New Restrictions on Accutane
April 12, 2002
The U.S. Food and Drug Administration (FDA) and Roche Pharmaceuticals have imposed new restrictions on prescription policies for the acne drug Accutane. Because the medication has been linked to severe birth defects in newborns, the new rules, which went into effect Wednesday, are designed to prevent pregnant women from using the drug.
The new restrictions require a potential female user to show a doctor two recent negative pregnancy tests and to agree to two forms of birth control or abstinence before being issued a prescription. Doctors may not prescribe Accutane for more than a one-month supply and must sign an agreement with Roche stating they will abide by the new rules. A yellow "qualifer" sticker, which will indicate to a pharmacist the patient has been approved to take the medication, must also be placed on all prescriptions. Pharmacists must not fill prescriptions for Accutane older than seven days or ones lacking a yellow sticker.
Accutane, approved by the FDA in 1982, has also been linked to depression and suicidal thoughts.
-- Article Courtesy of InjuryBoard.com
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