ADR that result in revision of patient information
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| The United States: Ziprasidone: Drug Safety Communication - Rare But Potentially Fatal Skin Reactions |
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The US Food and Drug Administration (FDA) is warning that the antipsychotic drug ziprasidone (marketed in the US under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the blood. DRESS can lead to death.
FDA reviewed information from six patients in whom the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was started. None of these patients died. Based on this information, FDA required the manufacturer of Geodon to add a new warning for DRESS to the Warnings and Precautions section of the drug labels for the capsule, oral suspension, and injection formulations.
Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm426624.htm
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. So far, the Department of Health (DH) has not received any adverse drug reaction report in relation to ziprasidone. In view of the FDA’s announcement, a letter to healthcare professionals will be issued to draw their attention and urge them to report any adverse drug reactions related to the products, and the matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. DH will remain vigilant on any safety updates of the drug.
Ends/ Friday, December 12, 2014
Issued at HKT 13:00
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