Monday, November 28, 2022

FDA confirms Adderall shortage in the US

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After weeks of anecdotal reports of frustration in filling Adderall prescriptions, the Food and Drug Administration on Wednesday confirmed a statewide shortage in the formulation of immediate-release amphetamine mixed salts, commonly known by the brand name Adderall.

Adderall is a stimulant that can treat ADHD. It requires a prescription, and as a controlled substance, supply is tightly controlled and distribution is limited.

Some people already knew there was a problem after reporting going weeks without medication and calling multiple pharmacies to fill prescriptions. Some patients have had trouble filling Adderall prescriptions since August.

“It’s like that feeling when you wake up for the first time in the morning and can’t really think, except for me all day without it [Adderall]. It’s really affecting my life,” Daryl Linley, a Wheat Ridge resident, told KMGH, an ABC affiliate in Denver.

Teva, the largest manufacturer of generic Adderall in the US, told ABC News, “The lineup we currently manufacture/distribute is on track to be consistent by the end of this year – or greater than our lineup at this time.” last year . The demand is not.”

The company said there were “temporary backlogs” as “national prescription rates have increased significantly, which may result in some limitation of product availability.” Teva says disruptions will only be “temporary” and expects inventories to recover within months.

Large retail pharmacies such as CVS and Walgreens have also encountered supply chain constraints. A CVS spokesperson told ABC News they are “aware of the temporary shortage of generic amphetamine drugs in the supply chain,” adding that their pharmacists “will work with patients prescribed this drug as needed.”

While another supplier of the drug, Sandoz Pharmaceuticals (a division of Novartis), told ABC News there is currently no “shortage” of Sandoz amphetamine (generic Adderall) on the market and the company is fulfilling all current customer orders.

Supply restrictions have led many to voice the challenges of having their prescriptions filled at their regular pharmacy.

In Kentucky, a Fayette County school board member Stephanie Spiers said at a meeting Monday that the issue was “significantly impacting our classrooms.”

“I spoke to a parent today who said she could have five pills,” Spiers said.

The lack of this key treatment for so many Americans, especially children, comes as the new school year gets underway. The CDC estimates that nearly 10% of children have ADHD in 2019, and those numbers may have increased during the pandemic.

There are many reasons for limited supply, including strict regulation due to its classification as a Schedule II drug, which the DEA defines as “drugs with a high potential for abuse, the use of which has the potential to result in severe psychological or physical dependence.” Additionally, labor shortages, supply chain issues, and an increase in the number of people prescribed the drug in recent years may impact supply.

“While stopping Adderall is generally not life-threatening, rebound symptoms, including inattention, hyperactivity, and impulsivity, can return and be distressing,” said Dr. Anish Dube of the American Psychiatric Association told ABC News.

Doctors and law enforcement officials warn that people should never buy Adderall outside of a pharmacy — even from a friend — as these pills could be counterfeit and/or laced with other deadly substances. The DEA says many counterfeit pills containing fentanyl are made to look like prescription stimulants like amphetamines (Adderall), but could be potentially deadly.

When people are having trouble getting their medication and feel like they’ve exhausted all options, they should call their pharmacist or doctor to discuss a plan.

“Those with more severe symptoms should discuss contingency plans with their psychiatrist about how to manage the symptoms without medication,” Dube said.

A “classroom of kids who’ve had to give up their cold turkey with medications because they can’t get them — we’ve got some issues here and we’re brewing,” Spiers said in Kentucky. “And it’s not just kids, it’s adults too. But for us here, our goal is that children who aren’t getting what they need, or who aren’t willing to come into the classroom, learn – and that creates a stressful environment for everyone involved. “

In their announcement, the FDA said they would “continue to use all the tools at our disposal to keep patients cared for.”

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