FDA: Qualaquin has serious side effects
SILVER SPRING, Md. Unapproved use of a drug used to treat malaria can cause serious side effects, prompting the drug’s manufacturer to develop a risk management plan, the Food and Drug Administration said.
The FDA said that use of Philadelphia-based AR Scientific’s drug Qualaquin (quinine sulfate) to treat nighttime leg cramps had caused serious and life-threatening bad reactions in 24 patients, including permanent kidney damage and two deaths, as well as reduction in blood platelet levels and internal blood clots.
The reports have prompted AR Scientific to develop a risk evaluation and mitigation strategy, or REMS, requiring that patients receiving Qualaquin be given a medication guide explaining how to use the drug and potential side effects.
“Healthcare professionals and patients should be aware that FDA has not approved the use of Qualaquin for the treatment or prevention of nighttime leg cramps,” FDA Center for Drug Evaluation and Research Office of Antimicrobial Products director Edward Cox said. “FDA has received reports that some patients have developed serious side effects when taking quinine for nighttime leg cramps.”
Watson seeks FDA approval for generic Renvela, confirms patent challenge
MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday.
Watson said it filed a regulatory approval application with the Food and Drug Administration for sevelamer carbonate for oral suspension. The drug is a generic version of Genzyme’s Renvela, used to control serum phosphorus in patients with chronic kidney disease who are on dialysis.
Watson’s application included a Paragraph IV certification, a legal assertion that the patents covering Renvela are invalid, unenforceable or won’t be infringed by a generic version, prompting Genzyme to file a patent infringement suit in the U.S. District Court for the District of Maryland. Watson’s case puts a stay of final FDA approval of Watson’s product for two and a half years or until the two companies resolve the matter before the court.
In May, Watson also filed for approval of a generic version of Renvela in tablet form.
NEVHC utilizing new robotic medication dispensing system
JOHNSON CITY, N.Y. A network of health centers in California is using Innovation’s robotic medication dispensing system, Innovation said Tuesday.
The Northeast Valley Health Corp., in San Fernando, Calif., is using Innovation’s PharmAssist ROBOTx dispensing system to fill prescriptions at its 12 health centers, including its mobile van, throughout California’s San Fernando and San Clarita valleys.
“Prior to implementing PharmAssist ROBOTx, we were struggling to keep up with the prescription volume across all our health centers, which was putting a lot of stress on our staff,” NEVHC director of pharmacy Rosie Jadidian said. “Since going live earlier this year, we are now able to complete our daily workload, which averages 650 prescriptions but goes as high as 1,200 prescriptions on some days.”
Jadidian said the system, which now fills around 50% of NEVHC’s prescriptions, has made it possible for the company to make plans to open a new health center without hiring a pharmacist.