Shire Suspends Sales Amid Safety FearsFeb 10, 2005 | Scotsman, UK Shire Pharmaceuticals saw its share price plunge 10% today after its best-selling drug was ordered off the shelves in Canada amid safety fears.
Canadian health officials demanded the suspension of sales of its Adderall XR hyperactivity treatment after the drug was linked to 20 sudden deaths.
They cited data showed that 14 children and six adults had died after taking the usual recommended doses of the drug, while there were also 12 reports of strokes in patients.
In a statement, regulators said: “The incidence of serious adverse reactions leading to death was higher in Adderall and Adderall XR combined than in the other drugs of this class.”
Shire said it had agreed to suspend sales of the drug in Canada even though it strongly disagreed with the conclusions of officials at Health Canada.
It was considering “appropriate responsive action” and said the issue was linked to labelling of the drug, which should stress that it should not be used by children or adults with heart problems.
Adderall XR was approved in Canada in January last year and launched the following month, with around 11,000 patients using it to treat attention deficit hyperactivity disorder in the country currently.
It contributed 10 million US dollars to annual revenues in its first year on the Canadian market. Global sales of Adderall XR account for 43% of the total turnover of the company.
Chief executive Matthew Emmens said: “We are surprised by this action from Health Canada. Shire remains confident in the safety and efficacy of Adderall XR.”
Labelling of the drug in the United States was revised in September and Shire said the same data had been considered by the Food and Drugs Administration (FDA) there.
Analysts said shares in Shire would have collapsed if investors thought that US regulators were likely to follow their Canadian counterparts in suspending sales of the drug.
Dr Jonathan Senior, of Evolution Securities, said: “Unless there is something lurking in the data that the FDA hasn’t seen then it is unlikely to lead to a withdrawal in the US, which would be a massive blow to them.”
The crisis that followed the withdrawal of the Vioxx painkiller manufactured by rival drugmaker Merck last year meant the FDA was likely to look again at the data, but Dr Senior said this would be to “dot the Is and cross the Ts”.
Shire, based in Basingstoke, is the UK’s third-largest pharmaceuticals group behind GlaxoSmithKline and AstraZeneca. The product is not available in the UK.