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Diet drugs for humans aren't the only variety to be dogged by safety issues: U.S. health regulators are examining whether some dog breeds are genetically predisposed to side effects from a canine anti-obesity treatment sold by Pfizer Inc. (PFE).
The U.S. Food and Drug Administration--which last week prompted Abbott Laboratories (ABT) to pull human diet drug Meridia from the market due to heart risks--plans to conduct a study of genetic information taken from blood samples and cheek cells of dogs that were given Slentrol, according to an agency document. The FDA said a preliminary analysis shows a "potential correlation" between certain side effects and specific breeds.
But Pfizer thinks the FDA is barking up the wrong tree. The New York-based drug maker doesn't want the agency to perform the study because it said there doesn't appear to be any link between specific dog breeds and adverse events associated with Slentrol. Moreover, the drug's known side effects--including vomiting, diarrhea and lethargy--are generally mild and already cited in the product's label, Pfizer said.
"We've not seen any correlation between specific dog breeds and specific adverse events" since Slentrol became the first FDA-approved canine-obesity drug when it was introduced in 2007, said Pfizer spokesman Rick Goulart. Pfizer monitors reports of adverse events for the drug.
The American Veterinary Medical Association, which said it has more than 80,000 U.S. veterinarians as members, also has expressed concern about the planned FDA study, saying it could be difficult to conduct and may cause concerns about the drug's safety, leading to decreased use.
The government agency proposed the study in a document published in the Federal Register in July. Pfizer and the veterinarians' group sent written comments to the agency in September.
The FDA didn't specify in the notice which kinds of adverse events it would track in its genetic analysis. The agency said its goal is to collect about 100 samples of genetic information. If the FDA identifies a genetic correlation to certain adverse events, it might modify the recommendations for how Slentrol is used, the agency said in the document.
An FDA spokeswoman declined immediate comment on the plan.
Pfizer said in its written response that the "vast majority" of adverse events reported from use of Slentrol have been for digestive disturbances and "vague systemic signs including lethargy." According to the product's label, almost one in four dogs who are given the drug experience occasional vomiting and diarrhea.
The most frequently reported breeds experiencing these events were Labrador retriever, beagle, golden retriever, dachshund, pug and Chihuahua, Pfizer said, adding that these breeds are among the most common in the U.S., and some have a predilection for obesity.
Pfizer also said the vast majority of animals benefit from Slentrol treatment without side effects. The company said studies have shown Slentrol-treated dogs lost an average of 12% of body weight over four months. Weight loss can help to ward off health problems including heart disease and arthritis, the company said.
Pfizer doesn't break out sales of individual animal-health products such as Slentrol. The company's global animal-health sales were $1.7 billion for the first half of 2010, or 5% of total company revenue.
Some large drug makers have sharpened their focus on the animal-health market. Pfizer, Merck & Co. (MRK), Eli Lilly & Co. (LLY) and others have bulked up their animal-drug businesses through acquisitions in recent years, partly due to rising demand for pet drugs.
What's more, so-called lifestyle drugs--those aimed at improving quality of life rather than directly saving a life--are making their way into the animal-health market. Another Pfizer animal drug approved by the FDA in 2007 was designed to prevent dog vomiting triggered by motion sickness and other causes.
The dispute over Slentrol comes in the wake of heightened regulatory scrutiny of human diet pills. In addition to the FDA's request for Abbott to withdraw Meridia, advisory panels of outside experts have recommended against agency approval of experimental anti-obesity drugs developed by Arena Pharmaceutical Inc. (ARNA) and Vivus Inc. (VVUS).
-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; email@example.com