The Food and Drug Administration ordered yesterday that a boldface label be put on packages of a popular birth-control patch, warning users that it exposes them to increased hormone levels putting them at higher risk for blood clots.
The move was widely hailed by relatives of women who have been debilitated or even killed by such clots.
They said it was a long-awaited acknowledgment that the Ortho Evra patch exposes women to greater dangers than standard birth-control pills.
“It’s a start. It doesn’t bring my granddaughter back, but it’s a start,” said Roberta Alloway, whose 18-year-old granddaughter, Zakiya Kennedy, died from a patch-induced clot on a city subway platform in April 2004.
“It will bring attention of this matter to other people who are using it, and that hopefully will keep more young women from dying,” she said. “Had it been there before, my granddaughter might still be here.”
The Post has run a series of articles detailing how dozens of women have been injured and killed by patch-produced clots.
Ortho-McNeil Pharmaceutical Inc., the New Jersey company that manufactures the patch, had long insisted its product was just as safe as standard birth-control pills.
But after the company submitted the results from the first of two epidemiological studies to the FDA, the warning label was ordered.
The bold label will say users can be exposed to as much as 60 percent more estrogen than if they used the pill, because it goes directly into the bloodstream rather than being digested first.
Amy Clark-Meachum, a lawyer for a Texas firm representing 30 women who’ve filed suit against Ortho-McNeil, says evidence shows that the number of serious incidents stemming from the patch was 14 times higher than those from the pill.
“There’s more that needs to be said by Ortho-McNeil,” she said. “It needs to be taken off the shelves.
“The longer this drug stays on the market, the more pulmonary embolisms we’ll see, the more strokes we’ll see.”
Ortho-McNeil says it will send detailed information about the warning to physicians, but stressed that the patch still “remains a safe and effective product, when used according to the product’s label.”
Kennedy’s grandmother said she doesn’t know why the company doesn’t just pull the patch from shelves.
“I don’t know what they’re waiting for. Maybe they haven’t made their quota or their money yet, or maybe not enough people have died yet,” she said.
lukas.alpert@nypost.com