Complex drug labels bury safety message

Article Abstract:

The Food and Drug Administration is working hard to improve package inserts in drug bottles by making them 'more user-friendly, more informative and more consistent. Critics say that inserts, which are supposed to provide information on the risks and benefits of drugs, makes prescribing complicated and confusing because they are printed in tiny typeface and medical jargon. Even doctors and FDA's expert advisers ignore package insert intructions, which could result in patients becoming sick or dying.

Drugs

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RU-486 may face FDA limits

Article Abstract:

Abortion rights activists claim the FDA intends to impose major restrictions on 'abortion pill' RU-486 before approving its sales in the US. Paul Blumenthal, medical director of Planned Parenthood of Maryland, says the FDA wants to track the use of RU-486 from the factory to medical offices and then to the patients. On the other hand, National Abortion Federation Dir Vicki Saporta believes few doctors would prescribe the drug because of the numerous restrictions being planned by the FDA.

Pharmaceutical Preparation Manufacturing, Contraceptive Hormones NEC, Hormones, Contraceptives

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RU-486 met with praise and condemnation

Article Abstract:

The FDA has finally approved on Sep 28, 2000 the abortion pill RU-486. The go signal came after more than four years since the non-profit Population Council, which owns the US rights to the drug, applied for FDA approval in Mar 1996. Danco Laboratories, which has been licensed by the Population Council to distribute and market RU-486 under the name Mifeprex, said that the drug will be available within a month.

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