Nexium – Proton-Pump Inhibitors (PPIs)

For some, the effects of heartburn last a few minutes. For others, the pain drags on for several hours. And that’s why millions of Americans turn to Nexium.

Advertised as “The Healing Purple Pill,” Nexium has a long list of known side effects. It can cause:

• stomach pain
• fever
• nausea
• headaches
• gas
• constipation
• dry mouth
• drowsiness

Scientists also linked the drug to Clostridium difficile (C. diff), an intestinal infection that spurs episodes of severe diarrhea.

People who take Nexium for an extended period have a higher risk of bone fractures, too. The once-daily pill can lead to a broken hip, wrist or spine. It has been associated with low magnesium after three months of use and low levels of vitamin B12 after three years.

But little is still known about Nexium side effects. It’s unclear whether Nexium can hurt unborn babies or harm breastfeeding newborns. A list of complications can be found on the Nexium website, but if you dig a little deeper, you’ll find out that there are more side effects linked to Nexium, and they’re very serious.

Studies + Science

With an estimated 15 million users in the United States alone, PPIs are among the most popular medications in the world. Scientists, however, are working to better understand the long-term effects of Nexium and other PPI drugs.

Dementia Damages

A recent study, published on Feb. 15 in the Journal of the American Medical Association (JAMA) Neurology, shows that Nexium may speed up the development of dementia. While analyzing data from a pool of 73,679 seniors aged 75 and older, researchers concluded that Nexium could increase the risk of mental deterioration by 44 percent.

Kidney Complications

Prior research published in the National Library of Medicine linked Nexium to acute kidney injury and an inflammation called acute interstitial nephritis, but recent studies suggest that a more damaging diagnosis might be on the horizon.

A new study published on Jan. 11 in the research journal JAMA Internal Medicine found that long-time PPI use could also lead to irrevocable kidney damage. Researchers studied more than 10,000 participants taking PPIs for almost 14 years and discovered an increased risk of developing chronic kidney disease (CKD).

Dr. Morgan Grams, an assistant professor of epidemiology at Johns Hopkins University in Baltimore, told CBS News that taking Nexium could increase the risk of chronic kidney disease by 20 to 50 percent. But people who took the drug twice in one day were more likely to develop kidney disease than the once-daily users, he said.

“We found there was an increased risk associated with an increasing dose,” Grams told CBS News. “That suggests that perhaps this observed effect is real.”

Chronic kidney disease slowly diminishes the body’s ability to filter waste and excess fluid from the blood. The exact cause-and-effect relationship is still unknown, but researchers suspect that dwindling magnesium or recurring inflammation could be the CKD-causing culprit.

Chronic kidney disease can come with frequent urination, puffiness from fluid and swelling, high blood pressure, anemia-induced fatigue, shortness of breath, headaches, numbness, bleeding, erectile dysfunction and more. But more frightening is that there may be no symptoms at all. If patients haven’t realized they’re sick, the slow-building damage could snowball into full kidney failure. It’s estimated that 20 million Americans have CKD.

Treatment Costs

Kidney failure, dementia, and other drug-related injuries might mean high medical bills. The U.S. National Institutes of Health said patients suffering from kidney disease may require dialysis or an organ transplant. These treatments could cost anywhere from $30,000 to $80,000 each year, according to the U.S. Department of Health and Human Services. The complex state of health insurance in the United States has left many wondering who will foot the bill.

Regulation Rewind

AstraZeneca introduced Nexium in 2001 and pushed out new variations in the following years. The FDA approved injectable Nexium IV in 2005 and two additional capsules in 2006 and 2008. The 24-hour Nexium found a place on pharmacy shelves in 2014, and though each version differs slightly from the last, all formulas contain the active ingredient esomeprazole.

Nine years after the drug was approved, the FDA added the risk of bone fractures to the warning label. One year later, in 2011, the FDA included that bone fractures result from high doses of PPIs taken for an extended period of time. Many of these safety announcements didn’t come without a fight.

A consumer rights organization called Public Citizen sued the FDA for failing to address health concerns related to Nexium and other PPIs, filing an official complaint in 2011. And in April 2014, Public Citizen pulled the FDA into the legal arena, demanding a black box warning be added to PPI labeling. It took three years for the FDA to respond.

Public Citizen succeeded in pushing the FDA to publicize the dangers of how certain drugs interact with PPIs. Thanks to consumer and advocate outreach, the regulatory agency added severe infectious diarrhea, vitamin B2 deficiency, acute interstitial nephritis and complications with long-term use to the label. However, the FDA didn’t include the risk of chemical dependency, along with a number of other side effects, to the drug’s labeling. Public Citizen’s request to add a black box warning to the drug was also denied.

In 2017, the Dublin-based pharmaceutical company, Perrigo LLC, received permission to manufacture a generic version of Nexium 24-hour even as over 8,450 lawsuits against Astrazeneca are pending in the New Jersey courts. These lawsuits allege that Nexium and similar PPIs have caused harmful kidney damage and that manufacturers negligently ignored these dangers.

Nexium’s Overuse

Dr. Pradeep Arora, a study author, nephrologist and associate professor at the SUNY Buffalo School of Medicine and Biomedical Science, told CBS News that it’s reasonable to believe PPIs can cause CKD. He said patients shouldn’t use PPIs to treat “simple heartburn.”

Despite the potential for long-term damage, the FDA explicitly allows people to take Nexium for extended periods at higher doses “either on their own, or based on a healthcare professional’s recommendation.” The lack of direct communication leaves many consumers unaware of the risks.

AstraZeneca’s Stock

While Public Citizen fights to ensure PPI users are informed, AstraZeneca makes big bucks off Nexium. The 2015 Pharma Report ranked the U.K.-based pharma giant as number one, with the company boasting a global revenue of $33.3 billion. Nexium sits atop the AstraZeneca pedestal, listed as the primary breadwinner for the company, currently bringing in an estimated $5.9 billion in annual sales.

The Next Steps

If you’re one of the millions of Americans using Nexium on a regular basis, it’s possible that you depend on the drug to relieve acid reflux. As a Nexium user, you have a right to know about each and every side effect. You have a right to decide if the risk is worth it. You have a right to know the truth.

The story is still unfolding. We’re here to keep you informed.

When you’re ready, we’ll support you to take action. Our crew of advocates will connect you with a legal network. If you’ve suffered because of Nexium side effects, we’ll guide you in an effort to gain compensation for mounting medical costs and changes to your quality of life.