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

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...