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Need for Speed: FDA Issues Notice on Adderall ShortagesNews – High Times

News – High Times

Anyone who is prescribed the ADHD and narcolepsy medication Adderall has been advised to seek alternative medication after a nationwide shortage was confirmed by the FDA last week, but the reasons behind the shortage remain a bit of a mystery.

The FDA didn’t give much of an explanation for the shortage other than to say one of the main manufacturers of Adderall (which is the brand name given to a particular combination of amphetamine and dextroamphetamine salts), Teva, was experiencing “ongoing intermittent manufacturing delays” and “other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet U.S. market demand through those producers.”

The good news is, at the moment most of those delays are scheduled to be resolved by October or November, which is an updated ETA originally slated for March of 2023. This means we will likely avoid running out entirely. Nonetheless, the FDA did advise patients to seek alternative treatments all the same. 

A New York Times article cited the nationwide rise in ADHD as the main cause of the shortage, and it cannot be overstated that reported cases of ADHD are indeed on the rise. As a heavily regulated Schedule 2 drug, Adderall manufacture is often slow in response to demand because of the red tape required in order to produce it, so the rise in ADHD may indeed be to blame but in terms of the shortage of Adderall itself, it is likely a bit of a mixed bag.

The usual suspects when things are in short supply lately are COVID-related supply chain issues or the ongoing war in Ukraine, but Hamilton Morris, a journalist and scientific researcher known for his TV show Hamilton’s Pharmacopeia, indicated on Twitter that the Adderall shortage could be due to a shortage of nitroethane, one of the potential raw ingredients used to make it. One of the main distributors of nitroethane, Sigma Aldrich, has it listed as unavailable on their website. A phone call to the media department at Sigma Aldrich was, alas, not returned fast enough to meet my deadline.

There truly is a nitroethane shortage that predates the war in Ukraine and COVID, there is almost no information about this online but it’s very real. The lab that I work in has been unable to source nitroethane for years. https://t.co/a5uIJt25lU pic.twitter.com/gaCgpor53C

— Hamilton Morris (@HamiltonMorris) October 15, 2022

Others disagreed, saying there’s no reason to believe there is a nitroethane shortage quite yet, but it would certainly explain things if it turns out to be true. Chemjobber, a blog dedicated to chemistry news and chemistry jobs, told High Times that while low nitroethane supply may be a potential factor, it’s essentially way more complicated than that.

“I strongly believe it is rarely API (active pharmaceutical ingredient) manufacturing that is the problem,” Chemjobber said. “That is a problem at the back of the chain, and there are 4-5 steps in front of it i.e. you could have a problem with tableting, or shipping, or labor etc.”

To that point, Teva did report earlier this year that they were having issues with labor shortages, a common complaint in the era of COVID-19. Thus, it’s not necessarily a shortage of one chemical as much as it seems to be a perfect storm of bad luck and the basic production limitations of any heavily regulated industry.

In terms of whether or not America will run out of Adderall, Chemjobber likened it to the toilet paper craze of early COVID and projected this too shall pass. It does also appear to be a good sign that Teva moved up its ETA by several months in the span of a week. Unfortunately, they didn’t call me back either.

The post Need for Speed: FDA Issues Notice on Adderall Shortages appeared first on High Times.

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