FDA calls for label revision on Ortho Evra birth-control patch

Share this article:

The FDA announced a revision to the labeling for the Ortho Evra birth-control patch, warning that women taking the drug may be exposed to 60% more estrogen than if they were taking a typical 35 microgram estrogen birth-control pill, levels that could lead to blood clots and strokes in patients.
The label change will include a new bolded warning about the higher exposure to estrogen, the agency said.
A spokeswoman for Ortho-McNeil Pharmaceuticals, the Johnson & Johnson subsidiary that manufactures the drug, told the Associated Press that the warning speaks for itself and that the companies have been cooperating with the FDA, which is distributing the warning to
healthcare providers.
In July, 10 women filed a lawsuit against J&J's Ortho-McNeil claiming the patch caused them to suffer strokes and blood clots. The lawsuit alleges the patch is "defectively designed" and "unreasonably dangerous."
In September the consumer advocacy group Public Citizen added Ortho Evra to its list of allegedly dangerous medicines, arguing that there is "no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood and equally effective oral contraceptives."

 

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.