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Although it’s often difficult to prove that a drug is the direct cause of a side effect, many pharmacists prefer to err on the side of caution and assume that the cause-and-effect relationship exists.
That’s the case with isotretinoin (Accutane) and its potential link to depression and suicide, as explained in a recent letter from Janet Woodcock, MD, director of the Center for Drug Evaluation and Research. As Woodcock’s letter points out, "When there is reasonable suspicion of an association, patients should be informed." (Read the full letter at www.fda.gov/cder/drug/infopage/accutane/default.htm.)
Pharmacists can help confirm patient understanding of all aspects of isotretinoin use when they counsel patients at the time of dispensing the drug. A revised informed consent form has been created for patients and parents or guardians of patients younger than 18 prior to the beginning of treatment with isotretinoin. The consent form addresses the possible link between the drug and depression or suicide. Included in the consent form is the following language:
• I understand that some patients, while taking Accutane or soon after stopping Accutane, have become depressed or developed other serious mental problems. Signs of these problems include feelings of sadness, irritability, unusual tiredness, trouble concentrating, and loss of appetite. Some patients taking Accutane have had thoughts about hurting themselves or putting an end to their own lives (suicidal thoughts). Some people tried to end their own lives. And some people have ended their own lives. There were reports that some of these people did not appear depressed. No one knows if Accutane caused these behaviors or if they would have happened even if the person did not take Accutane. Some people have had other signs of depression while taking Accutane (see below).
• Before I start taking Accutane, I agree to tell my health care provider if, to the best of my knowledge, I have ever had symptoms of depression (see below), been psychotic, attempted suicide, had any other mental problems, or take medicine for any of these problems. Being psychotic means having a loss of contact with reality, such as hearing voices or seeing things that are not there.
• Before I start taking Accutane, I agree to tell my health care provider if, to the best of my knowledge, anyone in my family has ever had symptoms of depression, been psychotic, attempted suicide, or had any other serious mental problems.
• Once I start taking Accutane, I agree to stop using Accutane and tell my provider right away if any of the following happen. I: