Are Injectable SFFC Polypeptide Drugs Safe? Case Report Demonstrating the Presence Of

Are injectable SFFC polypeptide drugs safe? Case report demonstrating the presence of haemolytic Bacillus Cereus in two illegal polypeptide drugs

S. JANVIER1,2, E. WATTIJN3, N. BOTTELDOORN3 ,B. DE SPIEGELEER2, E. DECONINCK1and C. VANHEE1

1Division of Food, Medicines and Consumer Safety, Section Medicines and Healthcare Products, Scientific Institute of Public Health (IPH), Brussels, Belgium

2Drug Quality and Registration (DruQuar) Group, Faculty of Pharmaceutical Sciences, Ghent, Belgium

3Division Communicable and Infectious Diseases, Section Foodborne Pathogens, Scientific Institute of Public Health (IPH), Brussels, Belgium

The phenomena of Spurious/Falsely-labelled/Falsified/Counterfeit (SFFC) medicines is a well-known global problem that comprises of both lifestyle drugs as lifesaving medicines. Adverse consequences range from serious infringements on intellectual property rights and significant economic losses to serious health issues, which in some cases have led to a deathly outcome. Abundant reports in literature can be found concerning the presence of chemical impurities and contaminants or issues relating to the proclaimed API. However for illegal polypeptide drugs the available information on the possible presence of micro-organisms is quite scarce. Therefore we screened 100 illegal injectable polypeptide drugs on the presence of bacteria. Sterility testing was performed based on the European Pharmacopoeia 2.6.1. by direct inoculation of the culture medium. Out of the entire sample set two samples showed bacterial growth after only 2 days with clear halo formations around the different colonies due to β-hemolysis. Analysis of different colonies via MALDI-TOF pinpointed the bacteria as members of the Bacillus cereus group. Subsequent polymerase chain reactions (PCR) for the diagnostic DNA fragments of Bacillus cereus confirmed that the bacteria were indeed Bacillus cereus. Moreover bacteria in both samples showed positive results for PCR reactions for different emetic and haemolytic toxins. Although Bacillus cereus is known as a food pathogen, also non-gastrointestinal infections have been reported in case reports of ‘classical’ drug users. Altogether, this case report clearly demonstrates the detrimental health risks regarding injectable polypeptide drugs and shows that the associated dangers of these type of drugs are not only limited to chemical substances.