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The Canadian health authority instituted such a labeling change earlier this year.
Sadly, medication has often replaced close personal attention; the best possible consequence of the labeling change would be a return to sustained scrutiny of depressed patients.
The labeling change is intended to make doctors more cautious about prescribing the drugs and patients more cautious about taking them.
But the rate for similar drugs, including Prozac by Eli Lilly, continued to increase in that age group through 2003 and fell off only slightly after the labeling change, in 2005.
But after complaints by an animal welfare group that the labels were misleading consumers into thinking that hens were receiving indisputably humane care, the Federal Trade Commission approved a labeling change last week.
Its argument that a change in Phenergan's labeling would have subjected it to liability for unauthorized distribution rests on the assumption that this labeling change would have rendered Phenergan a new drug lacking an effective application.
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But labeling changes may not work.
Already, some labeling changes are under way.
Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012.
In 1973 and 1976, Wyeth submitted supplemental new drug applications, which the agency approved after proposing labeling changes.
Kam-Hansen, S. et al. Altered placebo and drug labeling changes the outcome of episodic migraine attacks.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com