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CBS Evening News (US), July 17, 2005

Concerns over the safety of the birth control patch

MIKA BRZEZINSKI, anchor:

The birth control patch has been on the market for several years now, but an Associated Press review released today indicates women who use them may suffer from more blood clots than women who take the pill. Kelly Cobiella is here with more on that. Kelly, that doesn't sound too good.

KELLY COBIELLA reporting:

No, it doesn't Mika. And actually, this is not the first time we've reported on possible problems with the patch, but this AP study is the largest look yet, reviewing thousands of adverse reaction reports sent to the government in the two years since the patch hit the market.

The patch is one of the most popular forms of birth control on the market today, used by four million women. Dr. Wendy Wilcox says the reason is simple.

Dr. WENDY WILCOX (Montefiore Medical Center): Women can put it on and not think about their birth control for a week.

COBIELLA: Convenience that does not come without risk. Hormonal contraceptives like the pill have long been known to cause blood clots in certain women. The question now, is that risk higher using the patch? The Associated Press reviewed 16,000 reports of drug adverse reactions to Ortho Evra, submitted to the Food and Drug Administration in the past two years and found 17 cases of women who died from blood clots believed to be related to the patch. All were in their late teens and early 20s and apparently at low risk for blood clots.

In a statement to CBS News, the maker of the patch, Ortho-McNeil, said its product is safe and the reports `are consistent with the health risks of other hormonal birth control methods.' And the company questions the AP's conclusions, saying, they are not based on science but on `spontaneous reports.' The FDA agrees, telling CBS news, the `data is not precise enough to tell whether there is or isn't an increased incidence' of fatal blood clots. Dr. Wilcox's advice?

Dr. WILCOX: I think every patient who's on the patch should, if they are concerned, talk to their doctor about it, find out what their own individual risk factors are.

COBIELLA: Most doctors and the FDA say there is no reason to stop using the patch altogether, because for the vast majority of women using it, it is both effective, Mika, and safe.

BRZEZINSKI: OK. But clearly, there's still some debate here, but do doctors have any idea what might be causing these problems?

COBIELLA: No, but they do speculate. One of the reasons could be the dosage or the way it's absorbed through the bloodstream as opposed to through the liver, with traditional oral contraceptives. Either way, the way to find out is through a clinical trial, and as yet, no plans for that.

BRZEZINSKI: All right. Kelly, thank you very much.

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