DEA Allows Increased Vyvanese Production to Tackle Schedule II Drug Shortages

Aw, gee. Thanks, DEA.

The DEA finally eased restrictions for Vyvanse (lisdexamfetamine), one drug used to treat conditions like ADHD and narcolepsy.

But there are so many other conditions that need stimulants.

I take Adderall for narcolepsy. I cannot function without Adderall. Literally cannot function.

The federal government has gone haywire regarding controlled substances for ADHD, narcolepsy, and other conditions that need stimulants.

It leaves us in limbo since, at least in Oklahoma, we cannot refill until two days before we run out of the medicine. We can only get 30 days at a time. We can only fill in the state where we reside. We have to call around for 20mg XR, and if no one has it, we have to hope the pharmacy has 60 10mg XR pills.

Vyvanese is an alternative to Adderall if none of the nearby pharmacies don’t have Adderall.

The FDA predicted an increase in the need for Vyvanese in 2024. Now, before anyone says it’s overdiagnosing ADHD, I remind you again: We have no Adderall.

So, yeah, it’s not a shock that the demand for Vyvanese has risen. There’s a lack of Adderall:

DEA reviewed domestic data from the latest IQVIA report on stimulant prescribing that reflected increases in prescribing of lisdexamfetamine products from 2022 to 2023. In addition, FDA’s estimate of domestic medical need for lisdexamfetamine drug products predicted a 6 percent increase for 2024 domestic need when compared to 2023 observed need. Data reviewed by both agencies support an increase to the lisdexamfetamine APQ which is necessary to meet domestic demand.—In addition to reviewing export data extracted from DEA’s internal databases, DEA also obtained access to new data sources in 2024 that allow DEA to more accurately forecast foreign demand for domestically controlled substances that are not always internationally controlled, such as lisdexamfetamine. The export data showed that exports of drug products containing lisdexamfetamine increased from 8,573.351 kg in 2022 to 11,502.175 kg in 2023. Extrapolation utilizing previous years’ reported data suggests the export requirements for lisdexamfetamine active pharmaceutical ingredient and finished dosages likely will continue to increase in 2024 and beyond. An increase in domestic manufacturing of the active pharmaceutical ingredient and finished dosages is necessary to supply lisdexamfetamine products to foreign markets.

The companies can increase the production quota by 24%.

I guarantee you that the misdiagnosis and Adderall abuse are minor compared to those who need it.

I also guarantee you the shortage is only because of the DEA, not overprescribing or misdiagnosing ADHD/ADD.

Again, other conditions need stimulants, not just ADHD.

Tags: FDA, Medicine, Science

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