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Entries Tagged as 'Accutane'

FDA Imposes Stronger Rules for Accutane for Treating Severe Acne

August 15th, 2005 · No Comments

The Food and Drug Administration announced strengthen new regulations Friday for the acne drug Accutane-aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the drug, the Agency said.
Accutane (and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it […]

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FDA Increases Restrictions on Accutane

November 29th, 2004 · No Comments

The Food and Drug Administration on Tuesday unveiled new restrictions for Accutane, a drug indicated for the treatment of a specific type of severe acne that is not responsive to other therapies.
The goal of the strengthened risk minimization action plan (RiskMAP) for Accutane and its generic equivalents is to reduce the risk of birth defects […]

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Research Group Warns Pregnant Woman Against Acne Medicines

April 26th, 2004 · No Comments

Pregnancy and powerful acne medicines like Accutane don’t mix. That’s the message pregnancy counselors with the Organization of Teratology Information Services are trying to convey to pregnant women, health care providers, pharmaceutical companies, and decision-makers in the federal government.
OTIS, a nonprofit organization that conducts research and provides education on the effects of drugs and chemicals […]

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Consumer Group Tells FDA to Withdraw Accutane From Market

March 1st, 2004 · 13 Comments

Consumer advocacy group Public Citizen told a U.S. Food and Drug Administration advisory committee to withdraw the acne drug Accutane from the market. Accutane has been linked to causing birth defects.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, said the drug causes birth defects as malformations of the heart and brain, and can […]

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