Defective Product Recall Lawsuit
Premarin Side Effects Lawsuit
Premarin Side Effects Lawsuit
On August 4, 2011, the Supreme Court of British Columbia allowed a class action lawsuit against Pfizer’s subsidiary Wyeth Pharmaceuticals, the maker of hormone drug Premarin, to proceed. The lawsuit originally filed by Dianne Stanway, a Sechelt native, represents all women who developed breast cancer due to the use of the drug between 1977 and 2003 to ease symptoms of menopause. The plaintiffs have accused Wyeth Canada of marketing the drug without proper safety research and warning for patients.
Premarin, a mixture of estrogen hormones, has been marketed by Wyeth since 1942 as a hormone replacement therapy for the treatment of menopause symptoms, such as vaginal dryness, itching, irritation, burning, and hot flashes. Its primary goal is to boost production of sex hormone estrogen in women with ovarian failure or those lacking natural estrogen in their body. The drug therapy is also prescribed to prevent osteoporosis in postmenopausal women and used in the cancer treatment in both men and women.
Premarin Side Effect Complaints
Premarin has been linked to heart problems, breast cancers, blood clot, vaginal bleeding, liver disease and birth defects. The first comprehensive research report on the drug was made public in December 1975. The study, conducted by Ralph Nader’s Health Reserach Group, discovered that taking the drug on long-term basis put patients at the risk of uterine cancer. The findings were presented to the Advisory Committee of Gynaecology and Obstetrics constituted by the FDA.
In 1976, the FDA directed the manufacturer to attach a label warning to the drug informing users aboutthe heightened risk of developing uterus cancer. In 2002, another comprehensive study undertaken by Women's Health Initiative and sponsored by U.S. National Institutes of Health also highlighted the close link between Premarin and the breast cancer risk.
A large-scale clinical trial by it demonstrated that long-term treatment with the drug therapy resulted in strokes, cardiovascular problems, blood clots, and breast cancer.
In July 2005, WHO’s International Agency for Research on Cancer categorized Premarin therapy as carcinogenic to humans. In April 2006, a government study led by Hawaii University scholars held that the drug is responsible for blood clots in elderly women.
A German survey conducted in 2004 also confirmed the drug’s association with breast cancer. According to a report published in the Archives of Internal Medicine by researchers from the University of Texas in October 2010, women using Premarin therapy are at 21 percent greater risk of developing painful kidney stones.
Wyeth has been facing about 15,000 Premarin Lawsuit. In 2006, a Philadelphia resident, Mary Daniel, was awarded $1.5 million in compensation and undisclosed punitive damages. A Nevada court ordered the manufacturer to pay $17–19 million each to three plaintiffs, who suffered from breast cancer due to Premarin side effects, in 2007. In a similar case, a New Jersey woman got $1.5 million in compensation.
Pfizer, which took over Wyeth in 2009, has set aside $722 million to resolve Premarin Lawsuit in the United States. The amount earmarked does not include compensation to be paid in 3,300 settlements already made before May 2011. In 2008, an Arkansas jury held Wyeth for breast cancer in women and awarded plaintiff Donna Scroggin $27.5 million in punitive damages. In 2009, a Philadelphia jury ordered Pfizer to pay $28 million to a cancer survivor, who claimed to have got the disease after using Premarin for 11 years.
Side Effects of Premarin
Premarin Cardiovascular Side Effects
Patients sensitive to fluid retention due to epilepsy, fluid retention, heart disease, asthma, renal dysfunction are more vulnerable to cardiovascular side effects of Premarin. Such side effects include increase in blood pressure, pulmonary embolism, superficial venous thrombosis, myocardial infarction, and thrombophlebitis.
Premarin Oncologic Side Effects
Prolonged use of Premarin causes oncologic side effect, which include breast cancer, ovarian cancer, and higher risk of endometrial carcinoma.
Premarin Genitourinary Side Effects
Breakthrough bleeding, abnormal withdrawal bleeding, vaginitis, changes in pattern of vaginal bleeding, dysmenorrhea, increased size of uterine leiomyomata, cystitis-like syndrome, change in degree of cervical secretion and cervical erosion, burning and irritation, site reactions of vulvovaginal discomfort, endometrial hyperplasia, genital pruritus, and precocious puberty are some of the Genitourinary side effects of Premarin.
Premarin Metabolic Side Effects
Reduction in carbohydrate tolerance and increase in serum triglyceride levels are some of the metabolic side effects of the drug if continued for a long time.
Premarin Gastrointestinal Side Effects
Long-term use of Premarin risks causing oral pigmentation, pancreatitis, cholestatic jaundice, nausea, abdominal cramps, ischemic colitis, vomiting, bloating, and ischemic colitis. In some patients, increased incidence of gallbladder disease has also been reported.
Premarin Hematologic Side Effects
Prolonged use of estrogen therapy might lead to Hematologic side effects, which include hypercoagulability. Some cases of hemolytic uremic syndrome have been reported as a result of conjugated estrogen therapy.
Premarin Hepatic Side Effects
Women taking long-term contraceptives or isolated estrogen therapy are more vulnerable to hepatic tumors, hepatic hemangiomas, liver cell adenomas, enlargement of hepatic hemangiomas, and focal nodular hyperplasia.
Premarin Nervous System Side Effects
Headache, stroke, migraine, chorea, dizziness, nervousness, dementia, exacerbation of epilepsy, and mental depression are some of the nervous system side effects of Premarin. Some of the rare cases also include growth potentiation of benign and malignant meningiomas.
Premarin Psychiatric Side Effects
Patients with severe depression are more likely to experience rapid mood cycling due to the use of Premarin.
Premarin Respiratory Side Effects
Prolonged Premarin use might have respiratory side effects, including exacerbation of asthma, pulmonary embolism, increased hypoxic ventilatory response, and increased ventilation. Besides, some rare cases of exacerbation of pulmonary lymphangioleiomyomatosis have also been reported.
Premarin Dermatologic side effects
Scalp hair loss, rash, chloasma, hirsutism, melasma, erythema nodosum, erythema multiforme, and hemorrhagic eruptions are the known dermatologic side effects of Premarin. In some cases, the side effects are so severe that discontinuation of the drug also does not reduce their impact on the patient’s condition.
Premarin Endocrine Side Effects
Reduced fasting plasma glucose, increased thyroxin-binding globulin levels, increased thyroid serum levels and reduced resin uptake of T3 result from the use of the drug.
Premarin Ocular Side Effects
Premarin might impact the eyes adversely, causing intolerance to contact lenses and retinal vascular thrombosis.
Other Premarin Side Effects
Breast pain, tenderness, secretion, enlargement, and fibrocystic changes are some other side effects of Premarin. Besides, Premarin might cause weight changes, edema, leg cramps, changes in libido, aggravation of porphyria, fever, shortness of breath, depression, flu syndrome, increased or decreased interest in sex, sore throat, sinus inflammation, runny nose, stomach pain, weakness, and vaginal inflammation, among others.