FDA panel rejects Sanofi diet pill, cites psychiatric risks
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Sanofi- Aventis SA's weight loss pill Acomplia shouldn't be approved in the United States because the company hasn't showed that the benefits outweigh the risk of suicidal thoughts among those taking the drug, an advisory panel said.
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The Food and Drug Administration warned consumers not to buy or use Actra-Rx or Yilishen because the supplements contain an ingredient that could lower blood pressure to unsafe levels.
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A federal advisory panel voted unanimously yesterday that the first drug to enhance the sex drive of women should not be approved because of a lack of information about its long-term safety.
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Labels that warn about potential suicide risks for young patients taking antidepressants need to be stronger. That&#39;s the word from a Food and Drug Administration advisory panel Tuesday.
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The American Psychiatric Association commends the Food and Drug Administration, and in particular its Psychopharmacologic Drugs Advisory Committee and its Pediatric Advisory Committee, for its public hearing on safe antidepressant use in pediatric patients
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A top official of the US Food and Drug Administration said Friday that he and his colleagues &quot;categorically reject&quot; earlier Congressional testimony that the agency has failed to protect the public against dangerous drugs.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of a  Sanofi-Aventis antibiotic and some other prescription drugs on  Tuesday.
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The U.S. Food and Drug  Administration said on Thursday it "generally supports" an  advisory panel's conclusion this week that antidepressants  sometimes raise the risk of suicidal behavior in youth.
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A US advisory panel on Friday recommended against approving AstraZeneca&#39;s new stroke prevention medication, Exanta, citing concerns about the drug&#39;s effect on the liver.
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The U.S. Food and Drug Administration  said on Friday that Senate testimony by a veteran FDA  researcher regarding safety risks for five drugs does not  reflect the views of the agency.
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An experimental Sanofi-Aventis diet drug helped people lose much more weight than a placebo in an eagerly anticipated two-year trial, researchers said on Tuesday.
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U.S. regulators have rejected GlaxoSmithKline Plc's  experimental drug gepirone ER for adults with major depression.
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Food and Drug Administration experts are recommending new label warnings about possible dangerous psychiatric side effects of influenza drugs Tamiflu and Relenza, according to FDA documents.
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U.S. regulators warned on Monday that Sanofi-Aventis SA's antibiotic Ketek should no longer be used to treat patients with sinusitis and bronchitis, saying the controversial drug carries too many risks.
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Epilepsy drugs used by millions of people may increase the risk of suicidal thoughts or behavior, the Food and Drug Administration warned in an alert to doctors Thursday.
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A U.S. Food and Drug Administration preliminary analysis found a level of heart-attack risk with GlaxoSmithKline Plc'sdiabetes drug Avandia similar to what was reported in a study earlier this week, the agency confirmed on Friday.
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All studies to date provide inconsistent data about the potential contribution of GlaxoSmithKline Plc's diabetes drug Avandia to heart attack risk, the head of the Food and Drug Administration said in testimony prepared for a congressional hearing on Wednesday.