The American drug regulator said yesterday it would be reviewing the safety of two AstraZeneca treatments after studies raised fears they could increase the risk of heart attacks. The drugs, for stomach ulcers, are Prilosec and Nexium - its top seller with sales of $5bn (£2.5bn) a year.
AstraZeneca shares plummeted 87p, or 3.5%, on the news to £24.30, wiping £1.3bn off the value of the company. It comes shortly after a similar scare over GlaxoSmithKline's diabetes drug Avandia.
The US Food and Drug Administration and Health Canada said AstraZeneca had submitted data in May from two studies of patients with severe GERD, where stomach acid gets into the windpipe and erodes it. The studies sought to compare the effects of the two drugs to surgery.
The regulator said yesterday those results had "raised concerns that long-term use of Prilosec or Nexium may have increased the risk of heart attacks, heart failure, and heart-related sudden death in patients taking either one of the drugs".
The regulator added, however, that additional data since May suggested there was no link to heart problems: it said its preliminary conclusion was that "collectively, these data do not suggest an increased risk of heart problems". But it said it would complete a safety review within three months.
Alastair Forbes, professor of gastroenterology at University College London, said Prilosec, which has been around since 1989, and Nexium, launched in 2001, had been used in vast amounts.
He said: "This is the FDA trying to be responsible and not to sound guilty that they might have known or suspected something. What they are doing here is being very cautious."
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