We are very pleased to see the story on 60 Minutes give greater recognition of the sex differences in drug response. Research at AZCERT has documented the greater sensitivity of women to the effects of medicines that have effects on the heart and prolong the QT interval on the ECG, the influence of their menstrual cycle and the corresponding increase in life-threatening arrhythmias and deaths in women. For seven medicines removed from the market for inducing these arrhythmias, all had greater numbers of women reported as harmed. Over 90 prescription medicines are listed on the CredibleMeds site because they have this effect on the heart. Whenever data have been available for analysis, more women are reported to have developed heart arrhythmias with these medicines. Everyone, especially women, are encouraged to complete the My Medicines Forms (www.CredibleMeds.org) to determine if the medicines they are taking have an increased risk of causing arrhythmias.
We agree that the FDA should require analysis of data for sex differences in effectiveness and safety for all medicines during development. Research on marketed drugs should be required when there is scientific evidence of a possible difference.
View this week's episode of 60 Minutes, "Sex matters: Drugs can affect sexes differently" below: