Regranex

FDA Issues Boxed Warning Regarding Regranex

June 6, 2008 - The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

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Regranex - Learn more from drug side effect attorneys

FDA Announcement

Nationwide Regranex Lawsuits

On June 6, 2008, the U.S. Food and Drug Administration (FDA) announced the addition of a boxed warning to the label of Regranex Gel 0.01% (generic: becaplermin) due to the increased risk of cancer deaths in patients who use 3 or more tubes of the product.

What is Regranex?

Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

What’s the Problem?

The boxed warning came from a retrospective study that compared cancer incidence and cancer deaths among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed.
The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. Additionaly, the FDA has cited that there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

“In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex,” said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. “Regranex is not recommended for patients with known malignancies.”

Read More: FDA Announces New Labeling Changes for Regranex - Product to carry boxed warning

Regranex Lawsuit - Know Your Legal Rights

If you or somebody you know has been injured or killed by Regranex, you should contact one our Regranex attorneys as soon as possible. Regardless of your situation, you are sure to have questions. The only way to get your questions answered is to learn your legal rights and that is where our Regranex lawyers come in.

An experienced Mass Tort law firm can answer your questions and provide you with a free case evaluation regarding the potential to seek financial recovery through litigation. While we understand that a financial recovery will not bring back a loved one or compensate for a lifelong disability, we also urge you to exercise your right to seek legal counsel regarding your potential Regranex lawsuit.

Please use the form below to contact one of our Mass Tort attorneys handling Regranex claims.