SMC UK: Expert reaction to European Medicines Agency recommendation to suspend the diabetes drug Avandia (rosiglitazone)
Our colleagues at the Science Media Centre in London gathered comment on the move overnight by the European Medicines Agency to suspend the diabetes drug Avandia. Comment from New Zealand scientists will be added here as they come in.
Donald RJ Singer, Professor of Clinical Pharmacology and Therapeutics, British Pharmacological Society, said:
“People with diabetes are at increased risk of cardiovascular disease. Despite lowering blood sugar, there is increasing concern that the tablet treatment for Type 2 diabetes rosiglitazone may in fact increase risk of heart failure and other serious cardiovascular disorders.
“Both the European Medicines Agency (EMA) and the US drugs regulator, the Food and Drug Administration (FDA) have today issued important new guidance placing major restrictions on the use of rosiglitazone. The EMA recommended suspension of the drug throughout Europe, either as separate treatment or in combination tablets.
“The FDA has been less cautious, in allowing restricted availability of rosiglitazone to patients with Type 2 diabetes who are not able to tolerate other tablet treatments and would otherwise need to move on to insulin injections. It is interesting that the EMA has not yet taken the definitive step of complete withdrawal of the drug. However high quality evidence is needed to convince the EMA about justification of a future limited clinical licence for sub-groups of Type 2 diabetics in whom the benefits of rosiglitazone may outweigh its potential cardiovascular risks.
“It is very important that patients on rosiglitazone seek medical advice before changing treatment so that their condition remains well-controlled as their diabetic regime is adjusted. As advised by the MHRA for the UK in July, in countries where rosiglitazone is still available, it remains important that patients already at increased risk from heart failure or coronary disease seek medical advice as soon as possible to change to more appropriate treatment.
“The recent experience with rosiglitazone points to the need for rigorous clinical trials to ensure that the best quality studies are available at the earliest possible stage, to make sure that, for drugs in clinical use, the benefits of treatment outweigh any risks. This is both particularly challenging and important for conditions like diabetes in which patients are already at high risk of complications from the underlying medical disorder.”
Dr Terry Maguire, community pharmacist and former member of Committee on Safety of Medicines, said:
“It’s no great surprise that the EMA have taken this decision today, as the weight of evidence suggesting that the long term risks associated with Avandia use outweighed the benefits was compelling. Certainly regulators and pharmaceutical manufacturers should learn lessons for this episode that will have left the public and health professionals concerned and a little confused about the licensing arrangements in the UK. I would remind patients that they should now follow the advice of their medical practitioner or pharmacist regarding what action they should take personally if they are currently taking Avandia.”
Dr Anthony Cox, Lecturer in Clinical Therapeutics at Aston Pharmacy School, said:
“Rosiglitazone’s withdrawal from the European market was inevitable given the evidence of harm from cardiovascular events and its limited benefits. There are lessons here about the whole process of drug regulation, from licensing to monitoring the drug once on the market and the role of the pharmaceutical industry in trial design and data collection. The public perception of the pharmaceutical industry is important, as events that undermine trust are a public health concern.
“As an aside, while the EMA has been accused of being less open, in terms of decision making, than the US regulator, the decision of the FDA to allow the drug remain on the market using a restricted access process to control risk is surprising, and in the long term unlikely to be sustainable.
“People taking rosiglitazone should not panic; while important, the risks are small to the individual in the short-term, and they should consult with their medical practitioner or pharmacist before taking any action.”
Professor Kent Woods, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said:
“Patient safety is the top priority for the MHRA and we have been constantly monitoring the situation regarding rosiglitazone. Today’s suspension means that clinicians should review all patients currently on rosiglitazone and take appropriate action, according to the individual clinical situation, to change to another suitable treatment.”
Below you will find a link to the video of the press conference held on Avandia at the European Association for the Study of Diabetes (EASD) annual meeting in Stockholm yesterday.
This press conference was held within minutes of the EMA/FDA announcements on Avandia. You may quote any of the speakers directly from this video, and photos are available to use free of charge on the second link below.
The speakers, from left to right, were:
Professor Clifford Bailey EASD/Aston University, Birmingham
Professor David Matthews, EASD/ Oxford University
Dr David Kendall , American Diabetes Association (ADA)
Professor Ulf Smith, EASD President and University of Gothenburg
Video of Press Conference: webcast.easd.org/EASD_Press_Conference_Avandia.avi
A simultaneous decision to significantly restrict access to the drug has been taken by the FDA in the US:
Here are two useful links to background information on Avandia. Please bear in mind they are likely to be out of date for a little while yet as websites are updated.
Info from the US National Library of Medicine:
Info from the European Medicines Agency: