PHARMACY

Study: Children at greater risk of ADHD if mother has gestational diabetes, low socioeconomic status

BY Allison Cerra

NEW YORK — Mothers that have low socioeconomic status and develop gestational diabetes during pregnancy are more likely to bear children that are diagnosed with attention deficit hyperactivity disorder, according to a new study published in the Archives of Pediatrics & Adolescent Medicine.

Researchers led by Yoko Nomura of CUNY Queens College in Flushing, N.Y., compared 212 offspring (ages 3 and 4 years) of mothers with and without GDM in an economically diverse sample. What they found was that exposure to maternal GDM was associated with a two-fold increased risk for ADHD at 6 years of age, compared with those not exposed. The same rang true for children exposed to low SES — exposure to the factor was associated with a two-fold increased risk for ADHD at 6 years of age. Additionally, when the relationship of GDM and SES exposure was examined, the study authors also found that children were 14 times more likely to develop ADHD when exposed to both GDM and low SES.

"This study demonstrates that children of mothers with GDM raised in lower SES households are at far greater risk for developing ADHD and showing signs of suboptimal neurocognitive and behavioral development," the authors conclude. "Since ADHD is a disorder with high heritability, efforts to prevent exposure to environmental risks through patient education may help to reduce the nongenetic modifiable risk for ADHD and other developmental problems."


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PHARMACY

FDA approves new REMS for fentanyl-based painkillers

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said Tuesday.

The FDA announced the approval of a single REMS for transmucosal immediate-release fentanyl, or TIRF, drugs. The new system, which takes effect in March, will allow prescribers and pharmacies to enroll into one system instead of individual systems for each product. TIRF drugs include ProStrakan’s Abstral, Cephalon’s Fentora and Actiq, Archimedes Pharma’s Lazanda and Meda Pharmaceuticals’ Onsolis.

"This TIRF REMS will ensure safe use and access to these drugs for patients who need them," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "We have worked with the sponsors of both the innovator and generic drugs to develop this single, shared system that will streamline the process and decrease the burden of the REMS on the healthcare system."


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FDA panel to review potential new use for Xgeva

BY Allison Cerra

THOUSAND OAKS, Calif. — Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

Amgen will participate in a meeting of the Oncologic Drugs Advisory Committee on Feb. 8, where the panel will review results from clinical studies in support of Xgeva as a treatment of castration-resistant prostate cancer in men that are at high risk of developing bone metastases, a new indication for the drug. The company said there currently is no approved treatments to delay or prevent the spread of cancer to bone among this specific patient population.

The sBLA was submitted this past June, and a Prescription Drug User Fee Act action date has been scheduled for April 26 of this year. If approved, this will be the second indication of Xgeva in the United States.


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