|May 7, 2018
New Scrutiny for an Old Drug
The latest drug to come under FDA scrutiny is the generic gabapentin, the 9th most prescribed medication in the US. Commissioner Scott Gottlieb has stated, “I don’t want to be sitting here 5 or 10 years from now lamenting that we didn’t take more aggressive action.” Many physicians are not aware that people are using gabapentin, often mixed with opioids and other substances, to achieve a modified mental status. The AP reports that, according to medical journal articles, 15 to 25% of opioid users also use gabapentin. While it is not considered addictive, it has featured in a rising number of overdoses.
Some states are adding gabapentin to their tracking databases, and Kentucky has classified it as a “scheduled substance.” It appears that increased prescribing levels originated at a time when the drug’s original manufacturer began aggressive marketing. In 2004 the company, Warner-Lambert, pleaded guilty to charges of promoting gabapentin for a wide range of uses not approved by the FDA and paid over $430 million in settlement of the charges. Warner-Lambert was purchased by Pfizer in 2000.
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