Three drug companies have told the Food and Drug...

WASHINGTON -- Three drug companies have told the Food and Drug Administration they will no longer sell high-dose birth control pills containing more than 50 micrograms of estrogen after Oct. 31, the FDA said Thursday.

The companies, G.D. Searle and Co., Ortho Pharmaceutical Corp. and the Syntex Corp., are sending letters to doctors giving them six months notice that they will discontinue distributing pills with more than 50 micrograms of estrogen after Oct. 31.


'At the end of October, pharmacies can return for credit or sell what's on their shelves,' of their stocks of the discontinued pills, FDA spokeswoman Susan Cruzan said.

The pills being phased out -- Norinyl 2 and Norinyl 1 +80 by Syntex; Enovid E-21 and Ovulen by Searle; and Ortho-Novum 1/80 and Ortho-Novum 2 mg by Ortho -- contain 75 to 100 micrograms of estrogen, while the most commonly prescribed pills today contain 30 to 35 micrograms of the female hormone, the FDA said. A microgram is one one-thousandth of a milligram.

Patients who switch to a lower-dose pill may experience some light bleeding while they adjust, the FDA said.

The agency's Fertility and Maternal Drugs Advisory Committee concluded three months ago that high-estrogen pills are no more effective than low-dose pills, and that they appear to contribute to a greater risk of heart attack, blood clots in the lung and legs, and stroke.


'I applaud the responsible decision of these manufacturers,' said FDA Commissioner Frank Young in a statement. 'Low-dose contraceptives are quite safe and for healthy young women are considered to be the most effective, reversible means of preventing pregnancy.'

Currently, the FDA said, about 400,000 women in the United States use high-estrogen pills, the FDA said.

The first birth control pill, Enovid 10, containing 150 micrograms of estrogen, was approved in 1960. Since then, manufacturers have progressivly decreased the estrogen and progesterone content of oral contraceptives.

Since 1970, the FDA has recommended doctors prescribe the lowest dose estrogen pill possible for patients.

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