Stolen insulin vials still on the market, FDA warns
ROCKVILLE, Md. Stolen vials of a brand of long-acting insulin may be on the market, the Food and Drug Administration has warned.
The FDA issued a statement Wednesday warning consumers that stolen vials of Novo Nordisk’s Levemir (insulin detemir [rDNA origin]) were not stored or handled properly and may be dangerous for people to use, and that it had received reports of harmful side effects in patients who had used them.
Novo Nordisk warned in June that some of the 129,000 vials of Levemir stolen from a facility in North Carolina had turned up at a hospital in Houston. The vials came from lots numbered XZF0036, XZF0037 and XZF0038.
FDA allows DoD to distribute swine flu test to soldiers
ROCKVILLE, Md. The Food and Drug Administration will allow the Department of Defense to distribute a test for detecting the swine flu in soldiers serving overseas.
The FDA announced Tuesday that it had issued an emergency use authorization for the test, developed by the Centers for Disease Control and Prevention and called the CDC swH1N1 Influenza Real-Time RT-PCR. An EUA allows the use of unapproved medical products or unapproved uses of them during a declared public health emergency. The 2009 H1N1 influenza virus was declared a global pandemic this summer, making it the first influenza pandemic since 1968.
“The FDA worked quickly with the Defense Department to authorize the use of this test to better protect our troops,” FDA commissioner Margaret Hamburg said in a statement. “The test will aid in more rapid diagnosis of 2009 H1N1 influenza infections so that deployed troops can quickly begin appropriate medical treatment.”
Study finds leukotriene modifiers work best for asthma sufferers
WILMINGTON, Del. Asthma patients have an easier time controlling their disease with oral controllers than with a common type of inhaled drug, according to a new study.
In a peer-reviewed study requested by WellPoint, conducted by HealthCore and published in Mayo Clinic Proceedings, patients taking oral controllers called leukotriene modifiers had better clinical results than those taking inhaled corticosteroids.
“Clinical superiority of the inhaled products has been well-documented in clinical trials, and the HealthCore study confirmed this for those who take their medication properly,” HealthCore VP clinical affairs Joseph Singer said in a statement. “However, we were surprised to discover that in looking at all patients in real-world settings, oral controllers appeared to be a better choice of treatment because of better compliance.”
Common leukotriene modifier brands include Merck & Co.’s Singulair (montelukast sodium), AstraZeneca’s Accolate (zafilukast) and Cornerstone Therapeutics’ Zyflo (zileuton).