E-DRUG: U.S. FDA on Anti-Acne Drug

[srahmad@essential.org]

E-DRUG: U.S. FDA on Anti-Acne Drug
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T98-9                       Print Media:          301-827-6242
Feb. 25, 1998               Broadcast Media:      301-827-3434
                            Consumer Inquiries:   800-532-4440


     IMPORTANT NEW SAFETY INFORMATION ABOUT ACCUTANE

FDA today is advising consumers and health care providers of new safety 
information regarding the prescription anti-acne drug Accutane 
(isotretinoin) and isolated reports of depression, psychosis and rarely 
suicidal thoughts and actions.

Accutane was approved in 1982 to treat only a very special type of acne -- 
severe nodular acne that has not responded to other therapies.

Although the Accutane label already included information regarding 
depression as a possible adverse reaction, the agency felt health care 
providers and others needed additional information as a result of adverse 
event reports the agency has received.

FDA and the drug manufacturer are strengthening this label warning, even 
though it is difficult to identify the exact cause of these problems. Such 
problems could already be more common among the patient populations likely 
to be on the drug.

However, because some patients who reported depression also reported that 
the depression subsided when they stopped taking the drug and came back 
when they resumed taking it, the agency and the manufacturer felt the
strengthened labeling was warranted as a precautionary measure.

Given the complex nature of depression and suicidal conditions, the new 
label information will advise health care providers that merely 
discontinuing the drug may be insufficient to remedy these adverse events, 
and that further evaluation may be needed.

In the event of Accutane-related adverse events, health care providers are 
urged to contact the manufacturer, Roche Laboratories at 1-800-526-6367 or 
FDA MedWatch at (phone) 1-800-FDA-1088, (fax) 1-800-FDA-0178 or (mail)
FDA, HF-2, 5600 Fishers Lane, Rockville, MD 20852.

Consumers seeking the latest safety information about FDA-regulated medical 
products also can find it at http://www.fda.gov/medwatch/safety.htm on the 
MedWatch Website.

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