Accutane, the name under which the medication isotretinoin was marketed for years after its initial release, is used to help treat severe cystic acne. For many users, this medication proved to be extraordinarily effective in helping to treat their acne. Unfortunately, a number of serious side effects have since been associated with the use of Accutane, ranging from extremely severe birth defects to life-altering gastrointestinal disorders such as Crohn’s disease and ulcerative colitis.
As a result, many former Accutane users have pursued lawsuits against the drug’s manufacturer in order to receive compensation for the serious damages they and their children may have suffered because of their treatment with this medication.
Accutane Side Effects
Accutane has been linked to a considerable range of different types of side effects, some of which can directly damage the health of users while others may have an impact on the children of those who used this medication during pregnancy. At the National Injury Law Center, we understand how much the lives of those who have suffered from Accutane’s side effects can be impacted as a result, and we are committed to helping victims of Accutane side effects in their pursuit of justice.
The following are among the most commonly reported side effects of Accutane:
- Ulcerative colitis
- Inflammatory bowel disease
- Crohn’s disease
- Depression and suicidal tendencies
- Severe birth defects
These are just some of the more serious side effects of Accutane use; a wide range of other negative effects have also been noted among users of this medication, some of which can have extremely negative consequences on the patient’s health and quality of life.
The main ingredient, known as the active ingredient, in Accutane is a chemical compound known as isotretinoin. This compound has similar properties to vitamin A and retinoic acid, and is useful in the treatment of acne because it helps to reduce oil gland function, which causes cystic acne to develop. In addition, Accutane may contain a number of inactive ingredients, which can include:
- Titanium dioxide
- Methyl and propyl parabens
- Hydrogenated vegetable oil
- Edetate disodium
- Butylated hydroxyanisole
These are the ingredients present in each Accutane pill. Other inactive ingredients may be present in pills of different dosages.
Get Help Today
No one should have to pay for the devastating side effects that Accutane use can have on their own. In many cases, these side effects can permanently damage an individual’s health, leading to life-long medical expenses and potentially rendering the individual permanently disabled. Worse, the effects on the health of children born to mothers who were prescribed Accutane can be so severe that the child may not survive.
Fortunately, by pursuing a lawsuit against the manufacturers of Accutane, those who have suffered these and other consequences from Accutane use may be able to secure the compensation they need. If you have been the victim of serious side effects resulting from Accutane use, the attorneys at the National Injury Law Center understand what you may be going through, and we are committed to ensuring that dangerous drug manufacturers are held responsible for their actions so that victims don’t have to pay for the costs of drug side effects on their own. Contact us today at 888-273-6041 to learn more about how we can help you fight for justice in this difficult situation.
Accutane and the FDA
Accutane was first approved by the FDA on May 7, 1982, and quickly became a popular treatment for acne among a wide range of users. While Accutane was categorized as a “Class X” drug for pregnant women, meaning that its medical benefits were clearly outweighed by potential complications for children born to users of the medication, initial labeling did not go far enough to emphasize the risks posed by Accutane to pregnant women. As a result, the FDA first instituted the SMART (System to Manage Accutane Related Teratogenicity) program, in 2000, and later the iPledge system, both of which required users to pass a wide range of different regulatory benchmarks in order to qualify for Accutane prescription.
In 1998, the FDA first required Accutane to begin carrying warnings of possible psychiatric side effects on its labeling. A 2005 FDA alert also warned patients of the potential for suicidal thoughts and behavior as a result of Accutane usage. Additionally, between 1997 and 2002, the FDA received a range of reports linking the drug to irritable bowel syndrome.
History of Accutane
Accutane was developed by Dr. Gary Peck for the pharmaceutical company Hoffman – La Roche in 1982. After the drug was approved by the FDA, it quickly became one of the most popular treatment options for severe acne available in the United States. At the time of its production, its potential to cause severe birth defects was known, with FDA labeling indicating that patients should not be prescribed the medication if they were pregnant. However, not enough action was taken to warn patients of the need to avoid sexual activity or take effective contraceptive measures, resulting in far too many patients and their children being exposed to the risk of the development of severe birth defects. As a result, the FDA eventually instituted two separate programs, first the SMART program and later the iPledge program, which placed strong restrictions on Accutane use to help prevent these types of problems from occurring.
Hoffman – La Roche had begun to receive a substantial number of reports suggesting that the drug might be linked to the development of irritable bowel syndrome and other gastrointestinal disorders, even publishing these findings in a 1994 internal company document. Nevertheless, no further action was taken to reduce the risk that this problem posed to consumers, and as a result, Accutane has been the subject of a considerable number of lawsuits arising from patients who have suffered colitis, IBS and IBD, and other illnesses.
Additionally, Accutane use has been linked to psychological problems, particularly depression and suicidal behavior. In 1997, the FDA learned that Hoffman – La Roche had failed to disclose to the agency that its French warning labels required acknowledgement of potential suicidal behavior, and as a result, these warnings were added to Accutane in the U.S. in 1998. In 2005, the FDA released a new alert warning of suicidal dangers associated with Accutane use after nearly 200 suicides had been linked to use of the product.
In 2002, Hoffman – La Roche’s patent for Accutance expired, and a wide range of generic products began to be produced. This, combined with the rash of lawsuits faced by the company from many of the different side effects associated with the drug, eventually led the company to discontinue its production in the United States in 2009, though it continues to sell forms of isotretinoin in other markets.
Contact an Attorney
If you have been the victim of serious health problems or other issues caused by Accutane use, you shouldn’t have to pay for the consequences on your own. With the help of an attorney, you can pursue the compensation you need to deal with these consequences. However, there is not an indefinite amount of time available in which you can file a lawsuit, so it is important to take action as soon as you can. Contact the attorneys at the National Injury Law Center today by calling our offices at 888-273-6041 to speak with a qualified legal professional and learn more about what we can to help.