Accutane is a medication first created and sold by Hoffmann-LaRoche Inc. that is used to treat severe acne. The generic name is isotretinoin and there are several other brand names for the drug. The U.S. Food and Drug Administration (FDA) first approved Accutane in 1982. This medication has helped many people with the most severe cases of acne get clearer, and in some cases totally clear, skin after all other treatments failed.
Unfortunately there are many possible side effects, including serious gastrointestinal disorders, suicidal thoughts, and birth defects. The effect on unborn babies was known early on, but not enough was done in the first decade of its use to prevent these birth defects. Several lawsuits have been started and settled over the side effects. Roche no longer makes Accutane, but other companies manufacture isotretinoin under the generic name and other brand names.
Uses for Accutane
Accutane is most often used for severe acne. This is acne that is nodular, or in other words disfiguring. It is also only used after other treatment methods have failed to work for a patient. The drug may also be prescribed for other skin conditions including rosacea, sweat gland infections, folliculitis, a type of skin infection, and several different types of conditions that cause patchy and thickened skin.
Isotretinoin is a type of drug in the retinoid class. These compounds are known to work on the skin to reduce inflammation and to promote the sloughing off of dead skin cells. Although up to 85 percent of people who use the drug for severe acne see permanent improvement, it takes time to see results. one course of Accutane requires about four or five months, and initially can make the skin condition worse and cause serious dryness. For those who stick with it, though, most experience relief from acne.
People who use Accutane may experience a number of side effects. Some are severe, some are serious, and some may even be life-threatening. Because of the many possible side effects, Accutane is only used for the most severe types of acne that does not respond to other medications. The most common side effects are:
- Trouble moving
- Joint and bone pain
- Inflammation, dryness, and itching on the skin, especially the lips
- Eye inflammation, itching, redness, or burning
- A rash or skin infection
Rare side effects that can occur with Accutane are stomach pain, back pain, blurred vision, behavioral changes, diarrhea, headaches, depression, thoughts of suicide, vomiting, muscle pain, eye pain, yellow eyes, yellow skin, and rectal bleeding. Some of these symptoms, though uncommon, can be severe and serious and should be reported to a doctor. Some of the more common side effects go away as treatment continues and the body adjusts to the medication.
One of the side effects of Accutane that can become debilitating is inflammatory bowel disease. The original maker of the drug did not report this as a side effect and claimed they did not know about it. Even now, after several case studies have been reported, it is difficult to make a definite connection between the use of the drug and the development of gastrointestinal issues. There is evidence, though, and some patients have suffered severe distress.
The conditions that may be caused by taking Accutane are ulcerative colitis and Crohn’s disease. Both of these are serious medical conditions characterized by inflammation in the large intestines, abdominal pain and discomfort, severe diarrhea, and serious complications like fistulas, bowel obstructions, and rectal bleeding.
After evidence made it clear that Roche knew there was a possible connection between inflammatory bowel disease and their medication, they pulled Accutane. The company claimed it was the cost of lawsuits that led them to stop making Accutane, not concerns about its safety for patients. Some of the people who sued the company over debilitating gastrointestinal problems received millions of dollars in settlements.
Yet another serious side effect of Accutane emerged after it was approved. In rare cases patients taking it experience depression and thoughts of suicide. As with inflammatory bowel disease, finding a definite connection has been difficult, but the evidence is compelling. Between 1983 and 2013, nearly 900 cases of psychiatric disorders were reported that may have been connected to using Accutane. Among these were several suicides. Eventually the FDA required labeling to warn of this possible side effect.
Lawsuits have been started against Roche because of the possible psychiatric side effects. In one example, a family from Florida sued Roche after their teenager stole an airplane and flew into a building and died. The death was ruled a suicide and the family filed a suit for $70 million in damages, claiming Roche new about the possibility of spontaneous depression and suicide.
Most controversial of all for Roche’s Accutane has been the birth defects. The possibility of defects was known early on, and the FDA required a warning label from the start. It is known to increase the risk of having a miscarriage, of a premature birth, and of birth defects that include cleft palate, heart defects, ear and eye problems, water on the brain, and microcephaly, or a small head. Lasting effects include developmental delays and disabilities.
In lawsuits against Roche for birth defects from Accutane, plaintiffs have argued that the company did not do enough to warn against the possibility of defects. They have also argued that the side effect of birth defects is unreasonably dangerous.
Precautions for Women
Women who are capable of being pregnant are supposed to be told about precautions before using Accutane. It is not recommended for any woman who may be pregnant or may become pregnant while taking the medication. Doctors recommend that a woman use an oral contraceptive and one other type of birth control starting at least one month before beginning a course of Accutane. A pregnancy test before starting Accutane is also recommended even if oral contraceptives have been used. Women should continue using oral contraceptives for one month after stopping use of Accutane.
Doctors are also supposed to counsel their patients on the risk of birth defects before writing a prescription for Accutane. Female patients should be given all the information about the risks of exposing a fetus to Accutane, especially during the first trimester. If these guidelines are followed and women are made aware of the risks and the recommended precautions, birth defects can be avoided.
The issue of birth defects caused by Accutane and other isotretinoin brands is serious enough that a special registration website was created to prevent pregnancy in women using the medication. Through the FDA website, called iPledge, prescribers of Accutane must register their patients’ negative pregnancy test results and the two types of birth control that they have promised to use for the duration of taking Accutane. The site is a way to hold both patients and prescribers accountable and to provide women with information and resources.
Accutane may be off the market, but generic and alternate brands of the same medication are still available. For some patients this medication has been life-changing in the most positive way, but the risks are high and it isn’t clear that those risks were always communicated clearly. Many people have suffered the effect of birth defects, inflammatory bowel disease, and suicidal thoughts because of Accutane. If you are one of these people, a lawsuit is a viable option and could get you the money you need to recover from your experience with Accutane.