FDA Implements “Black Box” Warning for Essure, Eschewing a Total Recall

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.

Pharmacy Recalls and Dangerous Medications

As can be seen from the discussion above, even FDA-approved medications can be extremely dangerous even if taken properly. And if they are taken improperly, the chance for a serious or fatal pharmacy error skyrockets.

Drug manufacturers have a duty to the general public to ensure that what they are marketing and selling is safe. Of course, some side effects are to be expected, but those side effects should be made known to the patient prior to deciding to take the medication. If the patient is not informed of known dangers associated with taking a medication, several parties may be held liable, depending on the specific circumstances of the situation. Many times, a physician has a duty to warn patients of known dangers. But if the manufacturer does not disclose the dangers to the doctor, they too may be liable.

Have You Been the Victim of a Dangerous Drug?

If you or a loved one has recently been the victim of a dangerous drug, you may be entitled to monetary compensation. Even in cases in which some of the side effects were made known to you, that may not preclude a court from finding a drug manufacturer liable for your injuries if the warning was not sufficient. Contact a dedicated Maryland pharmacy error attorney today at 410-654-3600 to set up a free consultation. Calling is free and will not result in any obligation on your part unless we are able to ultimately help you obtain compensation. Call today.

More Blog Posts:

What to Do if the Pharmacist Gives You the Wrong Medication, Pharmacy Error Injury Lawyer Blog, March 1, 2016.

Protecting Yourself against Serious Pharmacy Errors, Pharmacy Error Injury Lawyer Blog, February 19, 2016.

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