Proton-pump Inhibitor Injuries

You have likely seen commercials on television for drugs such as Prilosec, Nexium and Prevacid. These proton pump inhibitors come in prescription strength and over-the-counter versions of a drug that reduces acid in the stomach. Though generally accepted as safe and reliable for long-term use, some people who have taken PPIs have suffered injuries, and have taken legal action against the manufacturer of the drug.

Some of the popular types or brands of proton pump inhibitor drugs (and their respective manufacturers) include:

• Prilosec (omeprazole) AstraZeneca
• Nexium (esomeprazole) AstraZeneca
• Prevacid (lansoprazole) Takeda Pharmaceuticals
• Protonix (pantoprazole) Pfizer
• AcipHex (rabeprazole) Eisai Inc.
• Dexilant (dexlansoprazole) Takeda
• Kapidex (dexlansoprazole) Epocrates

How do proton pump inhibitors work?

The U.S. Food and Drug Administration (FDA) approved omeprazole, the first proton pump inhibitor, in 1989. PPI’s work by blocking the production of acid in the stomach. PPIs can be obtained by prescription, or in an over-the-counter (OTC) strength. Proton pump inhibitors are commonly used to:

• Treat ulcers
• Reduce acid reflux
• Treat H. pylori, a bacterium that can cause stomach ulcers
• Prevent and treat ulcers from taking NSAIDs
• Prevent and/or treat other conditions where it is required to reduce acid in the stomach

(Patient.info)

However, despite their reputation and popularity, there have been concerns about the safety of the drug when taken for long periods.

What types of adverse effects have some people suffered after taking proton pump inhibitors such as Nexium, Prilosec, or Prevacid?

An article in JAMA Internal Medicine reports that “. . .mounting evidence demonstrates that PPIs are associated with a number of adverse effects and are overprescribed. The study looked at the risk of chronic kidney disease, which was 50% higher in PPI users compared to nonusers.” Additional adverse effects from taking PPIs include:

• Kidney disease
• Bacterial infections
• Stomach cancer
• Bone fractures due to decreased bone density
• Small bowel injury
• Dementia
• Heart attack
• Stroke
• Premature death

What does the FDA say about PPIs such as Nexium, Prilosec and Prevacid?

Because the long-term use of PPIs has been linked to decreased bone density, the FDA issued a Drug Safety Communication regarding the possible increased risk of hip, wrist and spine fractures from the use of proton pump inhibitors. Patients shown to be at higher risk for fractures has been taking the drug for one year or longer. The FDA issued another safety warning about the link between taking PPIs and an increased risk of Clostridium dificile, which is a bacterium that can cause diarrhea that does not improve. The FDA directed drug manufacturers to change their labeling information to include the risk of C. diff with use of the drug. The FDA encourages consumers who have suffered an adverse event from taking a drug to report it to their Med Watch Adverse Event Reporting program

What can you do if you have been injured after taking PPIs?

PPIs generate more than $10 billion for their manufacturers. Now that they are available over the counter, they have grown to become one of the most consumed medicines in the U.S.

Consumers who have sustained injuries such as kidney injury and disease or heart attacks after taking Nexium, Prevacid and the other PPIs for years, have taken legal action against the drugs’ manufacturers because they failed to warn consumers about the long-term risks associated with taking the drugs. The government has settled with Pfizer for promoting its PPI for off-label uses not approved by the FDA, and there have been other, undisclosed settlements against PPI manufacturers for bone fractures. AstraZeneca settled a consumer class action regarding its marketing of Prilosec and Nexium.

Consumers who have suffered injuries or adverse effects after taking PPIs can consult with an experienced defective drug lawyer to discuss their legal options.

If you or a loved one has suffered an injury due to a defective medical device, our attorneys at McGowan, Hood, Felder & Phillips, LLC can help you obtain the justice and compensation you deserve. We handle the most complex cases and are committed to delivering results on your behalf. To set up a free consultation with a defective medical device attorney from our team, complete our contact form or simply call us today at 803-327-7800.