Prilosec (omeprazole), the original "purple pill" for frequent heartburn, has received FDA approval to be sold as an over-the-counter (OTC) medicine. Prilosec OTC, as it will be known, will be a pink tablet in its non-prescription form. It is expected to arrive in stores this fall. Proctor & Gamble, which will market the OTC medication for its maker, AstraZeneca, received FDA approval after changing its packaging to better explain the medicine’s proper use.Heartburn occurs when the stomach’s acidic contents back up into the esophagus, and is experienced as a burning sensation in the chest or throat. Prilosec OTC is different from other nonprescription heartburn remedies. While other heartburn medications act as acid reducers or antacids, Prilosec OTC is a "proton pump inhibitor," which modifies the stomach’s production of acid by stopping the stomach’s acid pumps. Prilosec OTC is the only nonprescription heartburn medicine intended to provide extended relief of frequent heartburn (two or more episodes per week), and should not be taken for immediate relief of heartburn or before eating a spicy meal. Consumers should read the packaging carefully before taking this or any medicine.
The OTC medicine will come in the same 20 mg dose as the usual prescription. Each package will have 14 pills, enough for two weeks. If consumers do not feel relief within two weeks of taking Prilosec OTC regularly, or if heartburn returns in less than four months, they should see a doctor. Such a result may indicate that the consumer has a more serious condition, such as gastroesophageal reflux disease (GERD).
Side effects from Prilosec OTC are uncommon, but some consumers may experience headache, diarrhea, constipation, upset stomach, vomiting, stomach pain, cough, cold symptoms, dizziness, or rash.
Prilosec OTC is expected to cost less than $1 per pill—less than one fourth the cost of prescription Prilosec. However, patients with a small prescription co-pay in their insurance plan may find themselves paying more for Prilosec OTC than they would have for a prescription.
Prilosec has been available as a prescription since 1989, and was the top-selling prescription medicine from 1996 to 2000. However, in 2001, its patent ran out and a cheaper generic version became available. The OTC marketing is seen by some as a way to revive flagging sales of the medicine. Because of the cost of clinical studies leading up to its OTC approval, Proctor & Gamble will have exclusive rights to sell the OTC version for three years, during which no one else can market OTC omeprazole. AstraZeneca, meanwhile, is focusing its marketing energy on its next-generation heartburn pill, Nexium.
Heartburn remedies are a lucrative business. It is estimated that over 60 million people suffer from heartburn, and as many as 15 million people may experience daily heartburn. OTC medicines, including best-seller Pepcid, account for $1.2 billion in annual sales, while prescription Prilosec sales alone grossed $5.6 billion in 2001. Proctor & Gamble expects Prilosec OTC to bring in $200 million to $400 million in its first year of sales.
Prescription Prilosec will still be sold to treat more serious conditions, including ulcers, GERD, and inflammation of the esophagus, which require a physician’s diagnosis and oversight.
