Accutane (isotretinoin) is prescription drug used to treat severe cystic acne. The drug was created by Swiss global health-care company Hoffman-La Roche, or Roche. Accutane was most often used when other acne treatments failed. Many Accutane users experienced reduced acne at the price of unwanted side effects. Severe Accutane side effects included Crohn’s disease, birth defects, and suicidal tendencies.
What Is Accutane?
Accutane is a retinoid, which means it is chemically related to vitamin A. Accutane works by interacting with the sebaceous glands. It alters the size of the glands, as well as the ability for them to produce oil. The drug also helps decrease the bacteria already present in a patient’s sebaceous glands.
Accutane is primarily used when severe acne fails to respond to topical treatments or antibiotics. Dosage sizes depend on the patient’s body weight. Doses range from 0.5 to 1 milligram per kilogram of body weight. Most Accutane patients take the drug daily for roughly 15 to 20 weeks. If the acne returns, patients can repeat the treatment process.
History of Accutane
Accutane received FDA-approval in 1982. It was originally created and marketed as a chemotherapy treatment. A year after its release, Accutane received its first report of birth defects after a woman took the drug during pregnancy. From the period of 1983 to 1988, nine notices were sent to doctors from the FDA. These notices alerted doctors of the severity of birth defects, since Accutane’s label did not adequately cover the risks.
In 1983, one of the discovering scientists of the drug, Dr. Frank Yoder, wrote to the Journal of American Medicine. In this letter, he informed the public that Roche was unclear about the drug’s toxicity. In 1985, the FDA issued a black-box warning for Accutane. It required the package insert to alert users of the high risk of fetal deformities and death.
In 1988, the government developed a special program designed to prevent pregnancy while taking Accutane. Other countries had stricter policies for preventing birth defects. In Britain, women had to agree in advance to abort any pregnancies that occurred during Accutane use.
The Centers for Disease Control and Prevention (CDC) conducted a study on pregnancies that were exposed to Accutane. The results were then published in an effort to raise awareness of birth defect dangers. In 1998, the CDC sent the FDA a letter that recommended taking Accutane off the market. In June 2009, Roche recalled Accutane. The company claimed the recall was an economic decision, as generic isotretinoin brands were dominating the market.
Severe Accutane Side Effects
One of Accutane’s most notorious side effects is severe birth defects when taken during pregnancy. It is estimated that 42 percent of Accutane-exposed pregnancies resulted in birth defects to the infants. These birth defects included malformations of the infant’s eyes, ears, face, skull, heart, and brain.
Inflammatory Bowel Disease
Roche denies being aware of gastrointestinal side effects from Accutane. However, early animal testing revealed that dogs experienced gastrointestinal bleeding. Additionally, the company conducted a study of 523 patients. More than one-fifth of these patients experienced gastrointestinal disorders.
Patients continue to sue Roche for gastrointestinal conditions such as ulcerative colitis and Crohn’s disease. Patients with these conditions experience severe symptoms like rectal bleeding, diarrhea, and vomiting. Some cases are so debilitating that parts of the bowel must be surgically removed.
Depression and Suicide
Many Accutane patients have developed psychiatric problems. Hundreds of depression episodes from isotretinoin use were reported to the FDA between 1982 and 2000. In 2005, an Accutane study was published in the book Drug Injury: Liability, Analysis, and Prevention. The study revealed that suicide ad suicidal behavior reports from Accutane reached 500. This meant that prior to 2005, Accutane caused the fourth highest adverse reaction count.
Milder Accutane Side Effects
Most Accutane users experience side effects in some form. Milder side effects are typically not a concern unless they worsen or become painful.
Milder and more common Accutane side effects include:
- Muscle ache
- Dry eyes and skin
- Swollen or bleeding gums
- Skin and nail changes
- Hair loss or growth
- Slower healing of sores and cuts
- Weakened or thickened bones, which may increase injury
More than 7,000 lawsuits have been filed against Roche for the devastating side effects of Accutane. To date, more than $50 million in damages has been awarded to Accutane lawsuits. Cases can be complex due to the slow and frequent addition of FDA warnings issued for the drug. Prescription dates, diagnosis dates, and warning publication dates can be important factors when evaluating a claim. Accutane patients should seek an experienced attorney to discuss filing an Accutane lawsuit.