When the Food and Drug Administration (FDA) first approved Accutane for use in 1982, it also noted that the acne treatment -- taken orally and by physician's prescription -- should have a "category X" warning. This warning held that, for pregnant women considering the use of Accutane, its risks to the unborn baby greatly outweighed any possible benefit from using the drug during pregnancy.
Even so, after only nine months of consideration, the FDA approved Accutane's use as an acne treatment in May of 1982. And today, many who have taken the defective drug now need an Accutane lawsuit.
An official at manufacturer Hoffmann La Roche noted at the time that the FDA had provided it with a "fast-track approval" for the drug. In fact, this was the first Accutane approval given by any country in the world. The approval came so quickly that it took Roche an additional four months before it was ready to market and sell the acne medication, which began in September of 1982.
Just one year later, the Public Citizens Health Research Group petitioned the FDA to reconsider its warnings on Accutane packaging, stressing that they were inadequate. The group had found that Accutane was believed to cause not only birth defects, but also the bowel disease Crohn's Disease, along with spontaneous abortions and other health problems. It asked the FDA to require package inserts in non-technical terms to alert users of such problems. The FDA refused.
In the next several months, birth defects due to Accutane became more widely known, and the FDA and Roche in 1985 did require an upgraded warning on Accutane's packaging. In fact, this was a serious, so-called "black box" warning, the FDA's most severe action before demanding a product recall. Yet Accutane continued to be widely sold -- and deformed babies continued to be born.
By 1988, as birth defects continued, many citizens and journalists began questioning if the FDA had approved Accutane too quickly. However, even in view of serious Accutane side effects, the FDA did not require its recall, but rather again revised its warnings on Accutane's packaging. By working with physicians, the FDA achieved the result of having Accutane prescribed for far fewer pregnant women, which led to a decline in birth defects.
Accutane then became less of a focus by concerned health groups, and it remained on the market without as much rancor. Yet some still questioned whether the FDA was serving Roche, rather than protecting the public's best interests, in regard to Accutane.
In the past decade, Accutane also became known for its users committing suicide. This put more pressure on the FDA to control or recall it. It must be noted, though, that the FDA has no authority over patients or the physicians who continued to prescribe Accutane.
Eventually the FDA required physicians to get patients to sign consent forms before prescribing Accutane. Such forms described various health risks associated with Accutane.
Yet the FDA never has demanded a recall of Accutane. Rather, manufacturer Roche itself recalled and discontinued selling the defective drug in June of 2009. This occurred only after Roche was hit with multi-million-dollar jury verdicts in plaintiffs' behalf in Accutane lawsuits. Roche also may have stopped selling Accutane on the basis of competing generic drugs Sotret, Claravis and Amnesteem cutting into its market. All such acne medications have the active ingredient Isotretinoin, which is known to cause assorted health problems.
Roche also has withdrawn Accutane from 11 other international markets, although most other countries have been more restrictive and cautious from the start about allowing Accutane prescriptions than was the FDA in the United States. Indeed, Accutane still could be legally marketed in America if Roche had not withdrawn it, and generic Accutane products Sotret, Claravis and Amnesteem, while also harmful, continue to be sold.
This has not stopped Accutane victims from prevailing in Accutane lawsuits. If you believe you or a loved one were injured by Accutane acne treatment, notify an Accutane lawyer or defective drug attorney with Accutane Lawsuit Lawyer.com to explore an Accutane lawsuit. Simply fill out the free case evaluation form on this Web page or call toll-free to 1-800-339-0606 and launch the process of gaining your financial recovery from Accutane injury losses.