Excerpts:
Hundreds of reports of suicides, psychotic reactions and other serious problems tied to the popular stop-smoking drug Chantix were left out of a crucial government safety review because Pfizer Inc., the drug’s manufacturer, submitted years of data through “improper channels.” Some 150 suicides — more than doubling those previously known — were among 589 delayed reports of severe issues turned up in a new analysis by the non-profit Institute for Safe Medication Practices.
New reports don’t change FDA’s position
FDA officials said the new reports did not change the agency’s position on the risks and benefits of the controversial drug, which received a black box warning that included suicide — the strongest caution possible — in 2009, according to agency officials who would not speak on the record. “At this point, based on the data, FDA does not have any new safety concerns with Chantix, though those that have been established remain under active review,” the agency said in a statement posted in response to the ISMP report.
Read the full article here: http://www.msnbc.msn.com/id/43187290/ns/health-health_care/
The Emperor’s New Drugs
Exploding the Antidepressant Myth
by Irving Kirsch Ph.D.
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