Regulatory Focus™ > News Articles > GSK Warns Some of its OTC Weight Loss Drug Has Been 'Tampered With'

GSK Warns Some of its OTC Weight Loss Drug Has Been 'Tampered With'

Posted 26 March 2014 | By Alexander Gaffney, RAC

Pharmaceutical manufacturer GlaxoSmithKline is warning consumers that some bottles of its over-the-counter weight loss drug Alli (orlistat capsules) have "tampered with" in at least seven US states.

News of the tampering was announced by GSK in a 26 March 2014 press release, in which the company said it was working with the US Food and Drug Administration (FDA) to determine what had happened and the extent of the problem.

GSK said the tampered products had packaging that appeared to look authentic, but that the façade quickly eroded once the packaging was opened. Some bottles contained a "range of tablets and capsules of various shapes and colors," while other had no labeling or other measures meant to protect against product tampering.

Tamper-resistant packaging was first put in place in the 1980s after bottles of Tylenol, manufactured by Johnson & Johnson, were tampered with and adulterated with cyanide capsules. Several consumers died, and J&J won acclaim for its prompt reaction and subsequent efforts to introduce new protective measures.

So far, GSK seems to be borrowing several pages from J&J's Tylenol playbook, but not the entire book.

For example, while its warnings indicate how consumers can ensure that their products are authentic, the company has not yet recalled authentic lots of product associated with the inauthentic lots.

The company said that consumer safety remains its "primary concern," and that it has initiated an investigation along with FDA.


GSK Statement

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