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Drug Injury

Accutane®

Accutane, or isotretinoin [eye-so-TRET'n-o-in], is an oral drug prescribed for severe nodular acne, the emotionally scarring type that causes pus-filled lesions and pitted scars. It is also used to treat several different forms of cancer, including brain and pancreatic cancer. Since the early 1980s, Accutane has been considered the biggest breakthrough drug to permanently clear severe acne that was unresponsive to other treatments. However, since its approval, Accutane's growing list of side effects has come under close scrutiny by the Food and Drug Administration (FDA). From the beginning, users were warned against severe birth defects associated with Accutane use. Later, severe depression was added to the list of possible serious side effects. Others include seizures, stroke, and permanent loss of sight.

Accutane Birth Defect Warning

Accutane comes with the following warning: "Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported."

Accutane Has Been Linked To Suicide And Depression

FDA ALERT: Suicidal Thoughts or Actions: In addition to the strengthened risk management program, FDA continues to assess reports of suicide or suicide attempts associated with the use of isotretinoin. All patients treated with isotretinoin should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop isotretinoin and they or their caregiver should contact their healthcare professional right away if the patient has any of the previously mentioned symptoms. Discontinuation of treatment may be insufficient and further evaluation may be necessary.

How Risky is Accutane Use?

Before its approval, studies showed that Accutane could cause fetal abnormalities in lab animals and, once it was approved, the FDA warned users of potential birth defects with Accutane use. According to the New York Times, since 1982, 25 to 35 percent of babies whose mothers took Accutane during their pregnancy suffered malformations of the head, face and heart. Many more developed learning disabilities and other problems not obvious at birth. More recently, numerous reports of severe depression and suicide attempts have been linked to Accutane users.

What Other Serious Side Effects Are Associated With Accutane?

In Accutane's Medication Guide, which is given to every prescribed user, the FDA lists the possible serious side effects known to be associated with Accutane use:

• Birth defects–deformities, miscarriage, premature birth or death of the baby
• Mental problems–depression, sleeping disorders or suicidal thoughts and attempts
• Brain problems–severe headaches, seizures or stroke
• Stomach problems–inflammatory bowel disorder, abdominal pains, rectal bleeding or dark urine
• Bone and muscle problems–back and joint pain
• Hearing problems–hearing loss or constant ringing
• Vision problems–loss of sight, blurred vision or painful dryness
• Lipid problems–high levels of cholesterol and other fats
• Allergic reactions–fever, rash or red patches and/or bruises on legs
• Others–including trouble breathing, convulsions, slurred speech and blood sugar problems

What Should I Do If I Am Taking Accutane?

If you or someone you love took Accutane and suffered from severe depression, inflammatory bowel disorder, or had a child born with serious birth defects, we want to help. Contact us today to learn how we may be able to help you.

Do not discontinue taking any medications without first consulting your physician. This article is for informational purposes only. It is not intended to constitute medical advice and should not be viewed as such. For medical advice, you should always consult with your physician.

Accutane® is a registered trademark of Hoffman-La Roche. The reference to the registered trademarks of Hoffman-La Roche is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by or associated with Hoffman-La Roche, the FDA, or the New York Times.

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