Earlier last month, the Food and Drug Administration (FDA) issued a “black box” warning for a birth control medication, Essure. According to one local news source reporting on the newly released warnings, there have been over 5,000 women who have reported negative side effects while using Essure. These side effects include unplanned pregnancy, miscarriages, still births, and severe pain and bleeding. There are also some reports of women developing auto-immune disorders after taking the medication.
Despite the negative side effects, the FDA will continue to allow Essure to be marketed and sold in the United States. The FDA decided against a pharmaceutical recall and implemented a high-alert warning instead. The warning, known as a “black box” warning, is the most serious type of warning issued by the FDA. It requires that physicians provide patients with a written waiver prior to prescribing the medication. The waiver outlines the harms that the drug may cause.
According to another news source, the general response to the FDA’s action among women who had used Essure was that it fell far short of doing what needed to be done: issue a total recall. Support groups of women who have been harmed by Essure claim that the warning will not be taken seriously enough by prospective patients, and also that it fails to include all the potential side effects of using the product.
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