Other safety alerts
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| The United States: Drug Safety Communication: FDA clarifies Warning about Pediatric Use of Revatio (sildenafil) for Pulmonary Arterial Hypertension |
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FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in adults, not in children; however, health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.
FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with PAH. FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring. This recommendation was not intended to suggest that Revatio should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to prescribe or administer the drug.
The evidence behind FDAs initial recommendation has not changed, and the communication is clarifying the strength of the warning communicated in the Revatio drug label.
Please refer to the following website in USA for details:
http://www.fda.gov/Safety/MedWatch/../ucm391152.htm
In Hong Kong, Revatio Tab 20mg (HK-54170) is registered by Pfizer Corporation Hong Kong Limited and is a prescription-only medicine. The approved indication in Hong Kong is for the treatment of adult patients with pulmonary arterial hypertension, and its use in children and adolescents (<18 years) is not recommended. Related news was released by the FDA and was posted on the website of the Drug Office on 31 August 2012. In addition, a letter to healthcare professionals drawing their attention on the issue and advising them to balance the risk of possible adverse effects against the benefit of treatment was issued on the same day. The Department of Health will keep vigilant on any safety updates related to the drug.
Ends/ Tuesday, April 01, 2014
Issued at HKT 14:00
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