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ADVERSE EFFECTS from pet products Forum
This Forum is for the sole benefit of bringing to the public's attention adverse effects experienced by our pets from products considered 'safe' - and that can include anything from microchipping to flea sprays.
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Larry D. Bushong
Jun 28, 04 - 10:02 AM |
Deramaxx
A girl I know almost lost her dobe to the drug Deramaxx a year or so ago. Evidently there have been a lot of adverse reactions to the drug and have been reported to the FDA. Her message is below. I just looked at the latest Deramaxx product label to see the new Post Approval Experience information which I think is an invaluable addition to the label and can't believe that the FDA has approved the following wording: "In RARE [emphasis added] situations, death has been reported as an outcome of the adverse events listed above." How can anyone familiar with the English language and basic math characterize death as "rare" when according to the FDA's own statistics death and euthanasia together constitute fully 21% of the reported Adverse Drug Events for Deramaxx? That makes death and euthanasia the third most commonly reported sign associated with Deramaxx after vomiting and anorexia. It seems to me that as a result of this wording, the product is now grossly mislabeled and veterinarians and owners are being horribly misinformed about the Post Approval Experience. I can only assume that the FDA's Center for Veterinary medicine assumes we don't read these labels and they can therefore get away with misinforming vet and owners. I think it is time we let them know this is NOT the case by emailing the acting commissioner of the FDA, Lester Crawford, DVM and the director of the Center for Veterinary Medicine, Steven Sundlof, DVM and letting them knonw that we find this to be a complete failure on their part to uphold the public interest. Their email addresses are: Lester Crawford, DVM D.Commissioner@fda.gov Stephen Sundlof, DVM SSUNDLOF@CVM.FDA.GOV http://www.nytimes.com/2004/06/06/opinion/06SUN2.html New York Times When Drug Companies Hide Data Published: June 6, 2004 Eliot Spitzer, New York's attorney general, has a knack for terrifying industries that need to be disciplined. Fresh from his sallies against improper mutual fund trading and brokerage houses that tout stocks they know to be junk, Mr. Spitzer has now taken on pharmaceutical companies that suppress data showing their drugs to be useless or possibly even dangerous. Whatever the legal outcome of his first case in this area, Mr. Spitzer has identified a problem that needs to be fixed if doctors and patients are to make the best medical decisions. The attorney general's civil suit accuses the drug giant GlaxoSmithKline of committing fraud by concealing negative information about Paxil, a drug used to treat depression. The suit says that the company conducted five clinical trials of Paxil in adolescents and children, yet published only one study whose mixed results it deemed positive. The company sat on two major studies for up to four years, although the results of one were divulged by a whistle-blower at a medical conference in 1999 and all of the studies were submitted to the Food and Drug Administration in 2002 when the company sought approval for new uses of Paxil. At that time it became apparent that Paxil was no more effective than a placebo in treating adolescent depression and might even provoke suicidal thoughts. It is outrageous that any company should have the power to mislead doctors and their patients by stressing only positive results and hiding negative findings. The companies do have to submit their clinical trials when first seeking approval to market a new drug, and the F.D.A. publishes summaries of the data after approval. But once a drug is on the market, a company need not report any new trials that cast doubt on the drug's effectiveness unless it seeks further F.D.A. approvals. Safety information is supposed to be promptly reported to the agency, but whether a particular finding affects safety is mostly left to the companies to decide. The F.D.A. treats much of the data it gets as proprietary. Mr. Spitzer wants to hold GlaxoSmithKline liable for damages under a state consumer protection law, an approach that could prod the industry toward more responsible conduct. But surely even bolder action is called for. The drug companies should be forced to make public the results of all of their clinical trials the moment they are completed, and the findings should be disseminated widely to doctors in an easy-to-understand format. Only then will patients be confident that their doctors have enough information to prescribe medicines wisely. |
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