FDA Reviewing Heartburn Drugs on Heart Safety

Aug 10, 04:10 PM

Current Headlines: By Bruce Japsen, Chicago Tribune

Aug. 10--Amid criticism of its monitoring of drug safety after products reach the market, the Food and Drug Administration disclosed Thursday it is conducting a safety review of two of the world's most widely sold heartburn drugs -- Nexium and Prilosec -- after two small studies linked the medicines to potential heart attacks and death.

The agency said, however, that patients could continue taking Nexium and Prilosec, which is also sold in generic and over-the-counter form, because its larger review so far does not show an increased heart-attack risk.

Both drugs are taken by tens of millions around the world and fall into the class known as proton-pump inhibitors. That class of drugs is second only to the cholesterol-drug class in the amount of U.S. sales they generate in prescription form.

Nexium is the second-best-selling prescription drug in the U.S., generating more than $5 billion in annual sales, largely for treatment of gastroesophageal reflux disease, commonly known as GERD, as well as more serious acid-related disorders.

The cholesterol drug Lipitor, with more than $8 billion in U.S. sales last year, is the nation's top-selling drug, according to health information market research firm IMS Health.

Nexium and Prilosec are manufactured by AstraZeneca PLC.

"FDA has concluded preliminarily that these data do not suggest an increased risk of heart problems," said Dr. Paul Seligman, associate director of the Office of Safety Policy and Communication in the FDA's Center for Drug Evaluation and Research. "It's early in the process [of FDA's] evaluation."

The FDA said it hoped to complete its review in three months. The agency said it was primarily looking at Nexium and Prilosec but also observing other drugs in the popular class of proton-pump inhibitors, which includes Prevacid, sold by Lake Forest-based TAP Pharmaceutical Products Inc. Studies have shown Prevacid to work the same as both Prilosec and Nexium, with no statistically significant differences in their safety and efficacy.

The FDA has been under fire from some lawmakers and consumer groups over its safety-monitoring of drugs after they have been approved and on the market. This so-called "post marketing" surveillance has created controversy in the wake of the painkiller Vioxx, which Merck & Co. voluntarily pulled from the market in 2004 after studies showed increased risks of heart attacks and strokes. And earlier this year, the FDA again came under fire after a medical journal published studies that had shown that the diabetes pill Avandia was associated with increased risk of heart attacks before the agency spoke publicly about the drug's cardiovascular issues.

In the current case, the FDA said it was providing an "early communication about an ongoing safety review." The agency said the studies of Nexium and Prevacid were small but the agency would not provide specifics on how many patients were involved or how many of them had heart issues.

The drugs' maker said its conclusion was that "the products are not associated with an increased risk of cardiac events" and therefore do not change the drugs' overall risk-benefit profile. "Patients should not change their medication in the light of the study data," AstraZeneca said in a statement.

The FDA said it will continue to review the data from the study and eventually provide an update. "We are interested in the data from all similar products," the FDA's Seligman said.

Much is at stake. Proton-pump inhibitors have been taken by hundreds of millions of people around the world and generate more than $13 billion in sales in the U.S. alone.

The FDA Thursday did not mention potential risks for other proton-pump inhibitors, such as TAP's Prevacid.

"We have not seen any cardiovascular safety signals in our 58 clinical trials of more than 11,000 Prevacid patients and in our post-marketing surveillance," said Amy Martin, a spokeswoman for TAP, a joint venture of Abbott Laboratories and Takeda Pharmaceutical Co. of Japan.

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