Sunday 20 January 2019

Flu jabs cause rise in adverse drug reactions

MEDICINE: Number with side effects up by 900

SWINE flu vaccination led to a surge in reports of adverse reactions to drugs, the Irish Medicines Board (IMB) has revealed in its annual report.

An extra 900 reports of adverse reactions to the vaccine made the year one of the busiest ever for the board.

The board also seized just under half a million illegal tablets and capsules during the year and shut down more than 1,000 websites which were trying to sell medicines illegally in this country.

The seizures also included 1,650 packs of liquids, 440 packs of creams and 3,582 packs of other assorted illegal products.

The report describes as "unprecedented" the number of adverse reactions to medicines, which was up 19pc on the previous year with reactions to swine flu vaccination making a significant contribution to this rise.

Overall, the IMB received a total of 3,276 notifications of suspected adverse reactions to medicines during the year.

This compared to 2,742 the previous year and was up from 1,907 in 2006.

The vast majority of these reports came from pharmaceutical companies followed by reports from family doctors, community nurses and community care doctors.

There were 108 reports by patients, 81 from community pharmacists and 52 adverse reports from clinical trials.

During the year 108 applications were received and approved to carry out clinical trials. No applications were rejected. The IMB also had to deal with a 20pc increase in the number of medical products which breached legislation, and this led to the seizures of tablets, creams and other products.

The number of product recalls, however, showed a significant 30pc drop on the previous year with 91 human medicines and eight veterinary medicines being taken off the market.

The report says the outbreak of the swine flu pandemic and the introduction of the vaccination programme significantly increased the workload of a number of departments.

The information given in the adverse reaction reports was "particularly helpful" to ensure the safety of the new vaccines.

The IMB also upgraded its website to provide more detailed information about the vaccination programme.


Chief executive Pat O'Mahony said the IMB faces new challenges and opportunities for development.

"Strict controls on public sector recruitment will pose substantial challenges to ensure we can deliver on our public health remit and services to industry."

He added that it will continue to review funding and "look critically at our own cost base to ensure maximum use of resources".

The number of new medicines authorised by the IMB in 2009 increased from 1,268 in 2008 to 1,925 in 2009.


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