Our proton pump inhibitor lawyers are investigating injuries linked to these heartburn treatments. Prescription versions of the drugs include Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex. Over-the-counter brands include Prilosec OTC, Zegerid OTC and Prevacid 24HR. Proton pump inhibitors are extremely popular, with doctors writing roughly 113.4 million prescriptions for the drugs every year.
Prescription proton pump inhibitors like Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, and Aciphex are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Prilosec OTC, Zegerid OTC and Prevacid 24HR are approved for the treatment of frequent heartburn.
In recent years, proton pump inhibitors have been linked to a number of serious side effects, including:
- Increased risk of a hip, wrist or spine fractures
- Interference with the blood-clotting properties of Plavix
- Increased risk of serious cardiac event following a heart attack
If you or a loved one suffered one of these proton pump inhibitor side effects, you may be entitled to compensation for medical bills, lost wages, pain and suffering, and other damages. Our proton pump inhibitor lawyers are currently offering free case evaluations to victims of these injuries. We urge you to contact us today to protect your legal rights.
Proton Pump Inhibitors and Fractures
Proton pump inhibitors work by reducing acid in the stomach. Over time, this may inhibit the body’s ability to absorb calcium, which can lead to osteoporosis. In May 2010, the US Food & Drug Administration (FDA) announced that the safety labeling for both prescription and over-the-counter proton pump inhibitors would be updated to include information on an increased risk of certain fractures associated with their use.
The label change was based on the agency’s review of several epidemiological studies that reported an increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use. Some studies found that those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group.
The FDA advised that healthcare professionals and users of proton pump inhibitors be aware of the possible increased risk of fractures of the hip, wrist, and spine, and weigh the known benefits against the potential risks when deciding to use these drugs.
Proton Pump Inhibitors and Plavix
In November 2009, the FDA issued a public health alert to warn Plavix users that Nexium and Prilosec could reduce that drug’s anti-clotting effects. Prilosec inhibits the drug metabolizing enzyme (CYP2C19) which is responsible for the conversion of Plavix into its active form (active metabolite), the FDA said. As a result, patients taking both drugs could face a higher risk of heart attack or stroke.
The FDA issued the health alert after studies compared the amount of Plavix’s active metabolite in the blood and its effect on platelets (anti-clotting effect) in people who took Plavix and Prilosec versus those who took Plavix alone. A reduction in active metabolite levels of about 45 percent was found in people who received Plavix with Prilosec compared to those taking Plavix alone. The effect of Plavix on platelets was reduced by as much as 47 percent in people receiving Plavix and Prilosec together. These reductions were seen whether the drugs were given at the same time or 12 hours apart, the agency said.
Nexium also inhibits CYP2C19 and should also be avoided in combination with Plavix. The FDA advised people taking Plavix to consult their healthcare provider if they were currently taking or were considering taking Prilosec, Prilosec OTC or Nexium.
Proton pump inhibitors are often prescribed to Plavix patients to minimize gastric effects such as nausea and heartburn. According to the FDA, the level of CYP2C19 inhibition among other proton pump inhibitors varies, so it is unknown to what extent other proton pump inhibitors may interfere with Plavix.
Proton Pump Inhibitors After a Heart Attack
In September 2010, a study published of over 56,000 Danish patients discharged after a heart attack found that those who had at least one prescription for a proton pump inhibitor had a 29 percent increased risk of cardiovascular death or re-hospitalization for a heart attack or stroke in the 30 days after discharge compared with those who did not receive such a drug. The study was published in the Annals of Internal Medicine.
The study also cast doubt on concerns that proton pump inhibitors inhibit the effectiveness of Plavix. Among the patients in this study, the risk for additional cardiac events was exactly the same for those prescribed a proton pump inhibitor and Plavix, compared to those not prescribed a proton pump inhibitor. The researchers concluded that the increased risk of a heart attack, stroke or death is associated with proton pump inhibitors, and not the combination of Plavix and a proton pump inhibitor.
Proton Pump Inhibitors and Hypomagnesemia
The long-term use of proton pump inhibitors has been associated with hypomagnesemia, a condition caused by low levels of magnesium in the blood. In March 2011, the U.S. Food & Drug Administration (FDA) mandated that the makers of prescription proton pump inhibitors include information about the potential risk of low magnesium in the WARNINGS AND PRECAUTIONS sections of the labels for all prescription proton pump inhibitors. Proton pump inhibitors subjected to the new warnings included: Nexium, Dexilant, Prilosec, Zegerid, Prevacid, Protonix, AcipHex, and Vimovo.
Low serum magnesium levels can result in serious adverse events including:
- Muscle spasm
- Arrhythmias (irregular heartbeat)
According to the FDA, hypomagnesemia has been reported in adult patients taking proton pump inhibitors for at least three months, but most cases occurred after a year of treatment. Approximately one-quarter of these cases required discontinuation of proton pump inhibitor treatment in addition to magnesium supplementation. It is not understood why long-term proton pump inhibitor treatment sometimes results in hypomagnesemia. The FDA has recommended that healthcare providers consider obtaining serum magnesium levels before their patients begin treatment with prescription proto pump inhibitors. The agency said they should also consider periodic testing if patients are also being treated with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. In digoxin patients especially, low magnesium can increase the likelihood of serious side effects.