Birth Control Patch Warning Label to be Revised

Sandy Grinnell

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The FDA has approved changes to the warning labels on the Ortho Evra Contraceptive Transdermal (Skin) Patch. The label will now include a warning that

users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

The warning comes from a study completed by the Boston Collaborative Drug Surveillance Program at the request of Johnson and Johnson, manufacturers of the Birth Control Patch. The results of the study of women between the ages of 15 and 44 corroborated an earlier study that there was a greater risk of VTE indicated for the women in the age bracket.

As a result of the warning, it is extremely important for women who are using or considering to use the birth control patch to discuss their own personal risks of having serious blood clots and the increased risk they have if using the patch.

For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.