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But in 2005, after Ms. Bartlett's reaction, the F.D.A. recommended that all manufacturers of Nsaids strengthen their labels by specifically listing the risk of developing the skin reactions in the "Warnings" section of the label.
Dr. Lewis S. Nelson, a toxicologist with the New York University School of Medicine, said the evidence warranted "something a little bit more dramatic," like moving the statement to the "warnings" section of the label from the section on "indications and usage".
Importantly, the Warnings and Precautions section of the label describes the potential adverse effects that may be associated with administration of alvimopan 12 mg to patients recently exposed to opioids.
In the case of antibacterial agents, the need to include all available and scientifically valid data about a product is even more critical, as important clinical situations often do not appear (nor may they ever appear) in the "Indications and usage" section of the label.
Total carbohydrates are typically found in the top section of the label after the product's sodium content.
Similar(55)
The FDA issued a Drug Safety Communication in October 2010 and will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs.
Indeed, multiple reports of demyelinating diseases developing in patients using anti-TNF agents appeared, which in 2010 led to an update in the Warnings and Precautions section of the labeling of all of the TNF blockers to include peripheral demyelinating neuropathies.
Warning Section of the Label- At the top is usually the warning section and the toxicity label.
Shire also added a new section to another part of the label called the "warning" section, saying there were reports of sudden death at the usual doses of the drug in children with structural cardiac abnormalities or serious heart problems.
The nutritional table section of the food label was understood the best, and the nutritional declaration section the least.
Following the investigation, in August 2009, the FDA required an update to the Precautions section of the drug label to include information about neuropsychiatric events reported in patients using this drug [ 56].
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