Accutane's Effectiveness
- Until 2002, Roche Holding AG, a large pharmaceutical company that produces many cancer drugs, held the exclusive patent for Accutane (isotretinoin). It was the company's second best-selling drug until the patent expired in the early 2000s and generic equivalents became available. However, this also meant that Accutane alone came under fire when additional side-effects not noted in clinical studies arose. At the end of June 2009, Roche pulled Accutane from the market, allegedly because the drug had too much competition from generic competitors. However, Roche also faced numerous civil lawsuits, as well as some $33 million in damages awarded to patients who alleged that Accutane caused them to have bowel disease. Accutane continues to be sold and recommended by dermatologists, albeit by its generic brand names; however, doctors now exercise much more discretion before dispensing the drug.
- No one can dispute Accutane's effectiveness in resolving nodular/cystic acne; according to FDA studies, the drug combats the four factors that caused severe acne by reducing clogged follicles, preventing inflammation, and decreasing sebum (oil) production and the colonization of bacteria that cause acne. According to the American Academy of Dermatology, Accutane and its generic equivalents--Amnesteem, Claravis and Sotret--are still the most effective way to treat severe types of acne that can eventually lead to disfiguration and deep scarring. Most patients only require one round of oral treatment for 16 to 20 weeks before acne resolves.
- In 1983, the first incidence of fetal malformation was reported to the FDA, indicating that Accutane posed a serious risk to women who were pregnant or who intended to become pregnant. According to the FDA, Accutane also caused spontaneous abortions, premature births, and a host of fetal abnormalities. This led to the FDA establishing a risk management program, including its iPledge monitoring program. Girls and women in their child-bearing years must use two forms of contraception before beginning treatment with Accutane, as well as undergo routine pregnancy testing. They must also register with iPledge before starting treatment.
- Patients who take Accutane or a generic equivalent can expect certain common side-effects. Often, acne gets worse the first few weeks of treatment before it begins to resolve. Patients may also note dry skin and eyes and may require the use of heavy skin creams and lubricating eye drops. Temporary thinning of the hair, joint pain, and nausea/upset stomach are also common. However, Accutane also has more severe side-effects that should be reported to a doctor immediately, including bloody diarrhea, loss of hearing, severe depression, and even contemplation of suicide. Accutane also effects patients with other medical conditions--for example, those with diabetes may note that the drug causes their blood sugar levels to rise. For this reason, the AAD stresses that the decision to use the drug should be made jointly between a patient and his or her physician.
- Patients who use Accutane should take the medication daily with a full glass of water to reduce stomach upset. Keep the medication at room temperature in a place that's safe from children. Never share Accutane with others. Accutane works best when taken routinely, so make sure that your prescription is refilled on time so you don't have to skip a dose. If you have remaining pills at the end of your treatment regime, ask your doctor how to dispose of them.