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Saturday, March 10, 2012

Glaxo Issue Severe or Life-Threatening Warning on Lupus Drug

GlaxoSmithKline have sent out 'Dear Healthcare Professional' letters regarding new findings that their drug, Benlysta, used in the treatment of lupus, may result in severe or life-threatening hypersensitivity and infusion reactions.

Benlysta [belimumab] was approved by the FDA just one year ago and is delivered directly into a vein. Glaxo are now reporting that:

Recently, a number of post-marketing reports concerning serious acute hypersensitivity reactions, some of which appear to have been delayed beyond the typical 1-2 hours seen in previous clinical trials, have been identified. Patients have been reported to develop acute symptoms several hours after the infusion has been given, for example in the evening on the day the drug was administered. One patient died after she developed dyspnea, respiratory distress, hypoxia and angioedema following the second infusion of belimumab.

On approving the drug in March 2011, the FDA wrote, "Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta."

The Glaxo warning adds: The Package Leaflet is currently being revised.

But don't expect to see any full-page ads in the press or commercials on TV. These letters are just sent out to healthcare professionals who will no doubt be forced to make that "Benefit vs Risk" decision when administering Benlysta.

Ironically, earlier this month Glaxo Chief, Andrew Witty, criticized the UK government because he thought the drug approval process should be made quicker.

It would appear that Glaxo want to get the drugs on the streets then worry about the consequences later.

Benlysta has been on the market for just a year in the US. The FDA approved it by a 13-to-2 vote, despite concerns that the drug was only marginally effective. In the one year it has been on the market it has fattened the wallet of GlaxoSmithKline. This latest news about Benlysta's severe adverse reactions was found on the Irish Medicine's Board website - Ireland is hardly the biggest country in the world but GSK can always say, "Hey, we did send out warnings."

Earlier this year Judge Marcelo Aguinsky fined GlaxoSmithKline 400,000 Argentinian Pesos [about £60,000] for its part in the 2007/08 vaccine trials conducted in Argentina where 14 children died.

GlaxoSmithKline helps people to do more, feel better and live longer.

Parts 2 and 3

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