The Health Sciences Authority's recent investigations involving Power 1 Walnut and several other illegal sexual enhancement products found adulterated with toxic doses of glibenclamide is the most serious case of adverse dug reactions to illegal health products that we have encountered. If not for our astute healthcare professionals who promptly reported their suspicions about these products to us, potentially many more of our consumers could have been harmed by the serious health hazards posed by these products.

 

We would like to take this opportunity to express our sincere appreciation to our doctors, pharmacists, nurses and healthcare administrators who have contributed to this investigation in many ways. These include reporting of adverse drug reactions reports to us, retrieving suspected samples of products from patients or their relatives for analytical testing and interviewing patients on the source of the products.

 

We feel that it is also opportune to provide an update on our investigations to keep our healthcare professionals informed.

In addition to Power 1 Walnut, the other three illegal health products found to contain glibenclamide are counterfeit Cialis, Santi Bovine Penis Erecting Capsule and 中華牛鞭 (Zhong Hua Niu Bian). The amount of glibenclamide was found to vary among the different products and among different batches. The amount of glibenclamide detected from the samples obtained from patients were between the range of 14–100mg per tablet. The other adulterants detected in these products include varying concentrations of sildenafil, tadalafil and sibutramine.

As of 16 June 2008, we have 47 confirmed cases of adverse reactions to the adulterated illegal products and another 98 suspected cases where it is highly probable that the patient also consumed health products adulterated with glibenclamide as they exhibited similar symptoms of hypoglycaemia (e.g. giddiness, seizures, unconsciousness). These patients also have positive laboratory findings of glibenclamide (or its metabolites) in either their blood or urine. Ten presented in a coma state of which six have since passed away and the remaining four have permanent neurological damage. 

 

All the patients were males except for one female. Their ages range between 21–97 years, comprising 69% residents and 31% foreigners; 57% were Chinese, 17% Malay, 13% Indian and 13% of other races. Hypocounts of these patients upon presentation were reported to be as low as 0.7mmol/L. Clinical investigations revealed findings of positive urine/blood test for glibenclamide, high insulin and C-peptide levels.

We have assessed that the adulteration with glibenclamide is not limited to these four products and potentially can affect a wider range of illegal sexual enhancement products. It is likely that there could have been a mix-up at the source of manufacturing as we found that in products where glibenclamide was detected, the sildenafil concentration drops to very low levels. For instance, one particular batch of Power 1 Walnut from a patient contained 98mg glibenclamide and only 1mg of sildenafil.

 

HSA officers have intensified our surveillance and enforcement activities in this area. To date, more than 100,000 units of illegal health products have been seized and eight peddlers were caught dealing in such products and have been charged in court.

 

As part of our educational efforts to reduce demand of these products, we have also produced posters in foreign languages and depiction in cartoons to reach out to a wider audience.

We look forward to your continued support of reporting adverse drug reactions to the Pharmacovigilance Unit, HSA. A high level of vigilance by our healthcare professionals is essential in ensuring safer drugs on the market.

 

 

Editor-in-Chief

 

Chan Cheng Leng