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Prempro is a hormone drug manufactured by Wyeth Pharmaceuticals. With a generic name of conjugated estrogens and medroxyprogesterone acetate. The drug consists of two female hormones, such as estrogens (conjugated estrogen, estradiol) and progestin (medroxyprogesterone, norethindrone, norgestimate).
While estrogen is a sex hormone produced by the ovaries, medroxyprogesterone – often called progesterone – is vital in regulating the ovulation and menstruation cycles in women.
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Classified under natural and semisynthetic estrogens, the drug was approved by the United States Food and Drug Administration in 1994 for the treatment of moderate-to-severe symptoms linked with menopause, treatment of vulvar and vaginal atrophy, and the prevention of osteoporosis in women who have gone through menopause.
There are many side effects when using the drug, but its most severe include heart disease, stroke, blood clots, dementia, lupus, pulmonary embolisms, gallbladder disease, loss of vision, high blood pressure, high blood sugar and several types of cancer (breast cancer, endometrial cancer, ovarian cancer, and gallbladder cancer).
Wyeth Pharmaceuticals was later acquired by Pfizer, Inc.,who faced thousands of lawsuits from women who used Prempro after developing various diseases and illnesses. Plaintiffs who filed lawsuits against the companies often claimed that the hormone drug caused them to develop breast cancer.
Several plaintiffs won lawsuits against Pfizer, Inc., many of whom were awarded in millions. But the amount of lawsuits would not have been possible if it were not for a report published by the Women’s Health Initiative in 2002. The report detailed that Prempro increased health risks, including heart attacks, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, blood clots, dementia, and breast cancer.
Although Prempro has become very controversial in the pharmaceutical industry, the United States Food and Drug Administration never recalled or banned the drug from the market – thereby posing high danger to patients using the drug.
The drug carries a black box warning, stating safety precautions that the drug could increase risks of developing breast cancer and endometrial cancer, and should not be used to prevent cardiovascular disorders, and dementia.
What is Prempro?
Prempro is comprised of a mixture of estrogens (conjugated estrogen, estradiol) and progestin (medroxyprogestetrone, norethindrone, norgestimate). Estrogen is a sex hormone in females, which is produced by the ovaries. Medroxyprogesterone is another female hormone — typically called progesterone – that is vital in regulating ovulation and menstruation.
Carrying the generic name conjugated estrogens and medroxyprogesterone acetate, the drug is typically used in the treatment of menopause symptoms, which are caused by the body’s lack of estrogen production: hot flashes, vaginal dryness, burning, and irritation. Additionally, the medication is also used to prevent osteoporosis, or the thinning of bones.
Manufactured by Wyeth Pharmaceuticals (a pharmaceutical company later acquired by Pfizer, Inc. in 2009), the drug was first approved by the United States Food and Drug Administration in December 1994 and falls under the classification of natural and semisynthetic estrogens, plain.
Symptoms and Side Effects
Common side effects from the use of Prempro include nausea, vomiting, weight changes, breast tenderness, irregular vaginal bleeding, headaches, hair loss, fluid retention, vaginal yeast infection and back or abdominal pain.
Reports by the May Clinic have also stated that increased risks of side effects could occur when using the hormone medication in concurrence with other drugs such as isotretinoin (acne medication), felbamate, theophylline (lung disease medication) and/or paclitaxel (chemotheraphy drug).
Serious side effects may also occur while using the drug, these could be: heart disease, stroke, blood clots, breast cancer, dementia, cancer of the lining of the uterus, ovarian cancer, gallbladder cancer, lupus, severe asthma, pulmonary embolisms, high blood pressure, high blood sugar, gallbladder disease, liver problems, enlargement of benign tumors in the uterus, mental depression, loss of vision, increased blood calcium levels, and severe allergic reaction.
Prempro HRT Lawsuits and Litigation
Wyeth Pharmaceuticals faced several lawsuits for marketing the hormone drug, which reportedly caused 14,000 patients to develop cancer. Majority of the lawsuits pertaining to the drug claims that the medication caused the development of breast cancer.
In fact, it was because of a report released by the Women’s Health Initiative in 2002 that prompted an increase of filed lawsuits, while lowering drug sales. The report stated that the drug heightened the risk of heart attacks, stroke, blood clots, and breast cancer.
The first lawsuit with regard to the drug that reached a trial was in April 2006. Initially dismissed, the second litigation from the lawsuit eventually ended up in a settlement worth $1.5 million. The plaintiff in the case noted that the drug had caused her to develop breast cancer.
Another case of a woman who developed breast cancer was awarded a total of $9.45 million by decision of a Philadelphia jury. Of the overall amount, $6 million was for punitive damages to the woman’s family, while $3.5 million was for compensatory damages. The woman’s husband was also awarded $200,000 for loss of consortium damages.
It was in 2007 when three women from Nevada were awarded with a $134.1 million settlement, all of which also developed breast cancer from the use of the drug.
In February 2008, a Nevada judge ordered Wyeth Pharmaceuticals to pay a total of $58 million in punitive damages to three women who obtained breast cancer after using the company’s hormone drugs.
Both Wyeth Pharmaceuticals and Pfizer, Inc. were demanded to pay a woman from Arkansas $27.1 million in punitive damages in March of 2008. The jury found that both Prempro and Provera caused the woman to develop breast cancer.
The companies were deemed to manifest “reckless disregard” for the health risks from their drugs. Wyeth Pharmaceuticals paid for $19.3 million of the damages, while Pfizer, Inc. surrendered the remaining $7.8 million.
In 2011, Pfizer, Inc. agreed to pay $330 million through a settlement for over 2,200 lawsuits for Wyeth Pharmaceuticals. The company allegedly concealed the cancer risks linked with the menopause drug.
The same year, in December, a Philadelphia Common Pleas Court jury awarded three women in compensatory damages worth a total of $72.6 million, who were also suffering from cancer as a result of the use of the drug.
Another plaintiff by the name of Audrey Singleton claims that the hormone drug led to the development of her breast cancer, who eventually was awarded $10.4 million in the Pennsylvania State Superior Court in July 2012.
The lawsuit alleged Wyeth Pharmaceuticals of “[marketing] Prempro hormone replacement therapy for off-label purposes, and failed to adequately warn consumers as to the risks associated with using the medication.”
A U.S. District Court jury awarded a woman from Utah $5.1 million in damages in September 2012. Toshiko Okuda claims that the Wyeth Pharmaceuticals hormone drug also caused her to sustain breast cancer, prompting her to file for a lawsuit, which has been pending since 2004. The jury found the drug makers “negligent in failing to warn doctors and patients about the risk of breast cancer.”
Also in 2012, the company reportedly had paid a whopping $896 million to settle for lawsuits pertaining to the drug.
Aside from this, Pfizer, Inc. is setting aside another $330 million to cover another 4,000 lawsuits, as stated in their 2012 filing with the Securities and Exchange Commission. This sets the total amount for settlements to $1.2 billion.
A year later – in 2013, Pfizer, Inc. was required to pay $1.8 million in punitive damages to a woman from Connecticut – Margaret Fraser — after having developed breast cancer from the use of the hormone drug.
The ruling concluded by U.S. District Judge Janet Bond Arterton brings the award to a total of $5.76 million. Prior to the ruling, Margaret Fraser and her husband were awarded $4 million in compensatory damages in April 2012, thanks to a jury decision in New Haven, Connecticut.
FDA Recalls, Reports and Warnings
The drug has yet to be recalled for its dangerous side effects. However, common side effects of the hormone drug affect approximately 10 to 30 percent of its users, as per studies conducted by the United States Food and Drug Administration.
In 2002, the United States Food and Drug Administration released a statement regarding the outcome of the study by the Women’s Health Initiative. It stated:
“The increased risks of breast cancer and thrombeormbolic disease associated with estrogen and combination estrogen/progestin had previously been known or suspected. The increased risk of cardiovascular disease, including heart attack and stroke, in healthy women, is new information.”
It was in August 2002 when the United States Food and Drug Administration required Wyeth Pharmaceuticals to alter the label of the drug to add supplementary warnings, indicating that the drug should not be used to prevent coronary heart disease.
In January 2003, the United States Food and Drug Administration approved the addition of a black box warning to the drug, stating that the drug also should not be used to prevent cardiovascular diseases.
Additionally, the black box warning also includes information taken from a study by the Women’s Health Initiative, which highlighted the following cases in post-menopausal women within a 5-year conjugated equine estrogen treatment plan: increased risks of stroke, myocardial infarction, venous thromboembolism, and invasive breast cancer.
In 2009, following the large number of lawsuits against the drug manufacturer, the United States Food and Drug Administration required the black box label to add yet another warning: the increased risks of breast cancer.
The current black box warning for the hormone drug now has warnings for increased risks of cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia.
Also in 2009, another study was published in The Lancet, stating that the drug may also aid in the development of lung cancer. However, no other studies have yet supported this indication.
USA Today also reported on a study published on the Journal of the American Medical Association in 2010. The study revealed that in addition to increasing the risk of breast cancer or cancer in the lymph nodes, the drug also heightens the risk of fatality from breast cancer.
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