Proton Pump Inhibitors, or PPIs, are medications used to treat various types of conditions caused by excess stomach acid. The first PPI, omeprazole, came on the market in 1989, marketed by Astra AB (now AstraZeneca) as the brand Losec, eventually Prilosec. There are now several PPIs on the market, some of which are prescriptions, and other, like Prilosec, available over the counter.
Since these drugs have been available, several safety concerns have arisen leading to serious complications. The risks of taking PPIs include low magnesium levels, heart attacks, bone fractures, and antibiotic-related diarrhea. If you have taken PPIs, either over the counter or as a prescription, you may be eligible to file a lawsuit against the manufacturer. Some of these drug makers may have known about the risks and marketed their drugs as safe anyway. To help recover from the damage you have suffered, a lawsuit could bring you monetary compensation.
Types of PPIs
AstraZeneca’s omeprazole was the first PPI to hit the market, but there are now many different types. After AstraZeneca’s patent ran out for Prilosec, it brought out esomeprazole, brand name Nexium. Other generic PPIs include lansoprazole, rabeprazole, pantoprazole, and dexlansoprazole. Brand names for these are Prevacid, AcipHex, Protonix, and Dexilant. Omeprazole also comes in combination with sodium bicarbonate under the name Zegerid.
Uses for PPIs
Proton Pump Inhibitors act to reduce the amount of acid in the stomach, which helps to treat several conditions and symptoms. One of the main reasons that PPIs are used is to treat GERD, gastroesophageal reflux disease, and its symptoms. GERD is also known as acid reflux and it occurs when food, liquids, and acid move up the esophagus from the stomach. GERD is very uncomfortable and can also cause lasting damage to the esophagus. PPIs can stop the movement of acid, relieve symptoms, and prevent long-term damage.
PPIs can also be used to treat other conditions in which the stomach produces too much acid and to treat ulcers, sores in the lining of the stomach worsened by gastric acid. Over-the-counter forms of PPIs are often used to treat heartburn, the occasional, but uncomfortable, movement of acid upward from the stomach.
How They Work
PPIs work in the stomach to reduce gastric acid. They act on an enzyme complex in stomach cells that produce and excrete acid into the stomach. PPIs specifically inhibit, or block, the action of the proton pump, the last part in the process of creating and excreting acid. They can block the secretion of acid in the stomach by up to 99 percent.
Most people tolerate PPIs very well and do not experience any serious side effects. The most common side effects are constipation, nausea, diarrhea, itchy skin, and headaches. Some less common side effects are gas, anxiety, depression, and dizziness. The possibility of experiencing side effects is especially lessened if you take an over-the-counter PPI or if you only take one of these medications for a short period of time.
Low Magnesium Levels
Although short-term use of PPIs is considered to be safe and well-tolerated by most patients, the long-term use effects are less well studied. Since the first PPI, omeprazole, came on the market in 1989, several reports have been made and studies have been conducted that have uncovered some potentially serious consequences of using PPIs long term. One of these is a low level of magnesium in the body.
Gastric acid in the stomach may be bothersome for some people, but it plays an important role in breaking down food and releasing necessary nutrients into the bloodstream. While several different nutrients may be less well absorbed while taking PPIs, there is strong evidence that PPI use can lead to especially low levels of magnesium absorption.
The FDA issued a warning about this in 2011 and also warned that the problem cannot be corrected by adding magnesium supplements to the diet while taking PPIs. People suffering from this deficiency likely have to discontinue use of the PPI. If not corrected, low levels of magnesium can cause muscle spasms, an irregular heartbeat, and convulsions. Patients should report symptoms of low magnesium to their doctors: heart palpitations, a racing heart rate, muscle spasms, or tremors.
A study published in 2015 reported results that people taking PPIs have an increased risk of having a heart attack as compared to people not taking any of the medications. The risk is increased by as much as 16 to 21 percent. PPIs were also compared to another class of drugs used to treat heartburn called H2 blockers. The risk was increased for PPI users, but not for those using H2 blockers.
In previous similar studies patients with an increased risk for heart attack were taking a PPI plus another type of medication, an anticoagulant or blood thinner. This 2015 study is the first to look at patients using PPI and no other drugs, which gives more credence to the results that PPIs can increase the risk of having a heart attack.
In 2010 and 2011 the FDA issued notices and warnings about the risk of bone fractures for people taking PPIs. The first notification warned that people taking the drugs as either prescriptions or over the counter could be at an increased risk for weakened bones and fractures. Fractures were seen especially in the hips, wrists, and spine. The second notification released amended the previous warning to say that the risk was nearly zero for over the counter PPIs, but possible with larger doses of prescription medications.
Bacterial Infection and Diarrhea
In 2012 the FDA issued a warning that PPIs are associated with Clostridium difficile-associated diarrhea (CDAD). Anyone taking a PPI may get diarrhea as a side effect, but if it persists or is severe, it may be diagnosed as CDAD. This type of diarrhea is caused by a bacterial infection and is characterized by watery stool, stomach pains, and fever. Without treatment it can lead to serious gastrointestinal damage.
Customer and health advocacy have pushed to have the FDA require black box labeling on PPIs, but without success so far. A black box warning is reserved for serious and life-threatening risks of taking a medication and many believe that PPIs should carry one. While the FDA has issued some warnings about fractures, low magnesium levels, diarrhea, and heart attacks, these warnings came several years after PPIs first came on the market.
If it can be shown that the manufacturers of PPIs, both over the counter and prescription forms, knew of some of these risks, conducted inadequate safety trials, or knowingly marketed drugs that had serious risks, lawsuits against them could be successful in recovering monetary damages for people who suffered any of the side effects. If you suffered from taking a PPI, you could have a case. Talk to a lawyer about the possibility of suing for compensation.