Prilosec OTC & Nexium

AstraZeneca pharmaceuticals first introduced Prilosec after FDA approval in 1989.  Nexium was next brought to the forefront of heart burn relief remedies through a heavily publicized marketing campaign that had “The Purple Pill” known throughout every household in America. Approved by the FDA in February of 2001, Nexium came to life after several pharmaceutical companies created generic versions of the originally released Prilosec. The key ingredients of each drug are closely related, in fact  esomeprazole (Nexium) is a more specific form of omeprazole (Prilosec) and is considered more effective in some cases. A new formula of Nexium was re-released on October 25, 2006. Additionally, over the counter Prilosec (Prilosec OTC) was made available to consumers for purchase without a prescription in late June of 2003. 

Why Prescribed

Prilosec and Nexium, both regarded as proton pump inhibitors (PPI's), have been widely prescribed and purchased over the counter within the last 15 years. All three serve to treat the same general conditions of gastroesophageal reflux disease (GERD), gastric ulcers, and in turn encourage healing of both stomach lining and erosions on the esophagus due to such conditions.

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FDA Approved Uses for Prilosec

Prilosec, Prilosec OTC, and Nexium are approved for use in patients who suffer from gastroesophageal reflux disease (GERD). Prilosec was first approved for use in 1989, Nexium in 2001, and over the counter Prilosec was approved in summer of 2003.

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Side Effects of Prilosec and Nexium

Few negative side effects have been reported, but in some cases the following has been reported:

  • dry mouth
  • headache/migraine
  • diarrhea
  • stomach discomfort; constipation; gas

Also, inform your doctor if you have liver problems, as this condition may prevent you from being able to take Prilosec, Prilosec OTC, or Nexium, or may require you receive a dose tailored to your medical conditions. Allergic reactions can occur but were rarely reported. Contact a physician if you believe you are suffering from and allergic reaction or if you believe your medication is not working.

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Warnings and Alerts

Following the release of results from an independently administered 14 year study, The Food and Drug Administration (FDA) has begun a safety review of the most commonly used drugs in the world, Prilosec (omeprazole), Prilosec OTC, and Nexium (esomeprazole).

Two small scale studies were conducted consisting of various patients that all had one common factor – very acute cases of GERD. Patients were treated in one of three ways, surgery, medication (Prilosec or Nexium), or a placebo pill. Based on the results of the study, concerns have been raised that Prilosec and Nexium, originally created and approved for short term use, when used for an extended amount of time can increase patients risks of serious cardiovascular events. Among the most common concerns are heart failure and heart attack, either of which can result in sudden death, even without prior symptoms. These findings are compared to those who received surgery rather than those who were given Prilosec or Nexium.

The FDA is taking the results of this study in to consideration, but will not make any final decisions regarding action until a full review is completed within the next three months. Currently, they have not recommended that medical professionals stop prescribing the noted drugs, nor that current patients should alter their use of such.

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Drug Contraindications

Prozac is contraindicated in patients who take Digoxin (used to treat high blood pressure and other cardiac problems).

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Why does the same company manufacture three drugs for the same purpose?

Prilosec was the first drug manufactured by AstraZeneca pharmaceuticals in 1989. Due to lenient drug patent laws generic forms of Prilosec were created by alternative drug companies and sold for less. So AstraZeneca created a more specific version of Prilosec called Nexium and there specific version of the drug is now under patent with the more recently strict drug laws. Prilosec was then approved by the FDA to be distributed as an over the counter medicine.

Should I stop taking Prilosec or Nexium due to the safety review that is being conducted?

The FDA has recommended that patients continue to take their prescribed mediations as directed, and that healthcare providers still prescribe Prilosec or Nexium where they see fit.

Who can I call if I believe I have had severe cardiac events a result of taking one of these drugs?

First we are sorry for the pain that you have endured, but we want you to know you have rights as a consumer and as a patient. Please fill out the case review form to the right and one of our legal intake specialists will be happy to assist you in your time of need. Seek the final restitution you deserve.

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