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The Food and Drug Administration (FDA) has approved an update to the prescribing information for all proton pump inhibitors (PPI), a class of acid-suppressing drugs. The update was prompted by reports of cutaneous and systemic lupus erythematosus associated with these drugs; the events have occurred in patients as both new onset and as an exacerbation of existing autoimmune disease.
PPIs are indicated for the treatment of erosive esophagitis and gastroesophageal reflux disease (GERD).
The most common form of cutaneous lupus erythematosus (CLE) reported has been subacute CLE and has occurred within weeks to years after continuous use of PPI; generally, histological findings were observed without organ involvement.
Reports of PPI-associated systemic lupus erythematosus (SLE) indicated that it was milder than non-drug induced SLE. Onset typically occurred within days to years after starting PPI therapy. Most patients presented with rash, however arthralgia and cytopenia were also reported.
The updated labeling recommends that use of PPIs for longer than medically indicated should be avoided. Patients who show signs or symptoms of CLE or SLE should discontinue PPI treatment and be referred to an appropriate specialist for follow up. While most patients will improve within 4 to 12 weeks, serological testing may still be positive and elevated test results may take longer to resolve than clinical manifestations.
Agents affected by this labeling update include Aciphex (rabeprazole), Dexilant (dexlansoprazole), Nexium (esomeprazole), Prevacid (lansoprazole), PrevPac (amoxicillin, clarithromycin, lansoprazole), Prilosec (omeprazole), Protonix (pantoprazole), Vimovo (esomeprazole, naproxen), Zegerid (omeprazole, sodium bicarbonate) and corresponding generics.
For more information visit FDA.gov.
