Rare side-effects of new cancer drugs, particularly potential heart damage, are being under-reported in medical literature, according to academics in the US. They have called for ‘urgent reform’ and standardisation of the measurements of possible side-effects during clinical trials.
Dr Ronald Witteles, assistant professor of cardiovascular medicine at the Stanford University School of Medicine said: “It is a major issue when adverse events are not being counted in clinical trials, and this has led to a profound under-appreciation of the risk for heart failure and other adverse cardiac events.” Dr Witteles encountered a number of patients suffering from heart problems following treatment with a cancer drug. The drug has been approved by the US FDA, and is also approved for use on the NHS, for the treatment of kidney and gastrointestinal cancers, and pancreatic neuroendocrine tumours. The authors found that there was a ‘disconnect’ between reported incidences of cardiac toxicities in journals and in the FDA’s drug labelling. This labelling indicated that clinicians should be aware of the possible rare side-effects of heart damage in some patients using the drug.
