This Medical Product Alert relates to the confirmed circulation of falsified versions of Diazepam tablets circulating in Central Africa.
Since December 2014, over 400 patients in the north east region of the Democratic Republic of Congo (DRC) have suffered from an acute dystonic reaction affecting the muscles of the face, neck and tongue. This reaction usually lasts, without treatment, for between 3 to 4 days, sometimes re-occurs, and has resulted in up to 40 hospital admissions per week. A detailed investigation carried out in DRC has revealed that patients had been taking Diazepam to treat a wide range of illnesses.
PRODUCT ONE
Laboratory analysis of a product labelled as Diazepam has shown that it does not contain Diazepam, but contains between 10mg to 20mg of Haloperidol per tablet.
Haloperidol is an antipsychotic and is used primarily for the treatment of schizophrenia, and one of the known side effects is acute dystonic reactions affecting the face and neck. So far, all known patients suffering a reaction have recovered. However, the levels of Haloperidol present in the tablets represent a serious risk, particularly to the young.
Details and photographs of the product are available here.
This product is circulating in the Ituri Health District of the Democratic Republic of Congo and the adverse reactions have been focused in the vicinity of Nono.
WHO is requesting urgent vigilance for these tablets and careful examination of the contents of bottles marked SOLINA, Diazepam 5mg, as they should not contain tablets marked with the lettering AGOG.
PRODUCT TWO
The following version of falsified Diazepam is also circulating in the Democratic Republic of Congo in containers of 1000 tablets. They are labelled as manufactured by AGOG Pharma Ltd, and again contain yellow tablets bearing the lettering AGOG.
AGOG pharma has confirmed that this packaging and labelling is falsified and that they do not manufacture Diazepam. The tablets have not yet undergone laboratory analysis, but on the basis of confirmation that the labelling is falsified WHO request increased vigilance.
Details and photographs of the product are available here.
If you are in possession of the tablets shown in the photographs or containers bearing the batch number shown above please do not use them, contact a Pharmacist or Doctor as soon as possible for advice and report the incident to the National Medicines Regulatory Authority/ National Pharmacovigilance Centre. If you think you have taken this product please seek medical advice immediately.
If you have any information concerning the supply of these products please, contact rapidalert@who.int.
Details and photographs of the product are available here.