What is Accutane?
The prescription drug, Accutane, is a potent derivative of vitamin A. It goes by the generic name of isotretinoin, but is typically known by the following brand names:
Accutane is manufactured by Roche Pharmaceuticals, a Swiss-based company. The drug was introduced to the U.S. market in 1982. Accutane carries a warning that it should not be taken by pregnant women, or women who are planning to become pregnant while taking the drug.
The danger to the developing fetus is overwhelming. Fertile women who want to use the drug must sign an agreement that they will use two different birth control methods while on the drug. They must also undertake regular pregnancy tests prior to, during and upon completion of their treatments with isotretinoin. This is because Accutane could cause life-threatening or debilitating birth defects.
Patients taking Accutane need to have regular blood and liver function tests to make sure the drug is not causing harm to their health.
A number of other precautions must be taken while using the drug. For example, patients should not take any supplements that contain vitamin A while undergoing treatment. Additionally, certain prescription drugs are known to interact negatively with Accutane.
Patients also need to protect exposed skin from sunlight, and they should not use tanning beds and sun lamps.
What is Accutane Prescribed For?
Accutane is prescribed to treat severe acne of a nodular nature that does not respond well to other forms of treatments such as topical ointments or oral antibiotics. The drug exerts its action by reducing the amount of oil that is produced and released by the oil glands in the skin. It also causes a quicker turnover/renewal of skin cells.
While Accutane does appear to be highly effective as a treatment for severe acne, it does seem to cause a long list of side effects. Indications suggest that Accutane negatively affects a wide range of organs and systems throughout the body. These include:
– The nervous system
– The blood
– Psychiatric health: Depression, suicidal thoughts and attempts are alleged. Indeed, by the year 2005, 190 cases of suicide were linked to the use of Accutane
– Cardiovascular system
– Respiratory system
– Immune system
– Gastrointestinal system
– Metabolic system
The checklist of reported side effects is almost endless. The following are some of the more frequently reported side effects:
Common Side Effects of Accutane
– Dry, flaking and scaly skin
– Skin rash or infection
– Drying out of the mucous membranes
– Joint/bone pain
Less Common Side Effects of Accutane
– Inflammatory bowel disease
– Mental Depression/behavioral changes
– Impaired vision, especially at night
– Rectal bleeding
– Swelling of the brain
The lists above are not complete, yet they do make scary reading. No wonder a plethora of allegations and lawsuits surround the drug.
Allegations Concerning the Use of Accutane
Accutane injury lawyers have accepted cases pertaining to alleged undesirable effects that include inflammatory bowel disease, spontaneous abortions, birth defects, depression and suicide.
According to the website, accutanelawyers.com, juries have awarded millions of dollars to claimants who alleged that Roche Pharmaceuticals failed to provide warnings about potential side effects.
Obviously, in those cases, attorneys were able to prove beyond any reasonable doubt that Roche Pharmaceutical:
a) Failed in their duty of care
b) Their failure caused pharmaceutical injuries or deaths
All drugs carry risks, but drug makers have a responsibility to disclose all known side effects in a non-misleading and honest manner. When people choose to take prescription medications, their choices must be made as fully-informed consumers.
In addition, drug makers must keep the Food and Drug Administration informed about all known and reported side effects, even after the drug has won approval from the FDA. Drug companies should warn patients and the general public about all adverse effects brought about by a particular drug. When a drug manufacturer fails to abide by its duty of care and physical harm or death ensues, litigants have every right to seek compensation through a court of law.
In 1997, the FDA found out that health agencies in France had already asked Roche Pharmaceuticals to put a black box warning on Accutane. Roche had not informed the FDA of this. In 1998, such a warning was applied to Accutane in the U.S.A.
According to Julia Green at Harvard Law School, Accutane regularly challenged FDA regulations as the agency struggled to adapt its resources and tools to confront the challenges that an extremely efficacious but equally dangerous drug presented and continues to present.
It was the Dermatologic Drugs Advisory Committee that, in January 1982, suggested the FDA approve Accutane. The medication was classified as a top priority, “1A” drug, and given fast-track approval. It would seem that the FDA was not told about all the side effects that were noted during testing.
The FDA and Accutane
The FDA appears to have become aware of the potential risks to patients who use Accutane. To demonstrate:
• In 2005, the FDA issued an alert about suicidal ideation associated with Accutane use. A host of other side effects were also listed.
• In 2007, the agency issued the IPLEDGE Update. With this, the FDA sought to reduce the risks of fetal exposure to, and deleterious effects of, Accutane.
• In 2010, an IPLEDGE Update was issued. With this, the FDA sought to ensure safer prescribing and dispensing practices, with proper warnings given out about the potential side effects.
In addition, the FDA advises patients to report side effects associated with Accutane to the FDA MedWatch program. It also warns people not to purchase Accutane over the Internet.
Legal Claims against Accutane
According to www.drugwatch.com, Roche Pharmaceuticals has so far been ordered to pay in excess of $53 million to patients who used Accutane. Roche Pharmaceuticals continues to appeal a number of the verdicts even as more lawsuits are being filed. Individual settlements include:
• 2008: A litigant was awarded $10.5 in compensation for the inflammatory bowel disease that she developed while on the drug. She also received $78,500 toward medical expenses. The patient started taking Accutane at 12 years of age, and, by age 14 she was diagnosed with ulcerative colitis.
• 2010: Andrew McCarrell was awarded $25 million in compensation for the inflammatory bowel disease that he developed many years after he stopped taking Accutane. Andrew’s colon has had to be removed, and he has undergone at least five different surgical procedures. He suffers from constant pain and a much reduced quality of life.
• 2012: Two Accutane patients who developed ulcerative colitis while using the drug were awarded $18 million in compensation. A New Jersey court ordered Roche Pharmaceuticals to make restitution.
Class Action Lawsuits/Mass Torts
There are currently no class action lawsuits pending against Accutane. However, litigants can seek compensation via individual lawsuits or mass torts. A mass tort means that a number of different plaintiffs can jointly bring a civil action against a corporation in federal or state courts. This cuts down on a lot of separate civil actions against the same corporation. Sometimes, a mass tort can be categorized as a class action lawsuit.
New Jersey’s Supreme Court, in 2005, declared that all current and future Accutane lawsuits throughout New Jersey should be treated as mass torts.
Amidst all the lawsuits and continued reports of adverse side effects, Roche removed Accutane from the United States market in 2009. Nevertheless, isotretinoin can still be obtained in one of several generic forms.