MHRA Drug Safety Update: Sprayable fibrin sealants (Evicel, Tisseel and Artiss)-updated guidance on minimising risk of life-threatening and fatal air embolism
Source: MHRA
Area: Evidence > Medication Safety
The February Drug Safety Update from the MHRA includes updated guidance on reducing the risk of life-threatening and fatal cases of air embolism that have been reported with incorrect use of sprayable fibrin sealants administered using a pressure regulator device.
Fibrin sealants (also known as tissue adhesives or glues) are used in a wide range of surgical procedures to rapidly arrest bleeding and assist in subsequent wound healing. They can be applied by dripping the solution, or by spraying the solution using a pressure regulator, onto bleeding tissue where...
Source: NeLM - Patient Safety - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
MHRA Drug Safety Update: Denosumab 60 mg (Prolia) and rare cases of atypical femoral fracture with long-term use
Source: MHRA
Area: Evidence > Medication Safety
The February Drug Safety Update from the MHRA includes information on the development of atypical femoral fractures that have been reported rarely in patients with postmenopausal osteoporosis receiving long-term (?2.5 years) treatment with denosumab 60 mg (Prolia) in a clinical trial.
The following advice has been issued to healthcare professionals:
. During denosumab treatment, patients should be advised to report new or unusual thigh, hip, or groin pain. Patients presenting with such symptoms should be evaluated for an incomplete femoral frac...
Source: NeLM - Patient Safety - February 21, 2013 Category: Drugs & Pharmacology Source Type: news
MHRA Drug Safety Update: repeat enhanced cardiovascular monitoring when restarting fingolimod (GilenyaT) after treatment interruption
Source: MHRA
Area: Evidence > Medication Safety
The January issue of the MHRA's Drug Safety Update has highlighted the risk of bradycardia and heart block on starting fingolimod treatment, or re-starting fingolimod after treatment interruption which can be minimised through enhanced cardiac monitoring.
The MHRA has updated its advice on enhanced cardiac monitoring on the basis of new clinical pharmacology analyses and dose titration data. Please see link below for full details. (Source: NeLM - Patient Safety)
Source: NeLM - Patient Safety - January 30, 2013 Category: Drugs & Pharmacology Source Type: news
MHRA Drug Safety Update: routine monitoring of liver function for lenalidomide (RevlimidT)
Source: MHRA
Area: Evidence > Medication Safety
The January issue of the MHRA's Drug Safety Update recommends the routine monitoring of hepatic function with lenalidomide (RevlimidT) following reports of suspected adverse hepatic reactions and evidence to suggest that lenalidomide may be associated with drug-induced liver injury.
In light of this evidence, healthcare professionals are given the following advice:
. Routine monitoring of liver function with the same frequency as haematological monitoring* is recommended for patients receiving lenalidomide. This is particularly important in pa...
Source: NeLM - Patient Safety - January 30, 2013 Category: Drugs & Pharmacology Source Type: news
