Britain 'too hasty' over Pill warning

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The Independent Online
European drug authorities are split over the safety of the Pill, with the majority believing that Britain has been too hasty in its action to alert women to possible blood clot dangers of some brands of the oral contraceptive.

As the latest Pill scare showed no signs of abating last night following a Commons statement by Stephen Dorrell, the Secretary of State for Health, lawyers said at least 100 more women had come forward claiming serious illness after taking one of the seven newly designated "high-risk" brands. The number of potential legal actions against drug companies is now around 300.

An emergency meeting has been called by the European Agency for the Evaluation of Medicinal Products for later this week in an attempt to reach some consensus on prescribing, with representations from scientists and pill manufacturers.

British and German pressure for the agency to issue a strongly worded statement against the use of Femodene, Femodene ED, Triadene, Minulet, Tri-Minulet, Mercilon and Marvelon, is intense but some countries have no intention of supporting them.

The Committee on Safety of Medicines, the Government's drug watchdog, last week said women should change to another brand of Pill where possible. In Germany, where some of the initial research into these Pills began in the late Eighties, BfArM, the drug regulatory authority, has been pressing for a total ban on Femodene for some months. Last night the Federal Institute for Pharmaceutical and Medical Products in Berlin issued a warning to a million German women taking the Pill. However, the Agence du Medicaments, the equivalent body in France, said yesterday that "no user restrictions can be defined as yet".

Data from three trials showed that Pills containing the progestogens, desogestrel and gestodene, have twice the risk of venous thrombosis of older Pills, but the Dutch, Belgian and Swedish authorities believe that the British action was premature.

They say other data from the same studies due in four to six months time is expected to show that the protective effect of the "high risk" Pills against heart disease and stroke will far outweigh the thrombosis risk.

"It is possible that between five to nine lives could be saved from heart disease and stroke compared with one to two lives lost from thrombosis," one senior source said.

In the Commons Harriet Harman, Labour's health spokesman, said the Government's response to the Pill alert had been "woefully inadequate". GPs were not notified in advance and a helpline was swamped by calls.

However, Mr Dorrell defended his department's action: "We are dealing with people's lives, not the stuff of party politics," he said. "We are simply not able to carry on a cosy correspondence between the Secretary of State and 190,000 health professionals." Mr Dorrell promised a review of the alert procedures.

Rosalie Houghton, the solicitor co-ordinating action on behalf of Pill victims, said: "We certainly believe the CSM's announcement has strengthened our case. I would say it confirms our initial suspicions that these particular drugs were causing an increased incidence of thrombosis."

Mrs Houghton said the lawyers wanted to hear from as many women who think they may be affected as possible.

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