Hoffman La Roche, a known pharmaceutical company, manufactured Accutane, which was to be prescribed for treating a sever form of acne called nodular acne. The generic name or the constituent of Accutane is isotretinoin. The drug was recalled from markets following numerous lawsuits that alleged the drug to be responsible for causing side effects. Many of these side effects are severe and the drug apparently is not worth taking these risks. FDA shares a similar opinion and has been informing people about the possible risks.
La Roche has been sued by many patients that took Accutane and became victims of side effects, such as inflammatory diseases (IBD). They claimed that Roche failed to give sufficient warning to users regarding the severe side effects. Roche recalled Accutane from market and stopped its production in U.S. in 2009. Its production has been stopped in many countries, but it is still being produced under different brand names.
FDA does not allow sale of Accutane and has been warning against its side effects from time to time. In 2005, FDA issued a warning pertaining to psychiatric problems caused by Accutane. As regular reports of suicide or suicide attempts related to isotretinoin (Accutane) kept pouring in, FDA asked for close monitoring of patients using Accutane or its generic drugs. It has asked to closely monitor patients for any behavioral or mood change such as depression or suicidal thoughts, depressed mood, irritability, acting on dangerous impulses, anger or loss of interest in social activities. Sleeping disorders, changes in weight, change in appetite, downfall of performance, concentration problems were other behaviors notified. The warning also states that any patient suffering from any of the above symptoms should consulted a medical expert.
Following the reports related to birth defects, FDA forced harder restrictions on use of Accutane in the year 2006. FDA issued warnings about these side effects and advised patients to look for alternatives if they are expecting a child.
FDA has recommended following measures to check side effects of Accutane related to birth defects-
- All patients using Accutane (isotretinoin) were informed about the risk of birth defects, if Accutane is used during pregnancy.
- Physicians were asked to inform female patients of iPLEDGE system. Also females in their childbearing age were also asked to contact iPLEDGE system if they were using Accutane.
- Patients were also told not to donate blood while using and till one month after they have stopped using Accutane to avoid its transfusion in any other patient’s blood.
- FDA decided to regulate the selling of Accutane and other isotretinoin drugs. The drugs was to be sold by iPLEDGE pharmacies and to iPLEDGE patients on prescription by only iPLEDGE physicians from 1st March 2006.
- Patients were informed not to buy this drug on Internet and to buy this drug only on prescription by a doctor.
- FDA asked for close monitoring of patients using Accutane for any mood or behavioral change.
- FDA asked the patients to be fully informed about side effects of Accutane and stop using it and consult a doctor if following symptoms occur.
- Depressed mood, crying spells
- Aggression or agitation, changes in behavior
- Concentration problems, sleep problems
- Hallucinations, thoughts of suicide or hurting oneself
- Sudden numbness or weakness
- Blurred vision
- Severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate
- Loss of appetite
- Severe diarrhea, rectal bleeding
- Withdraw from family or friends
- Experience loss of energy
- Experience feelings of worthlessness or inappropriate guilt
