Bart Stupak (D-Mich.) committed suicide. The Congressman claimed that the acne drug was responsible, because his son had never been depressed before taking Accutane. In December 2002, before the Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee, Stupak claimed that use of Accutane remained uncontrolled, and demanded that the FDA more strictly regulate Accutane.

Another high-profile incident occurred in April 2002, when the mother of a teen-age boy who had flown a small aircraft into a Tampa, Florida office building filed a $70 million wrongful death and negligence lawsuit against Hoffmann-La Roche Inc. The lawsuit, filed in Hillsborough County Circuit Court, claims that Roche is responsible for the suicide of 15-year-old Charles Bishop, due to severe psychiatric side effects of the daily dose of Accutane he had been taking since April 2001.

In February 2002, Roche added to the Accutane label stronger language regarding possible psychiatric problems, and funded a brochure entitled "Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane (isotretinoin)." Roche continues to maintain that there is no mental health concern surrounding Accutane.

Alternatives to Accutane

The Accutane patent expired in February 2002. On November 11, 2002 Genpharm announced that the FDA had approved its isotretinoin product. Bertex Pharmaceuticals markets the drug under the name brand Amnesteem, and it carries much the same warnings as those that accompany Accutane. By February 2003, Ranbaxy Pharmaceuticals Inc. began selling isotretinoin under the brand name Sotret. Each manufacturer has its own controlled distribution system, and requires sticker warnings on the prescription prior to dispensing. On April 11, 2003 generic isotretinoin from Barr Laboratories was approved by the FDA, to be marketed as Claravis.

Get Help Now

While almost all medications have some anticipated side effects, a drug manufacturer has a duty to adequately inform physicians regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability."

If you or a loved one have taken Accutane and experienced any unusual side effects or suffered injury, you should contact a physician for proper medical attention. Your next step should be to contact an experienced product liability attorney, who will assess and protect your legal rights. To learn more about an attorney's role in a product liability case, read our article on getting legal help with a product liability issue.