Other safety alerts
|
| |
| The United Kingdom: Oral tacrolimus products should be prescribed and dispensed by brand name to avoid the risk of medication errors |
| |
MHRA issued an advice to healthcare professionals and patients regarding the safe us of oral tacrolimus prodcuts. MHRA recommended oral tacrolimus products should be prescribed and dsipensed by brand name to avoid the risk of medicatione errors. This recommendation follows the review conducted by the Commission on Human Medicines (CHM), which concluded that in light of the growing numbers of tacrolimus products, and to ensure maintenance of therapeutic response when a patient is stabilised on a particular brand, oral tacrolimus products should be prescribed and dispensed by brand name only. For details, please refer to the websites listed below.
Tacrolimus is a drug with a narrow therapeutic index, and even minor differences in blood levels have the potential to cause transplant rejection or adverse reactions. There were reports of unintended switching of pharmaceutical forms that led both to toxicity and to graft rejection reactions received by the MHRA.
This recommendation made by the MHRA does not imply that a patient’s treatment cannot be changed to a different tacrolimus pharmaceutical form or brand if the prescriber considers this appropriate. However, any changes between brands (which may or may not involve changes in dosing regimen) should be accompanied by careful therapeutic monitoring under the supervision of an appropriate specialist.
Please refer to the following website in MHRA for details:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/../CON152758 &http://www.mhra.gov.uk/home/groups/../con152759.pdf
In Hong Kong, tacrolimus in oral dosage form is registered under three brand names, namely Prograf Cap, Advagraf Prolonged-release Hard Cap and Tacrolimus Sandoz Cap, and all with strength 0.5mg, 1mg and 5mg. All the products are prescription-only medicines. In light of the MHRA's advice, a letter to inform healthcare professionals will be issued.
Ends/ Friday, May 25, 2012
Issued at HKT 14:00
|
| |
|
