Friday, Aug. 17, 1962

The Pills

Whether the American woman was seeking motherhood or trying to avoid it, she was subjected last week to nerve-racking reports about drugs she might be taking:

FOR CONTRACEPTION. The million or so women who have been using the new pills to avoid conception were victims of frightening reports from Britain and Norway. Several women in the U.S. and Britain have suffered from thrombophlebitis while taking norethynodrel,*and a few have died, said the British Medical Journal. In Norway, health authorities read the British report and hastily yanked the drug off the market.

Fact is, each year one out of every thousand women under 45--regardless of whether she is taking Enovid, or aspirin, or no drugs at all--will have an attack of thrombophlebitis. In a few of these cases, a blood clot from an inflamed leg or pelvic vein will travel to the lungs and cause serious illness or death. The danger that this will happen is known to be markedly greater in pregnant women.

At least 50,000 U.S. women have been watched carefully by their doctors while taking Enovid, and no ill effects have been reported. Though the Food and Drug Administration is studying the cases of women who developed thrombophlebitis while taking Enovid, it sees no proof yet of cause and effect, and no cause for alarm--only the need for caution.

DURING PREGNANCY. How narrow was the U.S. escape from the epidemic of malformed thalidomide babies became clear last week when Health, Education and Welfare Secretary Anthony Celebrezze announced that thalidomide (U.S. trade name: Kevadon) had been given to 15,900 U.S. patients, including 3,200 of child-bearing age, at least 207 of whom are known to have been pregnant. Most of the 207 women have had their babies, and apparently they did not take thalidomide in the second month of their pregnancies when it would have been harmful. As yet, no malformations have been reported.

For the future, said Celebrezze, the rules for testing new drugs should be tightened to provide that: > Manufacturers give FDA full details about distribution of drugs to doctors for investigational use in human beings. > Human tests shall begin only after extensive animal tests, and then must be executed by qualified investigators. >Manufacturers must notify FDA and all investigators immediately if a substantial doubt develops about a drug's safety, and FDA should have the power to stop further trials of the drug.

FDA, said the new Health Secretary, will issue such rules in about 60 days.

*Marketed in the U.S. by Chicago's G.D. Searle & Co. as Enovid; in Britain as Conovid, and in other countries as Enavid. A related British drug is Anovlar.

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