Ortho-Prefest Side Effects Injury Lawsuits. Ortho-Prefest (Generic: Estradiol & Norgestimate) is a single-tablet prescription hormone replacement therapy (HRT) indicated in women with an intact uterus for the treatment of moderate to severe vasomotor symptoms associated with menopause, treatment of vulvar and vaginal atrophy, and prevention of osteoporosis. Ortho-Prefest was approved by the FDA in 1999 and is manufactured by Ortho-McNeil Pharmaceutical. Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus.
Clinical trials tested post-menopausal women and found that Ortho-Prefest was safe and effective in reducing hot flashes and providing relief from vaginal atrophy. The most common side effects in clinical trials over a one-year period were headache and breast pain. These effects were rarely serious enough to cause women to discontinue treatment.
Other side-effects experienced by patients during trials included: back pain, fatigue, flu-like symptoms, abdominal pain, nausea, arthralgias (joint pain), dysmenorrhea (painful menstruation), vaginal bleeding, vaginitis, pharyngitis (inflammation of the throat), sinusitis and upper respiratory infections. Estrogens have been associated with increased risks of serious side effects including thromboembolic disorders, cardiovascular disease, and endometrial carcinoma in post-menopausal women.
Whistle Blown On Johnson & Johnson
Ex Chief Medical Officer, Dr. Joel Lippman, claims that from 1998-2000, his last years at Ortho McNeil, he raised serious health concerns about Ortho-Prefest, a hormonal menopause product, which did not have adequate safety data to provide that it protected against uterine cancer as did other therapies.
Ortho McNeil disregarded Dr. Lippman’s concerns and launched the product. Johnson & Johnson, the parent company of Ortho McNeil transferred Dr. Lippman to Ethicon Inc., another J & J subsidiary in 200, shortly after Dr. Lippman made his complaint about Ortho-Prefest.