Avandia withdrawn in Europe, but remains in US
pharmafile | September 24, 2010 | News story | Sales and Marketing | Avandia, FDA, pharmacovigilance, safety
GSK’s diabetes drug Avandia is to be withdrawn from the market in Europe because of high levels of heart attack, heart failure and stroke in patients.
Europe’s regulator the EMA has ordered the suspension of the drug, but its US counterpart the FDA has decided to allow it remain on the market, albeit with further restrictions on it use.
A new analysis of all the available data by the UK’s regulator the MHRA concluded that Avandia’s benefits no longer outweighed its risks to patients, resulting in advice to withdraw the drug, which the EMA has now followed.
The decision to order its withdrawal is the culmination of a long period of doubt about Avandia’s side effects, concerns growing after a meta analysis was published in May 2007.
Many critics say regulators have been too slow to act, and were not vigilant enough in monitoring Avandia’s safety profile.
In particular, an investigation by BBC programme Panorama in early September this year revealed that the MHRA had made its recommendation to withdraw Avandia in June, but that the EMA had not yet acted on the advice.
It is not clear why the EMA delayed its decision. The agency commented that: ”Emerging evidence points strongly to a modest increased risk for rosiglitazone.”
The EMA pointed out that because diabetes itself raises the risk of heart attacks and strokes, it has been difficult to clearly establish whether Avandia had been ”causative, contributory or coincidental in these cardiovascular disorders.”
Patients currently taking Avandia are advised to consult their doctor about alternative treatment, but should not stop treatment before seeing their doctor.
The EMA indicated that Takeda’s Actos (pioglitazone) a medicine in the same class, was not linked to the same levels of risk as Avandia.
A statement issued by charity Diabetes UK said it welcomed the move to protect patients, but added: We would urge the EMA to make swifter decisions in the future to ensure patient safety.”
FDA decides to keep Avandia on market
US regulator the FDA has reached a different conclusion, however, saying that the drug should stay on the market but with further restrictions on its use.
The FDA says Avandia should remain available for patients with type II diabetes who cannot control their diabetes on other medications.
“The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,” said FDA Commissioner Margaret A. Hamburg. “We are seeking to strike the right balance to support clinical care.”
The recent investigation by the BBC Panorama programme also alleged that there were serious irregularities around the RECORD trial, which was the basis of the drug’s approval in the US and Europe.
The FDA has now ordered GSK to commission an independent reajudication of the endpoints reported in the RECORD trial, to ascertain if there had been any distortion of the data.
The FDA says it could change its mind when this analysis is presented to it.
Meanwhile, another trial named TIDE, which compares Avandia with Actos, and was originally demanded by the FDA, has been suspended. TIDE was the last on-going trial of Avandia, but will now be wound up.
Andrew McConaghie
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