Showing posts with label drug safety. Show all posts
Showing posts with label drug safety. Show all posts
Thursday, May 24, 2012
Effects of Funding Policy Changes and Health Warnings on the Use of Erythropoiesis-Stimulating Agents [Original Contributions]
Effects of Funding Policy Changes and Health Warnings on the Use of Erythropoiesis-Stimulating Agents [Original Contributions]
Purpose:
To characterize the effects of formulary changes and governmental safety warnings on use of erythropoiesis-stimulating agents (ESAs) in patients with cancer.
Patients and Methods:
We conducted a cross-sectional time-series analysis using health administrative data from Ontario, Canada. From January 1997 to December 2009 we identified all ESA initiations among patients diagnosed with cancer. We explored the effects of two formulary changes that progressively liberalized coverage for ESAs, first by rescinding the requirement for blood transfusion in 2003 and then by removing all restrictions in 2007. We also explored the effect of US Food and Drug Administration and Health Canada warnings issued in the second quarter of 2007. To assess regional variability in ESA use, we determined prescription rates for each of Ontario's 14 regional cancer centers.
Results:
After the first formulary change, the ESA initiation rate increased to 1.66 new users per 1,000 patients with cancer, 374% more than predicted (P < .001). After the second formulary change, the initiation rate increased to 3.97 new users per 1,000 patients with cancer, 73% more than predicted (P < .001). After the safety warnings, this rate declined 81% by study end (P < .001). We found significant regional variation in ESA use.
Conclusion:
Formulary access and safety warnings had significant impacts on the new use of ESA drugs in patients with cancer. This suggests that both are effective means of influencing the use of these drugs. Variable ESA prescription rates across our region may reflect a lack of consensus regarding their utility.
Monday, April 16, 2012
open access: PLoS ONE: Proteins from Avastin® (bevacizumab) Show Tyrosine Nitrations for which the Consequences Are Completely Unclear
PLoS ONE: Proteins from Avastin® (bevacizumab) Show Tyrosine Nitrations for which the Consequences Are Completely Unclear
"......A major finding indicating pathogenetic or toxic properties of nitrated proteins was presented recently: assembly of alpha-synuclein and fibrinogen were deteriorated by nitration of only a small fraction of proteins [25], [32]. As for fibrinogen, nitration is accelerating the rate of fibrin clot formation [33]. It cannot be ruled out, therefore, that nitration of Avastin® may lead to side effects based upon probable disturbed protein-protein interactions as aggregations that in turn may lead to a series of complications as listed in the drug information sheet.
As to the underlying cause of tyrosine nitration it remains open, whether it can be considered as a post-translational modification of the immunoglobulin Avastin® or technical in nature, or both [34]-[38].
Taken together, it remains unclear if the observed nitrations and other PMs detected on Avastin® may be responsible for different biological or pharmacotoxicological properties and effects. Quantification of nitrations and their presence in several batches of the product has to be taken into considerations on probable toxicity as well, but corresponding in vivo analyses based upon these findings should be carried out by the manufacturers to probably save this protein drug that may have strong potential in tumor therapy."
Thursday, March 17, 2011
Drug company (Mylan Pharmaceuticals) recalls pills over dangerous labelling mix-up (Mylan-Minocycline/ Mylan-Amlodipine)
"A pharmaceutical company has launched a voluntary recall of a drug which may have been mislabelled — with possible "life-threatening" consequences for patients with high blood pressure, says Health Canada.
Following a complaint by a pharmacist regarding a prescription product containing the wrong medication, Mylan Pharmaceuticals is recalling one lot of Mylan-Minocycline 50 mg capsules and Mylan-Amlodipine 5 mg tablets, both sold in bottles of 100.
The risk, says Health Canada, is that patients sensitive to tetracyclines or minocycline may be taking minocycline in error, due to mislabelled bottles.
"In addition, a patient who requires MYLAN-AMLODIPINE for their high blood pressure or angina will not get the medication needed to help them treat these conditions," said a Health Canada statement.
Mylan-Amlodipine is used to treat high blood pressure and chest pains. Mylan-Minocycline is used to treat certain types of skin infections, urinary tract infections, gallbladder infections, and respiratory tract infections such as bronchitis, pneumonia, and sinusitis.
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