Drug firm warns of syringe glitch

The U.S. Food and Drug Administration has issued a safety advisory on syringes produced by a Costa Mesa company, warning that the applicator cap may crack and leak.

Officials with manufacturer Valeant Pharmaceuticals discovered the mistake with its Diastat AcuDial, a pre-filled syringe used to dispense topical gels that treat epilepsy. Company officials estimate between 2% and 6% of the syringes may be cracked and cause leaks, preventing the patient from receiving the full dose of a medicine that prevents epileptic seizures.

Spokesman Jeff Misakien said company officials discovered the problem and contacted physicians, pharmacists and the FDA. Company officials are asking pharmacists to inspect the syringes before dispensing them, and patients should check them before use. Instructions for inspecting the caps can be found at www.diastat.com.

“We have told people that if they discover a crack, they need to take it to the pharmacy and the pharmacy will replace it,” Misakien said.

If the product leaks during application, or if the patient continues to have seizures, call 911.

Valeant officials said they had no plans to recall the product because it’s the only medicine on the market used to treat acute repetitive seizures. Company officials said they have identified the source of the manufacturing problem and will have a new product on the market by June or July.

About 30,000 residents in Orange County suffer from epilepsy. Roughly one-third don’t have seizure control and suffer regular epileptic outbreaks, according to the Epilepsy Alliance of Orange County.