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FDA posting postmarketing drug safety evaluations

You can access U.S. Food and Drug Administration (FDA) postings on postmarketing drug safety evaluations online. For more information, click here.

The Avandia saga

Read an interesting editorial about Avandia here. A U.S. Food and Drug Administration panel recommended keeping the drug on the market, but increasing warnings about the drug’s potential to increase risk for heart attacks.

Avastin may lose metastatic breast cancer indication

An U.S. Food and Drug Administration (FDA)-advisory panel has voted to strip Avastin’s indication for metastatic breast cancer because the drug is not effective for this indication. Final action will be taken by the...

FDA halts Avandia trial enrollment

The U.S. Food and Drug Administration (FDA) notified GlaxoSmithKline that the post-marketing trial of Avandia (rosiglitazone) is on “partial clinical hold,” meaning no new patients can be enrolled until further notice by the FDA....

FDA approves new drug for severe drooling

On July 28, the U.S. Food and Drug Administration (FDA) approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years. Read more...

Infusion pump resource from FDA

The U.S. Food and Drug Administration has devoted a section of its website to infusion pump safety. It includes a link for reporting an infusion pump problem. Read more here.

FDA announces July 22-23 meeting to discuss extended-release and long-acting opioid analgesics

The U.S. Food and Drug Administration announced a joint meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting to discuss Risk Evaluation and...

FDA News

On April 30, McNeil Consumer Healthcare, in consulation with the U.S. Food and Drug Administration, issued a voluntary recall of all lots of over-the-counter children’s and infants’ liquid products, including Children’s Tylenol, Children’s Motrin,...

FDA approves new drug for osteoporosis

On June 1, the U.S. Food and Drug Administration (FDA) approved Prolia (denosumab), an injectable treatment for postmenopausal women with osteoporosis who are at high risk of fractures. Read more here.

FDA clears STERIS system

On April 5, the U.S. Food and Drug Administration cleared the STERIS System 1E Liquid Chemical Sterilant Processing System. The device is used to process reusable heat-sensitive devices such as endoscopes. It does not...

FDA orders recall of Baxter infusion pumps

On May 3, the U.S. Food and Drug Administration (FDA) announced that it has ordered Baxter Healthcare Corp. to recall and destroy all of its Colleague Volumetric Infusion Pumps, reimburse customers for the value...

New boxed warning for propylthiouracil

On April 21, the U.S. Food and Drug Administration announced the addition of a boxed warning to the label for propylthiouracil. The warning includes reports of severe liver injury and acute liver failure in...

Ozone-depleting inhalers to be phased out

On April 13, the U.S. Food and Drug Administration announced that seven metered-dose inhalers used for asthma and chronic obstructive pulmonary disease will gradually be removed from the market because they contain ozone-depleting cholorofluorocarbons...