Flu jab may be fatal to some pensioners
By Beezy Marsh, Health Correspondent
(Filed: 29/10/2005)

Winter flu jabs are being linked to an increased risk of life-threatening illness among the elderly.

Dozens of pensioners taking Warfarin to ward off strokes have suffered internal bleeding after flu jabs, leading to fears of potentially fatal interactions between the vaccine and blood-thinning medication.

A Government committee has investigated safety fears over the winter flu vaccine and the clot-busting drug after a cluster of adverse reactions were reported by general practitioners.

Six pensioners at the same surgery were reported to have suffered internal bleeding after having the jab, leading to an inquiry by the Government's Committee on Safety of Medicines.

Medical records going back 35 years show a further 25 cases of suspected serious interactions between Warfarin and the flu vaccine. In three cases, the adverse reactions - reported to the Medicines and Healthcare Products Regulatory Agency - were fatal.

Since 2001, a total of 449 adverse reactions to the flu jab have been reported. Twenty people are known to have died after the jab, with the causes of death including sudden death, blood poisoning, heart attack, pulmonary embolism and pneumonia.

But because many of the patients receiving the injection were elderly, experts say it could be coincidental that they died shortly after vaccination, and no evidence of a causal link has been established.

However, CSM experts were concerned that the flu jab - which is mainly aimed at the over-65s, who are a target group for anti-stroke medication - could be destabilising Warfarin and increasing the risk of fatal internal bleeding.

A total of 14 million flu jabs are expected to be given this winter, with demand heightened by the potential bird flu pandemic.

The World Health Organisation has urged all those eligible, including the over-65s, people with asthma and diabetes, to have the jab to reduce the likelihood of getting the flu virus, which if it came into contact with avian flu may spread it to humans.

During the CSM investigation it emerged that neither the flu vaccine itself nor the Government's Green Book, which advises doctors on drug interactions, mentioned problems with Warfarin.

But another medical "bible", the British National Formulary, does state that the action of Warfarin is occasionally enhanced by the influenza vaccine.

Thirteen medical studies into the possible reaction between the flu jab and Warfarin were examined. Three supported the theory, eight did not and two found that the flu jab actually encouraged blood clotting.

The CSM inquiry concluded that if a risk of interaction did exist, " it may not be possible to define those at risk", and it has decided against warning GPs to watch out for internal bleeding among pensioners on Warfarin who have the flu jab.

The report added: "The available evidence does not allow any firm conclusions to be drawn on causality and no regulatory action was recommended."

A spokesman for the MHRA last night defended the decision of the CSM and said that in the cases of the three fatalities the reporting doctor did not "specifically state that the event was due to an interaction between influenza vaccine and Warfarin."

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