Other safety alerts
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| United States: Approval of new Risk Evaluation and Mitigation Strategy for Qualaquin (quinine sulfate) |
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On 8 July 2010, the U.S. Food and Drug Administration (FDA) warned that the unapproved use of the malaria drug Qualaquin (quinine sulfate) to treat night time leg cramps had resulted in serious side effects and prompted the manufacturer to develop a risk management plan aimed at educating health care professionals and patients about the potential risks. FDA has now approved a risk management plan to warn against the use of this drug for such unapproved uses. The risk management plan (REMS) requires that patients be given a Medication Guide explaining what this medication is and is not approved for, as well as the potential side effects of this drug. In addition, the REMS requires that the manufacturer issue a Dear Health Care Provider Letter warning of the risk of serious and life-threatening hematologic reactions, including serious bleeding due to thrombocytopenia, and hemolytic-uremic syndrome/ thrombotic thrombocytopenic purpura, which in some cases may result in permanent kidney damage.
Please refer to the following website in the FDA for details:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm218424.htm
On 9 July 2010, the above issue has been reported in our website, and Qualaquin is not registered in Hong Kong.
Ends/Thursday, August 5, 2010
Issued at HKT 12:30
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