Why Do Drugs and Medical Devices Receive Black Box Warnings?

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Last week, we published a blog on the dangerous type 2 diabetes drug Invokana. Once the FDA has evidence that an FDA approved product has serious or life-threatening risks, it can receive a black box warning. The FDA required a black box warning for Invokana after receiving evidence that it increases the risk of leg and foot amputations.

A black box warning is the strictest type of warning required by the FDA for a drug or medical device. This warning is only reserved for drugs and medical devices that can cause you serious harm. The black box warning describes a list of serious or life-threatening risks associated with using the product.

Deadly or serious side effects may not be noticed while these products are in the process of receiving FDA approval. A dangerous product may cause harm to consumers for years before a black box warning is issued. Invokana was FDA-approved in 2013, but only received a black box warning earlier this year.

It may take months or years before the FDA decides to issue a black box warning for a product. The FDA receives adverse event reports from consumers or their physicians. These are reports that warn a drug has caused serious or deadly side effects. The FDA investigates adverse event reports and then decides whether to take further action. Studies may also determine that a drug or medical device is associated with serious health risks. These are also taken into consideration by the FDA.

Hundreds of FDA approved products carry black box warnings. You can tell if a drug or medical device you are using has one of these warnings. Look on the labeling or marketing materials for a black box that surrounds text describing the risks associated with using the product.

Can I File a Lawsuit if I am Harmed by a Dangerous Drug or Medical Device?

If you or a loved one were harmed while using a dangerous drug or medical device, then our attorneys could discuss your situation at no cost. The Philadelphia defective drug attorneys at Eisenberg, Rothweiler, Winkler, Eisenberg & Jeck, P.C., could help you determine whether you have options to pursue damages.