Monthly Archives: May 2012
ISSUE: FDA notified healthcare professionals that it is aware of the study published in the New England Journal of Medicine May 17, 2012 reporting a small increase in cardiovascular deaths, and in the risk of death from any cause, in persons treated with a 5-day course of azithromycin (Zithromax) compared to persons treated with amoxicillin, ciprofloxacin, or no drug. FDA is reviewing the results from this study and will communicate any new information on azithromycin and this study or the potential risk of QT interval prolongation after the agency has completed its review.
BACKGROUND: Azithromycin belongs to a class of antibacterial drugs called macrolides, which have been associated with cardiovascular effects; specifically, prolongation of the QT interval. In 2011, FDA reviewed macrolide drug labeling information related to QT interval prolongation and TdP. The WARNINGS AND PRECAUTIONS section of the Zmax drug label (azithromycin extended release for oral suspension) was revised in March 2012 to include new information regarding risk for QT interval prolongation, which appears to be low. The drug labels for clarithromycin and erythromycin also contain information about QT interval prolongation in the WARNINGS section. FDA is in the process of updating risk information in the drug labels for additional macrolide antibacterial drugs.
RECOMMENDATION: Patients taking azithromycin should not stop taking their medicine without talking to their healthcare professional. Healthcare professionals should be aware of the potential for QT interval prolongation and heart arrhythmias when prescribing or administering macrolides.
Do you think this model can work in a South Africa setting? Where the pharmacists work under what is called a collaborative practice agreement with the primary-care physicians. This allows pharmacists to make adjustments to certain kinds of medications within certain parameters, and they are able to write the prescription and sign it without any additional cosignature from the physician. This gives people who were doing home BP monitoring the ability to have frequent and close contact with a healthcare professional who could help them make changes based on their home BP measurements.
As well as its use in hypertension, this approach is employed for the management of other chronic conditions, such as diabetes, hyperlipidemia, asthma, and depression.
The Minister of Health has, in terms of section 22A (2) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965), on the recommendation of the Medicines Control Council, made and updated the Schedules.
Click here for the updated Schedules document: Schedules March2012
Patients taking warfarin have a nearly 50% lower risk for stroke than those taking aspirin, but their risk for major bleeding was twice as high. They noted that taking warfarin for four years or more may be more effective at preventing stroke and death. The key decision will be whether to accept the increased risk of stroke with aspirin or the increased risk of primarily gastrointestinal hemorrhage [stomach bleeding] with warfarin.