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Prempro 11 articles

FDA approves Pfizer’s new hormone treatment for hot flashes, prevention of osteoporosis

The Food and Drug Administration (FDA) has approved Duavee, Pfizer’s new hormone treatment for menopause-related hot flashes in women who have not had a hysterectomy, and to prevent osteoporosis in post-menopausal women. Duavee is the first FDA-approved drug that combines a mixture of estrogens with another compound, bazedoxifene, which acts like estrogen to protect bone density. The FDA rejected bazedoxifene as an osteoporosis treatment in 2009 after numerous delays based on concerns that the drug could increase the risk for strokes and blood clots. Duavee enters a profitable market that already includes Hisamitsu Pharmaceutical Co.’s Brisdelle and Eli Lilly & ... Read More

Jurors award Utah woman $5.1 million in HRT-breast-cancer case

A Utah woman was awarded $5.1 million in compensatory damages by a federal jury that found hormone replacement therapy (HRT) drugs caused her to develop breast cancer, and that the drug companies who developed and marketed HRT were negligent because they failed to adequately warn users of the risks associated with the menopause treatment. The plaintiff, 73-year-old Toshiko Okunda, filed her lawsuit in 2004. She had a hysterectomy in 1985 at the age of 47, and because of severe menopausal symptoms, was prescribed over the next 17 years various doses and combinations of HRT including Premarin, Provera and Prempro. In ... Read More

Compensatory and punitive damages awarded in HRT lawsuit

Hundreds of lawsuits alleging that Wyeth Pharmaceuticals’ hormone replacement therapies (HRT) caused breast cancer have been settled in recent months including one in Pennsylvania where a judge upheld a verdict against the drug company, including a $6 million punitive damages award. Wyeth had heavily promoted its HRT drugs Premarin and Prempro as safe and effective treatments for bothersome symptoms of menopause. The pharmaceutical company even promoted the pills for their added benefit of protecting women against heart disease and dementia. But evidence was beginning to surface that the drugs were actually far more dangerous than the public or doctors ever ... Read More

Two breast cancer survivors awarded $100 million in HRT lawsuits

The message was heard loud and clear – powerful drug companies that make billions from products they know pose a significant risk of life-threatening health consequences to the people who take them, owe their victims. Big time. This week, Pfizer, which recently acquired Wyeth, the makers of the hormone replacement therapies (HRT) Prempro and Premarin, were hit with more than $100 million in two punitive-damage awards from Philadelphia juries. The two plaintiffs, Connie Barton and Donna Kendall, claimed the drugs caused their breast cancer. The evidence was startling. Plaintiffs attorneys proved that Wyeth launched a massive campaign to push the ... Read More

Study: HRT puts women at greater risk for ovarian cancer

Use of hormone replacement therapy (HRT) among postmenopausal women has been linked to a sharply increased risk of ovarian cancer, according to a study conducted by a team of researchers in Denmark. The study included data from 900,000 Danish women ages 50 to 79 over eight years and found 140 extra cases of ovarian cancer – or a 38 percent greater risk of contracting the disease compared to women who did not use HRT. “Even though this share seems low, ovarian cancer remains highly fatal, so accordingly this risk warrants consideration,” the researchers, led by Lina Steinrud Morch of Copenhagen ... Read More

Drop in breast cancer rates linked to reduction of HRT use

A new study published this week in the New England Journal of Medicine suggests a sudden decrease in breast cancer in several countries worldwide is likely linked to the 2002 Women’s Health Initiative (WHI) finding that hormone replacement therapy (HRT) after menopause can dramatically increase a woman’s risk of breast cancer and other serious health problems, the Wall Street Journal reports. Prior to the initiative in 2002, more than 200,000 American women were diagnosed with breast cancer each year. After 2002, that rate dropped below 190,000 each year since. Statistics from other countries show similar results. Despite the findings, some ... Read More

FDA approves Premarin cream to treat dyspareunia

Wyeth Pharmaceuticals recently announced FDA approval of its Premarin Vaginal Cream to treat moderate to severe dyspareunia, or painful sexual intercourse, according to RTT News. Premarin is a low-dose mixture of estrogen hormones. Dyspareunia is a disorder that follows the atrophy or thinning of the vagina and vulva, a condition that can occur in menopause. The .5-gram cream has two dosing regiments – 21 days on followed by 7 days off, or twice weekly. FDA approval of the cream and its dosing regime was granted based on results from a multi-center clinical study that included a 12-week, randomized, double blind ... Read More

Wyeth to stop making HRT, focus on cancer research

Wyeth, the pharmaceutical company that makes hormone replacement therapies Prempro and Premarin, announced today that it is ending its research in its signature areas of contraceptives and menopause treatments to focus on other female problems such as ovarian and breast cancers, according to the Associated Press/Washington Post. The changes, which go into effect immediately, are part of “Project Impact,” a restructuring plan announced by Wyeth in January that cuts 10 percent – or about 5,000 – of its workforce. As part of Project Impact, the company will narrow its focus to find more successful new drugs especially those for which ... Read More

High court may bar claims for FDA-approved drugs

The U.S. Supreme Court will hear arguments today in the first of two cases this term that consumer advocates fear could shut courthouse doors to patients injured by FDA-approved drugs or medical devices. Legal experts say the cases could also affect lawsuits already filed by tens of thousands of Americans challenging the safety of blockbuster drugs such as Celebrex and Prempro and a host of medical devices. The case before the court today was brought by the family of a New York man who suffered severe medical complications when a balloon catheter burst during a procedure to clear his arteries. ... Read More

Wyeth must pay $134.1 million in menopause drug lawsuit

Wyeth must pay $134.1 million, including $99 million in punitive damages, over its mishandling of menopause drugs that helped cause three Nevada women’s cancers, a jury ruled. The panel ruled Oct. 12 that the company owed the women $35.1 million in compensatory damages. Jurors in state court in Reno concluded today that Wyeth, the largest maker of hormone- replacement medicines, should also pay Arlene Rowatt, Jeraldine Scofield and Pamela Forrester punitive damages for concealing the breast-cancer risks of its Prempro and Premarin drugs. “We got the word out that a lot of women have been injured by this type of ... Read More