ADR that result in revision of patient information
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| Canada: Gadolinium-Containing Contrast Agents - Update on Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) |
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Health Canada announced that Gadolinium (Gd)-containing contrast agents (GBCA) have been linked to a rare and potentially fatal disease, Nephrogenic Systemic Fibrosis (NSF) in patients with kidney disease. While NSF development is considered a potential class-related effect of all GBCAs, current evidence suggests that the extent of risk for NSF following exposure to any specific GBCA vary among the agents. Health Canada has worked with the Canadian Marketing Authorization Holders of the GBCAs to update the prescribing information for these agents.
GBCAs are indicated for providing contrast enhancement in the magnetic resonance imaging (MRI) investigations. Eight GBCA products are currently authorized for sale in Canada: Ablavar (gadofosveset trisodium) Gadovist (gadobutrol), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine), Omniscan (gadodiamide), OptiMARK (gadoversetamide), ProHance (gadoteridol) and Primovist (gadoxetate disodium).
The current Canadian prescribing information for GBCAs is outlined below.
- OMNISCAN, OPTIMARK and MAGNEVIST are contraindicated in:
1. Patients with chronic severe renal insufficiency where glomerular filtration rate is <30 mL/min/1.73m2;
2. Patients with acute kidney injury (AKI) (including those with acute renal insufficiency of any severity due to the hepato-renal syndrome or patients in the perioperative liver transplantation period) and
3. Neonates up to 4 weeks of age due to their immature renal function.
- GADOVIST, ProHANCE, MultiHANCE, ABLAVAR and PRIMOVIST should only be used with extreme caution in patients mentioned above.
- All patients should be screened for AKI, renal dysfunction and reduced renal function prior to therapy.
NSF can result in fatal or debilitating systemic fibrosis. In such cases, the skin fibrosis extends beyond the dermis and involves subcutaneous tissues, muscles and internal organs. The disease was first described in the medical literature in 2000. A skin biopsy is necessary to exclude skin disorders with similar presentation.
NSF cases have been reported following single and multiple administrations of GBCAs. It is not always possible to identify a single causal agent. NSF has also been reported to occur following the sequential administration of some lower risk GBCAs.
Repeated or higher than recommended doses of a GBCA and the degree of renal function impairment at the time of exposure are risk factors for NSF. The risk of NSF in patients with mild to moderate renal insufficiency is not well characterized, and the cautious utilization of the lowest possible dose of GBCA in these patients is recommended. When administering a GBCA, the recommended dose should not be exceeded and a sufficient period of time should be allowed for elimination of the agent from the body prior to any re-administration.
For patients receiving hemodialysis, healthcare professionals may consider prompt hemodialysis following GBCA administration in order to enhance the contrast agent's elimination. However, it is not known currently if hemodialysis can help to prevent NSF.
Please refer to the following website in Health Canada for details:
http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../36711a-eng.php
In Hong Kong, there are nine registered pharmaceutical products belonging to gadolinium-based contrast agents (GBCAs). The products are Magnevist Inj (HK-32608), Omniscan Inj 0.5mmol/ml (HK-43493), Gadovist Inj 1mmol/ml (HK-51750) and 1mmol/ml (pre-filled syringe) (HK-57330), Primovist pre-filled syringe Inj 0.25mmol/ml (HK-54116), Dotarem Inj 377mg/ml (Vial) (HK-41578) and prefilled syringes, 377mg/ml (HK-41579), MultiHance Inj 334mg (China) (HK-55495)and Inj 334mg (Patheon Italia) (HK-57789). All of them are prescription-only medicines. So far, the Department of Health has not received any adverse reaction report in connection with GBCAs. Related news had been released by FDA and was posted on Drug Office website on 10 September 2010. Letter to inform healthcare professionals to draw their attention on the issue and urge them to report any adverse drug reaction related to the drug was issued on the same day. In view of Health Canada’s latest recommendations, the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, November 15, 2013
Issued at HKT 14:00
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