FDA Safety Alert: Stronger Warning for Pylera

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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The FDA recently ruled that Pylera will now require a boxed safety warning on its labeling. A boxed warning or “black box warning” is the most serious warning regarding potential side effects and is used to call attention to serious or life-threatening risks.

What is Pylera indicated for?

Pylera is used in combination with omeprazole to treat stomach and intestinal ulcers in patients with helicobacter pylori (h.pylori).

Why was Pylera given a boxed warning?

The boxed warning on Pylera is due to its potential for carcinogenicity, or the ability to cause cancer. During recent testing, Pylera has been shown to be cancer causing on mice and rats

If you are concerned about this boxed warning, be sure to talk to your doctor about other medications on the market for h.pylori. In fact, Prevpac and Omeclamox-Pak are both prescribed for h.pylori, and do not have a boxed warning.

What should I do if I experience an adverse effect to a medication?

An adverse effect to a medication should be reported to the FDA MedWatch program here. MedWatch is the FDAs safety information and adverse event reporting program. You can use MedWatch to report adverse events like serious side effects, product use errors, product quality problems, and therapeutic failures for human medical products, cosmetics, and prescription or OTC medications.

Call 1-800-332-1088 for more information on how to report an adverse effect.

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