The FDA just released its Drug Safety Newsletter (Vol. 2, No. 2). The purpose of the newsletter is to provide post-market information to doctors and other healthcare providers about drugs on the market and to encourage reporting of adverse events through the FDA’s MedWatch program. You can find the newsletter here.
The current issue focuses on three drugs that are highlighted here:
1) Qualaquin (quinine sulfate): approved to treat malaria, Qualaquin is frequently prescribed off-label for nocturnal leg cramps, restless leg syndrome, neuropathy, and other problems. The adverse reporting system indicates that it may hematologic events, including thrombocytopenia (low platelet count). There’s no indication that the off-label use is effective.
2) Reclast (zoledronic acid): Reclast is used to treat osteoporosis and Paget’s disease. This bisphosphonate may cause acute renal failure.
3) R-Gene 10 (arginine hydrochloride injection): R-Gene 10 is used to evaluate pituitary function. Most of the adverse event reports center around medication errors, including fatal overdoses, hypersensitivity, and other events.
Of course, consumers and healthcare providers should take care to notify the FDA of potential problems with any drug or medical device at www.fda.gov/medwatch/report.htm or 1-800-FDA-1088. This will help to get dangerous drugs recalled, and provides the impetus for additional safety tests.