FDA Opens Hearing on Painkillers
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A medical officer responsible for evaluating Vioxx testified that there were preliminary indications of heart problems with the painkiller, but it was difficult to sort through conflicting data.
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The next federal Vioxx trial, which opens in federal court here on Monday, focuses on a man who began taking the painkiller after its label said that it could increase the risk of heart attacks.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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At a hearing Thursday on Capitol Hill, senators excoriated top federal drug regulators for failing to realize three years ago that Vioxx, a pain pill that Merck withdrew in September, was dangerous.
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The dangers of over-the-counter painkillers will be prominently highlighted on the labels under a new proposal by the F.D.A.
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U.S. health officials said on Tuesday they want more visible side-effect warnings on the packages of over-the-counter pain relievers such as aspirin, ibuprofen and acetaminophen.
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Scientists and European regulators are now questioning the safety of other pain relievers like Vioxx, saying they also might raise the risk of heart attack and stroke.
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The spotlight is likely to be on Pfizer on Wednesday when federal drug regulators begin hearings on cox-2 drugs, the medicines that include Celebrex and Bextra.
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U.S. drug regulators on Wednesday will issue a public health advisory about the potential risks of a pain drug made by Cephalon Inc, an FDA official said.
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Medicines used by millions of Americans to relieve aches and pains will come under intense scrutiny starting Wednesday as U.S. scientists scour dozens of studies to determine if the drugs risk damaging the heart like Merck & Co. Inc.'s withdrawn arthritis pill Vioxx.
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Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear next week before a panel of European drug experts, who are meeting to consider curbs on the use of COX-2 painkillers.
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WASHINGTON  - A group of physicians and  families called on US regulators Tuesday to warn the public  about a rare but potentially fatal set of skin reactions linked  to taking the painkiller ibuprofen.
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The safety of common painkillers like ibuprofen is to be investigated, European regulators say.
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Drugs in the same category as Merck &amp; Co. Inc.&#39;s withdrawn Vioxx painkiller will get close scrutiny to see if they can also cause heart attacks, US Food and Drug Administration officials said on Thursday.
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The U.S. Food and Drug  Administration on Thursday ordered the review of preventative  studies involving Pfizer Inc.'s painkillers Celebrex and  Bextra, in light of recent evidence they may increase the risk  of heart attack and stroke.
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McALLEN - Local doctors and residents expressed concerns Tuesday that the Food and Drug Administrationâs warning to users of the over-thecounter pain reliever naproxen could unnecessarily scare patients and cause them to distrust other medications.
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The controversy over painkillers known as Cox-2 inhibitors like Vioxx, Celebrex and Bextra and major cardiovascular events has prompted a leading heart specialist to speak out.