Belgian medicines agency reinforces pharmacovigilance on new drugs

The Belgian medicines agency has decided to reinforce pharmacovigilance on drugs that have been launched on the market since January 2005.

"We are asking health professionals - doctors, pharmacists and dentists - to pay particular care to adverse events in connection with these products," said Thierry Roisin, head of vigilance at the Federal Agency for Medicines and Health Products (AFMPS).

In December, the Belgian Pharmacovigilance Centre (CBPH), that centralises pharmacovigilance reports for the country, sent health professionals a letter informing them of this initiative.

Since January 2005, just over 70 new molecules have been placed on the market. The CBPH reports to AFMPS and has drawn up a list of these molecules; henceforth, they will be identified by inverted black triangle in the list that can be consulted on the internet site www.afmps.be and will be updated every month to include any new molecules.

For medicinal products bearing an inverted black triangle the CBPH will request "systematic notification of suspicions of adverse events, even in cases where the causal relationship is not clear".

Roisin explained that the agency has adapted markings used in the UK. However, he said that the black triangle would not be placed on the packaging. He said: "These products are no more dangerous than any other, but because they're new, we need to concentrate on them."

Every year some 5,000 adverse event reports are notified in Belgium; this figure includes notifications sent in by the pharma industry.