Contraceptives Under Fire - Pharmaceutical Executive

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Contraceptives Under Fire


Pharmaceutical Executive

For companies producing contraceptives, April brought good news and bad news. The good news for Schering AG is that the UK anti-abortion group, the Society for the Protection of Unborn Children, lost its latest legal battle to stop over-the-counter sales of the company's "morning after" pill. SPUC claims that Schering's Levonelle (levonorgestrel) is not a contraceptive but an abortifacient and, therefore, should not be taken without the written consent of two doctors. Levonelle has been available in the United Kingdom without a prescription since December 2000.

High court judge Justice Munby threw the judicial review out, confirming that Levonelle is, indeed, a contraceptive. Ruling that all decisions about contraception should be left to the individual, he also denied SPUC leave to appeal and directed the group to pay legal costs for both the government and Schering.

A second Schering contraceptive faces problems in Holland following reports that it increases the risk of deep vein thrombosis. Out of 40 cases of DVT reported in women taking Yasmin (drospirenone/ ethinyles-tradiol), two proved fatal. Although no definite link with Yasmin has been shown, the Dutch medicines evaluation agency has asked the company to include a safety warning in Yasmin packets. Even before its approval, the agency had asked for further research on the product's side effects. Schering AG is still awaiting the results of a three-year study in 3,000 women.

Schering maintains that Yasmin is safe and estimates it has been used by half a million European women since its approval in late 2000. The company's own post-marketing studies show that, in its first year of use, only one Yasmin user suffered DVT, compared with five among women taking other oral contraceptives.

The April issue of the Lancet revealed further bad news for oral contraceptives. Studies by the International Association for Research on Cancer show the first solid evidence of a link between long-term use of the pill and cervical cancer.

The paper reported that women infected with the human papilloma virus who had taken the pill for five to nine years were almost three times as likely to develop cervical cancer as HPV-positive women who had taken the pill for shorter lengths of time. The rate rose to four times as likely in women who had taken the pill for a decade or more. Previous research indicates that HPV is present in all cervical cancer cases and, in fact, causes the disease. But not all women who test positive for HVP develop cancer. The new studies indicate that oral contraceptives may play a role in the progression.

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