Ortho Evra Contraceptive Transdermal Patch
Ortho Evra Contraceptive Transdermal Patch – the FDA modified the prescribing information for this patch to include the results of a new epidemiology study that found that users of this birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE) than woman using birth control pills. The study, which included woman ages 15-44 using the patch, showed that such woman were at a higher risk for developing VTE.
Compounded Menopause Hormone Therapy Drugs
Compounded Menopause Hormone Therapy Drugs – the FDA recently informed health care providers and patients that the Agency sent letters warning several pharmacy operations that the claims they make about the safety and effectiveness of their so- called “bio-identical hormone replacement therapy” or “BHRT” products are unsupported by medical evidence and are considered false and misleading by the agency. The pharmacy operations improperly claim that their drugs, which contain hormones such as estrogen and progesterone, and estriol are superior to FDA approved menopausal hormone therapy drugs and prevent or treat serious diseases, including Alzheimer’s disease, stroke, and various forms of cancer. FDA is concerned that the claims for safety and effectiveness and superiority that these pharmacy operations are making mislead patients, as well as doctors and other health care professional.