Download Nexium News: the “Purple Pill” Goes Over-The

Nexium News: the “Purple Pill” Goes Over-The-Counter
Effective March 28, 2014, the US Food and Drug Administration has approved the marketing and sale
of Over-The-Counter (OTC) Nexium (esomeprazole magnesium) 20 mg delayed-release capsules,
which previously had been available only by prescription since 2001.1 Nexium joins other proton
pump inhibitors (PPIs) already marketed OTC, such as Prilosec (omeprazole magnesium), Prevacid
24HR (lansoprazole), and numerous store/house brands. Similar to other launches, the approval of
OTC Nexium precedes prescription Nexium going off patent in May of this year, and follows a recent release of esomeprazole
strontium—a different high-cost salt form developed solely to take advantage of a patent loophole.2
Potential effects for HS clients include:
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Anticipated cost savings of up to 90%: Nexium 20 mg Rx capsules cost approximately $9.50 per “Purple Pill.” OTC pricing is
not available at this writing, but lower pricing is anticipated given that OTC Prilosec 20 mg delayed-release tablets cost less
than $1.00 per tablet.3
The therapeutic category of ulcer drugs should move out of the top ten spend as OTC and generic Nexium replace the
pricey brand.4
Proton Pump Inhibitors such as Nexium are seen in workers’ compensation co-prescribed with nonsteroidal anti-inflammatory
drugs (NSAIDs: naproxen and ibuprofen are examples) in certain patients considered at high risk for gastrointestinal ulcers.
Since ALL PPIs are considered equally effective with similar side effects,2 and OTC generic PPIs are less expensive, OTC generic
PPIs should be considered first by physicians for most patients.
Directions for Nexium 24HR advise to swallow one capsule whole every morning for 14 days to treat heartburn that occurs more
than 2 days per week, but PPIs may take up to 4 days to work. Self-treatment of heartburn should not exceed 2 weeks unless
directed by a doctor, although 14-day courses may be repeated every 4 months according to approved OTC labeling.
Despite OTC status, use of PPIs is not without potential harm; side effects include headache, diarrhea, other GI effects, increased
infection, and bone fractures. PPIs may become less effective and cause more acid to be secreted (rebound hypersecretion)
upon stopping therapy that has continued for more than a couple of months. For this reason, some physicians may prefer their
patients to use an antacid or histamine-2 blocker (for example Pepcid, Zantac, or generic OTC brands) as directed on the
packaging over PPIs for relief of occasional heartburn symptoms.
For questions regarding this eAlert or to learn more about our Clinical Rx Services please contact your dedicated Account
Executive.
Sources
1
US Food and Drug Administration. Nexium. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
Accessed: April 1, 2014.
2
Comparison of proton pump inhibitors. Pharmacists’ Letter. Full update May 2013. Available at:
http://pharmacistsletter.therapeuticresearch.com/pl/ArticleDD.aspx?pt=2&dd=290613. Accessed April 1, 2014.
3
Medi-Span Price Rx. Nexium and Prilosec. Available by subscription at: https://pricerx.medispan.com. Accessed April 1, 2014.
4
Healthcare Solutions 2013 Drug Trends. Data on file.
April 2014