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FDA Drug Safety Podcast for Healthcare Professionals: Severe liver injury associated with the use of dronedarone (marketed as Multaq)

January 20, 2011 10:22 am | Comments

On January 14, 2011, the Food and Drug Administration issued a Drug Safety Communication alerting healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart...

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FDA Drug Safety Podcast for Healthcare Professionals: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Highlight Potential for S...

January 20, 2011 7:24 am | Comments

On January 13, 2011, the Food and Drug Administration issued a Drug Safety Communication asking drug manufacturers to limit the strength of acetaminophen in prescription drug products, which are predominantly combinations of acetaminophen and opioids. This action will limit the amount of...

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FDA Drug Safety Podcast for Healthcare Professionals: Update to ongoing safety review of Lantus (insulin glargine) and possible risk of cancer

January 20, 2011 7:24 am | Comments

On January 12, 2011, the Food and Drug Administration issued a Drug Safety Communication updating the public about its ongoing safety review of Lantus (insulin glargine) and a possible increased risk of cancer.

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FDA Drug Safety Podcast for Healthcare Professionals: Abnormal heart rhythms associated with use of Anzemet (dolasetron mesylate)

January 18, 2011 4:24 am | Comments

On December 17, 2010, the Food and Drug Administration issued a Drug Safety Communication informing patients and healthcare professionals that the injection form of Anzemet (dolasetron mesylate) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in...

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FDA Drug Safety Podcast for Healthcare Professionals: Ongoing safety review of Recombinant Human Growth Hormone (somatropin) and possible increased risk of death

January 18, 2011 4:24 am | Comments

On December 22, 2010, the Food and Drug Administration issued a Drug Safety Communication informing the public about results from a study conducted in France—the Santé Adulte GH Enfant, or SAGhE, study.

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FDA Drug Safety Podcast: FDA reduces dose of acetaminophen in combination prescription products

January 18, 2011 4:24 am | Comments

On January 13, 2011, the Food and Drug Administration issued a drug safety communication announcing that all prescription combinations of opioids and acetaminophen can no longer contain more than 325mg of acetaminophen per tablet.

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FDA Drug Safety Podcast: Withdrawal of Products that Contain Propoxyphene

December 18, 2010 8:22 am | Comments

On November 19, 2010 the Food and Drug Administration issued a drug safety communication about the withdrawal of products that contain propoxyphene.

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FDA Drug Safety Podcast for Healthcare Professionals: FDA recommends against the continued use of propoxyphene

December 18, 2010 8:22 am | Comments

On November 19, 2010, the Food and Drug Administration issued a Drug Safety Communication recommending against continued prescribing and use of the pain reliever propoxyphene because new data show that the drug can cause serious toxicity to the heart, even when used at therapeutic doses.

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FDA Drug Safety Podcast for Healthcare Professionals: Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Sy...

December 18, 2010 8:22 am | Comments

On November 17, 2010 FDA issued a Stakeholder Advisory notifying healthcare professionals, especially those working in emergency and critical care settings, of reports of compatibility problems when certain needleless pre-filled glass syringes are used with some needleless intravenous, or...

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FDA Drug Safety Podcast for Healthcare Professionals: Invirase (saquinavir) labels now contain updated risk information on abnormal heart rhythms

October 25, 2010 12:23 pm | Comments

On October 21, 2010, the Food and Drug Administration issued a Drug Safety Communication notifying the public that new risk information has been added to the label of the antiviral drug Invirase, or saquinavir, describing a potential change in the electrical activity of the heart when...

FDA Drug Safety Podcast for Healthcare Professionals: Update to Ongoing Safety Review of GnRH Agonists and Notification to Manufacturers of GnRH Agonists to Add New Safety Inf...

October 21, 2010 11:22 am | Comments

On October 20, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication updating the public that FDA has notified the manufacturers of the Gonadotropin-Releasing Hormone, or GnRH, agonists of the need to add new safety information to the Warnings and Precautions...

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FDA Drug Safety Podcast: FDA issues warnings to marketers of unapproved 'chelation' products

October 19, 2010 6:21 am | Comments

On October 14, the FDA warned eight companies that their over-the-counter or OTC chelation products are unapproved drugs and devices. There are no FDA-approved OTC chelation products.

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FDA Drug Safety Podcast for Healthcare Professionals: Safety update for osteoporosis drugs, bisphosphonates, and atypical fractures

October 18, 2010 6:21 am | Comments

On October 13, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who...

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FDA Drug Safety Podcast for Healthcare Professionals: FDA Recommends Against the Continued Use of Meridia (sibutramine)

October 13, 2010 11:22 am | Comments

On October 8, 2010, the Food and Drug Administration (FDA) issued a Drug Safety Communication recommending against continued prescribing and use of Meridia, or sibutramine, because this drug may pose unnecessary cardiovascular risks to patients.

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FDA Drug Safety Podcast: FDA significantly restricts access to the diabetes drug Avandia

September 28, 2010 11:22 am | Comments

On September 23, the Food and Drug Administration announced that it will significantly restrict the use of the diabetes drug Avandia to patients with Type 2 diabetes who cannot control their diabetes on other medications.

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