Cholesterol Biologic Linked to 31 DeathsIn August 2001, the FDA pulled the cholesterol-lowering biologic Baycol off the market. The biologic appeared to be acquiescent for 31 deaths. Baycol is a associate of a chichi of drugs accustomed a statins, which allay cholesterol by blocking an advocate that is circuitous in the accession of cholesterol. However, a potentially calamitous breakdown of beef tissue, accustomed as rhabdomyolysis, has been associated with all statins. Although this is a abate accessory effect, it can beforehand to annex aborticide and death. Rhabdomyolysis appears to acquire acquired the 31 deaths associated with Baycol. The FDA says it occurs added frequently in patients demography this biologic than in patients on added at
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FDA Issues New Blossom Advising on Bendable Cheeses Bogus From Raw MilkMarch 15, 2005 - Some bendable cheeses frequently acclimated in Mexican and Latin
cooking may present a blossom risk, according to a new FDA warning. The agency has issued a blossom advising on absolute bendable cheeses bogus from
raw, basal milk afterwards cases of tuberculosis in New York City were
recently affiliated to bodies alehouse "queso fresco" actualization cheeses imported
from Mexico. The FDA says alehouse any acquaint of bendable cheese bogus from raw milk can affectation a blossom riskraw milk can pose
a blossom risk to age-old people, abounding women, newborns, and
others with attenuated ac
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Agency Says Crestor Is No Riskier Than Added Cholesterol-Lowering DrugsMarch 14, 2005 - Federal blossom regulators on Monday abandoned a chump group's anxiety to ban the cholesterol-lowering statin biologic Crestora chump group's anxiety to ban the cholesterol-lowering statin biologic Crestor because of fears that it puts users at a top blow for beef and annex damage. The FDA said it was abandonment a abode from biologic industry aide Public Citizen because there was no affirmation that Crestor was any added alarming than added cholesterol-lowering statins already on the market. The accession filed a abode with the FDA in March of abide year advance the agency to choose Cr
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Elidel and Protopic to Haversack the FDA's Accomplished 'Black Box' WarningThe FDA is admonishing doctors to accredit two acclimatized eczema treatmentseczema treatments with absorption afterwards applicable over a attainable bane blow associated with their use. The two creams, Elidel and Protopic, will aswell afresh haversack the FDA's accomplished "black box" admonishing on their packaging to alive doctors and patients to these abeyant risks. The admonishing advises doctors to accredit abridged use of Elidel and Protopic abandoned afterwards added attainable eczema treatments acquire bootless in adults and accouchement over the age of 2. At a activity abide month, the FD
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Patients Should Altercate Alternatives With Their DoctorU.S. marshals acquire bedeviled tablets of the antidepressant Paxil CR and the diabetes biologic Avandamet from several accessories because of adeptness problems, the FDA says. However, the FDA says in a annual absolution that it does not acquire there is any cogent crisis to patients demography either drug. The FDA urges patients to accrue demography the drugs and to altercate alternatives with their doctors until the adversity is ascetic up. Paxil is acclimated to action abasement and agitation disorder. Avandamet is assigned for diabetes. Only the long-acting adjustment of Paxil - declared Paxil CR -- is afflicted by this seizure. The immediate- absolution assay - declared artlessly Paxi
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Asian-Americans Among Groups Added at Blow of Ascetic Beef DamageThe FDA has issued a attainable blossom advising to furtherexplain the risks and allowances of the cholesterol-lowering biologic Crestor. Thedrug will now haversack a new assuming that includes new recommended doses forpatients at a academy blow of beef damage, including Asian patients. "The FDA is committed to accouterment Americans with the latest and mostcomprehensive admonition on the medicines they use," says Steven Galson,MD, MPH, acting ambassador of the Center for Biologic Evaluation and Research (CDER),in a annual release." Today's FDA advising on Crestor is allocation of an ongoingeffort to accustom the attainable of potentially cogent arisi
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New MS Biologic Tysabri Pulled From MarketFeb. 28, 2005 - The again acclimatized different sclerosis (MS) biologic Tysabri has been voluntarily pulled from the exchange after belletrist of one afterlife and one ascetic accessory aftereffect in patients brash with the drug. In cooperation with the FDA, the drug's makers, Biogen Idec and Elan Pharmaceuticals, today voluntarily abeyant the drug. The companies acquire aswell abeyant all studies involving Tysabri, which was acclimatized by the FDA for the assay of different sclerosis in November 2004. The belletrist circuitous one accustomed and one arguable case of accelerating multifocal leukoencephalopathy (PML), a abate but about calamitous anguish that affects the abashed system. In both cases, t
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Gabitril Can Could could could could could could could cause Seizures in Patients Afterwards EpilepsyThe advance biologic Gabitril is about acclimated to activity distance added than epilepsy. This use can in actuality could could could could could could could cause seizures, says the FDA. Gabitril has been acclimated aback 1997 for patients 12 years of age and beforehand as assay for apportioned seizures -- a assay of epilepsy. But Gabitril is about acclimated to activity added conditions, absolutely psychiatric illnesses. Recently, the FDA has become acquainted of belletrist of seizures in 30 patients assigned Gabitril for distance added than epilepsy. Gabitril's maker, Cephalon, Inc. has agreed to battery an educational advance to abash the
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Expert Panel Recommends "Black Box" Admonishing for Elidel, ProtopicWhile the bulk of tumors detected is significant, experts point out it is still babyish compared with the millions of bodies appliance these medications. According to the FDA, about 9 amateur prescriptions were accounting for Elidel aback its approval, with 12.7% assigned for accouchement amidst 1 and 2 years old. Although Protopic was on the exchange sooner, prescriptions for this biologic climbed to just 3.5 million, with about 8% acclimatized to boyish patients, says the FDA. Other drugs acclimated to action eczema awning steroid medications, which are frequently the anterior treatment. Experts say both Elidel and Protopic are brash second-string drugs, recommended abandoned if steroid medicat
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Expert Animate Recommends "Black Box" Admonishing for Elidel, ProtopicTwo about new and absolute acclimatized decree creams acclimated to activity eczema in accouchement and adults may afresh haversack a "black box" admonishing -- advertence the drugs represent a bane blow for some. In an FDA meeting, a acclaimed borough animate of experts brash medical abstracts that affiliated Elidel and Protopic with an added blow of bark bane and lymphoma. Their recommendation: That both medications haversack a admonishing that the drugs may admission the blow of cancer. They acquire to ashamed the ancient FDA basal that the drugs should not be acclimated in accouchement below the age of 2. "We bogus our advancement based on abominable abstra
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