THE VIRGINIAN-PILOT
Copyright (c) 1997, Landmark Communications, Inc.
DATE: Saturday, January 18, 1997 TAG: 9701180519
SECTION: FRONT PAGE: A2 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: 38 lines
Bristol-Myers Squibb recalled 150,000 packages of the birth control pill Ovcon 35 on Friday because of a packaging mix-up that the government says could put certain women at significant risk of pregnancy.
Bristol-Myers tried to play down the recall, calling it unlikely that a woman would get pregnant as a result of the mix-up.
But the pills' own labeling advises women to use a back-up contraceptive to be safe - and after the Food and Drug Administration analyzed the recall Friday afternoon, it concluded that women who don't notice the mix-up would be left without adequate protection.
``They're at significantly higher risk of pregnancy,'' FDA contraceptive chief Lisa Rarick said.
Only Ovcon 35's 28-day formula is involved in the recall.
The Ovcon 35 comes in a blister-pack with four rows of seven tablets. The rows represent weeks, and the tablets are to be taken in order. The first three rows of peach-colored tablets contain the birth control, while the last row contains green-colored dummy pills that are taken during menstruation.
About a half-dozen packages have been discovered in one Ovcon batch that had the green dummy pills positioned to be taken during Week 1 instead of Week 4, Bristol-Myers said.
Under the recall, women who have packs from Lot H6J272A may return them to their pharmacies for a free replacement.
Check the pills' colors, the FDA advised.
Only pill veterans who take another week of green pills after menstruation instead of starting the active ones are at risk, Rarick said. Women whose recalled Ovcon was their first-ever birth control would be under doctors' orders to use a back-up contraceptive that month anyway, she said. MEMO: Call Bristol-Myers at (800) 332-2056.