Following the lead of their US counterparts, regulators in Europe have proposed stronger warnings on anaemia drugs used in cancer patients.

Specifically, the European Medicines Agency (EMEA) has recommended updating the product information for
epoetin-containing drugs stating that blood transfusion “should be the preferred method of correcting anaemia in patients suffering cancer”. The agency’s Committee for Medicinal Products for Human Use (CHMP) has reviewed new data from studies that showed an increased risk of tumour progression, venous thromboembolism and shorter overall survival in cancer patients who received drugs such as Amgen’s Aranesp (darbepoetin alfa) and Johnson & Johnson’s Eprex (epoetin alfa).

Following this review, the CHMP has concluded that the benefits of epoetins “continue to outweigh their risks in the approved indications”. However, in cancer patients with a “reasonably long life-expectancy”, the risk/benefit ratio switches and transfusions provide the best option, though the committee agreed that there is no problem of epoetin-containing medicines for the treatment of anaemia in patients with chronic renal failure.

The CHMP review follows similar recommendations made by the US Food and Drug Administration earlier this year to restrict use of the drugs. Amgen said it remains in contact with the EMEA over how Aranesp’s labelling should be updated, and looks forward to the final language later this year.

New warning for Arcoxia in Europe
The EMEA has also said that the prescribing information for Merck & Co's painkiller Arcoxia (etoricoxib) should be updated to include a warning about the risk of heart-related side effects in patients administered the product. Also, the CHMP has recommended that the label for the COX-2 inhibitor, which is approved already for rheumatoid arthritis and osteoarthritis in Europe, be expanded to include ankylosing spondylitis.

Regulators in the USA have been less than impressed with the virtues of Arcoxia. The FDA issued a non-approvable letter for its painkiller last year after one of the agency’s advisory committees voted 20-1 against recommending approval, citing a possible link to increased risks of heart attacks and strokes.