Accutane (isotretinoin) is an oral drug that is prescribed to treat severe forms of acne. It is estimated that between 8 and 12 million people have been prescribed this medication in the United States alone. Because the drug is so powerful, it can lead to severe side effects, many of which have not been adequately disclosed to consumers. More than 70,000 adverse events related to the drug have been reported to the FDA since its approval in 1982. The actual number of adverse events may be significantly greater, since it is estimated the great majority of all adverse events are never reported.

Severe Accutane Side Effects

Accutane has been linked to such severe side effects as:

• Inflammatory Bowel Disease: This term encompasses a group of diseases that cause the intestines to become swollen and red. The disease is usually recurrent, and lasts a long time. Symptoms include vomiting, abdominal cramping and pain, diarrhea, weight loss, intestinal bleeding, and rectal bleeding. Two types of inflammatory bowel disease associated with Accutane are Crohn's Disease and Ulcerative Colitis. Crohn's disease typically causes ulcers along the small and large intestines. Ulcerative Colitis typically causes ulcers along the lower section of the large intestines.
• Kidney Damage: Accutane can lead to a type of kidney damage known as acute glomerulnephritis, which is an inflammatory disease of both kidneys. The kidney is no longer able to effectively filter toxins from the bloodstream to make urine. Symptoms of the disease include fatigue, nausea and vomiting, breathing difficulty, vision problems, swelling in parts of the body, high blood pressure, and reddish or cloudy urine.
• Liver Damage: Accutane may lead to certain diseases of the liver such as hepatotoxicity, cirrhosis, fatty liver, and hepatitis.
• Pseudotumor Cerebri: Also known as benign intracranial hypertension, it is caused by increased pressure in the brain. Symptoms include headaches, nausea, vomiting, double vision, ringing noises in the ears, momentary losses of vision, blurred vision, and loss of peripheral vision in one or both eyes. If left untreated, pseudotumor cerebri can lead to blindness.
• Tendencies to Suicide: The manufacturer of Accutane has warned that the drug may lead to "depression, psychotic symptoms and rarely suicide attempts". Since 1982, there have been over 142 suicide attempts linked to Accutane. In October 2001, Congressman Bart Stupak's son committed suicide while on the drug.
• Severe Birth Defects: Birth defects that resulted from Accutane use include ear abnormalities, eye abnormalities, skull abnormalities, cleft palate, facial dysmorphia, cardiovascular abnormalities, parathyroid hormone deficiency, and thymus gland abnormalities.

Roche, the manufacturer of Accutane, has acted improperly in failing to properly warn consumers of the dangers associated with using Accutane. Many users were not even aware that these side effects may have resulted from their use of Accutane. The FDA has required Roche to change the warning label for Accutane many times to include the severe side effects. Warnings for Inflammatory bowel disease, kidney damage, and pseudo tumor cerebri have been added to the label. In addition, Accutane use is no longer permitted for pregnant women, due to the high risk of resulting birth defects. A black box warning, the toughest warning the FDA can issue for a drug, has been added to Accutane for a risk of birth defects and serious mental problems such as depression and suicidal behavior. In June 2009, Accutane was pulled from the U.S. and 10 other markets by its manufacturer Roche, although it is still available in generic versions. To date, Roche has paid out over $33 million for victims who have suffered severe side effects from Accutane.

Contacted our Experienced Attorneys

The lawyers at the Pintas & Mullins Law Firm have extensive knowledge about drug litigation. If you or a loved one has suffered the side effects listed above and you suspect Accutane may have caused them, contact our office immediately. Each drug case is unique, and most have a specific time frame in which you can file a claim. Our law firm can provide you with a free no-obligation consultation and explain your legal rights.

Resource Links

Isotretinoin/Accutane Information
Visit this site for information from the FDA about Accutane warnings, updates, and the medication guide for the drug.

Information for Healthcare Professionals: Accutane
The FDA provides special information to doctors about certain drugs. Visit this site to learn more about the warnings that are given to medical professionals about Accutane.