FDA UPDATES WARNING ON BLOOD CLOTS ORTHO EVRA CONTRACEPTIVE SKIN PATCH FOR BIRTH CONTROL STUDY SAYS PATCH HIGHER RISK FOR CLOTS THAN BIRTH CONTROL PIL

FDA UPDATES WARNING ON BLOOD CLOTS ORTHO EVRA CONTRACEPTIVE SKIN PATCH FOR BIRTH CONTROL STUDY SAYS PATCH HIGHER RISK FOR CLOTS THAN BIRTH CONTROL PILLS

The U.S. Food and Drug Administration FDA, has approved additional changes to the Ortho Evra Contraceptive Transdermal Skin Patch for birth control label to include the results of a new epidemiological study. The advantage of a birth control patch is that you don't need to remember to take pills. A new study of the patch found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism VTE or DVT, than women using birth control pills. Venous thromboembolism can lead to a blood clot in the lung called a pulmonary embolism.



Ortho Evra is a prescription birth control patch that releases ethinyl estradiol, an estrogen hormone and norelgestromin, a progestin hormone through the skin into the blood stream. Because the hormones are processed by the body differently than hormones from birth control pills, women using the product will be exposed to about 60 percent more estrogen than if they were using typical birth control pills containing 35 micrograms of estrogen. Increased levels of estrogen may increase the risk of side effects, including VTE. Women should discuss with their health care provider the possible increased risk of VTE with Ortho Evra, which is applied once a week, and balance this risk against the increased chance of pregnancy if women do not take their birth control pill daily.




Birth control pills are one risk factor for blood clots or DVT or blood clots in the lung called a pulmonary embolism. Symptoms of a blood clotin the lung can include shortness of breath, chest pain, fever, cough and coughing up blood.

Click Here for More About Symptoms and Risk factors for Blood Clot and Lung Blood Clots



The label changes to the birth control patch are based on a study conducted by the Boston Collaborative Drug Surveillance Program (BCDSP) on behalf of Johnson and Johnson. The birth control patch was studied in women aged 15-44. These recent findings support an earlier study that also said women in this group were at higher risk for blood clot.



"For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.



"This is an example of FDA working in tandem with the drug manufacturer to keep the public informed of new safety data and epidemiological studies that may impact health decisions about the use of FDA approved products. In September 2006, the FDA revised the label for Ortho Evra to warn women of the risk of VTE based on two epidemiology studies. One study, conducted by i3 Ingenix, showed that some women using the patch were at a two-fold greater risk of developing VTE. The other study, conducted by BCDSP, showed they were not at increased risk compared to women using birth control pills containing 30-35 micrograms of estrogen and the progestin norgestimate.

FDA Approves Update to Label on Birth Control Patch