FDA Recommends Label Changes for Yaz, Ortho Evra Over Blood Clot Risks


An advisory panel of the Food and Drug Administration (FDA) recently recommended warning label changes to popular birth control products, including the prescription drug Yaz and the Ortho Evra birth control patch.

In response to increasing evidence that some birth control pills, including Yaz, cause an increased risk for blood clots among other health risks, the FDA is asking an independent panel of experts to review reports of complications and make a recommendation regarding warning label changes.

“We believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” said documents released by FDA scientists following their own review and quoted in a Dec. 6 Associated Press article.

Yaz and many other birth control pills contain the synthetic hormone drospirenone, which a number of studies in recent years have indicated raises the risk for blood clots. Yaz has also been associated with an increased risk for heart attack, stroke, liver damage and gall bladder problems.

Likewise, FDA drug advisers also recommended that the warning label for Johnson & Johnson’s Ortho Evra better clarify the risk of blood clots associated with the birth control patch. Although Ortho Evra lacks drospirenone, it includes a greater amount of the estrogen hormone ethinyl estradiol than birth control pills. Ortho Evra patches have also been linked to an increased risk for stroke and heart attack among other conditions.

If you believe you suffered health complications related to the use of Yaz, Yasmin or Ortho Evra birth control patches, please contact us for a free case evaluation and to locate an experienced product liability attorney near you.