In 1982, Roche Pharmaceuticals started manufacturing, marketing, and selling Accutane (isotretinoin) in the United States. For the next several decades Accutane was considered an effective treatment for severe acne. By 2009, however, due to severe side-effects to thousands of Accutane users, Accutane had been pulled off the market by Roche. Isotretinoin, however, is still sold under the brand names Sotret, Claravis, Amnesteem.
Roche Pharmaceuticals, currently based in Basel, Switzerland, is one of the largest pharmaceutical companies in the world by revenue generating close to $48 billion dollars per year. Roche’s company goals are to help create break-through medicines for patients, to continue to be a leader in cancer treatments, and to help be one of the “leading developers of targeted treatments combined with corresponding diagnostics.” Roche accomplishes these goals by working with partners from around the globe, including Genentech in the United States and Chugai in Japan.
Although Roche was one of the first companies to mass produce Vitamin C, much of their research is now focused on cancer therapies, including Avastin and Herceptin. They also have developed Tamiflu, which is a popular and aggressive treatment for influenza.
Although Hoffmann-La Roche Inc. had sold Accutane to more than 13 million patients for the treatment of severe acne since 1982, they announced in July of 2009 that they would no longer sell the drug for “business reasons.” Business reasons include the declining sales of the acne medication, which was at the time estimated at less than 5% of the isotretinoin market, and the increase of personal injury claims against the pharmaceutical giant, which has cost the company millions of dollars.
Claimants in the personal injury claims against Roche argued Accutane caused severe side-effects which the company failed to warn patients against, including increased risk of depression, suicide, psychosis, and birth defects. Roche continues to argue they did all they needed to do to ensure their patients were safe and have for many years continued to work in cooperation with the FDA and the American Academy of Dermatology.
F. Hoffmann-La Roche & Co. was founded on October 1, 1896, by Fritz Hoffmann-La Roche. Success came early to Fritz Hoffmann-La Roche when he recognized the importance of manufacturing medicines and the mass production of medications to fight disease. In fact, F. Hoffmann-La Roche & Co. became one of the first companies to specialize in the mass production of vitamins and derivatives, mass producing the first synthetic Vitamin C under the brand name Redoxon in 1934. By 1914 the company had expanded their business worldwide by opening subsidiaries in the United States, England, and Italy. The product inventory sold also expanded and by 1957 the company had introduced a class of tranquilizers called benzodiazepines. Over the next forty years the company successfully manufactured and sold other medications including cancer fighting drugs, antidepressants, tuberculosis medications, rheumatoid arthritis medications, medications to combat malignant tumors, medications for the prevention of gastric ulcers, and medications to help with transplant rejection, insomnia, and many more.
Although Accutane has many critics, many patients had great success with the drug. Accutane was effective at treating acne for many patients because of its ability to eliminate excessive oil production in the skin, eliminate clogged pores, and kill excess bacteria P., which can cause acne and inflammation. Unfortunately, users of Accutane did run the risk of suffering minor to severe side-effects. Roche increased their efforts to notify patients and created the iPLEDGE™ program. Under this program women were warned about the dangerous side-effects of using isotretinoin (Accutane) if they were pregnant or were planning to become pregnant. This program was Roche’s attempt to limit their liability from Accutane and provide adequate warnings of the risk of Accutane for the unborn. Unfortunately, women who did use the drug while pregnant substantially increased their risk that their baby would be born with severe birth defects. Under this program, doctors must be registered and activated with the iPLEDGE program and can only prescribe isotretinoin to registered patients.
Unfortunately, Accutane is not only potentially dangerous to the unborn. Patients also reported they suffered severe side-effects from the use of Accutane. Uncommon, more severe side-effects from the use of Accutane included depression, suicidal thoughts, increased pressure on the brain, and increased problems with the skin, pancreas, liver, stomach, bones, muscles, hearing, vision, lipids, allergic reactions, blood sugar, or red and white blood cells. While few patients suffered severe side-effects, most users did experience dry and chapped eyes, lips, and nose. All patients taking isotretinoin should be under the care of a doctor.