By Hilary White

ROME, July 30, 2009 ( – The Italian pharmaceutical regulator is expected shortly to approve the sale of the deadly abortion drug, popularly known as RU 486, under the brand name Mifegyne, according to the Italian daily La Repubblica. The Italian Pharmaceuticals Agency (AIFA) announced the impending approval on Wednesday.

The move by the AIFA comes despite restrictions in Italian law allowing only surgical abortion, as well as warnings of the danger of maternal deaths recorded in association with RU 486 around the world.

During a 2006 Rome conference of the International Federation of Professional Abortion and Contraception Associates (FIAPAC), the drug was touted as a “safe” alternative to surgical abortion. The manufacturer of RU 486 was among the sponsors of the conference. The health minister of the time, Livia Turco, reportedly sent greetings to the conference through Maura Cossutta, a Deputy of the Italian Parliament and a member of the Party of Italian Communists.

However, the decision to approve the drug comes despite extensive scientific literature showing its dangers. In 2007, the bimonthly magazine of AIFA reported on 9 deaths of women that have been associated with the drug, but recommended its approval nonetheless. A 2008 study was also forwarded to AIFA, published in the Italian Journal of Gynecology and Obstetrics, that reported 16 maternal deaths associated with RU 486, a mortality rate significantly higher than the surgical method. This report also cited the higher rates of complications associated with chemical abortions.

Shortly after the publication of this study, in February 2008, the Scientific and Technical Committee (STC) of AIFA gave a positive opinion about the drug, a step toward official approval for sale.

The approval is expected despite a warning by the STC that AIFA has “deemed it necessary to ask a series of measures to minimize risk, which include the use of the product in strict accordance with the approved indications and dosage, in full compliance with the provisions of Law 194 [that legalises abortion in Italy],” and “with use restricted to hospitals with an intensive monitoring of the use and adverse events.”

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