Novartis' Maalox Total Relief Rebranding Reflects FDA AER Evolution
This article was originally published in The Tan Sheet
FDA's request that Novartis rebrand a Maalox line extension is the latest illustration of the agency taking action based on a relatively small number of serious adverse event reports
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Critics of drug labels' effectiveness say reducing errors in the use of OTC drugs depends largely on a change manufacturers oppose - reining in umbrella branding
FDA's warning May 12 to consumers not to swallow Benadryl Extra Strength Itch Stopping Gel is another blow to manufacturer Johnson & Johnson's reputation following multiple high-profile recalls by the firm's subsidiary McNeil Consumer Healthcare (1"The Tan Sheet" May 10, 2010). The agency warned the public not to consume the gel when it discovered 121 adverse event reports linked to cases of mistaken ingestion of the gel - seven of which were serious - between 2001 and 2009. FDA said consumers confused the topical product with Benadryl oral liquid products, which have similar consistency and packaging. The agency did not ask J&J to stop using the umbrella name for the product as it recently asked Novartis to rebrand a Maalox line extension that was not an antacid (2"The Tan Sheet" Feb. 22, 2010). However, J&J has added "For Skin Use Only" to the product labeling and launched consumer studies to identify other causes of confusion
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