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PUBLICATIONS

PUBLIC ALERT NOTICE ON CONTAMINATED ISOTAB® 20MG (ISOSORBIDE MONONITRATE).

The attention of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to the World Health Organization (WHO) Information Exchange System, Alert No. 125 on “Contaminated Isotab® (Isosorbide mononitrate) incident in Lahore Pakistan”.

 

The contaminated Isotab® (Isosorbide mononitrate) purportedly manufactured by Efroze, Karachi, Pakistan was implicated in the deaths of 107 patients and serious adverse reactions in more than 450 patients in Lahore (Punjab, Pakistan). Tests carried out on Isotab® revealed that the drug was contaminated with pyrimethamine in quantities large enough to cause substantial overdose.  From the information available to date, the contamination has only been found in the production batch J093, as samples of the same medicine tested from other batches have not shown any contamination with Pyrimethamine.

Although Isotab® (Isosorbide mononitrate) is not registered by NAFDAC for distribution in Nigeria, other brands of the anti-anginal medicine (Isosorbide mononitrate) are duly registered by NAFDAC and available in the Nigerian market.

Consequent on the above, NAFDAC hereby alerts healthcare providers and patients on this medication to be vigilant and ensure they do not purchase or use this contaminated batch. While affirming that Isotab® and other unregistered medicines are not approved for free sale in Nigeria, we urge healthcare professionals and patients who obtain their drugs from outside sources to exercise necessary caution in making their purchases.

NAFDAC is committed to ensuring that all medicines offered for sale in Nigeria are safe and of appropriate quality. We urge you to forward to the National pharmacovigilance Centre, NAFDAC, all reported adverse reactions to medicines used in your facilities or by your patients.

For further clarification on this alert and other medicine related issues, please contact the NPC by email: This email address is being protected from spambots. You need JavaScript enabled to view it. or call 07098211221.

 Source: WHO Information Exchange System. Alert No. 125

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