Other safety alerts
|
| |
| The United States: FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies |
| |
FDA notified the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma. This safety information has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk. Healthcare professionals should consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm250606.htm
In Hong Kong, there are 4 registered pharmaceutical products, namely Revlimid Cap 5mg, 10mg, 15mg and 25mg, containing lenalidomide. They are registered by Celgene Ltd and are prescription-only medicines. The above safety information were released by the US FDA, UK MHRA, EMA and Health Canada and were posted on the website of Drug Office on 9 April, 5 May, 24 September 2011 and 4 May 2012. A letter to inform healthcare professionals was issued on 9 April 2011. The issue has been discussed in the meeting of Registration Committee of Pharmacy and Poisons Board on 28 Feburary 2012. The Committee decided that the package insert of lenalidomide-containing products should be updated to include the appropriate safety information. Department of Health will keep vigilance against any new safety information in relation to the drug.
Ends/ Tuesday, May 08, 2012
Issued at HKT 14:00 |
| |
