The expert group refused to bow to British and German pressure to warn millions of women to stop taking them because of fears of blood clotting. The advice of the Committee for Proprietary Medicinal Products (CPMP) is not binding on the 15 national drug regulatory authorities of members of the European Union - many of whom disagreed with the British decision - but will certainly influence guidance locally in these countries.
Schering Health Care, which makes three of the Pills designated "unsafe" by British drug authorities, welcomed the CPMP's decision. "We are very pleased that the CPMP have reinforced the company's confidence in its products but we retain our surprise and disappointment at the [Government] decision last week."
The Committee on Safety of Medicines last week advised 1.5 million women taking Pills containing the synthetic progestogens, desogestrel and gestodene, to change to another brand. Three independent studies had found that these Pills had twice the risk of venous thrombosis than other brands containing different progestogens.
The CSM's decision has been widely criticised by doctors, family planning experts and scientists who say that the decision was "premature and irresponsible," causing widespread anxiety in women. It has also been suggested - and denied by the Department of Health - that the increased cost of the new Pills was a driving force in the decision.
Following a two-day meeting in London, CPMP experts said: "In view of its benefit/risk re-assessment, the CPMP did not consider it appropriate to withdraw combined oral contraceptives containing gestodene or desogestrel."
The committee agreed that the three studies "indicate a somewhat greater risk of non-fatal venous thrombembolic events" but pointed out that the risk of blood clots with all combined oral contraceptives is still "substantially" less that that in pregnancy.
The statement reminded doctors and women of the existing contra-indications for the use of combined oral contraceptives including a history of or existing venous thrombosis, cerebrovascular or cardiovascular diseases; obesity, and varicose veins. .
The committee has asked the three main Pill manufacturers, Schering, Organon and Wyeth, to provide more data on the safety of their products before the end of the year, and said it would review it by April 1996, when further advice would be expected.
A spokesman for the Department of Health said that it welcomed the CPMP's conclusion that there is a twofold increase in clotting risk with the Pills. "This is consistent with the advice we have taken steps to pass on."Reuse content