Prescription Stimulant Use Varies Widely Across US

MedicalResearch.com Interview with:

Brian J. Piper, PhD, MS Department of Basic Sciences Geisinger Commonwealth School of Medicine Scranton, PA 18509

Dr. Piper

Brian J. Piper, PhD, MS
Assistant Professor of Neuroscience
Department of Basic Sciences,
Geisinger Commonwealth School of Medicine,
Scranton PA 18509 

MedicalResearch.com: What is the background for this study?

Response: The U.S. accounts for five percent of the world population but more than 92 percent of the world’s spending on pharmacotherapies for Attention Deficit Hyperactivity Disorder (ADHD). According to the 2011 National Survey of Children’s Health, ADHD increased to 11.0 percent of U.S. children, seven percent of girls and 15 percent of boys. Interestingly, ADHD rates were much lower among Hispanic children.

The 2013 revision to the Diagnostic and Statistical Manual of Mental Disorders broadened the criteria such that it became easier to diagnose adult ADHD. Together, we hypothesized that use of amphetamine (Adderall), methylphenidate (Ritalin), and lisdexamfetamine (Vyvanse) would be increasing. We also predicted that there would be some regional differences in stimulant use.

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Banned Stimulants Remain in Supplements, Despite FDA Efforts to Remove Them

MedicalResearch.com Interview with:

Pieter Cohen, M.D. Associate Professor of Medicine Cambridge Health Alliance Assistant Professor of Medicine Harvard Medical School

Dr. Cohen

Pieter Cohen, M.D
Associate Professor of Medicine
Department of Medicine
Cambridge Health Alliance
Somerville MA 02143

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Since ephedra was banned from supplements in 2004, a variety of experimental stimulants have been introduced into sports and weight loss supplements as ephedra replacements.  The FDA has made some efforts to remove these emerging stimulants from supplements, but whether FDA action to remove these stimulants has it’s intended effect is not known.

We studied the effect of FDA action to remove four experimental stimulants from supplements.

We found that the FDA public notices did not work.  The stimulants remained in supplements even years after the FDA moved to remove them.

MedicalResearch.com: What should readers take away from your report?

Response: Given the regulatory paradigm under which supplements are sold, consumers cannot trust that they will be effective or safe.  Clinicians should understand that supplements might contain hidden ingredients that have potent drug-like effects and consider the effects of supplements when patients experience unexplained symptoms.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: One of the most concerning findings was that one stimulant appeared in the supplements analyzed only after the FDA warned that it was not permitted to be sold in supplements. Future studies should investigate whether FDA announcements regarding new experimental stimulants might have the unintended consequence of firms learning about the stimulant and then adding it to their supplements.

Disclosures: Dr Cohen was subject of a civil suit brought by Hi-Tech Pharmaceuticals, a supplement company, regarding β-methylphenylethylamine;  The jury found in Dr Cohen’s favor. Dr Cohen has collaborated in research with NSF International and received research support from Consumers Union. No other disclosures were reported.

Citation:

Cohen PA, Wen A, Gerona R. Prohibited Stimulants in Dietary Supplements After Enforcement Action by the US Food and Drug Administration. JAMA Intern Med. Published online October 22, 2018. doi:10.1001/jamainternmed.2018.4846

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Small Increased Risk of Cardiac Birth Defects With ADHD Drug During Pregnancy

MedicalResearch.com Interview with:

Krista F. Huybrechts, M.S., Ph.D. Assistant Professor of Medicine at Harvard Medical School Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital. Boston, MA 02120

Dr. Krista Huybrechts

Krista F. Huybrechts, MS PhD
Assistant Professor of Medicine
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital
Harvard Medical School
Boston, MA 02120  

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In recent years, use of stimulant medications in adults, including women of reproductive age, has increased substantially.

However, data regarding the safety of stimulant medications in early pregnancy are sparse and conflicting.  For example, two recent cohort studies failed to detect an association between use of methylphenidate in early pregnancy and overall or cardiac malformations, while another found an 81% increased risk of cardiac malformations, although the estimate was imprecise.

Given the rapidly increasing use of stimulant medications during pregnancy and among women of reproductive age who may become pregnant inadvertently, there is an urgent need to better understand their safety.

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