ADRs that result in revision of product information or suspension of marketing authorisation
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| The United Kingdom: Crizotinib (Xalkori): risk of cardiac failure |
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Crizotinib (Xalkori) is licensed to treat adults with previously treated anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer.
There have been reports of severe, sometimes fatal, cases of cardiac failure in patients treated with crizotinib. A review by European medicines regulators of data from clinical trials and reports from clinical practice has concluded that this side effect is common (ie, occurs in between 1 in 10 and 1 in 100 patients who take crizotinib).
Up to 25 February 2015, about 14,700 patients worldwide have received crizotinib since licensing. Forty cases of cardiac failure have been reported in the post-marketing setting. In most cases cardiac failure occurred within 1 month of starting treatment with crizotinib, and affected patients with or without pre-existing heart disorders. The reports included some cases with evidence of symptoms of cardiac failure resolving on stopping crizotinib, and cases with evidence of symptoms reoccurring when it was reintroduced.
In the UK, the MHRA has received 2 Yellow Card reports of suspected heart failure with crizotinib up to 3 November 2015, 1 of which was fatal.
The MHRA advises healthcare professionals of the following:
• Monitor all patients for signs and symptoms of heart failure (including dyspnoea, oedema, or rapid weight gain from fluid retention)
• Consider reducing the dose, or interrupting or stopping treatment if symptoms of heart failure occur
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/crizotinib-xalkori-risk-of-cardiac-failure
In Hong Kong, there are two pharmaceutical products containing crizotinib, namely Xalkori Cap 200mg (HK-61969) and 250mg (HK-61968) registered by Pfizer Corporation Hong Kong Limited (Pfizer HK). Both products are prescription-only medicines and their package inserts do not have warnings on cardiac failure. So far, the Department of Health (DH) has received four adverse drug reaction cases related to crizotinib, and none of them was related to cardiac failure. According to the Dear Healthcare Professional Letter in the MHRA announcement, Pfizer UK Ltd would include the new warnings to the Summary of Product Characteristics of the products in UK. In view of the MHRA announcement, letters to inform local healthcare professionals will be issued. DH will contact Pfizer HK to follow-up, and the issue will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Friday, November 13, 2015
Issued at HKT 15:00
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