Accutane side effects have proven to be serious enough to lead to a discontinuation of the medication by maker Roche Pharmaceuticals. Generic versions are still available, but the original manufacturer found it to be more trouble than it was worth. Due to some of the side effects the company faced numerous lawsuits and had to pay out millions of dollars in settlements to patients who were harmed.
The side effects of Accutane range from the less serious, like skin irritation and dryness, to very serious, like birth defects and severe gastrointestinal conditions. If you were harmed by Accutane, you may have suffered and felt that you were never warned about all the side effects. You may even be one of the people who sued and was rewarded with compensation. Now that Accutane has been pulled from the market, many more people will be spared the damaging side effects.
Accutane was developed by Roche as a treatment for severe acne, specifically acne that does not respond to other medications and that causes scarring or disfigurement. For these patients, finding relief from this type of acne was great, but for too many, the complications and side effects were hard to live with. In addition to acne, Accutane, and now the generic form offered by some other companies, can be used to treat skin infections and rosacea.
The generic drug that Roche called Accutane is isotretinoin. It is a retinoid medication that reduces inflammation and also causes dead cells to slough off from the outer layer of skin. Both of these effects help to treat acne. One course of isotretinoin takes four to five months. It takes time for it to work, but in the meantime it can cause a number of problematic side effects.
Side Effects of Accutane
Some of the most common Accutane side effects are difficulty moving, bone pain, joint pain, itch, red, and dry skin, including the lips, inflamed and itchy eyes, nosebleeds, and skin infections. These are not comfortable side effects, but for many people who relied on Accutane to be the last line of defense against acne, they were worth the benefits of finally getting relief.
More rarely, Accutane has been found to cause some more serious side effects. These include diarrhea, changes in behavior, headaches, vomiting, stomach and back pain, muscle pains, eye pain, yellow skin and eyes, and rectal bleeding. These are not very common symptoms of using Accutane, but they can be very serious and may require discontinuation of the medication. Some of these or the milder side effects may go away or lessen as the body adjusts over time to the drug.
Suicidal Thoughts and Behaviors
The discovery that isotretinoin could cause changes in behaviors and suicidal thoughts only came after the U.S. Food and Drug Administration (FDA) approved it in 1982. Over a thirty-year period the FDA collected around 900 instances of patients using Accutane and experiencing psychiatric disorders. Among these cases were several instances of suicide. Although it has been hard to make a firm connection between the medication and suicide, the FDA thought the evidence was serious enough to include a warning on the packaging.
Gastrointestinal Side Effects
Other serious Accutane side effects include those that affect the gastrointestinal system. Some nausea, diarrhea, or vomiting is not uncommon with using isotretinoin, but in rare cases these symptoms became debilitating. Inflammatory bowel disease, Crohn’s disease, and ulcerative colitis have all been connected to using Accutane.
The symptoms of these conditions are not just painful or uncomfortable, they can be debilitating. The embarrassment and the severity of the symptoms have been known to cause people to stay at home, to stop going to work, and to stop socializing with friends and family. The symptoms, like abdominal pain, severe diarrhea, bowel obstructions, fistulas, and rectal bleeding, can all have life-changing consequences for patients.
It is this range of serious side effects that played a major role in Roche ultimately pulling Accutane from the market. The people who suffered from these gastrointestinal conditions suffered so much that they sued the company and it was facing many lawsuits and millions of dollars to pay out in settlements. Judges and juries found that Roche was negligent and that the people experiencing such painful symptoms had no idea of the severity of the risk before they started using Accutane.
The second controversial Accutane side effect that led to so many lawsuits and contributed to the decision to pull it is the increase in risk of birth defects for women using it during pregnancy. Plaintiffs in cases against Roche claim that the company knew of this risk earl on in the development of Accutane and that the FDA should have insisted that the drug include a warning label about birth defects.
Women using Accutane while pregnant have been found to be at an increased risk for having a miscarriage, for having a baby prematurely, and for giving birth to a baby with a number of possible defects. These include cleft lip and palate, water on the brain, microcephaly, eye defects, ear and hearing problems, and heart defects.
The risk of birth defects is considered serious enough that the FDA started a website for doctors to register the women using isotretinoin. Those prescribing the medication must register a patient through the site and include the results of a negative pregnancy test. Women taking isotretinoin are highly encouraged to not only take a pregnancy test first, but to use multiple forms of birth control one month before treatment, all throughout a course of the medication, and for one month after discontinuing it. Women on the registration site must pledge to use two specific types of birth control before starting a course of isotretinoin.
Lawsuits over Accutane side effects have had a huge impact on Roche. People who suffered severe and debilitating gastrointestinal disorders, who gave birth to children with birth defects or experienced heartbreaking miscarriages, and even those who lost a family member to suicide, all had good reason to sue Roche over Accutane and its side effects. The cost of these lawsuits led to millions of dollars in settlement fees because Roche was found to be negligent.
Accutane may be off the market and Roche out of the business of selling isotretinoin, but this generic drug is still available. Anyone thinking of using it should know of these serious potential side effects in order to make an informed decision. Previous users who did not have all the information suffered greatly in some cases. If you have used this medication or are considering it, think of the side effects and make a balanced choice.