Archive for March, 2012

FDA plans expert review of metal-on-metal hip implants

The Food and Drug Administration is planning an expert review of metal-on-metal hip replacements to be held June 27-28. The panel is expected to gather information from researchers, doctors and patients to help the agency decide if it needs to implement new testing and review standards for medical devices like the all-metal hip replacements.

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FDA issues Celexa heart disease warning

The Food and Drug Administration has issued a Celexa warning about the risk of a rare heart condition among patients who take the antidepressant drug. The agency said that it plans to add a new label warning that Celexa can increase the risk of QT syndrome—a rare heart disease that causes problems with the heart’s electrical activity.

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FDA Adds More Warnings to Antidepressant’s Label

In a follow-up to a warning that high doses of the popular antidepressant Celexa can cause potentially fatal abnormal heart rhythms, the U.S. Food and Drug Administration has issued new dosing and use recommendations. The latest recommendations note that Celexa in any dose should not be given to patients with certain conditions due to the risk of suffering these heart problems.

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Don’t Overdo It with Acetaminophen

Bad Wire in Heart Device Led to 22 Deaths, Study Says

A defect in wires that connect hearts to defibrillators caused at least 22 deaths, possibly as a result of a short circuit that is difficult to detect during routine monitoring, according to a study in the journal Heart Rhythm. The manufacturer of the wires, St. Jude Medical, estimated that about 79,000 patients in the United States and about 49,000 patients elsewhere have had the wires implanted.

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Study warns of excess bleeding risk with Pradaxa

A new study published in the New England Journal of Medicine warns that the lack of an effective treatment for severe bleeding caused by Pradaxa may put the lives of patients at risk. The study by researchers at the Haematology Society of Australia and New Zealand examined the cases of dozens of patients who experienced excess bleeding after taking Pradaxa.

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Minor falls more risky with new blood thinner, Utah docs warn

A study published in the Journal of Neurosurgery adds to a growing chorus of concern about Pradaxa. Approved in October 2010, Pradaxa has been shown in clinical trials to do a better job than other blood thinners at reducing the risk of stroke in some patients. But once bleeding starts, it’s largely irreversible, because there’s “no known agent” to counteract Pradaxa’s effects.

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