In the wake of the debate sparked by off-label use of Roche's cancer blockbuster Avastin being linked to eye infections, a group of European patient organisations have raised concerns about the unlicensed use of medicines.
The European Alliance for Access to Safe Medicines (EAASM), the European Federation of Neurological Associations, the European Men’s Health Forum and the European Depression Association have issued a statement calling for a professional code of practice about off-label use. The groups have spoken out following the US Food and Drug Administration's warnings about the use of Avastin (bevacizumab) which is often prescribed off-label to treat wet age-related macular degeneration.
At least 16 people in Florida and Tennessee have suffered serious eye infections through unlicensed use of Avastin, and some have been blinded. Now, the European patient groups note that "there have also been reported cases of adverse events in Europe caused by similar off-label use of the same medicine".
In Germany, they say that "five cases of serious eye inflammation has resulted in legal action by the patients involved, and in Austria, eight cases of eye inflammation have been reported".__ They are concerned that "the true extent of the problem is not known and there are likely to be unreported occurrences across Europe". This is due to the fact that there are "no formal and obligatory mechanisms (unlike the case where a medicine is prescribed within its licensed clinical indication) for reporting adverse events involving unlicensed and off-label medicines".
Jim Thomson, chair of EAASM, said that “our message is 'enough is enough'.” He added that the FDA "was able to act because it was made aware of the problem. In Europe it’s a matter of chance as to whether the regulatory authorities are made aware of similar problems because there is no mandatory mechanism to report adverse events in medicines used this way".
Mr Thomson concluded by saying that “we strongly believe unlicensed and off-label medicines should only be used when a licensed product is unavailable". In addition, "patients should be informed and provide written consent for the medicine to be used and there should be a mandatory adverse event reporting system in place".
VA suspends Avastin use for wet AMD
The patient group's protest comes as the US Department of Veterans Affairs suspended use of Avastin pending an investigation into the reports of infections and blindness. Doctors have been using the cancer blockbuster because it is a fraction of the cost (around $50 per injection) compared with an approved drug - Roche's own Lucentis (ranibizumab), which costs around $2,000.