Other safety alerts
|
| |
| European Union: European Medicines Agency recommends restricting use of cilostazol-containing medicines |
| |
The European Medicines Agency’s Committee on Medicinal Products for Human Use (CHMP) has recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication (i.e. a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk) should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks.
The recommendations follow a review of current evidence which indicates that the modest benefits of these medicines, i.e. their ability to increase the distance patients are able to walk, are only greater than their risks, in particular the risks of side effects affecting the heart or serious bleeding, in a limited subgroup of patients.
The CHMP recommended that cilostazol should only be used in patients whose symptoms have not improved despite prior lifestyle changes such as exercise, healthy diet and stopping smoking. In addition, cilostazol-containing medicines should not be used in patients who have suffered severe tachyarrhythmia (fast, abnormal heart rhythm), or recent unstable angina, heart attack or bypass surgery, or who take two or more antiplatelet or anticoagulant medicines such as aspirin and clopidogrel. Doctors are recommended to review their patients at their next routine appointment and assess the continued suitability of cilostazol treatment.
In conclusion, the CHMP considered that although on average the efficacy of cilostazol is modest, there is a small group of patients in whom it is of clinical relevance, not least in helping them to begin exercise programmes. Although suspected adverse drug reaction reports have raised some safety concerns, these have not been substantiated in the clinical trial data, and it remains possible to exclude high-risk patients in clinical practice. CHMP therefore recommended a number of measures aimed at targeting use of cilostazol to the population most likely to benefit, and in whom the risk of side effects is low. Detailed recommendations for patients and healthcare professional are available at the link below.
http://www.ema.europa.eu/../news_detail_001746.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, there are three pharmaceutical products containing cilostazol registered under the name Pletaal (HK-47373, HK-51136 and HK-61321). All are prescription-only medicines. In view of the EMA's recommendation, a letter to healthcare professionals will be issued. The issue will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The Department of Health will keep vigilance on any safety updates on the above issue from EMA and other overseas regulatory authorities.
Ends/Saturday, March 23, 2013
Issued at HKT 12:30
|
| |
