To the over 4 million Ortho Evra "birth control patch" users: news about two new studies.
We wrote last November about the FDA's new warning labels:
The new bolded warning specifically states that women who use Ortho Evra are exposed to about 60 % more total estrogen in their blood than if they were taking a typical birth control pill containing 35 micrograms of estrogen...The manufacturer, Ortho McNeil Pharmaceuticals is conducting additional studies to compare the risk of developing serious blood clots in women using Ortho Evra to the risk in women using typical birth control pills...Apparently, two such studies recently were reported by the FDA; here's CBS and Yahoo coverage: "Danger Lurking In Birth Control Patch?" and "Birth-Control Patch Users Face Clot Risk."
Randolph E. Schmid, Associated Press Science Writer, and AP's Andrew Bridges, wait until the second-to-last paragraph of their two-page article to say,
The investigation by The Associated Press found that patch users die and suffer blood clots at a rate three times higher than women taking the pill. About a dozen women died in 2004 from blood clots believed linked to use of the patch, the AP reported. Dozens more suffered strokes and other clot-linked problems.AP clings to the same misinformation campaign we quoted last November:
The Associated Press used the Freedom of Information Act (FOIA) to obtain adverse drug reaction reports for Ortho Evra from the FDA and reportedly found that of the 23 cases in which death was the outcome, doctors reviewing the cases found 17 that appeared to be blood-clot-related, including 12 from last year.Twenty-three deaths, not just 17, not just 12. Yet they get us thinking small by only reporting one year, or only one resultant mechanism of death.
Since the FDA estimates that it receives reports of only between 1% and 10% of the serious adverse drug reactions that actually occur, the death rate for Ortho Evra may be significantly higher.
This week's articles report that
One new study found users of the Ortho Evra patch had twice the risk of clots compared with women taking birth-control pills, although a second analysis found no difference in risk between the two forms of birth control.They caution that these are interim results that require further interpretation, so one assumes the final evaluations could get better, get worse or remain the same.
Stay tuned to this Bat Channel for that news when it comes out.
Our original coverage of this health news was posted September and October 2004, and I believe Christina at RealChoice had covered it even before we did. We also had some lively discussions going on at Em's post A Hard Pill To Swallow, about why the birth control pill has been abandoned by former users.
For anyone who'd like to DYOR on how this mess all began, here's the FDA webpage for the original Approval Package for this product, including Medical Reviews, Chemistry Review(s), Pharmacology Review(s), Statistical Review(s), Microbiology Review(s), Clinical Pharmacology Biopharmaceutics Review(s) and other various and sundry documents.
And while I'm certainly no fan of ambulance chasers (and thus won't hotlink them), I accidentally found four law firms with this story on their websites:
Sadly, the lawsuits have already begun.
posted by Annie @ 7:31 PM 
