Pfizer, the maker of Premarin, announced a voluntary recall of one lot of 1.25mg tablets due to an incorrect expiration date on the bottle label.
What is Premarin?
Premarin is an estrogen product commonly used to treat moderate to severe symptoms of menopause such as vaginal dryness, burning, irritation, and hot flashes. Estrogen is also sold under the brand names Cenestin and Enjuvia. The affected product has Lot #M35953S and NDC 0046-11040-91. The expiration date on the bottle label is 11/17, but the correct expiration date is September 2017. The product is available in 1,000-count bottles and was distributed nationwide by Pfizer subsidiary Wyeth Pharmaceuticals.
The U.S. Food and Drug Administration (FDA) said the recall involves over 1,300 bottles totaling more than 1.3 million tablets. The FDA has designated the recall as Class III, which means the use of the recalled product is not life-threatening or likely to cause a serious adverse event. The attorneys at Parker Waichman state that Pfizer has previously had to face litigation involving Premarin.
The History of Premarin
Premarin was brought to market in 1942, initially as a tablet, later in an intravenous solution, and in 1978, as a topical cream. The FDA approved a lower-dose Premarin for the prevention of osteoporosis (bone loss). Hormone replacement therapy (HRT) was favored for decades to relieve some of the symptoms of menopause. However, in 2002, the Women’s Health Initiative declared that hormone replacement therapy could pose life-threatening risks including heart attacks, cancer, and strokes, WebMD reports. After the release of this news, HRT declined in popularity. However, for women who suffer from extreme and debilitating hot flashes, hormone replacement therapy is an effective solution.
Uses for Premarin
Premarin contains a combination of the estrogens, a female sex hormone with many attributes. Premarin is on occasion used to prevent osteoporosis in women after menopause. For women who have an abnormally low level of estrogen resulting from a medical condition such as ovarian failure, Premarin is used as an estrogen replacement. Certain estrogen products may also be used by men and women to treat cancers, such as certain types of prostate cancer, and breast cancer that has spread to other parts of the body.
Every drug has risks as well as benefits. It is vital for the patient to consult a medical professional to have the necessary information to be able to choose the appropriate treatment. Personal injury lawsuits frequently focus on allegations that drug manufacturers may fail to sufficiently alert doctors and patients about side effects. Drug makers may even conceal potential risks.
Premarin Breast Cancer Lawsuits
In the United States, about 10,000 breast cancer lawsuits have been filed. The plaintiffs allege that Premarin use led to the development of breast cancer. The plaintiffs maintain that the drug manufacturers were aware, or should have known about the risks, but neglected to warn women or the medical community. Plaintiffs say they would not have taken Premarin had they been adequately informed of the possible side effects. Pfizer accepted an agreement to settle these allegations for $772 million.
Aside from the United States, class action lawsuits were filed in Canada against Wyeth and Pfizer for neglecting to reveal the risk of breast cancer. A British Columbia court approved a $13 million settlement in June 2015.
The Premarin breast cancer lawsuit emerged in response to findings of the Women’s Health Initiative (WHI) study that implied that hormone replacement was linked to an increased risk of breast cancer and life-threatening cardiac events. The WHI study is the most comprehensive trial of estrogen therapy and hormonal therapy. Approximately 16,000 women participated in the study. The trial began in 1991. Fifty percent of the women took Prempro (a combination of Premarin and a progestin) and the other half took a placebo. The National Institute of Health (NHI) declared that Prempro was associated with an increased risk of breast cancer and due to these concerns, the trial was stopped.
When the trial was discontinued, there was a 26 percent increased risk of invasive breast cancer in women on hormone therapy. One hundred sixty-six women taking Prempro developed invasive breast cancer compared to 124 women taking a placebo. Monitoring of the trial participants is ongoing. Researchers said, in October 2010, that the use of estrogen and hormonal therapy raised the participants’ risk of dying from breast cancer. The risk increased from 1.3 deaths per 10,000 women per year to 2.6 deaths per 10,000 women per year. These results prompted reevaluation about the long-term health consequences linked to hormonal therapy and HRT use declined.