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Accutane Recalls

Accutane, a synthetic form of Vitamin A, was developed to treat severe acne by Hoffman-LaRoche. The drug provided effective acne reduction, typically producing clear skin in a few short months. Accutane functions as an oil gland inhibitor, reducing the amount of oil the skin could produce, while simultaneously diminishing cell reproduction and growth. Although Accutane was originally designed for and approved as a treatment for extreme cases of acne, several medical professionals prescribed the medication for less severe skin issues. In such cases, the possible side effects of the drug could potentially surpass the benefits.

Accutane Lawsuits

Lawsuits against Roche and many of the medical professionals who prescribed the medication began to emerge as patients claimed they experienced a wide range of unreported side effects and health risks. The plaintiffs claimed Roche failed to provide adequate information about the side effects of the medication and noted several side effects that were not previously associated with Accutane, such as suicidal tendencies, miscarriages and birth defects, depression, back and joint pain, weakened skin, stroke, alopecia, heart attack, aggressive behavior, vision problems, erectile dysfunction, dry mucous membranes, bone loss, inflammatory bowel disease, anaphylaxis, allergic vasculitis, pink eye, seizures, psychosis, ringing in the ears, lowered white blood cell count, and liver damage.

FDA Response

With lawsuits against Roche building, the Food and Drug Administration (FDA) stepped in and issued a warning label for Accutane. The label had to accompany all medication packaging and marketing and explain the risks associated with taking the drug. With the imposition of the FDA’s warning label, Roche experienced some success in its court cases. The company won a case in federal court in which an Accutane user claimed that the medication caused him to suffer through a severe case of inflammatory bowel disease, eventually resulting in the removal of a portion of his colon. Roche also managed to emerge victorious in a New Jersey appeals court, which found that the company had adequately warned patients of the possible side effects and risks involved with taking the medication and should not be held liable for the difficulties individual users experienced with the drug.

Accutane and Pregnancy

Accutane should not be used by pregnant women; however, those who choose to take it must meet the FDA requirements of taking part in a risk management program called iPLEDGE, which is designed to protect the fetus from Isotretinoin, a generic form of Accutane. The program was instituted to ensure that users of the medication are aware of and understand the risks of birth defects and miscarriage associated with the drug before taking it. If conception occurred after the patient was prescribed Accutane or any of its generic forms (Isotretinoin, Amnesteem, Claravis, Decutan, Istane, Sotret, Ratane, and Raccutane), her doctor should have insisted that she cease using the medication and seek immediate testing for toxicity. Women that did not receive such a warning may be justified in pursuing legal action and financial compensation

Manufacturer Accountability

Medical professionals can be held responsible for negative outcomes resulting from a patient’s lack of knowledge about a medication’s side effects and risks. If a doctor fails to ensure that his or her patient has received as much pertinent information about the risks of any given drug to make a informed decision about using the medication, he or she may be considered negligent. Individuals that began taking Accutane prior to Roche adopting a warning label were typically victorious in their lawsuits due to their medical professional’s negligence to fully explain the risks associated with the medication.

Off the Market

Roche ceased production of Accutane in 2009, citing profit loss due to the increased production and use of generic brands. However, during the time it was available, 13 million people have been prescribed and treated with Accutane. You should consider seeking legal representation if you or an associate has experienced negative side effects or ongoing health complications due to using Accutane.