Isotretinoin, also known by its brand name Accutane, is a prescription medication used to treat acne. It can also be used to prevent and/or treat some forms of cancer. However, women who are pregnant or planning to get pregnant should avoid taking Accutane. Isotretinoin is known to cause birth defects if a woman takes it during pregnancy. These birth defects can be severe and include deformities of the heart, face, and brain.
Accutane: Many Uses, Many Perils
The Swiss pharmaceutical giant Hoffmann-La Roche developed Accutane in 1982 based on the effectiveness of high dosages of Vitamin A to hinder the production of the fatty acids that cause acne. Isotretinoin is a naturally-occurring member of the Vitamin A family and is present in the body in small amounts. In its pharmaceutical form, isotretinoin is used to treat:
- Cystic acne
- Harlequin-type ichthyosis
- Lamellar ichthyosis
- Cancers of the brain, pancreas, and other organs
Accutane can also be used to prevent squamous-cell carcinomas, a major variant of skin cancer.
Accutane is primarily used to treat severe cases of acne. As a retinoid, it inhibits the production of oil in the sebaceous glands. Accutane is usually prescribed after all other forms of acne treatments have failed to clear cystic acne. Isotretinoin has a 70%-80% efficiency rate in treating severe cases of cystic acne when it is processed into Accutane or similar drugs. Because it was the nearest thing to a cure to acne, many women took Accutane to treat the skin condition even at the risk of side effects such as headaches, dry skin, and dry eyes.
Risks to Adult Patients
Unfortunately, the social benefits of having a clear complexion and acne-free skin are outweighed by Accutane’s adverse side effects. The drug affects many parts of the body and has serious psychological effects in adult patients. These adverse effects include:
- Diabetes mellitus
- Crohn’s disease
- Anaphylactic reactions
- Dry eyes
- Benign intracranial hypertension
- Reduced night vision
- Dryness in the nasal passages
- Back pain
- Anxiety disorders
- Suicidal thoughts
Adverse Effects on Pregnant Women
According to the U.S. Food and Drug Administration (FDA), women who are pregnant or plan to become pregnant should not take Accutane or any derivative of isotretinoin. Per the FDA’s pregnancy drug categorization system, Accutane is a Category drug. Category X drugs have been proven to cause high numbers of birth defects in babies whose mothers take them.
The FDA has placed a black-box warning, its most severe drug advisory, on Accutane. Per the warning label, women are urged not to take Accutane if they are pregnant or have a chance of becoming pregnant in the near future. The black box warning states, “If a pregnancy does occur during treatment with a woman with Accutane, the prescriber and patient should discuss the desirability of continuing the pregnancy.” In addition, sexually-active women who are taking isotretinoin sold under the brand names Amnesteem, Claravis, and Sotret should use two forms of effective birth control or abstain from sexual activity until the treatment has ended.
Accutane and Birth Defects
According to the U.S. Centers for Disease Control and Prevention (CDC) and the March of Dimes, Accutane and similar retinoid drugs cause a high number of birth defects. The CDC reports that isotretinoin has an incidence rate of 25.6% of neonatal defects, including:
- Cleft palate
- Heart defects
- Hydrocephaly (unusually large fluid spaces in the baby’s brain)
- Microcephaly (unusually small head)
- Eye abnormalities
- Ear abnormalities
- Facial dysmorphism
- Intellectual disabilities
- Central nervous system malformations
New mothers who were on isotretinoin medication before their pregnancy should not breastfeed their babies.
The FDA, Roche, and Accutane Safety Issues
Due to the plethora of health risks from the use of isotretinoin medications such as Accutane, the FDA and Roche Pharmaceuticals, the original developer and marketer of isotretinoin, have set up systems that ensures the safe prescription of the drug in the U.S.
The original system put in place by the FDA and Roche was the System to Manage Accutane Related Teratogenicity (SMART). SMART was implemented in 2002. It required Roche and other pharmaceutical companies to provide warning labels, stickers on prescription paperwork, consent forms for the patient, and educational materials, including patient use guides and videos. SMART also required pharmacists and physicians to read clinical studies and other research literature highlighting the risks associated with Accutane.
The FDA’s current Accutane/isotretinoin management system is called iPledge. It replaced SMART in 2005. Its two main goals are to prevent pregnant women from taking isotretinoin and to prevent pregnancies in women who are taking the drug.
The iPledge program is mandatory and includes male as well as female patients, physicians, and pharmacists. Every isotretinoin distributor, prescribing healthcare professional, and patient is required to register through the iPledge computer database. In addition, male and female patients must meet the program’s qualification criteria and monthly program requirements. Before each monthly treatment, doctors have to counsel patients about the risks of isotretinoin and sign iPledge forms stating that the patients received the counseling.
The FDA’s program also requires female patients to choose two reliable birth control methods to use while on isotretinoin therapy for acne or other applicable health conditions.
Who is Responsible if Accutane/Isotretinoin Causes Birth Defects?
Because the prescription of isotretinoin is restricted in the U.S. by the FDA under its iPledge program, the legal responsibility falls on the various manufacturers who make the drug. Hoffman-Roche, the parent company of Roche Pharmaceuticals, developed Accutane in the early 1980s and continues to produce and distribute it outside the U.S. under other brand names. Since 2002, however, other pharmaceutical companies that make generic isotretinoin may be held responsible in personal-injury cases.
Roche withdrew Accutane from the U.S. market in June 2009. Roche cited the high cost of defending itself in court from a multitude of personal-injury lawsuits. Many persons who took Accutane from 1982 to the first decade of the 21st Century developed health problems such as Crohn’s disease or gave birth to babies with neonatal defects. However, generic isotretinoin drugs became available in 2002 after Roche’s patent expired Although the brand name Accutane is no longer used in the U.S., its formula is still in use and the potential for birth defects persists.