Other safety alerts
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| Singapore: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) associated with ziprasidone |
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HSA would like to inform healthcare professionals about overseas cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) that have been reported with the use of ziprasidone.
Ziprasidone (Zeldox, Pfizer Private Limited) is an antipsychotic drug that has been registered in Singapore since 2002. It is indicated for the treatment of schizophrenia, related psychoses, prevention of relapse and for maintenance of clinical improvement during continuation therapy. It is also indicated for the treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
DRESS is a serious adverse drug-induced reaction that is potentially life-threatening. It has a delayed onset, usually appearing two to six weeks after initiation of the causative drug. Manifestations of DRESS may include cutaneous reactions such as rash or exfoliative dermatitis, fever, lymphadenopathy, eosinophilia and other systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, pericarditis and pancreatitis. The estimated incidence of this syndrome ranges from 1 in 1,000 to 1 in 10,000 drug exposures, with a mortality rate of up to 10%. The pathogenesis of DRESS is unclear and there is no specific treatment for DRESS. Early recognition of the syndrome, prompt discontinuation of the offending agent and supportive care are important in the management of DRESS. Treatment with corticosteroids may also be considered in cases with extensive organ involvement.
In December 2014, the US FDA issued a drug safety communication informing that ziprasidone was associated with DRESS. This safety communication followed the review of six worldwide cases of DRESS associated with the use of ziprasidone that were reported to the FDA Adverse Event Reporting System (FAERS). In all six cases, the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was initiated. Of these, a recurrence of symptoms following the discontinuation and re-initiation of ziprasidone was reported for three cases, where a faster time to onset of the symptoms was observed following the re-initiation. Three cases were reported to have concomitant therapy with drugs associated with the occurrence of DRESS. While none of the cases reported death, serious outcomes including hospitalisation had been reported.
In view of the consistency of the case characteristics to the signs and symptoms of DRESS, the temporal relationship between ziprasidone initiation and the onset of symptoms, and the reported cases of positive re-challenge, FDA’s assessment concluded that an association between ziprasidone use and the occurrence of DRESS was supported. Based on the available evidence, the FDA had requested for the package inserts (PI) of ziprasidone-containing products to be updated to include warnings on the risk of DRESS.
HSA has not received any adverse drug reaction reports of DRESS associated with ziprasidone use. The local PI for Zeldox has been strengthened to include warnings on the risk of DRESS.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../risk-of-drug-reactionwitheosinophiliaandsystemicsymptomsdressass.html
In Hong Kong, there are five registered pharmaceutical products containing ziprasidone, namely Zeldox for Inj 20mg/ml (with solvent) (HK-51214) and Zeldox Cap 20mg (HK-48922), 40mg (HK-48923), 60mg (HK-48924) and 80mg (HK-48925). All of them are prescription-only medicines registered by Pfizer Corporation Hong Kong Limited. Related news has been released by the US FDA, and was posted on the Drug Office website on 12 December 2014. Letter to healthcare professionals was issued on the same day to draw their attention to the new warning. So far, the Department of Health (DH) has not received any adverse drug reaction report on ziprasidone. The matter was discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board (the Committee) in February 2015. The Committee decided that the package insert of the products should be updated to include the new safety information. The DH will remain vigilant on any safety updates of the drug.
Ends/ Monday, June 15, 2015
Issued at HKT 15:00
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