The FDA Names Accutane a “Category X” Drug, Blames it for Severe Birth Defects
Accutane is an acne medication that has been on the market since the early 1980s. It is primarily used for recalcitrant nodular acne and cystic acne, which are severe and often unaffected by other treatments and medications.
Though effective in treating the skin disorder, Accutane has been known to cause a number of birth defects when taken by pregnant mothers. These birth defects include:
- Ear problems
- Injury to the thymus
- Cardiovascular injuries
- Eye and vision problems
- Irritable bowel syndrome
- Facial structure abnormalities
- Mental health and psychological issues
- Inhibition of parathyroid gland development
Given the large number of injured children being born to mothers who used Accutane, the FDA has made it a Category X drug, now requiring that it come with a black box warning and explicit language regarding pregnancy and birth defects.
The chemical name for Accutane is isotretinoin. You can find isotretinoin on the market today under various other brand names, such as:
A number of families have sued the makers of Accutane and other drugs containing isotretinoin and successfully recovered millions of dollars to help their injured children access the lifelong, specialized care they need.
Birth Defect and Product Liability Attorneys Serving Sedalia Families
Our team at Kempton & Russell is dedicated to serving families like yours. We know the devastating personal, physical, and financial toll that drug-induced birth defects can take on affected children and their families. Our Sedalia product liability lawyers understand that no amount of money can make things right—but we believe it is unfair for you and your loved ones to absorb the full cost of caring for a child with a birth defect, especially if it occurred because of a dangerous medication.
We can help. Call (660) 722-4115 to speak to a member of our team, or send us an email to tell us how we can serve you.