Is Avandia a risky drug

Tue, 13 Jul 2010
Backers and opponents of the diabetes drug Avandia, manufactured by GlaxoSmithKline Plc, will attend a meeting in the US to finally settle a safety debate that has been raging for three years – does Avandia increase the risk of heart attacks?

Scientific experts will meet to decide if the drug is safe to stay on the market.

The Food and Drug Administration (FDA) is expected to make its final decision in the coming months after sorting through very conflicting data.

If the drug is taken off the market UK based Glaxo could face a barrage of lawsuits.

The diabetes drug was initially a big seller generating revenues of £771m in 2009 (2.7 per cent of Glaxo’s total group sales). However sales have since plummeted since its safety came into question.

In addition The European Medicines Agency is looking into the benefits and risks attached to the drug.

Consumer groups are putting pressure on the FDA to make a decision as they feel the public needs protection. Some see the drug as more dangerous than Actos, a rival pill whereas others are not convinced that Avandia increases the risk of heart attacks.

Glaxo defend the medicine and representatives of the company will present their data to the panel of scientists along with FDA staff and other experts who will be called to give evidence.

From this the panel of experts will be asked to choose if the drug should stay on the market without a heart attack warning or to recommend a withdrawal. Other options include restricting use or increasing the warnings that come with the medicine.

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