Need for Speed: FDA Issues Notice on Adderall Shortages

Anyone prescribed the ADHD and narcolepsy drug Adderall is urged to seek alternatives after a nationwide shortage was confirmed by the FDA last week, but the reasons behind the shortage are a bit of a mystery. stay.

The FDA didn’t explain much about the shortage, other than to say Teva, one of Adderall’s leading manufacturers (which is the brand name given to a particular combination of amphetamine and DextrophetheTamine salts). Delays” and “Other manufacturers continue to produce amphetamine mixed salts, but there is not enough supply to continue to meet U.S. market demand through these producers.”

The good news is, at this point, most of these delays are expected to be resolved by October or November, which was originally an updated ETA scheduled for March 2023. Nonetheless, the FDA has advised patients to seek alternative treatments as well.

a new york times paper The nationwide rise in ADHD has been cited as a major cause of the shortage, and it cannot be overstated that reported cases of ADHD do exist. riseAs a heavily regulated Schedule 2 drug, Adderall production is often slowed to meet demand due to the deficit required to produce it, so the increase in ADHD may actually be responsible. Hmm, but in terms of Adderall’s own shortcomings, it’s probably a bit of a mixed bag.

The usual suspects when things are running low these days are Covid-related supply chain problems or the ongoing war in Ukraine, but journalist and scientific researcher Hamilton Morris, known for his TV show Hamilton Pharmacopoeia, on Twitter, indicates that the Adderall deficiency may be due to a lack of nitroethane, one of the potential raw ingredients used to make it. Nitroethane’s primary distributor, Sigma-Aldrich, lists it as unavailable on their website. Alas, calls to Sigma Aldrich’s media department weren’t returned quickly enough to meet my deadline.

Others objected, saying there was no reason to believe there was still a nitroethane shortage, but if it turned out to be true, it would certainly explain things. ChemJobber, a blog dedicated to chemistry news and chemistry jobs, high times A low supply of nitroethane could be a potential factor, but it’s fundamentally much more complicated than that.

“We strongly believe that API[active pharmaceutical ingredient]manufacturing is a problem, very rarely,” says Chemjobber. “It’s a problem behind the chain, and there are four or five steps before that, which means there can be problems with tablets, shipping, labor, etc.”

At that point, Teva reported earlier this year that they were having labor shortage issues. This is a common complaint in times of Covid-19. So it’s not necessarily one chemical missing. It seems to be a complete storm of bad luck and a fundamental production limit in a regulated industry.

As for whether America will run out of Adderall, Chemjobber likened it to the early Covid toilet paper epidemic and predicted that this too would pass. It also seems like a good sign that Teva has moved up the ETA in months over the course of a week. Unfortunately they didn’t call me either.