Tuesday, December 11, 2007

Nasal spray causes seizures in children

A nasal spray designed to stop kids wetting the bed is under review by Australian authorities after US regulators linked it with seizures and death.

The drug, desmopressin, has been found to trigger potentially-fatal attacks in some people who have used the intranasal formulation.

The US Food and Drug Administration has received 61 reports of serious adverse events, including two deaths, and warns it should no longer be used.

It said children were particularly at risk of the seizures, which are caused by hyponatremia, or an abnormally low concentration of sodium in the blood.

A spokeswoman for Australia’s Therapeutic Goods Administration said the authority “was aware of the issue” and would review the product in light of the new reports.

This would ascertain whether warnings should be strengthened or the product listed as restricted use, she said.

Desmopressin is made by several manufacturers and comes in a variety of formulations, including tablets.

The FDA had received 61 reports of hyponatremic-related seizures associated with the use of desmopressin. The nasal spray was used in 36 of the cases, with 25 involving children.

More than half of all affected were also taking another medication, making it difficult for authorities to establish a definite causal link.

The formulation in no longer approved in the US and the FDA has warned all other formulations should be used cautiously in patients who are on other medication or might need to drink more fluids because of activities such as exercise.

The drug works by limiting the amount of water that is eliminated in the urine and is used to prevent excessive thirst, urination and dehydration caused by injury, surgery and certain medical conditions including a form of diabetes.


Post a Comment

<< Home