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:

Email Newsletters

More in News

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union

Rep access continues to shrink

Rep access continues to shrink

Sales reps are experiencing even more limited physician access, according to a report by Chicago consultancy ZS Associates.

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% ...

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.