Dextroamphetamine

THURSDAY, Sept. 12, 2024 -- Prescriptions for amphetamine stimulants to treat ADHD have increased significantly in recent years, particularly during the pandemic. Unfortunately, high doses of stimulants like Adderall can increase the risk of psychosis or mania by more than fivefold, a new study finds. Patients had a nearly 63% increased risk of psychosis or mania if they took any prescription amphetamine within the past month, researchers reported Sept. 12 in the American Journal of Psychiatry . Those on heavy doses of amphetamines were at even greater peril of a psychotic episode, with an 81% increased risk, results show. The highest risk occurred in patients taking 30 milligrams or more of dextroamphetamine, which corresponds to 40 milligrams of Adderall, the study says. “Stimulant medications don’t have an upper dose limit on their labels, and our results show that it is clear that dose is a factor in psychosis risk and should be a chief consideration when prescribing stimulants,” said lead investigator Dr. Lauren Moran , a pharmacoepidemiology researcher at McLean Hospital in Belmont, Mass. “This is a rare but serious side effect that should be monitored by both patients and their doctors whenever these medications are prescribed,” Moran added. Moran said she pursued this study based on her experiences as an inpatient psychiatrist. She and her Mclean colleagues would regularly see patients experiencing their first episode of psychosis. Medical records would reveal the patients had been prescribed high doses of stimulants by their doctors. For the study, researchers analyzed data on nearly 1,400 patients admitted to Mass General Brigham Hospital between 2005 and 2019 who were in the throes of their first episode of psychosis or mania. They compared those patients against more than 2,700 people hospitalized for other psychiatric conditions like depression or anxiety. They found that people taking amphetamines had a higher risk of psychosis and mania, and that the risk was greatest with heavy doses. This link could be explained by the fact that amphetamines prompt the release of dopamine, a brain hormone also implicated in psychosis, researchers said. People taking amphetamines for ADHD shouldn’t be alarmed, Moran said, but they might want to talk with their doctor about the dosage they’ve been prescribed. There also are alternative drugs to treat ADHD that don’t increase mental health risk. For example, this study found no increased risk of psychosis or mania in prescriptions for methylphenidate (Ritalin), Moran noted. “There’s limited evidence that prescription amphetamines are more effective in high doses,” Moran said in a Mass General Brigham news release. “Physicians should consider other medications our study found to be less risky, especially if a patient is at high risk for psychosis or mania.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

To address an ongoing shortage of ADHD drugs, the Drug Enforcement Administration has increased the production quota on Takeda's Vyvanse and its generic versions by 24%. Less than four months after Teva’s Adderall was erased from the FDA shortage list, supply problems with another attention-deficit/hyperactivity disorder (ADHD) treatment, Takeda’s Vyvanse and its generic versions, are such that the U.S. Drug Enforcement Administration (DEA) has increased (PDF) production quotas on the drug by 24%.The move comes eight weeks after an FDA request to the DEA to bump up production limits. As Schedule 2 controlled substances, Vyvanse (lisdexamfetamine) and Adderall (amphetamine/dextroamphetamine) are subject to DEA limitations that help prevent them from being abused.The DEA has raised the aggregate production quota on lisdexamfetamine by 6,236 kilograms, according to a final order set to be published Thursday in the Federal Register. Of that figure, 1,558 kg has been allocated to domestic demand for medications, while the remaining 4,678 kg addresses foreign demand for the products.“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA wrote in its notice. Because the drugs are so tightly controlled, there is a ripple effect when one has a supply issue. Shortages of ADHD drugs have persisted since the summer of 2022 when a labor problem on Teva’s packaging line reduced the supply of Adderall. That issue then triggered increased demand and supply issues with most of the 11 companies making generic versions of Adderall, including Sandoz, Amneal and Sun Pharma. Then, in June of last year, Takeda reported in a statement on its website that it was experiencing “low inventory” for Vyvanse brought on by increased demand and a manufacturing delay. In addition, the timing of Vyvanse's shortage raises a question around the economics of producing the medicine in the aftermath of generic launches. Takeda reported its Vyvanse supply shortfall last June, and the first U.S. generics ⁠launched two months later. Lawmakers and industry watchers have repeatedly flagged that ⁠economic factors can drive drug shortages when companies don't see a potential profit motive in dedicating their manufacturing equipment to low-margin—or even loss-making—products. Meanwhile, on the DEA's manufacturing allocation, the agency last summer committed to “reviewing and improving” the quota process. In 2022, that limit was not met, and drugmakers sold only 70% of their allotted quota for the year, making for some 1 billion extra doses that could have been produced, the FDA and the DEA revealed in a joint letter (PDF).At the time, the agencies said they had called on manufacturers to confirm production increases and asked that those that opt to no longer produce the meds “relinquish” their remaining quota so the DEA can redistribute it.