Category Archives: FDA media releases

Xigris (Drotrecogin alfa activated): concerns of serious bleeding and increased death trigger FDA safety review

On February 4th, 2009 the FDA announced an ongoing safety review of Xigris (Drotrecogin alfa [activated]). An introduction from Wikipedia: Drotrecogin alfa (activated) (Xigris, marketed by Eli Lilly and Company) is a recombinant form of human activated protein C ( rhAPC) that has anti-thrombotic, anti-inflammatory, and profibrinolytic properties. Drotrecogin alpha (activated) belongs to the class…

FDA recommendations on clopidogrel (Plavix) because of decreased response and PPI interactions

Pharmamotion has now a new page containing updates on  clopidogrel PPI interactions. The FDA issued today an early communication about an ongoing safety review of the antiplatelet agent clopidogrel bisulfate (Plavix). The backgroung to this is the recent evidence of: A decreased response to clopidogrel in some patients. Since clopidogrel is a prodrug, genetic polymorphisms…

FDA updated information about a safety review of Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia), and Simvastatin (Zocor)

FDA updated yesterday ( January 8, 2009) information related to their review of the ENHANCE trial: On January 25, 2008, FDA announced that it would be reviewing data from the ENHANCE trial (Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia). (http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm). Preliminary results from this…Continue Reading

Degarelix (Firmagon) for prostate cancer: now approved by FDA

Related to EMEA’s positive opinion on degarelix (Firmagon) for prostate cancer, FDA issues this press release dated Dec. 29, 2008: FDA Approves Drug for Patients with Advanced Prostate Cancer The U.S. Food and Drug Administration recently approved the injectable drug degarelix, the first new drug in several years for prostate cancer.  Continue Reading

FDA approves gadofosveset trisodium (Vasovist) as first contrast agent for magnetic resonance angiography (MRA)

FDA press release about the approval of Vasovist (gadofosveset trisodium), the first contrast agent for magnetic resonance angiography. Dated December 24, 2008. FDA Approves First Imaging Agent to Enhance Scans of Blood Flow Helps detect possible blood vessel problems The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for…Continue Reading

FDA approves imatinib (Gleevec) for a new indication: GIST tumors.

FDA press relase about the approval of imatinib (Gleevec) for the treatment of GIST tumors: FOR IMMEDIATE RELEASE December 19, 2008 FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer The U.S. Food and Drug Administration today approved Gleevec (imatinib mesylate) for a new indication –Continue Reading

FDA approves plerixafor (Mozobil) for use in multiple myeloma and non Hodgkin’s lymphomas

From the FDA’s newsroom: FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used…Continue Reading

Antiepileptic drugs (AEDs): FDA requires warnings about suicidal thoughts and behaviors (suicidality)

The FDA will require manufacturers of antiepileptic drugs (AEDs) to inclued a warning about the increased risk of suicidal thoughts and behaviours when using these drugs. This is a transcript of the original press release dated Dec. 16, 2008: FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications The U.S. Food…Continue Reading

An FDA advisory panel voted to ban formoterol (Serevent) and salmeterol (Foradil)

From JournalWatch: FDA Panel Votes to Ban Two Drugs for Asthma An advisory panel to the FDA voted Thursday to ban two long-acting beta agonists, Serevent (salmeterol) and Foradil (formoterol), for treating asthma in adults and children. When taken without an inhaled corticosteroid, these drugs canContinue Reading

FDA: statins do not increase the risk of amyotrophic lateral sclerosis (ALS)

From FDA’s patient safety news website: Statin Use and the Risk of ALS A recent FDA analysis provides new evidence that using statins does not increase the risk of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease also known “Lou Gehrig’s Disease.” Cholesterol-lowering statins such as Lipitor (atorvastatin calcium) and Zocor (simvastatin) have been shown to…Continue Reading

FDA video on Ephedrine and Epinephrine: how to prevent mistakes in their administration.

From FDA Patient Safety News: “Drug Name Confusion: Ephedrine and Epinephrine The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of mix-ups between ephedrine and epinephrine. Not only do the names of these drugs look and sound similar, but since they’re both used as vasopressors and vasoconstrictors, they’re often stored next…Continue Reading

Phenytoin and fosphenytoin linked to Stevens Johnson syndrome and toxic epidermal necrolysis

From the FDA website: FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across…

Tapentadol approved by FDA as treatment for moderate to severe pain

FDA news release about the approval of pentadol to alleviate moderate to severe Pain: The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100…

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