Pfizer Recalls Premarin Due to Incorrect Expiration Date. Premarin (conjugated estrogens) is an estrogen product manufactured by Pfizer. Other brand names for Premarin include Cenestin and Enjuvia. Premarin is typically used to treat symptoms of menopause such as hot flashes, vaginal dryness, burning and irritation.
In October 2016, Pfizer voluntarily recalled one lot of Premarin 1.25 mg tablets because the medication bottle contained the wrong expiration date.
The recalled product contains Lot #M35953S and NDC 0046-1104-91. The expiration date listed on this lot is 11/17. The correct expiration date for this lot of Premarin is September 2017.
Pfizer subsidiary Wyeth Pharmaceuticals distributed the Premarin nationwide. According to the U.S. Food and Drug Administration (FDA), the recall affects more than 1,300 bottles totaling over 1.3 million tablets.
The recall has been designated as Class III, which describes a situation where exposure to the recalled product is unlikely to cause adverse events. Personal injury attorneys at Parker Waichman note that Pfizer has faced litigation over Premarin in the past.
Premarin Breast Cancer Lawsuits, Side Effects
Lawsuits have been filed alleging that Premarin led to breast cancer. Plaintiffs in the litigation alleged that the drug makers knew or should have known about the risks, but failed to warn patients or the medical community. Lawsuits alleged that plaintiffs would not have taken Premarin if they were fully informed of the potential side effects. Some 10,000 Premarin breast cancer lawsuits were filed in the United States. In May 2011, Pfizer agreed to settle these allegations for $772 million.
Premarin lawsuits were not limited to the United States, drug injury lawyers note. In Canada, class action lawsuits were filed against Wyeth and Pfizer alleging the companies failed to disclose the risk of breast cancer. In June 2015, a British Columbia court approved a $13 million settlement to resolve the suit, which was the first of its kind in Canada.
The Premarin breast cancer litigation and safety concerns stem from the findings of the Women’s Health Initiative (WHI) study, which suggested that the use estrogen and progestin were associated with an elevated risk of breast cancer and serious cardiac events. WHI, the largest and longest trial of estrogen therapy and hormonal therapy, involved 16,000 women.
The trial, which began in 1991, involved half of the women taking Prempro (a combination of Premarin and a progestin) and the other half taking a placebo. In July 2002, the National Institutes of Health announced that Prempro was associated with a higher risk of breast cancer.
The trial was stopped due to breast cancer concerns. At the time, women taking hormonal therapy had a 26 percent increased risk of invasive breast cancer. In total, 166 women taking Prempro developed invasive breast cancer compared to 124 women taking a placebo.
Follow-up monitoring of participants has been conducted throughout the years. In October 2010, researchers found that the use of estrogen and hormonal therapy in these participants increased the risk of dying from breast cancer from 1.3 deaths per 10,000 women per year to 2.6 deaths per 10,000 women per year. These follow-up findings fostered concerns about the long-term health consequences associated with hormonal therapy.
Premarin contains a mix of estrogens, a female sex hormone that plays many physiological roles. Premarin is used to treat symptoms associated with menopause, including hot flashes (also known as severe vasometer symptoms), vulvar and vaginal atrophy. In addition to treating symptoms of menopause, Premarin is also sometimes used to prevent osteoporosis in postmenopausal women.
It can also be used as an estrogen replacement in women who have an abnormally low level of estrogen due to a medical condition, such as ovarian failure. In some cases, Premarin is used for cancer treatment in men and women.
All drugs have both risks and benefits; personal injury lawsuits usually focus on allegations that a manufacturer failed to warn patients and their doctors about side effects, preventing them from making a fully informed decision.
Premarin has been on the market since 1942. The U.S. Food and Drug Administration (FDA) first approved the drug in oral tablet form, then as an intravenous solution in 1956 and as a topical cream in 1978. The FDA approved Premarin in lower doses for the prevention of osteoporosis.