# Best-Selling Prescription Drug Aims to Go Over the Counter (Prilosec)



## JeanG (Oct 20, 1999)

The url for this article is: http://my.webmd.com/content/article/1728.62314 Best-Selling Prescription Drug Aims to Go Over the Counter Experts Say Approval Is Likely, but Not a Guarantee By Ori Twersky WebMD Washington Correspondent Reviewed by Dr. Michael W. Smith Oct. 16, 2000 (Washington) -- The world's best-selling prescription drug -- a heartburn medication -- may soon be available in the U.S. without a prescription. This Friday, an expert advisory committee to the FDA is scheduled to vote on whether or not to permit the sale of Prilosec (omeprazole) over the counter. And while the FDA is not bound by its advisors' vote, the federal agency generally does follow its committees' advice. The heartburn medication Prilosec is the world's best-selling prescription drug based upon its 1999 sales of about $5.9 billion. But if approved for over-the-counter sale in the U.S. by the FDA, it would join an already crowded market that includes Tagamet HB, Gaviscon, Pepcid AC, Mylanta, Zantac 75, and Axid AR. The advantage to Prilosec is that it offers a 24-hour treatment option, says Steven Pray, PhD, professor of nonprescription medications at Southwestern University School of Pharmacy in Weatherford, Okla. As a proton-pump inhibitor, or inhibitor of the proton acid pump in the acid-secreting cells of the stomach lining, it would also offer consumers an additional over-the-counter treatment option, Pray tells WebMD. "The major selling point is the 24-hour coverage, but sales could also be driven by people looking for other treatments," Pray says. There are other prescription-only proton-pump inhibitors on the market, but the FDA is focusing on Prilosec because its manufacturer specifically filed an application for over-the-counter approval of the drug. The FDA cannot and does not initiate these types of actions on its own. Pray says that there is little to prevent Prilosec from making the transition. For one, heartburn is a condition that consumers can diagnose without the aid of a health care professional, he says. The drug has also been available for about 17 years, during which no apparent safety concerns have emerged, he tells WebMD. But that doesn't mean there are no concerns. In this case, the committee is likely to focus on variety of issues, including whether the long-term use of Prilosec could increase the risk of stomach cancer, says Randy Juhl, PhD, dean of the School of Pharmacy at University of Pittsburgh and a past chairman of the FDA committee. And although that is at best a remote possibility, even that risk still plays a role in the larger question the committee will be asked to address, Juhl tells WebMD: What are the consequences? For instance, he says, if the drugmaker attempts to prevent the long-term use of Prilosec, to prevent the hypothetical risk of stomach cancer, through the label -- will consumers follow those labeling instructions? According to at least one recent study conducted by researchers at the Center for Digestive and Liver Diseases in Mexico, Mo., drugs such as Prilosec do not lead to stomach cancer. But they did suggest that people on these drugs might need to take vitamin B-12 supplements to prevent immune disorders -- that can occur from these drugs due to burnout of the stomach's acid producing cells -- which in turn can cause a decrease in vitamin B-12, which nourishes the immune system. Studies have also raised other issues concerning the general effectiveness of proton-pump inhibitors as well as people's general ability to use these medications appropriately. One such study just presented at the 66th annual scientific meeting of The American College of Gastroenterology casts doubt on whether Prilosec does in fact provide 24-hour relief. The researchers found that almost half of all proton-pump inhibitor users experience heartburn symptoms sometime during the day or night, suggesting that the drugs do not provide 24 hours of relief. The study also found that almost half of all proton-pump inhibitor users also take other acid relievers to deal with these symptoms, indicating that consumers often leave their physicians in the dark regarding their condition. There is also one final concern -- one that the FDA committee is forbidden to address but could play a role in how committee members view the application, Juhl tells WebMD. The committee cannot consider the financial cost to consumers when voting on the application, he says. But in terms of the final cost to consumers, committee members understand that the approval of an over-the-counter dose might also be a mixed blessing, Juhl tells WebMD. Over-the-counter drugs traditionally are priced significantly lower than their prescription counterparts, which would make the approval of an over-the-counter dose of benefit to people paying for prescriptions out of their own pockets, Juhl says. But considering that insurers usually do not cover over-the-counter drugs, the approval of an over-the-counter dose might be a financial burden on people counting on their insurance to cover the cost. This situation might be especially true for the poorest of the poor, who count on government programs to pick up the bill, he tells WebMD. At about $3.45 per capsule, the cost for the prescription drug amounts to a little over $100 for a 30-day supply, Emily Denney, a company spokeswoman, tells WebMD.


----------

