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

Jan 20 2011

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...

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...

Jan 20 2011

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...

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

Jan 20 2011

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.

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

Jan 18 2011

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...

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

Jan 18 2011

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.


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

Jan 18 2011

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.

FDA Drug Safety Podcast: Withdrawal of Products that Contain Propoxyphene

Dec 18 2010

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

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

Dec 18 2010

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.

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

Dec 18 2010

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...

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

Oct 25 2010

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...

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Blogs

When Is Software The Answer To Regulatory Concerns About Your Investigations?

When Is Software The Answer To Regulatory Concerns About Your Investigations?

Jan 30 | John Ager, Technical Consultant, Life Science, Kepner-Tregoe, Inc

Document management software enables investigators to present the information used to reach conclusions clearly and concisely and it helps reviewers to track and approve investigations.

The Benefits of Professional Project Management

The Benefits of Professional Project Management

Jan 13 | Thorsten Vammen, Director at GEA Liquid Processing in Skanderborg, Denmark

Some companies feel that they can project manage new processing facilities themselves, bringing in sub-contracted help only when it’s needed. Self-managing is possible, but there may be a better way.

Multimedia

Government Seeking $1T Campaign Against Alzheimer's

Government Seeking $1T Campaign Against Alzheimer's

Jan 18 | Video

Government advisors tried to set priorities for a national campaign to treat and manage Alzheimer's disease, which is projected to cost more than a trillion dollars in care by 2050. But as Dr. Jon LaPook reports, the plan does not include any funding.

ADHD Drugs in Short Supply

ADHD Drugs in Short Supply

Jan 11 | Video

Parents of children with attention deficit disorders are forced to travel from pharmacy to pharmacy in search of prescription medicines with no guarantees they will be available.

Study: Link Between Statins And Diabetes

Study: Link Between Statins And Diabetes

Jan 10 | Video

A recent study reveals that women who take statins may have a greate chance of developing diabetes.

Avastin Shows Promise in Fight Against Ovarian Cancer

Avastin Shows Promise in Fight Against Ovarian Cancer

Jan 5 | Video

Two recent studies show that Avastin, already approved for other cancers - but still controversial, could help women buy more time in their fight against ovarian cancer.

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