U.S. warns about bed-wetting drug after two deaths
(Adds Sanofi comment)
WASHINGTON Dec 4 (Reuters) - U.S. health officials alerted the public on Tuesday about the deaths of two patients who were treated with a prescription drug to control bed-wetting.
The Food and Drug Administration said it was unclear whether the drug, desmopressin, had contributed to the deaths. But the agency said nasal versions were no longer approved for treating bed-wetting and doctors should consider other options.
Desmopressin is sold under the names DDAVP Nasal Spray, DDAVP Rhinal Tube, DDVP, Minirin and Stimate Nasal Spray. Makers include Sanofi-Aventis (SASY.PA) and several generic companies.
Other forms of the drug "should be used cautiously" in patients at risk of sodium imbalances that can be caused by over-hydration, the FDA said.
The agency reviewed 61 reports of patients treated with desmopressin who developed seizures related to hyponatremia, when sodium is too low. Two of the patients died.
"The direct contribution of desmopressin to the deaths is unclear," the FDA said in a notice posted here. The patients who died were ages 28 and 80, FDA spokeswoman Susan Cruzan said.
Thirty-six seizure reports were associated with intranasal forms of the drug, the FDA said. Those versions should not be used in patients with hyponatremia or a history of the condition, the FDA said.
The agency also said treatment with desmopressin tablets should be stopped during episodes that may trigger extra fluid intake, including fever, recurrent vomiting, diarrhea and vigorous exercise.
Sanofi-Aventis spokeswoman Terri Pedone said the company had removed the bed-wetting use and updated the warnings and other sections in the prescribing instructions for its desmopressin products.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick and Braden Reddall)
((Reuters Messaging: lisa.richwine.reuters.com@reuters.net; +1 202 310-5691)) Keywords: BEDWETTING/DRUG
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