Proton Pump Inhibitors Implicated in Lupus Reports, Prompting Label Update

Published on October 28, 2016 by Sandy Liebhard

Proton pump inhibitors like Nexium, Prilosec and PrevAcid have been implicated in reports of cutaneous and systemic lupus erythematosus. According to Monthly Prescribing Reference (MPR), labels for all prescription medications in the class are being updated to reflect this potential risk.

A posting on the U.S. Food & Drug Administration’s (FDA) website in August indicated that the agency was looking into such reports.  According to MPR, the adverse events were seen as both new onset and as an exacerbation of existing autoimmune disease. The most common form of cutaneous lupus erythematosus (CLE) reported has been subacute CLE, occurring within weeks to years after continuous proton pump inhibitor use.

Reports of systemic lupus erythematosus (SLE) associated with proton pump inhibitors indicated that it was milder than non-drug induced SLE. Onset occurred within days to years after treatment with a proton pump inhibitor was initiated.

The label modifications approved by the FDA will state that proton pump inhibitors should not be taken longer than medically necessary. Treatment should be discontinued if patients show symptoms of CLE or SLE, and they should be referred to an appropriate specialist. In most cases, patients improved within 4 to 12 weeks. However, MPR noted that “serological testing may still be positive and elevated test results may take longer to resolve than clinical manifestations.”

Proton Pump Inhibitor Side Effects

Nexium and other proton pump inhibitors are approved for the short-term treatment of GERD and other peptic disordes. In 2013, more than 15 million Americans used prescription drugs in this class, at a cost of more than $10 billion. However, some research has suggested that a large percentage of these prescriptions are inappropriate, raising concerns that the drugs are being overused. In recent years, the long-term use of Nexium had other proton pump inhibitors has been linked to a wide range of serious side effects, including chronic kidney disease and kidney failure, an increased risk of heart attacks, B12 deficiency and dementia.

Over the past year, a growing number of lawsuits have been filed in U.S. courts on behalf of individuals who allegedly developed serious kidney complications related to the use of proton pump inhibitors. Plaintiffs claim that the drug manufacturers have been aware of reports linking proton pump inhibitors to kidney failure and other renal complications, yet continued to represent that the medications did not pose any risks to the kidneys.

Earlier this month, plaintiffs pursuing proton pump inhibitor lawsuits in federal courts filed a motion with the U.S. Judicial Panel on Multidistrict Litigation seeking centralization of their claims before a single judge in the U.S. District Court, Middle District of Louisiana. The October 17^th filing indicated that at least   15 proton pump inhibitor lawsuits involving acute interstitial nephritis, chronic kidney disease and kidney failure are already pending in federal courts around the U.S. Plaintiffs asserted that the litigation could eventually grow to include hundreds of similar claims.