FDA ISSUES WARNING REGARDING BIRTH CONTROL PATCH

NOVEMBER 01, 2006
Anna D. Garrett, PharmD, BCPS, CPP

The FDA recently announced an update to the product labeling for the Ortho-Evra contraceptive patch. Information regarding the risk of developing venous thromboembolism has been changed, based on increased concerns that the patch increases the risk of blood clots, compared with other types of birth control with similar ingredients. Two recent studies produced conflicting data regarding this issue, but the agency determined that the concerns were great enough to support the labeling change.

The majority of women can use the patch safely. The risk of embolic events, however, increases significantly with smoking, high blood pressure, diabetes, high cholesterol, a family history of clotting disorders, heart attack, stroke, chest pain, certain types of cancer, jaundice, or liver tumors. Women should consider an alternative method of birth control if any of these conditions exist.

Dr. Garrett is a clinical pharmacist practitioner at Cornerstone Health Care in High Point, NC.




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