Accutane, a drug developed to fight the most severe cases of nodulocystic acne, has been implicated in a number of side effects far more devastating than the condition the drug is prescribed to treat.
Further, it appears that Hoffman-LaRoche, also referred to as Roche Laboratories, was aware of many of these severe side effects before the drug was even approved, and callously and intentionally sought to hide data showing the serious and often deadly effects of the drug.
In fact, since its introduction in 1982, Accutane has been responsible for more damaging side effects reported to the FDA than any other drug, and these side effects have been responsible for over twenty changes to Accutane labeling since the drug was introduced.
Some of the side effects linked to use of Accutane include the following:
- Suicidal ideation, suicide attempts, and suicide
- Severe birth defects and fetal death
- Irritable Bowel Syndrome (IBS)
- Inflammable Bowel Disease (IBD)
- Other side effects
One of the most publicized and most disturbing side effects of Accutane has been the psychological effects that have been linked to the drug, including depression, psychosis, suicidal ideation, suicide attempts, and completed suicides. Thus far, at least 240 cases of suicide have been linked to Accutane use—a number that the FDA estimates may represent as little as 1% of actual cases.
Making these allegations even more disturbing is the fact that Roche, the drug’s manufacturer, not only sought to avoid admission of this side effect, but in much of their marketing material, they appear to have tried to establish the opposite—that Accutane had positive psychological effects because it helped cure acne.
At least as early as 1985, Roche is known to have been aware of the damaging and often fatal effects of Accutane. Yet it was not until fifteen years later, in 2000, that Roche added sufficient warnings to their packaging material, fully disclosing the potential psychological effects of the drug.
Severe Birth Defects and Fetal Death
Even before Accutane’s initial FDA approval in 1982, Roche Laboratories was aware that the use of the drug had potentially serious effects to pregnant women and their fetuses. Following the drug’s approval and introduction, reports of Accutane-related birth defects were being reported to the FDA, leading the consumer group Public Citizen to petition the FDA to require serious warnings about this danger on Accutane’s labeling.
By 1990, the FDA estimated 900 to 1,100 cases of birth defects could be directly attributed to Accutane use, and that Accutane use was also responsible for 11,000 to 13,000 cases of fetal death, or miscarriage.
In 1998, the FDA issued a memo concluding that Roche had not acted in good faith in warning the public about these side effects, but it was not until the FDA threatened to remove Accutane from the market that Roche finally conceded to include warnings about its potentially dangerous effects for pregnant women.
In 2000, as a result of consumer and regulatory pressure, Roche introduced a program called S.M.A.R.T. (System to Manage Accutane Related Teratogenicity), in cooperation with the FDA, designed to reduce the incidence of birth defects and miscarriage as a result of Accutane use by pregnant women.
Despite these measures, however, as recently as 2002, the FDA has concluded that pregnant women are not being warned sufficiently of the potentially damaging effects of Accutane, and has encouraged efforts to increase awareness of these issues, and reduce the number of Accutane related birth defects and miscarriage significantly.
Irritable Bowel Syndrome (IBS)
Irritable Bowel Syndrome (IBS), sometimes referred to as spastic colon or Inflamed Bowel Syndrome, is a condition in which patients suffer from various degrees of gastrointestinal difficulty, resulting in diarrhea, constipation, or both, in alternating patterns.
Despite many clear evidence of a strong correlation between IBS and Accutane use, current regulations only require voluntary reporting of this potential side effect, meaning that health professionals prescribing Accutane to their patients are not required to inform the patient of this risk.
A related side effect of Accutane is Inflammable Bowel Disease (IBD), which is much more severe than IBS.
Lupus is an incurable autoimmune disorder that causes a patient’s autoimmune system to attack their own tissue, resulting in severe pain, fatigue, weakness, hair loss, swelling, and other symptoms. Although there is strong evidence showing correlation between Accutane use and lupus, Roche Pharmaceuticals has yet to include any warning on their packaging about this side effect.
Other Reported Side Effects
In addition to these, Accutane use has been implicated in a number of other side effects as well, including:
- Damage to the central nervous system
- Bone and muscle damage
- Hearing and vision problems
- Liver, kidney, and pancreas damage
- Skin problems
- Crohn’s disease
- Ulcerative colitis
- Rectal bleeding
- Damage to the central nervous system
What To Do
If you or a loved one has suffered from side effects of Accutane that you were not sufficiently informed of, seek medical attention for any ongoing medical issues, and contact an Accutane attorney in your area with experience in dealing with drug company liability.
You and your family deserve compensation for the damages you’ve suffered as a result of negligence and disregard for your health.