The warning comes following testimony before the U.S. Congress in which several parents indicated that they believe their children's suicides were linked to Accutane. In addition, the FDA reports that since the drug was placed on the market the agency has received 66 reports of suicide by patients taking the medication. Also, the agency has collected about 1,400 reports of adverse psychological events suffered by Accutane users.
In order to address this concern, the FDA is requiring Hoffman-LaRoche, the manufacturer of the prescription acne drug, to issue strenthened warnings indicating that the drug may be linked to suicidal thoughts and actions. Hoffman-LaRoche will be required to include information about the risks on consent forms that are to be signed by each patient taking the drug.
Under the new FDA guidelines, each person currently taking Accutane will receive a medication guide. The guide will outline the drug's potential side effects, including those associated with psychological problems. The FDA only issues medication guides with those products that pose serious side effects and significant public health concerns. Thus, the agency only provides about 10-15 such guides each year.
The acne medicine will also now come with a modified consent form. The new consent form will warn Accutane users that the drug may be linked to suicide. It requires patients to disclose to their doctors any personal or familial history of depression, psychosis, suicidal behavior, or other serious mental health problems. Patients under the age of 18 will also be required to obtain the signature of a parent or guardian in order to receive the prescription.
Patients on Accutane will also be required to visit the doctor's office more often under the new guidelines, in order to detect any potential adverse effects early. Doctors will be required to meet with patients monthly to monitor patient progress for continued use. Patients are also instructed to cease using the medication if they experience feelings of sadness, crying spells, loss of interest in normal activies, unusual fatigue, difficulty concentrating, changes in normal sleep patterns, irritability, appetite loss, withdrawal from friends and family, or thoughts of inflicting harm to self or others.
This is the third labeling change--designed to increase awareness of potential psychological side effects--that Accutane has undergone since being marketed in the United States. However, the FDA maintains that insufficient data exist to establish a causal link between Accutane and suicide. The manufacturer of Accutane also claims no evidence exists establishing such a link. Hoffman-LaRoche claims that the drug does not seem to cause the types of psychological changes in the brain necessary to cause depression.
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