GALS' PATCH PERILSep 21, 2006 | New York Post
Labels on a popular birth-control patch will be updated to warn women that the danger of blood clots in their legs and lungs are higher for them than for women using the pill, federal officials said yesterday.
The new warnings came months after a manufacturer settled dozens of lawsuits involving the patch and more than two years after a Manhattan fashion student collapsed and died after using one.
The move by the Food and Drug Administration follows a series in The Post which detailed the dangers associated with the trendy contraceptive and uncovered dozens of women who had died or been crippled after wearing the device.
The Post also revealed evidence that the manufacturer's chief researcher was hired in 2000 after faking hormone data in previous scientific studies for another company in the mid-1990s.
The FDA said it updated the label on the Ortho Evra birth-control patch to reflect the results of a recent study that said women using the patch faced twice the risk of clots as women on the pill.
The patch, which is worn on the skin, delivers pregnancy-blocking hormones. It's replaced once a week and is viewed as more convenient than daily pills.
In April, 2004, aspiring model Zakiya Kennedy collapsed on a Midtown subway platform and died from a blood clot in her lung.
The medical examiner blamed the patch, which the 18-year-old had worn briefly.
Kennedy's family filed a multimillion-dollar wrongful-death suit which is still pending against the manufacturer's parent company, Johnson & Johnson, and Mount Sinai Hospital, where a doctor prescribed the patch. They applauded the new label.
"That's a good thing that they updated it," said Kennedy's grandmother, Roberta Alloway. "That should help get the message across that it's a dangerous product."
Alloway said her ultimate goal is to get the product off the market entirely. In the meantime, she said she hopes the new label is easy to read and understand.
"Unfortunately, my granddaughter had to die to bring it to the forefront," Alloway said.
The FDA said it was issuing the updated label despite conflicting results from another study that there was no added risk in using the patch instead of the pill.
"Health-care providers need to balance the risk of higher estrogen exposure with Ortho Evra with the risk of pregnancy if the pill is not taken daily." said Dr. Daniel Shames of the FDA.
Researchers believe estrogen may promote coagulation of the blood, which can result in clots that cause heart attacks or strokes.