ADRs that result in revision of product information or suspension of marketing authorisation
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| The United States: Drug Safety Communication: The US Food and Drug Administration requires multiple new safety measures for leukemia drug Iclusig (ponatinib) |
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The US Food and Drug Administration (FDA) is requiring several new safety measures for the leukemia drug Iclusig (ponatinib) to address the risk of life-threatening blood clots and severe narrowing of blood vessels. Once these new safety measures are in place, the manufacturer of Iclusig, ARIAD Pharmaceuticals (ARIAD), is expected to resume marketing to appropriate patients. Healthcare professionals should review these additional safety measures and carefully consider them when evaluating the risks and benefits of Iclusig for each patient.
The required safety measures involve label changes to narrow the indication, provide additional warnings and precautions about the risk of blood clots and severe narrowing of blood vessels, revise recommendations about dosage and administration of Iclusig, and update the patient medication guide. A risk evaluation and mitigation strategy (REMS) is also required. In addition, ARIAD must conduct postmarket investigations to further characterize the drug’s safety and dosing.
In October 2013, FDA requested ARIAD to voluntarily suspend marketing of Iclusig based on a steady increase in the number of serious vascular occlusion events identified through continued safety monitoring of the drug. This observation represented a significant change in the safety profile of Iclusig as the proportion of patients on the drug experiencing vascular occlusion events such as blood clots and severe narrowing of blood vessels was significantly greater than the proportion reported at the time of its approval in December 2012. During the marketing suspension, Iclusig treatment has been available through single patient or emergency investigational new drug applications.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm379554.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been released by the FDA and EMA, and was posted on the website of Drug Office on 12 October 2013, 1 November 2013, 9 November 2013 and 23 November 2013.
Ends/ Saturday, December 21, 2013
Issued at HKT 13:00
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