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FDA Issues Another Warning Regarding PPIs
February 2012 – The FDA issued a warning stating PPIs could increase the risk of developing Clostridium difficile-associated diarrhea. The warning comes as a result of findings from the Adverse Event Reporting System.
Medications prescribed to treat gastroesophageal reflux disease (GERD), or heartburn, are incredibly common, and many Americans are taking some sort of medication to prevent and treat the condition.
The two most common types are proton pump inhibitors (PPIs) and H2 receptor antagonists, known as H2 blockers.
PPIs include prescriptions such as Nexium (esomeprazole), Prevacid (lansoprazole) and Prilosec (omeprazole). H2 blockers include Pepcid (famotidine) and Zantac (ranitidine). Both are approved for over-the-counter and prescription usage.
Heartburn medications are designed to soothe the digestive tract and relieve indigestion by neutralizing stomach acids and reducing the amount of acid produced by the stomach.
Currently, more than 15 million Americans use PPI medications, which have been in use since 1981. Consumer Reports cited data from IMS Health that the market for PPI medications was $9.5 billion in 2012.
Unfortunately, PPIs have been linked to an abundance of health issues, including kidney problems. According to TIME magazine, scientists found “PPI users had a 15% higher risk of early death compared to non-PPI users and a 23% higher risk of dying during the study than people who didn’t rely on any heartburn relief drugs at all.”
A study in the Journal of the American Society of Nephrology studied the effects of PPI medications versus H2 inhibitor medications. Researchers found that those taking PPI heartburn medications were 98% more likely to develop kidney failure and 28% more likely to develop chronic kidney disease than those who had used H2 inhibitors.
The following severe side effects are associated with PPIs, according to various studies:
As with any medication, it is important to discuss the risks associated with the drug with your medical provider before taking the prescribed medication.
The heartburn medication lawsuit claims that long-term use of PPI medications such as Nexium, Prevacid, or Prilosec can increase the risk of kidney disease. The lawsuit alleges that manufacturers of the prescription drugs failed to warn consumers of certain risks and side effects that could result from usage.
In 2017, there were roughly 5,000 cases pending in lawsuits around the country.
If you experienced any adverse side effects, it is important to not only report the adverse events to the FDA but also to contact an experienced lawyer.
March 2011 – The FDA issued a warning saying that after PPIs have been used for an extended period of time, there is a risk of low magnesium levels.
May 2010 – A warning was issued stating PPIs could increase the risk of bone fractures including bones of the hip, wrist, and spine.
Karol, Gabrielle. “Heartburn Medications Causing Serious Health Problems, Lawsuits Claim.” KXTV, KXTV, 13 May 2017, www.abc10.com/article/news/investigations/heartburn-medications-causing-serious-health-problems-lawsuits-claim/103-438411481
Lazarus, Benjamin. “Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease.” JAMA, American Medical Association, 1 Feb. 2016, jamanetwork.com/journals/jamainternalmedicine/fullarticle/2481157.
Ogbru, Omudhome Ogbru. "PPIs (Proton Pump Inhibitors) Side Effects, List of Names & Adverse Effects." MedicineNet, www.medicinenet.com/proton-pump_inhibitors/article.htm.
Park, Alice. "Popular Heartburn Drugs Linked to Higher Risk of Early Death." Time, 5 July 2017, time.com/4845332/heartburn-drugs-proton-pump-inhibitor/.
Stein, Rob. "Popular Heartburn Pills Can Be Hard To Stop, And May Be Risky." NPR, 15 Feb. 2016, www.npr.org/sections/health-shots/2016/02/15/465279217/popular-heartburn-pills-can-be-hard-to-stop-and-may-be-risky.
Last Modified: May 19th, 2019 @ 06:23 pm
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