FDA Warning - Nexium & Prevacid Side Effects
How dangerous are defective heartburn drugs Nexium and Prilosec? Dangerous enough that there has been an FDA warning of kidney damage and stomach or gastric cancer from Nexium and Prilosec usage.
Nexium, Prevacid, Prilosec Labels Feature FDA Warnings
In December of 2014, the Food and Drug Administration ordered labels for Nexium and Prilosec products to be revised in order to include warnings of acute kidney injury and kidney inflammation, which also is known as nephritis. These Nexium and Prilosec side effects can result in kidney failure -- even death. The FDA had been urged to add such warnings by a nonprofit watchdog group, Public Citizen Inc., in 2011. In fact, Public Citizen filed a lawsuit against the FDA for failing to make warnings for the defective antacid drugs, also known as proton pump inhibitors (PPI).
Finally, after three years, the FDA did the right thing and revised Nexium and Prilosec labels to include FDA warnings of possible dire consequences of the drug. Even so, this was not a “black box” warning, but rather a revision of the drugs’ standard labeling. Still, the change did constitute an FDA warning for Nexium and Prilosec, and given the fact that they are among a family of PPI drugs, the warning also had implications for additional PPI drugs such as Prevacid, Dexilant, Aciphex, Protonix and Zegerid, not to mention generic substitutes.
Other FDA Warnings for Nexium, Prilosec
FDA warnings for PPI drugs such as Prevacide, Nexium and Prilosec have included a warning about the side effect of fractured bones. The FDA in 2010 issued a warning to consumers who used such PPI drugs. Then, in 2011, the FDA issued another warning about the danger of patients developing low magnesium levels, also known as hypomagnesemia, after using PPI drugs. Such a condition includes symptoms of cardiac, neurological and muscular effects.
Why Are FDA Warnings of Kidney Damage and Kidney Failure Needed for Nexium, Prilosec?
As for why FDA warnings are needed for Nexium, Prilosec and other PPI drugs such as Prevacid, the problem lies in the fact that such drugs have been shown to contribute to chronic kidney disease and, ultimately, stomach cancer, kidney failure, which can cause death.
But chronic kidney disease isn’t the only dangerous Nexium or Prilosec side effect or complications. Among others are: A list of PPI drugs’ other side effects, according to diagnoses, also includes:
- Arrhythmia or other heart problems
- Broken or fractured bones
- Acute interstitial nephritis
- Acute kidney inflammation
- Acute kidney injury
- Kidney failure
- Kidney-related death
- Tetany, also known as muscle spasms
- Clostridium difficile infection
Studies Also Warn of Nexium, Prilosec Risks
Besides the FDA, studies also have warned about Nexium and Prilosec risks. Such studies include:
- Research at the SUNY Buffalo School of Medicine and Biomedical Science in Buffalo, N.Y., which survey more than 24,000 people who, from 2001-2008, developed chronic kidney disease. Fully 25 per cent of these kidney patients, it turned out, had taken a PPI drug such as Nexium or Prilosec. These patients had faced nearly twice as much risk of premature death.
- A study led by Dr. Morgan Grams, an assistant professor of epidemiology at Baltimore’s Johns Hopkins University, and Dr. Benjamin Lazarus of Australia’s Royal Brisbane and Women's Hospital found that people taking PPI drugs had a 20-50 per cent higher rate of chronic kidney disease than persons who did not take the drugs. The study concluded that increasing doses of PPI drugs led to increased risk of kidney ailments.\
- Another study of PPI drugs led by Dr. Ziyad Al-Aly issued a warning that patients shouldn’t assume that over-the-counter medicine such as many PPI drugs is fully safe. Al-Aly warned patients not to take PPI drugs unless it was medically necessary and to limit their use to the minimum amounts necessary.
- A study based in Copenhagen in 2009 indicated that using a PPI drug could cause a “rebound” acid release if the drug was discontinued. The indication is that persons who use PPI drugs could become dependent on them.
- An article in the PLOS One journal of the Public Library of science in June, 2015 indicated that PPI drug usage also could raise the danger of heart attack by 16 to 21 per cent, even among persons who lacked a previous history of having heart disease.
- A study conducted at Washington University and the Clinical Epidemiology Center at the Veterans Administration in St. Louis, published in April of 2016 in the Journal of the American Society of Nephrology, had another Nexium warning. It warned that sustained, long-term use of PPI medications such as Nexium could lead to an increased risk of kidney danger of 96 per cent, as well as an increased risk of chronic kidney disease of over 25 per cent.
Why Nexium, Prilosec Kidney Failure Lawsuits are Needed
Victims of dangerous drugs have legal rights. In this case, Nexium and Prilosec lawsuits are needed to protect victims from financial losses after suffering injuries such as kidney damage or kidney failure due to the defective drugs. The Willis Law Firm can help you file such a lawsuit if someone in your family was harmed by a defective heartburn drug. Contact us today for a free legal review of your case.