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(13 Jun 2007) HEADLINE: Federal health panel rejects weight-loss drug --------------------------------------- CAPTION: A Food and Drug Administration panel unanimously rejected a closely watched weight-loss drug from Sanofi-Aventis SA, on concerns the drug increases the number of psychiatric events like depression and suicidal thinking among users. (June 13) ---------------------------------------- [Notes:ANCHOR VOICE] [Notes:VO --SHOTS OF PANEL] A FEDERAL HEALTH ADVISORY PANEL HAS UNANIMOUSLY REJECTED A NEW WEIGHT-LOSS DRUG AFTER HEARING TESTIMONY THAT THE DRUG CAN CAUSE PSYCHIATRIC PROBLEMS. TESTS FIND IT CAN INCREASE THE RISK OF SUICIDAL THOUGHTS, EVEN AMONG PATIENTS WHO HAVE NO HISTORY OF DEPRESSION. [Notes:VO --SHOTS OF DRUG] THE DRUG IS CALLED RIMONABANT (rih-MOAN-uh-bant) -- AND IT'S MANUFACTURED BY SANOFI-AVENTIS (sih-NO-fee uh-VEHN-tiss). IN STUDIES -- PATIENTS WHO RECEIVED THE TABLET ONCE DAILY REPORTED TWICE AS MANY PSYCHIATRIC SIDE EFFECTS -- INCLUDING DEPRESSION AND ANXIETY --- AS THOSE WHO RECEIVED A SO-CALLED 'SHAM' TREATMENT. [Notes:SOT --] 'i think these psychiatric side effects are prevalent...some of them are quite significant. [Notes:SOT --] 'I have very high concern about the safety data. When you look at the lifetime animal studies, it's clear we need more longterm data in humans" [Notes:VO -- SHOTS OF DRUG] ALTHOUGH THE DRUG IS CURRENTLY MARKETED IN EUROPE, IT'S NOT YET AVAILABLE IN THE U.S. THE PANEL TOOK TWO VOTES -- AND UNANIMOUSLY VOTED AGAINST IT BOTH TIMES -- MAKING IT UNLIKELY THE F-D-A WILL APPROVE IT. BUT THE AGENCY IS SET TO MAKE A FINAL DECISION IN LATE JULY. [Notes:SOT] people who are overweight and obese are desperate, desperate for any measure (cut) word spreads like wildfire.' [Notes:SOT] 'we are going to have massive use of the drug and we just have small group of people for two year study, yet this is presented as a drug that's going to be lifetime. [Notes:VO] THE MANUFACTURER ADMITS THE DRUG IS NOT APPROPRIATE FOR PEOPLE WITH A HISTORY OF DEPRESSION. IT ALSO SAYS DOCTORS SHOULD SCREEN PATIENTS FOR DEPRESSION BEFORE WRITING A PRESCRIPTION. EXPERTS SAY EVEN IF THE F-D-A DOES APPROVE THE DRUG, IT WOULD LIKELY COME WITH STERN WARNINGS -- WHICH IS SOMETHING THE MANUFACTURER EMBRACES Find out more about AP Archive: http://www.aparchive.com/HowWeWork Twitter: https://twitter.com/AP_Archive Facebook: https://www.facebook.com/APArchives ​​ Instagram: https://www.instagram.com/APNews/ You can license this story through AP Archive: http://www.aparchive.com/metadata/youtube/266938bc4e3a5a170656de2ca93b9571

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