# Panel: Popular Heartburn Drug Shouldn't Go Over the Counter (Prilosec)



## JeanG (Oct 20, 1999)

The URL for this article is: http://my.webmd.com/content/article/1728.62492 Panel: Popular Heartburn Drug Shouldn't Go Over the Counter Data Doesn't Show Consumers Would Use It Appropriately, Members Say By Ori Twersky WebMD Washington Correspondent Reviewed by Dr. Gary D. Vogin Oct. 20, 2000 (Washington) -- A panel of expert advisers to the FDA concluded Friday that the world's best-selling prescription drug -- the heartburn treatment Prilosec -- should not be allowed to be sold without a prescription because consumers may not use it appropriately. The application for approval to sell Prilosec over the counter (OTC) was filed by the U.K.'s AstraZeneca, in conjunction with Procter & Gamble of Cincinnati. While Prilosec appears safe and effective, the information supplied by the companies simply did not support the proposed nonprescription use, the FDA advisers said. Their data also failed to demonstrate that consumers could use this drug without the intervention of a health care professional, the panel said. One of the committee's main concerns was with the product's proposed label, says panel chairman Eric Brass, MD, PhD. "I believe that the data gives every assurance this drug will provide efficacy for the prevention of heartburn. I have limited questions about safety. [The panel's decision] has to do with developing a label to convey to consumers how to use this drug appropriately," explains Brass, who is chairman of the department of medicine at Harbor-UCLA Medical Center in Torrance, Calif. While the FDA is not bound by the decision, it usually follows its committees' advice. Prilosec belongs to a class of drugs called proton-pump inhibitors (PPIs), which work as strong acid blockers. These drugs are believed to offer 24 hours of prevention from heartburn. Prilosec is not only the world's top-selling treatment for chronic heartburn, but also the best-selling prescription drug, based on its 1999 sales of about $5.9 billion. To establish the drug's effectiveness as an OTC medication, the company presented two types of studies, some designed to show that Prilosec is effective, and others that consumers can use the drug appropriately in an OTC setting. A total of 11,600 people participated in the clinical studies, and 13,000 people in the consumer-use studies. About 30% of the study participants got complete relief with Prilosec, and more than 60% got adequate relief, says Nora Zorich, MD, PhD, a medical director at Procter & Gamble. Most also demonstrated that they understood the label, with more than 90% taking no more than one dose daily and about 78% using the drug for less than 10 days, as the label indicates, says Bernard Schachtel, MD, a professor of medicine at the Yale University School of Medicine. Side effects for the OTC dosage were similar to those commonly associated with prescription doses of the drug, says Douglas Levine, MD, chief medical officer for gastrointestinal drugs at AstraZeneca. The clinical studies found no evidence that the drug will cause liver damage, stomach cancer, or any other serious problems, he says. There also was no evidence that consumers will overdose, or that the drug presents a danger to either pregnant women or children, Levine says. The most common side effects seen in the studies were related to a reduction in platelets (a component of blood clotting), as well as fever, and potential interactions with other drugs. But despite the drug's apparent effectiveness and relative safety, the FDA reviewers raised certain concerns that played a large role in the panel's final decision. For example, although the chance of anyone on Prilosec experiencing a severe side effect, such as liver damage, appears minimal, this chance will increase once the drug is used by millions of people without prescriptions, says FDA reviewer Mark Avigan, MD, CM. Also, the number of adolescents in the clinical trials was small, and the drug historically has been considered a danger to pregnant women, due to the harm to embryos seen in animal studies, he says. And while the OTC dose of Prilosec does appear effective at preventing heartburn, it does not seem to relieve the symptoms, adds Larry Goldkind, MD, another member of the FDA review team. Although prevention is a proposed use for the drug, it appears that most consumers associate Prilosec with symptom relief instead, says Karen Lechter, JD, PhD, who reviewed the proposed label. In answer to these questions, Zorich notes that the label recently was revised to state that the drug is meant for the treatment of frequent heartburn, rather than symptom relief. A section also was added to caution consumers against persistent use, along with a sentence encouraging people with persistent symptoms to seek the help of a health care professional, she says. On top of that, Procter & Gamble plans to develop a consumer booklet and videotape, in which it will explain the condition, when to see a physician, and what other treatment options are available, she says. But in making its decision, the panel noted that even 65% of those people using the product only for heartburn prevention exceeded the 10-day limit recommended on the label, and that the drug's availability OTC might prevent frequent sufferers from seeking a doctor's help. The panel also said that the data presented in support of the drug appeared weaker than expected, based on the level of effectiveness suggested by prescription doses of Prilosec. To address these concerns, the panel requested that the company provide additional information to support both the proposed label and the effectiveness of the OTC dose. Among those dissenting with the panel's decision were a couple of visiting experts in gastroenterology, who noted that prolonged use of the drug would not necessarily be a problem, considering that there are virtually no safety concerns and that long-term use could be the correct treatment, anyway. Still, a Procter & Gamble representative says the company was encouraged by the outcome of Friday's meeting. "It's quite common for the committee to request additional data for a [prescription] to OTC switch," says Tom Blinn, vice president of OTC health care at Procter & Gamble. "We will work closely with the FDA to provide the data requested." Currently, approved OTC treatments for heartburn include Tagamet HB, Gaviscon, Pepcid AC, Mylanta, Zantac 75, and Axid AR. If it eventually is approved for the U.S. OTC market, Prilosec would become the first PPI to make the transition


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