FDA Novartis Late with Dog Painkiller Reports
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Novartis AG failed to give the government prompt, accurate reports about deaths of dogs treated with a painkiller in the same class of medicines now linked to heart problems in humans, US regulators have charged in a letter.
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FRIDAY, Nov. 17 (HealthDay News) -- Just-released data from a trial that was stopped early in 2004 for safety reasons is re-igniting debate on the safety of two popular painkillers.
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GAITHERSBURG, Md.  - U.S. scientific advisers  began hearing evidence on Wednesday about the benefits and  risks of pain killers taken by millions of Americans as  regulators weigh moves following Merck & Co. Inc.'s recall of  its arthritis pill Vioxx.
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Responding to continuing criticism that it mishandled internal warnings that the painkiller Vioxx had deadly side effects and that antidepressants were
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WASHINGTON -- The Food and Drug Administration is preventing an agency scientist from presenting the largest, most up-to-date study of popular painkillers like Bextra, Celebrex and Vioxx during an FDA meeting next week on heart risks posed by the drugs, a US senator charged.
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New reports suggest another drug company moved too slowly to pull a dangerous medication from the market and question the Food and Drug Administration&#39;s ability to protect the public.
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The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.
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A US Food and Drug Administration official who attempted to publish his negative findings about the now-withdrawn painkiller Vioxx said that agency officials ridiculed the results and ultimately delayed publication, The New York Times reported Thursday.
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Researchers in the US have halted a government study involving a non-steroidal anti-inflammatory drug known as Naproxen, brand Aleve, after data indicated possible increased heart risks associated with the painkiller.
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Novartis AG  cut its full-year results outlook as generic competition pressured sales of a key blood-pressure drug, and said U.S. regulators had delayed the approval process for an important cancer treatment.
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US health regulators have warned of heart risks connected to over-the-counter painkiller naproxen, creating additional confusion over the safety of similar drugs after recent warnings for two other painkillers.
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Novartis' pain killer Prexige did not  raise the rate of serious heart issues and led to fewer ulcer  problems compared to normal anti-inflammatory drugs, results of  a study of over 18,000 patients showed.
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12/21/04 -- It&#39;s the third largest pain relief drug in recent months to be linked with an increased risk of heart attack and stroke.
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The safety of Celebrex and other pain relievers was questioned Wednesday as scientists in the United States and regulatory agencies in Europe said they feared such drugs might raise the same risk of heart problems as those blamed on the arthritis medicine Vioxx.    One key researcher charged the U.S...
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The US regulator to beef up monitoring of drug safety after criticism over a painkiller linked to heart disease.
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Novartis' pain killer Prexige did not  raise the rate of serious heart problems and led to fewer ulcer  problems compared to normal anti-inflammatory drugs, results of  a study of over 18,000 patients showed.
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The Food and Drug Administration  ignored danger signals from its own scientists about Merck and  Co. Inc.'s Vioxx painkiller, Sen. Charles Grassley told a  hearing Thursday into the drug's withdrawal in September.