The Purple Pill Goes OTC

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November 20, 2014

By Josh Willoughby, Pharm.D. Student

Heartburn is a common health problem that affects 25% of Americans on average each year. It has been reported that in the United States alone, approximately $14 billion is spent annually.[1] Heartburn normally presents itself with a burning sensation in the chest or upper abdomen that moves upward into the throat. There are many different medications for treatment of heartburn, so it is important to know which one is the best option for self-treatment. Recently, the well-known “purple pill” for heartburn became available to patients without the need for a prescription. In late May of 2014, Pfizer Inc. announced the introduction of a new over-the-counter heartburn medication, known as Nexium 24HR.[2] Nexium, the popular “purple pill”, previously had been on the market as a prescription-only medication, but has now made the jump to over-the-counter (OTC), just as competitors Prilosec and Prevacid did years before. The switch to OTC will now allow consumers greater access and more affordable options for treatment of heartburn.

Nexium 24HR is a proton pump inhibitor or PPI, meaning that it blocks acid pumps in the stomach, which are the controlling factors in causing heartburn. PPIs are effective for treating frequent heartburn that occurs at least two days a week. Relief begins in two to three hours, but it may take between one and four days for the maximum effect to set in. Though this medication may have a slower onset of relief compared to antacids, PPIs last the longest out of any OTC heartburn treatment (approximately 12-24 hours). Nexium 24HR currently comes in a delayed-release, enteric coated form, allowing the medication to work in the body where it is needed. Nexium 24HR should be taken 30-60 minutes before meals for full effect. Taking the medication each morning would be the easiest way to ensure that the patient does not forget to take it. It is recommended that the medication be taken once daily for two weeks and then stopped for at least four months. If heartburn continues to occur, contacting the primary physician is suggested.1

Nexium 24HR comes in 22.3 mg strength, compared with the prescription-only 20 mg and 40 mg strengths. Even with the slight difference, compared with the prescription strengths, the 22.3 mg dose is equivalent to 20 mg esomeprazole, the medication’s active ingredient.[3] Nexium 24HR capsules should not be crushed or chewed. This will cause the medication to be released before it reaches the small intestine, where it needs to be activated. Nexium 24HR should not be taken by patients who have trouble swallowing food, are vomiting blood, or have black or bloody stools. Those who have lightheadedness, sweating, dizziness, or chest pain should not take Nexium 24HR and should contact a doctor. Nexium 24HR should not be taken by patients younger than 18 years old. Patients taking warfarin, clopidogrel, cilostazol, antifungals, anti-yeasts, digoxin, diazepam, tacrolimus, HIV medications, or methotrexate should ask a doctor before starting Nexium 24HR.[4]

Since prescription-strength Nexium originally came on the market in 2002, it quickly surpassed the other PPIs in sales through heavy marketing by AstraZeneca. The “purple pill” became the most purchased PPI over its competitors Prevacid (Lansoprazole) and Prilosec (Omeprazole). Based on Consumer Report’s data before the release of Nexium 24HR, Lansoprazole 20 mg and Omeprazole 20 mg (both OTC) were the cheapest effective PPI options.[5] Currently, a box of Nexium 24 HR costs about $18, while Omeprazole 20 mg only costs around $13 for a box of 28 capsules. Clinical evidence has shown no proof that Nexium is more effective than Prilosec (Omeprazole) in treating heartburn. In fact, both medications are nearly identical in their chemical structures. However, research studies have found that Nexium 20 mg and 40 mg are slightly more effective than Prilosec 20 mg in healing the esophagus, but no tests have been done to compare against Prilosec 40 mg.[6]

Because Nexium has not been tested against the higher strength of Prilosec, it remains unknown whether or not it is a better treatment option. Due to the fact that Nexium and generic Prilosec (Omeprazole) are almost identical in structure and have similar effectiveness, one should pause before choosing the more expensive option, Nexium. Most likely due to increased advertising, Nexium has become the preferred PPI on the market over the past decade. However, based on the current scientific and clinical data, I would recommend generic Prilosec OTC (Omeprazole) over Nexium 24HR to patients on the basis of increased cost savings. Paying more for a medication that has not been conclusively proven to be better than another medication is really not in anyone’s best interest. Hopefully, future studies will discover whether or not these medications significantly differ in efficacy, so that both medical professionals and patients alike will be better informed. With this information, what proton pump inhibitor would you recommend or choose for treating yourself and why?

References

  1. Heartburn and Dyspepsia. (2012). In D. Krinsky et al (Ed.), Handbook of Nonprescription Drugs: An Interactive Approach to Self-Care (17th ed., pp. 219-228). Washington DC: American Pharmacists Association.
  2. Pfizer Brings Frequent Heartburn Relief Over-the-Counter with New Nexium 24HR. (2014, May 27).
  3. Esomeprazole (Lexi-Drugs). (2014, May 1).
  4. Nexium 24HR. (2014, May 27).
  5. Consumer Reports, Using the Proton Pump Inhibitors to Treat Heartburn and Stomach Acid Reflux, 1-15. (2013).
  6. Zablocki, E. (2004). Proton Pump Inhibitors are the Preferred Treatment for Ulcers. Managed Healthcare Executive, 48-49.

Posted in: Gastrointestinal Health