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The FDA needs a more active drug safety surveillance system and more authority over drugmakers when it finds serious adverse events, according to a leading consumer watchdog group.
The FDA issued a public health advisory last week warning physicians that use of erythropoiesis-stimulating agents (ESAs) is associated with an increased risk of death and serious life-threatening side effects.
The FDA last month issued letters to manufacturers of all attention-deficit/hyperactivity disorder (ADHD) products asking them to implement new guides, saying it is concerned about cardiovascular risks and adverse psychiatric symptoms.
Nonsteroidal anti-inflammatory drugs (NSAIDs), with the exception of aspirin, increase the risk of heart attack and stroke, the American Heart Association (AHA) said, recommending that these drugs not be used as the first line of treatment for patients at risk for heart disease.
Women who take estrogen as hormone replacement therapy to counter the effects of menopause may be better off using a transdermal patch than swallowing a pill, according to a recent study.
The FDA issued letters to manufacturers of all attention-deficit/hyperactivity disorder (ADHD) products asking them to implement new medication guides, saying it is concerned about cardiovascular risks and adverse psychiatric symptoms.
GlaxoSmithKline (GSK) has alerted healthcare providers about the increased risk of fractures related to Avandia, Avandamet and Avandaryl tablets, which are used to treat Type 2 diabetes mellitus.