Although there was never an official or forced Accutane recall, production of this medication did halt in 2009 over concern for the risks it poses to patients. Many people called for a recall, but it never materialized. Accutane is a medication that was made by Hoffmann-LaRoche, often known as just Roche. It was developed to treat severe acne, forms of the skin condition that did not respond to other types of treatment.
While many people finally found relief from the embarrassment and discomfort of acne when using Accutane, the drug proved to have too many side effects and potential complications. These included serious gastrointestinal side effects, suicide, and even the possibility of birth defects. Lawsuits have settled some of these instances, but still no official recall of the drug ever occurred and generic forms of it can still be used.
What is Accutane?
Nodular acne, which is a severe kind of acne that causes disfiguration, is very difficult to treat. Accutane, which is the generic drug isotretinoin, was designed to treat this type of acne when other types of medications failed to bring any relief. It has also been prescribed to treat other skin conditions like skin and sweat gland infections, rosacea, and other conditions.
The U.S. Food and Drug Administration (FDA) approved Roche’s Accutane in 1982, so this medication has been on the market for decades. It belongs to a class of drugs called retinoids. These compounds work by reducing inflammation in the skin and by promoting the turnover and sloughing off of the top layer of dead skin cells. Accutane has been proven to be effective for severe cases of acne, but one course can take months to work and it causes some significant side effects, the least of which is severely dry skin.
Reasons for an Accutane Recall
Isotretinoin has brought many patients relief. These people may have thought they would never find a treatment that would make the condition of their skin better. Unfortunately, to get the relief from Accutane requires suffering through some serious side effects. In addition to dry skin these include joint pain, bone pain, dry, inflamed lips, skin rashes and infections, eye inflammation and irritation, nosebleeds, and difficulty moving.
None of these, however, were damaging enough to warrant an Accutane recall. Some people called for a recall of the product over several more serious complications experienced by some patients using the medication. One of these is inflammatory bowel disease. For a long time, only case studies and anecdotal evidence could prove a link between gastrointestinal distress and Accutane, but stronger evidence was reported in 2009. A study found that people using Accutane were nearly two times more likely to have inflammatory bowel disease. The risk increased the longer a patient used the medication.
Another major complication of Accutane for some users is the increase in suicidal thoughts. This effect is not common, but for those who experience it, it can obviously be life-threatening. Almost a thousand cases of people using Accutane and developing some type of psychiatric disorder were reported to the FDA between 1983 and 2013. Several people from this list committed suicide. The effects of this can be devastating enough to warrant lawsuits and several families did blame Roche and filed suits seeking compensation after the suicidal death of a loved one using Accutane.
Finally, Accutane is known to be connected to birth defects when women use the product during pregnancy. This risk was known early on and the FDA included a warning about it on Accutane’s labeling from the beginning. Risks of using Accutane during pregnancy include miscarriages, premature births, and defects that range from microcephaly to water on the brain to eye and ear problems to a cleft palate and any number of heart defects.
While other complications are severe and long-lasting, they are relatively rare. Birth defects, however, may be more common with Accutane than many people find acceptable. The risk is serious enough that women using Accutane are expected to take strong precautions against getting pregnant and are supposed to take a pregnancy test before starting a course of the medication.
The problem is serious enough that the FDA even created an online registry to help prevent women who use Accutane from getting pregnant. Doctors that prescribe the medication to a woman has to register the negative pregnancy test online and the woman must pledge that she will use two forms of birth control while going through a course of the medication.
No Recall, but Accutane Discontinued
Roche has faced thousands of lawsuits over the complications associated with Accutane. People have sued the company over losing a loved one to suicide, because of severe gastrointestinal distress, and of course, because of birth defects and pregnancy complications. In spite of all the lawsuits and the evidence that the drug is so risky, the FDA never issued a recall and Roche never voluntarily recalled the medication.
Roche did, however, eventually decide to discontinue Accutane. The likely reason that the company finally made this decision was the ongoing cost of lawsuits. Rather than genuine concerns for patients, the company probably found that the cost of settlements could no longer be offset by the revenue generated by Accutane. This was especially true once generic versions of isotretinoin became available from other drug manufacturers. Roche stopped making Accutane in 2009, but since it was never recalled, generic versions are still available.
If you have been harmed by the use of Accutane or isotretinoin generic products, you may have been hurt because a recall should have been issued, but never was. You may feel as if the drug company and the FDA failed you and that you should have known more about the risks before starting a course of the medication. If you do feel this way, you may want to speak to a lawyer who can help you decide if you have a case to make against Roche or another drug maker and what you can do next to make your claim and seek compensation.