Accutane Lawsuit

Accutane, also known as isotretinoin or roaccutane, is considered a miracle drug by some dermatologists. It was first developed as a chemotherapy drug until it was revealed that it could also dramatically clear up troubled skin.

Dermatologists won't prescribe Accutane lightly. It is usually a last resort after other antibiotics and topical treatments have been used, and the patient still suffers from severe scarring acne. Accutane can provide great benefits in battling severe acne, however numerous serious side effects have been reported against the medication.

Accutane has been very profitable for the pharmaceutical giant Hoffman-LaRoche since the drug was approved by the FDA in 1982. However, concern over alleged serious side effects has reversed that trend.

Mild to Medium Side Effects

• Headaches

• Chapped lips

• Dry skin

• Dry eyes

• Thinning hair

• Dry nasal passages/nosebleeds

Serious Side Effects

• If Accutane was used while pregnant, miscarriage, birth defects, premature births, and deaths in babies

• Depression, suicide attempts, suicide

• Hepatitis and liver damage

• Inflammatory bowel disease, ulcerative colitis, Crohn's Disease, and rectal bleeding

• Spontaneous osteoporosis, decrease in bone density, bone fractures, delay in healing of bone fractures, and muscle weakness

• Decreased night vision

• Temporary or permanent hearing loss

• Temporary high cholesterol

• Severe allergic reaction

FDA Response

The FDA instituted programs informing patients of the risks if they chose to use Accutane. In addition to a detailed warning brochure, the FDA requires all patients to sign a consent form. There have also been a sequence of programs put in place in an attempt to protect pregnant women, but those have so far failed to reduce the number of birth defects. In 2002, 20 years after the drug was first approved, Roche began the SMART program (System to Manage Accutane-Related Teratogenicity) but it was not very effective in preventing birth related side effects. It was replaced on December 31, 2005 by the FDA's iPledge program. This program requires doctors, patients, and pharmacies to register with iPledge to prescribe, use, or fill prescriptions for Accutane or any other forms of the chemical.

Legal Consultation

If you or a family member has suffered from any of the birth related complications from prenatal Accutane exposure or any of the other side effects listed, please contact us to determine if you are eligible to file a lawsuit. It's important to have representation that is experienced with Accutane claims. After all, you can be assured that Roche's lawyers will be experts in the matter.