Asthma wonder jab could kill, warn the Americans
UK Daily Mail |
February 22, 2007
The U.S. government has ordered stronger warnings to be carried on the labels of an asthma "wonder" jab widely available in the UK.
The move comes after some users developed a delayed and potentially life-threatening reaction to Xolair, which was licensed in the UK in 2005.
It was known that the drug could cause a severe reaction known as anaphylaxis, but U.S. doctors have now discovered the reaction can be delayed and occur even if there were no problems after a first dose.
Anaphylaxis causes breathing problems, a tight chest, swelling in the mouth and throat, dizziness or faintness and itching and hives.
Last night the British watchdog, the Medicines and Healthcare Products Regulatory Agency, said it had no plans to review safety labels.
Clinical trials have shown that Xolair, which is injected into the arm every fortnight, cuts attacks by over half in patients with severe asthma and reduces hospital admissions by almost 50 per cent.
The drug, also called omalizumab, is recommended for patients who have severe problems, such as reduced lung function, despite using highdose inhaled treatments.
The jab was licenced in the U.S. in 2003 but the Food and Drug Administration has now told its manufacturer, Genentech, to strengthen warnings on the label. The new version warns that anaphylaxis can occur up to 24 hours after the injection is given.
It tells doctors, and patients who are treating themselves, to be ready for "a potentially lifethreatening reaction".
But Britain's MHRA said it had no evidence that the drug, developed by Novartis, is unsafe. A spokesman said: "There are no alarm bells ringing for us at this time over this drug. We do not have similar data that the drug is unsafe at the moment but that's not to say we won't review it in the future.
"Just because the FDA are doing this does not mean that we will follow suit. However, we will look at their decision."
The UK has one of the highest rates of asthma in the world. More than 1,400 people die from it every year, and 69,000 have to be treated in hospital. Asthma costs the NHS £889million a year.
High-profile victims include the actress Charlotte Coleman, who starred with Hugh Grant in Four Weddings and a Funeral. She died of an asthma attack in 2001 at the age of 33.
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