FDA to Look at Adults
The Food and Drug Administration will examine clinical trial data for depressed adults to see if they, like children, suffered increased suicidal thoughts and behavior while taking antidepressants.
Janet Woodcock, acting FDA deputy commissioner, could not say how long the exhaustive analysis would take or how much it would cost. A Columbia University analysis of pediatric clinical trial data earlier this year examined just one-tenth of the information contained in the adult studies.
That pediatric study -- and the FDA's own internal reviews -- found that for every 100 children taking antidepressants, an extra two to three suffered heightened suicidal tendencies.
Those findings prompted federal advisers this month to push for strident black-box warnings to be added to labels for Celexa, Effexor, Luvox, Paxil, Prozac, Remeron, Serzone, Wellbutrin and Zoloft.
Artificial Heart's Failure
The maker of the first self-contained artificial heart has sent three executives to a Kentucky hospital to investigate the first death attributed to a malfunction.
The patient, Don Graham, died Sunday, about five months after becoming the 13th patient to receive the life-extending heart. The death was the result of an unspecified malfunction, Abiomed spokeswoman Andrea tenBroek said.
Valluvan Jeevanandam, chief of cardiac surgery at the University of Chicago Hospitals, who sits on an independent advisory panel overseeing the clinical trial of the AbioCor heart, said the death may justify holding off on plans to implant the device into a final patient in the nearly completed trial.
The AbioCor, under development for 22 years, is a softball-sized, completely implantable pump powered by batteries. The device has been able to extend for as long as 17 months the lives of patients at high risk of death from heart failure.
The trial's 14th patient, who received the AbioCor about three weeks after Graham, remains in intensive care at Jewish Hospital and is the lone survivor with the device.
U.S. Says Seized Drugs
Had Many Problems
The government said yesterday that intercepted drugs purportedly sent from Canada were made and shipped elsewhere, had been subject to a recall in Canada and had cheaper generic counterparts in the United States.
The Food and Drug Administration said the 439 packages of prescription drugs were ordered by Americans from the Web site CanadaRx.com.
Customs agents in Miami intercepted the drugs that they said had been shipped from CanadaRx's office in the Bahamas.
-- From News Services