Manufacturer: Roche Pharmaceutical
Date approved: June 1982
Status: Prescription Only. Patients must sign a consent form to use.
Approved uses: Severe acne
Off-Label uses: N/A
• Birth defects – including mental retardation and physical malformations.
• Suicide or Suicidal Thoughts
• Severity of Side Effects Increases with Accutane Purchased over the Internet
Related topics: Unsafe Drugs, Sotret, Claravis, Amnesteem, Isotretinoin, Birth Injury
Accutane Lawsuit Information
Accutane, or isotretinoin, is a drug used to treat severe recalcitrant nodular acne. The brand Accutane has been discontinued by manufacturer Roche Pharmaceutical, however it is still prescribed under the names Sotret, Claravis and Amnesteem. Accutane has been shown to cause birth defects such as mental retardation and physical malformations. In some users, especially teenagers, Accutane has been linked to psychiatric problems, including depression, psychosis and, in rare cases, suicidal thoughts, suicide attempts or suicide. Other side effects include central nervous system problems, liver disease, hearing and vision problems, bone and muscle damage, pancreatic damage and inflammatory bowl disease. The FDA requires Accutane users to sign a consent form because of the severity of possible Accutane side effects.
Serious Side Effects Associated with Accutane
Since 1982, a division of Hoffmann-La Roche, Inc. has manufactured Accutane in the United States. It is used to treat serious forms of cystic acne. Hoffmann-La Roche Inc. is the prescription drug unit of the Roche Group, one of the worlds leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics.
Accutane is a highly effective oral medication used to treat severe recalcitrant nodular acne that has not been helped by other treatments, including antibiotics. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe” by definition means “many” as opposed to “few or several” nodules.
Accutane, and its generics, contain Isotretinoin. People who suffer from the embarrassments associated with acne need to be aware that Accutane carries a significant risk of adverse side effects in certain patients.
Health complications and the legal issues surrounding those caused by Accutane involve the use by pregnant women and associated birth defects and the use by teenagers and associated depression and suicidal behavior. According to the Food and Drug Administration (FDA), women who are pregnant or who might become pregnant and women who are breastfeeding SHOULD NOT take the drug.
Over the past two decades, Accutane has been linked to a large number of dangerous, even life threatening, side effects including:
• Birth Injuries and Birth Defects
• Depression and Suicidal Tendencies
• Psychiatric Diseases
• Central Nervous System Ailments
• Liver Disease
• Inflammatory Bowel Disease
• Hearing and Vision Problems
• Bone and Muscle Damage
• Pancreatic Damage
As with most prescription drugs, the side effects and severity of complications associated with Accutane vary from patient to patient and from case to case. Not every fetus exposed to Accutane has resulted in a deformed child, however, there is an extremely high risk that a deformed infant may result if pregnancy occurs and the woman has/had been taking Accutane even for very short periods. In addition, there is an increased risk of spontaneous abortion, and there have been reports of premature births associated with the use of Accutane. There have also been reported cases of IQs lower than 85 in some infants.
Similarly, not every teenager or young adult who takes Accutane will experience depression or suicidal thoughts. However, the potential for these side effects has caused enough concern, and are serious enough, that the risks must be addressed and taken very seriously.
Steps have been taken to help prevent Accutane’s potentially dangerous and undesirable side effects. Since the introduction of Accutane, education has played a large part in reducing and preventing the drugs’ fetal risks by reinforcing the importance of pregnancy prevention by women using the drug.
Prevention has not stopped at educating patients. Frequent updates and information on potential side effects of the drug are provided to doctors and other health care professionals. This includes notification to doctors that Accutane may cause depression and/or psychosis, as well as suicide, in some cases. This is to help ensure that health care providers make educated and ethical decisions based on the patients’ history and personal needs. Doctors have also been advised to monitor patients very closely for symptoms of depression.
All prescription drugs come with educational material included in the packaging. Accutane’s packaging advises patients to watch for signs of depression, such as feelings of sadness, irritability, fatigue, loss of appetite, trouble concentrating, thoughts of hurting oneself or suicidal thoughts. Unfortunately, many patients who take Accutane due not consider the possible side effects, as their desire for clear skin and their need to regain a positive self-image takes precedence.
Due to the number of potential complications associated with Accutane and the severity of the side effects, the FDA now requires any potential user to sign a consent form. Additionally, pharmacists must give users a detailed warning brochure from the FDA called a Medguide (Medication Guide). Only three drugs in United States history have been required the use of a Medguide: Accutane, Thalidomide and Mifeprex.
Required Registration in iPLEDGE Program to Protect Consumers
Some of the most alarming side effects of Accutane involve use by pregnant women and associated birth defects. According to the Federal Drug Administration (FDA), women who are pregnant or who may become pregnant and women who are breastfeeding should not take the drug. Due to the severity of the potential side effects, the FDA continues to regulate the packaging and distribution of Accutane, even though it is an FDA approved drug.
In 2004, the FDA concluded that the existing Isotretinoin (a synthetic retinoid) risk management program called for some major revisions and improvements. In addition to educational programs and the extended literature included in the packaging, the FDA approved a strengthened risk management program called iPLEDGE. The program is aimed at preventing the use of Accutane during pregnancy.
iPLEDGE is a contract between doctor and patient. Manufacturers of Accutane are currently implementing a program that requires registration in iPLEDGE by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use the drug.
By March 2006, only those doctors and health care providers that are registered in the iPLEDGE program may prescribe Accutane, and only patients who have abided by iPLEDGE’s guidelines and who have signed an informed consent form may be prescribed the drug. Isotretinoin may only be dispensed by a pharmacy registered with iPLEDGE, and only wholesalers registered in the program may only make their stock available to those pharmacies.
Additionally, according to iPLEDGE, women who want to take Accutane must undergo two pregnancy tests, both with negative results, before starting the medication. These women may not take Accutane for at least month before they may become pregnant and for at least one month after a pregnancy. Women who are breastfeeding are also at risk for transferring the drug to their infant. While on Accutane, it is advisable that women use two forms of birth control to protect from unwanted pregnancy and from potential exposure to a fetus. Each woman also receives counseling prior to starting a course of Accutane detailing the risks and requirements for safe use of the drug.
Wholesalers and pharmacies must also comply with a separate manufacturers’ program that have specific requirements for distributing and dispensing the product. The FDA is in the process of approving this program under the Administration’s regulations, known as 21 CFR 314, Subpart H, that require restrictions on the distribution of drugs to assure safe use.