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Have patients sign handouts on HRT risks. (Prempro Class Action Lawsuit Filed).
Following the filing of a class action suit against Wyeth Pharmaceuticals and its combination hormone replacement therapy product Prempro, physicians who want to continue prescribing the product and others like it may want to take additional steps to protect themselves from the threat of litigation, one health law attorney recommends.
The law firm of Schiffrin & Barroway, Bala Cynwyd, Pa., filed the suit against Wyeth on July 11 in the Philadelphia County Court of Common Pleas.
In a prepared statement, the law Firm said that the complaint seeks to inform the public of increased risk of harm or death with Prempro, establish a fund for the medical monitoring of people taking Prempro, reimburse the money patients have paid for the product, and provide compensation to victims for personal injury or death.
The filing followed an announcement by the National Institutes of Health that it was discontinuing the combination hormone replacement therapy (HRT) arm of the Women's Health Initiative (WHI) a large multicenter trial involving thousands of women, after women taking Prempro were found to have an increased risk of invasive breast cancer, coronary heart disease, stroke, and pulmonary embolism. (See OB, GYN. NEWS, August 1, 2002, p. 1.)
An expedited article written by WHI researchers appeared on the Web site of the Journal of the American Medical Association in tandem with the NIH announcement. The study was subsequently published (JAMA 288 [3]:321-33, 2002).
Wyeth balks at the complaint. "We don't believe that there is any legal or factual basis for the claims against Wyeth," said Natalie de Vane, Wyeth's director of public relations in Philadelphia.
In a prepared statement on the WHI findings, Dr. Victoria Kusiak, Wyeth's vice president of ...
- Wyeth Informs Physicians of WHI Findings; - Company Reaffirms Role of...
- Press release article from: PR Newswire July 9, 2002 700+ words
...ongoing development of low-dose combination HRT and other options for menopausal patients, Wyeth remains committed to offering menopausal...President, Wyeth Research. About Combination HRT There can be side effects with...
- Combination HRT increases the risk of breast cancer, says Million Women Study.
- Newspaper article from: Pharma Marketletter August 18, 2003 700+ words
...stopped after an interim safety review revealed that combination HRT with Wyeth's Prempro (estrogen/progestin) increased...demonstrated that, unlike previously thought, combination HRT may not be cardioprotective; in fact, in one...
- US FDA advisers say combination HRT labeling, including Prempro, is fine.
- Newspaper article from: Pharma Marketletter October 13, 2003 700+ words
...October 7 that the label for Wyeth's Prempro and other estrogen...new data on fracture risk. Combination HRT for post-menopausal women...towards alternative therapies. Wyeth argued that no further changes...FDA, said Joseph Cambro, Wyeth senior vice president for clinical...
- Studies confirm adverse effects of combination HRT: more WHI data:...
- Magazine article from: OB GYN News Brunk, Doug September 15, 2003 700+ words
...acetate tablets manufactured by Wyeth Pharmaceuticals, compared...American medical director for Wyeth, supported this notion and...for the individual woman." Wyeth recently introduced two lower...investigators for using just one combination HRT product (Prempro), leaving...
- Combination HRT doubles breast density, quadruples risk of abnormal mammograms.
- Newspaper article from: Health & Medicine Week November 8, 2004 700+ words
...Heart, Lung, and Blood Institute and the National Cancer Institute, both of the U.S. National Institutes of Health, and Wyeth-Ayerst Research Laboratories funded the study, which involved researchers at 9 institutions and 15 WHI clinical-study sites...
- Combination HRT linked to dementia in older women: findings reinforce need to...
- Magazine article from: OB GYN News Tucker, Miriam E. July 1, 2003 700+ words
...the combination therapy (JAMA 289[20]:2673-84, 2003). In a statement released to the media, Prempro manufacturer Wyeth Pharmaceuticals noted that the women studied in the WHI were nearly 2 decades older than the typical hormone therapy patient...
- Experts still say no to long-term combination HRT.
- News wire article from: Australasian Business Intelligence August 26, 2003 700+ words
...replacement therapy (HRT). Research from the US and the UK has indicated that long-term use of oestrogen plus progestin combination HRT can increase the incidence of heart attacks, stroke and breast cancer. More information from the studies shows that the...
- Noven Announces Presentation of Data On Effect of Transdermal Combination HRT...
- Press release article from: Business Wire June 11, 2002 700+ words
...developer of advanced transdermal drug delivery technologies and prescription transdermal products, including the only combination HRT patch available in the United States. For additional information on Noven, visit http://www.noven.com.
