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Accutane Recall

Accutane is a powerful systemic drug used to treat severe acne. Hoffman-LaRoche, part of the international conglomerate The La Roche Group, has been the manufacturer of Accutane. The medication had previously netted approximately $1.2 billion of annual sales for Roche until it was discontinued in 2009. It was one of the company’s top selling drugs. Isotretinoin – Accutane’s generic form – is made from a synthetic form of vitamin A. It works by reducing the amount of oil produced by the oil glands. It also increases the rate of cell reproduction and growth. Isotretinoin is normally given after other acne treatments have been unsuccessful. This is the only medication approved by the U.S. Food and Drug Administration (FDA) to treat severe resistant nodular cystic acne.

Side Effects of Accutane

Some of the adverse reactions and complications of Accutane include: Birth defects, Depression, Crohn’s disease, Inflammatory bowel disease, Ulcerative colitis, Liver damage, Back and joint pain, Suicidal tendencies, Hair loss, Weakened skin, Dry mucous membranes, Aggressive behavior, Stroke, Heart attack, Vision problems, Allergic vasculitis, Erectile dysfunction, Bone loss, Anaphylaxis, Seizures, Lowered white blood cell count, Psychosis, Ringing in the ears

Accutane and Birth Defects

Within a year of the FDA’s approval of Accutane, reports began surfacing regarding pregnant women who were using Accutane and were giving birth to children with serious deforming birth defects. Other reports stated that many patients using Accutane were having different adverse effects, some serious.

Numerous lawsuits have been brought against Roche for adverse reactions caused by Accutane. It has been one of the top drugs with reports of adverse side effects.

FDA Response

The FDA required increased levels of warnings about side effects, including warning labels on the Accutane packaging and marketing campaigns, stating risks and complications of the medication. Roche also designed two programs to help reduce the number of pregnancies in women using Accutane; however, they were not successful.

The iPledge program is a mandatory distribution program implemented in the U.S. for Isotretinoin. It is intended to prevent patients from using the drug during pregnancy due to the high rate of birth defects associated with its use

As of March 1, 2006, patients and their doctors and pharmacists are required by the FDA to register and use a web site in order to receive this medication. Both female and male patients must register before taking Accutane. A patient must sign documents stating that they understand the dangers and complications of the medication and that they will use it as the guidelines state.

While a patient is taking isotretinoin, their doctor monitors the patient for physical and psychological effects.

Manufacturer’s Accountability

Although Roche discontinued the manufacturing of Accutane in June of 2009 – stating profit loss because of generic brands. The company is still accountable for some of the adverse reactions of Accutane patients.

Plaintiffs have been awarded millions of dollars in the U.S. for Accutane verdicts. Roche warned both health care providers and patients about certain risk of the medication for many years. Some cases have been found in favor of Roche for this reason. Patients may also have claims against health care providers, clinics, or others who prescribed Accutane. They can be considered negligent if they do not disclose the right information.

When patients need the medication, they should be provided with a list of all the side effects and controversies, how the medication works and the responsibility they have in taking Accutane. Isotretinoin should only be given in severe cases. Patients should be monitored very closely by their doctor. As of March 1, 2006, with the implementation of the iPledge program, a blood test is required every 30 days and the refill orders of Accutane are very strict.