The treatment usually lasts 4 or 5 months, at a cost of about $3000, including lab tests and doctor's visits. The drug is manufactured by Roche Pharmaceuticals and is also marketed under the generic names Amnesteem, Claravis, Isotretinoin, and Sotret. The FDA estimates that about 100,000 prescriptions for the drug are written in the US each month.
In July 2005, the FDA posted an Action Alert on its web site that said, all patients treated with the drug should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.
The FDA advised patients to stop taking the drug and contact their healthcare provider right away if they experiences any of the symptoms mentioned in the alert.
Accutane has been marketed in Canada since 1983. As of December 31, 2005, Health Canada had received 29 reports of vascular disorders or myocardial infarction suspected of being associated with the use of the drug.
But most importantly, the drug should not be used by women who are pregnant, or who may become pregnant. There is an extremely high risk that serious birth defects will occur if mothers-to-be take Accutane in any amount, even for a brief period of time. Any fetus exposed to Accutane can be affected and there is no way to determine whether or not a fetus has been harmed.
According to the March of Dimes Foundation, birth defects known to be associated with Accutane include: hydrocephaly (enlargement of the fluid-filled spaces in the brain); microcephaly (small head and brain); mental retardation; heart defects; ear and eye abnormalities; cleft lip and palate; and other facial abnormalities.
Accutane can cause these birth defects in the early weeks after conception, a time when a woman often doesn't know she's pregnant, the March of Dimes warns.
Accutane came on the market in 1982, which means Roche and the FDA had more than 20 years to eliminate its use by pregnant women and they failed in that mission miserably.
Between 1982 and 2000, Roche has documented reports of 1,995 pregnancy exposures and 383 live births. Of those births, 162 infants were born with birth defects. And between April 1, 2001, and August 15, 2003, the FDA has reports of 325 known pregnancies in women taking the drug.
So its not as if Roche and the FDA were not aware of the on-going problem. Researchers have also been sounding the alarm for years.
The researchers found that about 25% of the babies had physical abnormalities such as ear and jaw malformations, asymmetric faces, and brain abnormalities.
And although physical abnormalities seemed to miss some children, the study found about half of the children suffered from learning disabilities.