FDA calls for stronger warnings on sleep drugs
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The U.S. Food and Drug Administration on Wednesday ordered sleep disorder drugs to carry stronger warnings about their risks, such as drowsy driving and severe allergic reactions.
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British medical regulators urged physicians today to show greater caution in prescribing antidepressant drugs and said they should be clearly labeled with warnings
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Following a two-day hearing on the safety and efficacy of antidepressants in children, an FDA advisory panel on Tuesday voted 15 to 8 to recommend that all antidepressants carry a black box warning -- the strongest warning issued by the government -- to
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BETHESDA, Md.  - A U.S. advisory panel urged  regulators on Tuesday to require a "black box" warning on  antidepressant labels about the increased risk of suicidal  behavior in youth who take the drugs.
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Many people who take sleep medications think they work far better than laboratory measurements show they do.
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BOSTON A handful of therapy sessions does more to help chronic insomniacs get to sleep than the top-selling sleeping pill, according to a study that suggests American doctors are relying too heavily on medications.
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WASHINGTON - All antidepressants must carry a "black box" warning, the government's strongest safety alert, linking the drugs to increased suicidal thoughts and behavior among children and teens taking them, the Food and Drug Administration said Friday.    Because the warnings are primarily seen by doctors, the agency also is creating a medication guide for patients to advise them of the risk...
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WASHINGTON (BP)--The US Food and Drug Administration has unveiled stronger warning labels for the abortion drug RU 486, but pro-life advocates and the father of a teenager who died after taking the pill said that action is insufficient.
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The editors of the Journal of the American Medical Association (JAMA) are calling for an end to the US Food and Drug Administration&#39;s (FDA) role in post-market monitoring of the safety of drugs it approves.
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LONDON: British medical regulators urged physicians on Monday to show greater caution in prescribing antidepressant drugs and said such products as Prozac and Paxil should be clearly labeled with warnings about their use.
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U.S. regulators on Friday said Pfizer Inc's anti-smoking drug Chantix appears increasingly likely to be linked to serious psychiatric behavior, and called for stronger label warnings.
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A pair of Food and Drug Administration advisory panels called yesterday for new warnings for the widely used diabetes drug Avandia because of evidence that it significantly raises the risk of heart attack, but they stopped short of recommending that the drug be pulled from the market, as some FDA...
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The Food and Drug Administration needs more staff, funding and authority over the drug industry to better track the safety of medicines after they reach the market, an Institute of Medicine report said Friday.
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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 Thursday in an alert to doctors.
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A US advisory panel concluded Tuesday that antidepressants such as Prozac, Zoloft and Paxil should come with stronger warnings because they appear to increase suicidal behavior in children and teenagers.
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U.S. regulators on Thursday added new warnings about the potential risk of sudden hearing loss to best-selling impotence drugs Viagra, Cialis, and Levitra, used by millions of men.
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U.S. regulators on Thursday said warnings about the risk of sudden hearing loss linked to popular drugs for impotence, including Viagra, Cialis and Levitra, would be added to the drugs' labels.