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Get the FDA Patients Safety News

FDA Patient Safety News is a monthly video news show for health care professionals covering significant new product approvals, recalls and safety alerts, and offers important tips on protecting patients. 

Many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions. 

You can find more information about this webcast and download the video program at http://www.fda.gov/psn .

 

WARNING ON MEDICATIONS

FDA Urges New Tamiflu

WASHINGTON (UPI) -- The U.S. Food and Drug Administration Monday urged adding a new warning for the flu drug Tamiflu amid reports of psychiatric problems in patients who take it.

"It is still unclear whether these neuropsychiatric events are drug-related only, disease manifestation alone, or a combination of drug-disease expression," said an FDA staff summary posted on the agency's Web site.

The FDA reviewers said they evaluated 103 reports of hallucinations, suicidal behavior and other mental problems -- mostly among children -- from August 2005 to July 2006. Three deaths were from falls.

Nearly all the cases, 95 out of 103, came from Japan, the FDA staff said.

Tamiflu was prescribed 24.5 million times in Japan between 2001 and 2005, compared with 6.5 million times in the United States, which has more than twice the population, the FDA Web site said.

Tamiflu is made by the Swiss pharmaceutical company Roche Holding AG, which has discussed label changes with the FDA, a company spokesman said.

ABOUT PSEUDOEPHEDRINE AWARENESS

Pseudoephedrine laws offer opportunity for education, research

By Janice E. Sullivan, M.D., FAAP

The use of methamphetamine, a potent addictive psychostimulant, has reached epidemic proportions in the United States. An estimated 1.5 million people are regular users, and 12.3 million people have tried methamphetamine at least once.

In an attempt to curb production of methamphetamine, many states have enacted laws to restrict the sale of products that contain pseudoephedrine, the key ingredient in illicit methamphetamine production. Pseudoephedrine-containing cold preparations...More Coming soon!

 

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