Uncommon Side Effects of Accutane
Many people saw Accutane as a miracle drug for improving skin, but beneath the surface, much more serious, complicated and deadly effects were seen.
While people taking Accutane have reported many side effects, two caught the most attention from the FDA and the general public: birth defects and depression.
The FDA reported 172 cases of babies being born with defects or abnormalities after their mothers took Accutane. Between 1982 and 2006, approximately 2,000 isotretinoin patients got pregnant, and many of these pregnancies resulted in abortions, both by choice and naturally.
In 1982, the FDA issued a category X pregnancy rating for the drug and two years later, added a black-box warning telling patients of the risk of birth deformities. The black-box warning lists the following possible birth effects:
- Skull abnormalities
- Ear abnormalities
- Facial dysmorphia
- Cleft palate
- Eye abnormalities
- Central nervous system abnormalities
- Thymus gland abnormality
- Cardiovascular abnormality
- Parathyroid hormone deficiency
- Lower IQ
Roche Pharmaceuticals developed a program called SMART to help educate female Accutane users on birth defects caused by the medication and required the use of 2 forms of birth control. In 2005, the FDA approved a risk-management plan for Accutane and generic isotretinoin to replace SMART. The plan, called iPLEDGE, required monthly steps for prescribers, patients and pharmacists. Prescribers had to confirm the patient had counseling, enter two methods of contraception chosen by the patient and enter pregnancy test results. The patient had to answer education questions and enter 2 forms of contraception. The pharmacist was required to get authorization before dispensing the medication. Only doctors and pharmacists registered and activated with the program could provide isotretinoin or Accutane prescriptions.
Depression and suicide also became a side effect associated with Accutane. From the time of its release in 1982 to 2005, 190 suicides by Accutane users were reported. Seventy-two of the 216 drug-related suicides by adolescents were linked to Accutane. The FDA even considered the drug one of the top 10 most associated with depression and suicide attempts. Before undergoing Accutane therapy, prescribers were instructed to speak with the patient and their family members to determine any predisposition or history of a psychiatric disorder. The FDA also warned to closely observe patients treated with isotretinoin for any signs of mood disturbance, irritability or aggression.
Another side effect common in lawsuits against Accutane are gastrointestinal disorders. Crohn’s and ulcerative colitis are two types that have been link to Accutane use. From 1997 to 2002, there were 85 cases of Inflammatory Bowel Disease (IBD) associated with isotretinoin use. A study in 2005 found that Accutane was a possible trigger for IBD.
Other Accutane side effects include:
- Hearing and vision damage
- Liver and kidney damage
- Cardiovascular injuries
- Early closure of growth plates
- Diminished night vision
- Increased bone injuries and concussion risk due to weakened bones
- Severe joint and muscle pain
- Liver damage
- Autoimmune disease
- Red, cracked or sore lips
- Brittle nails
- Unusual hair growth or hair loss
- Increased reaction to UV exposure
- Peeling skin
- Bleeding or swollen gums
- Slow healing of cuts or bruises
- Dry eyes
- Muscle aches
- Increased susceptibility to colds