Accutane is a prescribed drug which is used to cure severe types of cystic acne which is considered as one of the common types of skin disease. It is produced in the USA by a department of Hoffmann-LaRiche, Inc., and was granted approval by the US Food and Drug Administration or US-FDA in1982. Accutane is a product name for the generic drug called isotretinoin. There are known benefits of Accutane but records show that it causes some birth defects when the drug is taken by pregnant women. There have been several lawsuits against this Accutane that claimed some links between the acne drug and depressive or suicidal behavior of an individual.
Known Side-Effects that Cause Birth Defects
It was reported then, that before the approval given by the US-FDA, there have been studies that indicated that Accutane can result to birth defects in animals. It was labeled as “Category X” which means that the acne drug must not be taken by pregnant women in all circumstances. Roche gave warning through its label against the use of Accutane by pregnant women, however, there still have been reported cases of birth defects due to Accutane. It was in 1988 when the company developed a voluntary program to stop pregnancies while taking the Accutane medications, which they call as Accutane Pregnancy Prevention Program or PPP.
Roche then, delivered PPP kits to physicians and asked them to review the material with the patients before prescribing Accutane. The materials include a booklet on contraception, consent forms for the patients to affix their signature, accepting their knowledge and understanding of the chances of birth defects which are related to the usage of Accutane. Roche went further into sponsoring a survey to evaluate the compliance of the program. He started packing Accutane in bubble packs which includes warnings which are in red and black, a picture of a deformed infant, and the symbol of “Avoid Pregnancy.” He also created a toll-free telephone line which is available in 13 languages and offered to pay the healthcare specialist for the contraceptive counseling and pregnancy testing conducted by them.
Roche created a toll-free telephone line, offered contraceptive information in 13 languages and proposed to pay an expert for contraceptive counseling and pregnancy testing. However, the 1999 survey results revealed that from 500,000 women who used Accutane from the period of 1989 to 1998, there were 3 out of 1,000 women who became pregnant. The US-FDA then asked Roche to make more changes in their labeling.
It was in April 10, 2002 when Roche launched a new program called System to Manage Accutane Related Teratogenicity or SMART. It was intended for women who were unable to avoid pregnancy. Roche started to deliver pregnancy tests to physicians so that to obtain Accutane prescription, the woman-patient must undergo two negative pregnancy tests and should pledge to use two types of birth control one month before the acne treatment until at least one month after the treatment is completed. She must read and sign a consent agreement where it describes the chances of birth defects which are related to the use of the drug. Then a Yellow Accutane sticker will be attached to the prescription and only prescriptions with this sticker attached will be accepted.
Since April 2004, the US-FDA is checking on the need for more protection from the use of Accutane and the chances of birth defects. There was one recommendation that let Accutane prescriptions only for patients who can be monitored on the national registry.
Side Effects: Depression and Suicidal Behavior
The inclination of several patients to be depressed and show suicidal behavior is another serious side effect of Accutane treatment. Between 1982 and May 2000, US-FDA got some reports that 37 Accutane patients in US committed suicide where 24 were still in the treatment and the 13 other patients committed suicide after the treatment. It also received some reports that there were 110 US Accutane takers were brought to the hospital for depression, suicide attempts, and suicidal ideation. There was another report that revealed that there were 284 Accutane users are with non-hospitalized depression.
Studies also gave hints that there is a relation between the vitamin A and depression. Chemically similar to vitamin A, there seem to have a reason to think that there is a link between taking Accutane and acquiring depression. With several studies that were made, still there is no scientific proof that Accutane can cause depression. However, FDA still sent letter to doctors giving them warning that taking Accutane may cause chances of acquiring depression and suicide.
The concern brought national issue in May 2000 when the son of Rep. Bart Stupak of Michigan committed suicide. The congressman pointed that the Accutane was the cause of his son’s death as he was never depressed before taking the acne drug. It was in December 2002 when Stupak said before the Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee, that taking Accutane was still uncontrollable and request that FDA must monitor and regulate strictly the Accutane drug.
Another famous incident happened in April 2002 when the mother of a young boy who flew a small aircraft an office in Florida filed a $70 million for unjust death and negligence against the Hoffmann-La Roche Inc. The case which was filed in Hillsborough County Circuit Court pointed that Roche was the reason for the suicide of a 15-year old named Charles Bishop caused by serious psychiatric side effects of daily dosage of Accutane drug which Charles Bishop was using since April 2001.
Roche added to the label of Accutane in stronger warning about the potential psychiatrist about the chances of psychiatrist issues in February 2002. He later launched a brochure named “Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane (isotretinoin).” Roche continues to claim that there is no mental health issue relating to Accutane.
Other Options to Accutane
Accutane patent was expired in February 2002 and in November 11, 2002, Genpharm declared that FDA granted them approval of its isotretinoin products. Bertec Pharmaceuticals sells the drug under the brand name of Amnesteem. It contains the same warnings with the Accutane. In February 2003, Ranbaxy Pharmaceuticals Inc. started to market isotretinoin under the brand title Sotret. Every producer developed their own controlled distribution and necessitates them to put the warning stickers on the prescription before dispensing. Then, Barr Laboratories launched a generic isotretinoin in April 11, 2003 and was approved by FDA. It is distributed by Claravis.
Get Help Now
Almost all medications have its own potential side effects and drug producers have is responsible to inform doctors sufficiently about the known risks relating to the drug. If the producer fails to do this, he/she is held responsible to the patients who are hurt due to insufficient warnings and under the legal theory called “product liability.”
If you or your loved took Accutane and experienced some side effects or suffered some injuries, you must visit your doctor for appropriate medical attention. Then, contact an experienced lawyer who will evaluate and safeguard your legal rights.
Click this to know more about the lawyer’s crucial role in a product liability case.