WHO warns public about falsified diazepam

The World Health Organisation (WHO) has reported 700 adverse events among patients taking falsified diazepam that actually contains a powerful anti-psychotic drug.

The health agency says the people injured by the drug - who include some 400 people from the Democratic Republic of Congo (DRC) in central Africa - have developed an acute muscular reaction (dystonia) affecting the face, neck and tongue that can require hospitalisation.

Around 40 people are being hospitalised per week in DRC, and such is the prevalence of the falsified medicine that the US FDA has also warned that people buying diazepam online in the US and elsewhere could be putting themselves at risk.

The dystonias caused by haloperidol typically last for three to four days and all patients have recovered, according to the WHO.

However, laboratory analyses have shown that the product does not contain diazepam but has between 10mg to 20mg of schizophrenia drug haloperidol per tablet - the latter is the maximum recommended dose in many markets and poses a serious risk, particularly to young people.

The case is an object lesson in the complexities involved in the illicit trade in what the WHO refers to as substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFCs).

The falsified tablets are light yellow in colour and are scored across the centre of the tablet on one side and bear the letters AGOG on the other side (see image). Agog Pharma Ltd is a pharmaceutical manufacturer based in India, according to the WHO, and sells generic drug products in central African countries notably Ghana and Zambia.

The drugmaker has confirmed that it does manufacture haloperidol tablets similar to the falsified product, but notes these are supplied in blisters of 10 tablets and boxes of 10 blisters under the Agohal brand name. It does not however manufacture diazepam.

Meanwhile, the tablets that tested positive for haloperidol were contained in white plastic bottles of 1,000 tablets and marked with the name 'Solina diazepam tablets BP 5mg'. The bottles indicate product is made by Centaur Pharmaceuticals Ltd, another Indian drugmaker which manufactures diazepam but not haloperidol.

Centaur says the bottles were not used in its manufacturing process but bear labels that the "batch number and dates of manufacturing and expiry are correct as shown on the packaging."

Finally, adding yet another layer of complexity is the discovery of a product containing tablets that resemble those shown above but are presented in 1,000-count bottles labelled as being made by Agog Pharma that are clearly counterfeit.

The WHO alert including additional photos can be seen here.