Do Medication Guides for PPI Kidney Disease and Prevacid Lack Consistency?

Washington, DCIt would come as no surprise that a common scourge amongst Americans remains acid reflux, and similar maladies. For them, a common prescription for a Proton Pump Inhibitor (PPI) serves to provide relief, and minimize the effects of heartburn and related ailments such as gastroesophageal reflux disease (GERD).

However, PPI drugs have their drawbacks – and this is evident by the number of what have been described as “nightmarishly complex” lawsuits presently consolidated in multidistrict litigation (In Re: Proton-Pump Inhibitor Products, MDL No. 2757). The number of lawsuits currently hovers around the one hundred level, however industry watchers suggest that cases currently under investigation could grow that number to 5,000 or higher.

The issue with the majority of lawsuits amongst the various PPI drugs involved – including lansoprazole, or Prevacid – involves alleged PPI Kidney Disease. There are other side effects as well, including diarrhea and bone fractures, the risk for which increases in association with taking PPI drugs for long periods of time. PPI hip fracture has been an issue for some plaintiffs, or so it is claimed. PPI hip fracture can lead to painful and debilitating health issues that may require hip replacement. A fall, stemming from a hip fracture, can have serious and sometimes life-threatening consequences for the elderly.

The risk for proton pump inhibitor hip fracture is increased in association with higher doses of proton pump inhibitor PPI.

However it remains the potential for kidney issue that equate to the most common complaints associated with proton pump inhibitor side effects. The kidney issue is that which formed the basis for a petition to the US Food and Drug Administration (FDA) by consumer advocacy group Public Citizen in 2011. The regulator updated warnings for PPI drugs over the potential for kidney problems three years later, in 2014.

Prevacid (lansoprazole) is a PPI drug indicated for the treatment of GERD and acid reflux. Manufactured by Takeda Pharmaceuticals USA Inc. (Takeda), Prevacid is licensed to BGP Pharma ULC for distribution in Canada.

Various studies released in 2015 and 2016 suggest that the risk for acute kidney injury and acute interstitial nephritis increases when a PPI such as Prevacid is used for 30 days or longer.

The product guide for Prevacid linked to the Takeda USA website for Prevacid references acute interstitial nephritis on page seven of a medication guide that runs 40 pages: “Acute interstitial nephritis has been observed in patients taking PPIs including PREVACID (sic). Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue PREVACID (sic) if acute interstitial nephritis develops. ”

It is presumed BGP Pharma ULC affords the same caution somewhere in the Canadian medication guide (revised April, 2015) for Prevacid that runs 95 pages, although reference to the kidney issue could not be readily found.

Curiously, however the official FDA medication guide for lansoprazole (Prevacid) posted by the federal regulator (revised December, 2015) appears to make no reference to kidney dysfunction. Diarrhea and bone fracture yes, together with other PPI side effects. But kidney dysfunction appears to be omitted.

Plaintiffs in PPI side effects lawsuits assert they had no warning about the potential for kidney disease or dysfunction. One of those plaintiffs is Terry Buzbee, who launched his PPI kidney disease lawsuit in New York Eastern District Court (Case No. 1:2016-cv-02934) at Brooklyn in June of last year. Defendants include Astra USA, Inc., Astra USA Holdings Corporation, AstraZeneca, L.P., AstraZeneca Pharmaceuticals, LP, AstraZeneca, AB, AstraZeneca, PLC, AstraZeneca, UK Limited, KBI Sub, Inc., McKesson Corporation, Takeda California, Inc., Takeda Global Research & Development Center Inc., Takeda Pharmaceutical Company Limited, Takeda Pharmaceutical U.S.A. Inc., Takeda Pharmaceuticals LLC., Takeda Pharmaceuticals U.S.A. Inc., Takeda Pharmaceuticals International Inc. and Zeneca Inc.

Buzbee alleges he began taking two PPI drugs – Nexium and Prevacid – in 2006. The plaintiff alleges he later suffered acute kidney injury that has resulted in a need for medical care and monitoring that he will require for the remainder of his days.