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FDA Warns of New Possible Side Effects for Nexium / Prilosec / Prevacid

October 11, 2017 By Law Offices of Thomas J. Lamb, P.A.


The most recent report from the FDA Adverse Event Reporting System (FAERS) for April – June 2017 provides updates on adverse events experienced by those taking proton pump inhibitors (PPIs) such as Nexium, Prilosec, and Prevacid.

The FDA provides the following list of PPIs:

  • Nexium (esomeprazole magnesium)
  • Nexium I.V. (esomeprazole sodium)
  • Prevacid (lansoprazole)
  • Prevacid Solutab (lansoprazole)
  • Prilosec (omeprazole)
  • Aciphex (rabeprazole sodium)
  • Esomeprazole strontium delayed-release capsules
  • Protonix (pantoprazole sodium)
  • Protonix (pantoprazole sodium)
  • Protonix IV (pantoprazole sodium)

These PPIs have been associated with an increased risk of several adverse side effects such as chronic kidney disease (CKD) and acute kidney injury (AKI).  A Medscape article from earlier this year provides more information on this association.

Despite the medical information available at present, the FDA does not deem it necessary to include warnings for such events on the labels for these drugs.

However, the FDA is currently investigating the relationship between PPI use and an increased risk in developing polyps in the stomach and duodenum (located in the small intestine).

At first, such a side effect may appear insignificant given that most polyps in these areas of the body do not become cancerous.

Additional research would reveal more cause for alarm, though, as certain types of stomach polyps can increase your risk of stomach cancer in the future according to the Mayo Clinic.

Furthermore, Cancer.org provides information on how a seemingly benign polyp in the duodenum could potentially lead to a major type of small intestinal cancer called adenocarcinoma:

Adenocarcinomas make up about 30% to 40% of small intestine cancers. This type of cancer starts from the cells that line the intestine. Most experts think that cancer of the small intestine develops much like colorectal cancer. It first begins as a small benign outgrowth called a polyp. Over time, the polyp can change into a cancer. Most small intestinal cancers develop in the duodenum and the rest occur in the jejunum and ileum.

It is important to realize that such scenarios represent the worst possible outcomes, and are not extremely likely.  As such, patients should discuss any concerns they have with their medical doctor before stopping a medication.

We are currently investigating drug injury cases on behalf of those who have used Nexium / Prilosec / Prevacid and been diagnosed with one of the following side effects:

  • Acute Interstitial Nephritis (AIN)
  • Chronic Kidney Disease (CKD)
  • End-Stage Renal Disease (ESRD)
  • Severe Renal Impairment
  • Kidney / Renal Failure
  • Acute Kidney Injury

For more information on PPIs and their potential side effects, we encourage you to visit our website and complete a free case evaluation form.

 

Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.


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: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Filed Under: Unsafe Drugs Tagged With: adverse events, drug injury law, drug safety developments, drug side effects, duodenal polyps, FAERS, FDA, FDA Adverse Event Reporting System, Nexium, ppi drugs, PPI drugs side effects, PPIs, Prevacid, Prilosec, proton pump inhibitors, stomach polyps

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