EMEA probes rise in adverse reactions

Date: 25/10/01

By Laurence Frost

EUROPEAN medicines watchdog EMEA is calling for extra resources to investigate a steep rise in reports of adverse reactions to drugs it has appropved.

These have ranged from hot flushes to death, according to doctors reporting side effects from licensed treatments.

The European Agency for the Evaluation of Medicinal Products is expecting to receive 35,000 such reports from doctors this year - up from around 26,000 last year, and 16,000 in 1999. EMEA spokesman Martin Harvey stressed that year-on-year increases were to be expected due to the sharp rise in the number of drugs licensed by the agency since its 1995 launch. But he said there was still a need to step up monitoring activities. "There are more and more new drugs on the market so we're getting more reports coming in," said Harvey. "We're not saying there's a crisis out there, but we've got more work to do so we need more people to do it." Only two EMEA-approved drugs had ever been suspended on safety grounds, he added.

Doctors report an adverse drug reaction, or 'ADR', whenever a patient suffers an unexpected side effect . EMEA said it was "unwilling" to divulge how many deaths had been reported in connection with ADRs. The agency is investigating the cholesterol reducer Baycol, withdrawn last August when manufacturer Bayer announced it had been linked to 52 deaths in Europe and the US. Another EMEA study concluded last month that 'third generation' contraceptive pills carried slightly higher risks of deep-vein thrombosis than other oral contraceptives.

EMEA says it needs more resources to meet increasing demands for in-depth reviews and investigations referred to it by national drug authorities. Director Thomas Lönngren is asking for 31 new staff for the London-based agency and a €4 million increase to its current budget of €66 million, of which 75 per cent is raised in commercial fees.

Besides gathering ADR reports from doctors and hospitals via national authorities, EMEA is already setting up an online database that will track the problems as soon as they are known from December. "This will improve our reaction time," said Harvey.

Established six years ago by a Union regula-tion, EMEA operates independently from the Commission, vetting and approving drugs on the basis of data from clinical trials using human volunteers. Before its launch, drug companies complained that approval in some member states could take as long as six years; EMEA's average is 178 days.

The 220-strong staff is bracing itself for an estimated 35 per cent increase in workload under the pharmaceutical review tabled by the Commission in July. Firms would be obliged to submit all new products to EMEA for approval instead of being allowed to choose between its centralised procedure and approval by national authorities.

The European Agency for the Evaluation of Medicinal Products (EMEA) is calling for extra resources to investigate a steep rise in reports of adverse reactions to drugs it has approved. Article forms part of a special report on pharmaceuticals.