Side Effects & Recall Lawsuit
Provera Side Effects Lawsuit
Provera Side Effects Lawsuits
Provera, manufactured by Upjohn Pharmaceuticals, a unit of Pfizer, has been linked to breast and uterine cancer, blood clot disorder, and a number of other side effects. The drug made up of medroxyprogesterone acetate is used to treat menopausal symptoms, abnormal menstrual cycle changes in females, irregular menstrual, uterine bleeding, and premenstrual tension. It regulates secretion of progesterone, a female sex hormone regulating ovulation and menstrual periods. The drug also prevents overgrowth of the uterine lining caused by estrogen replacement therapy.
Provera Side Effects Warnings
A major study the National Institute of Health conducted in 2002 linked Provera and similar hormone drugs to a significant increase in the risk of cardiovascular problems, blood clots, and breast cancer. The study advised patients having epilepsy, migraines, seizures, asthma, heart problems, and diabetes to avoid the medication or consult the doctor. According to another research by Women's Health Initiative Memory Study, elderly postmenopausal women treated simultaneously with the drug and the estrogen therapy are more likely to develop dementia.
The FDA has categorized Provera under the pregnancy category D. The drug can cause minor birth defects in children if expectant mothers are administered the drug. There have been reports linking the drug to genital abnormalities in babies born from mothers who took the drug during the first trimester of pregnancy. Male babies born from such mothers are likely to suffer from hypospadias, a condition in which the penis opens underside than the tip. Clitoris enlargement and labia fusion are the foremost problems the female fetus is likely to have due to the drug side effects.
A research report published in May 2003 by Women's Health Initiative Memory Study claimed that estrogen-progestin combination therapy used to treat menopause symptoms puts women at greater risk of breast cancer, blood clots, and heart disease. It cited the side effects of the drug, Prempro, which contains Provera, and another drug Premarin, resulting in the aforementioned conditions in female patients who have not undergone hysterectomy operations.
In November 2004, the FDA ordered Pfizer to include a black box warning on Depo-Provera, a contraceptive variation of the drug. The new label changes warned patients about the risk of permanent weakening and loss of bone density caused by long-term use of the drug.
Provera Side Effects Lawsuit
Provera causes common side effects, such as breast tenderness and increased milk flow, acne, allergic reaction, spotty skin, headache, and itching. The rare but severe side effects of the drug include blood clot problems, hives, vaginal bleeding, cervical erosion, hair overgrowth, breathing difficulty, and yellow skin and eyes. The following are the detailed side effects of the drug.
Oncologic Side Effects
The drug side effects significantly increase the risk of ovarian, uterine, and breast cancers. A large number of HRT studies have shown that synthetic progesterone makes receptors in the brain dependent on it. It adversely affects the mechanism that controls the activity of cells and organs. Researchers from New Zealand have suggested that women are more likely to develop oncologic side effects during the initial five years of the therapy.
Cardiovascular Side Effects
Higher doses of Provera lead to a hypercoagulable state that puts patients at the risk of thromboembolic problems, such as cerebrovascular accident, blood clot in veins, deep vein thrombosis, and pulmonary embolism. Patients already suffering from migraine, heart disease, and renal dysfunction are likely to develop edema or excessive fluid accumulation. Provera cardiovascular side effects also include hypertension and tachycardia.
Musculoskeletal Side Effects
According to post-marketing surveys and clinical studies, the drug causes bone mineral density alternation, osteoporosis, leg cramps, and other musculoskeletal side effects. High-level of progesterone and low-level of estrogen in postmenopausal period also contribute to the weakening of bones and muscles and puts patients at the risk of fractures.
Endocrine Side Effects
Endocrine side effects of Provera include breast tenderness, spontaneous flow of milk, abnormal rise prolactin level in the blood, excessive hairiness, acute adrenal insufficiency and low level of cortisol and adrenocorticotrophic hormone. The post-marketing reviews have documented Cushing's syndrome in many patients treated with moderate to high doses Provera therapy for a long duration.
Metabolic Side Effects
Weight gain and glucose intolerance are the most common metabolic side effects of Provera. It also adversely impacts lipid profiles in the body.
Genitourinary Side Effects
Genitourinary side effects of the drug include changes in libido, menstrual cycle, cervical erosion, and secretions. Patients suffer from normal menstrual flow suppression, irregular bleeding, vaginal cysts, and dyspareunia. Anorgasmia or problems in achieving orgasm during sex have also been reported in patients on Provera therapy.
Other Provera Side Effects
- Provera dermatologic side effects include alopecia, discoloration of face associated with pregnancy, rash, dry skin, scleroderma, and red nodules on legs.
- Nervous system problems induced by Provera side effects include somnolence, facial palsy, dizziness, headache, asthenia, convulsions, and depression.
- Gastrointestinal problems caused by the drug include anorexia, nausea, and abdominal pain.
- Jaundice and cholelithiasis are the most documented hepatic side effects of Provera.
The hormonal therapy drug was approved by the FDA in 1959. Its manufacturer currently faces about 5,200 cases in various U.S. courts for adverse reactions caused by the drug. The plaintiffs have sued Upjohn and parent company Pfizer for failing to inform patients about safety issues and fatal side effects associated with the drug. In February 2011, Pfizer earmarked more than $700 million to settle lawsuits against hormone-replacement drugs, such as Premarin, Prempro, and Provera.
In November 2009, a Pennsylvania court awarded $103 million to two Philadelphia women who were diagnosed with breast cancer after using the hormone replacement drugs. A few days later, the court ordered Pfizer to pay $34.3 million in compensation to Donna Kendall, who suffered from similar side effects of the hormonal drugs. In both cases, the court accepted the plaintiff’s plea that Pfizer had willfully failed to inform of cancer risks posed by the drugs.
In March 2008, a federal jury ordered Upjohn, maker of Provera, and Wyeth Pharmaceuticals, manufacturer of Premarin, to pay $27 million to an Arkansas woman, who developed breast cancer after using hormonal therapy to treat menopause symptoms. In May 2006, a New Jersey woman won $1.5 million compensation against Pfizer in a Provera lawsuit.