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Drug Safety and Availability

Editor's Note - Volume 2, Number 2, 2009

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In this issue, we describe three drug safety issues. In the first article, we discuss the relative risks associated with using quinine for unapproved indications. Quinine has only been approved for treatment of uncomplicated malaria. Despite several regulatory actions, the discrepancy between the incidence of malaria and large number of quinine prescriptions suggests that off-label quinine use (e.g., for the treatment of leg cramps) remains extensive. FDA continues to receive reports of patients experiencing serious adverse events, including thrombocytopenia, after quinine use.

Second, FDA has received reports of cases of acute renal impairment and failure associated with the use of Reclast (zolendronic acid). Reclast is the first bisphosphonate drug approved by the FDA for once-yearly intravenous treatment for osteoporosis in postmenopausal women. Data suggest there may be a higher risk for renal impairment and acute renal failure for patients who have compromised renal function, are experiencing dehydration, or might be taking concomitant nephrotoxic medications. FDA encourages healthcare professionals to monitor their patients’ renal function before and after a Reclast infusion.

Finally, we discuss the adverse event profile of arginine hydrochloride injection (marketed as R-Gene 10), a diagnostic tool used to measure the pituitary reserve for human growth hormone. This drug is mostly used in children to evaluate possible problems in growth and stature. Specifically, in this article we highlight medication errors (unintentional overdoses) that have resulted in serious adverse events, including deaths. This article also summarizes FDA’s analysis of non-medication error-related adverse events associated with the use of arginine hydrochloride.  

In each Newsletter, we bring to your attention a list of medicine-related safety issues. We hope you find the information useful. Feel free to share your comments with us at Comments. We also remind healthcare professionals to continue to report serious adverse events to FDA at MedWatch.


Renan A. Bonnel, PharmD, MPH
Sr. Scientific Editor


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