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Drug News

doi: 10.1097/01.NURSE.0000534099.79486.ed
Department: DRUG NEWS
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Warn patients about cannabis in breast milk...FDA cracks down on highly concentrated caffeine products...why parents resist childhood vaccinations...emollient bath additives fail to soothe

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NURSING MOTHERS

Warn patients about cannabis in breast milk

Researchers recruited eight women who regularly consumed cannabis, were 2 to 5 months postpartum, and were exclusively breastfeeding their infants. Breast milk specimens were collected after the women discontinued smoking a standardized cannabis product for 24 hours (baseline), and then at 20 minutes and at 1, 2, and 4 hours following discontinuation. They found low concentrations of delta-9-tetrahydrocannabinol, the primary active component of cannabis, at all the time points beyond time zero. However, no metabolites were detected at any point. The researchers estimated that infants who were breastfeeding exclusively ingested about 2.5% of the maternal dose, for an estimated daily infant dose of 8 mcg/kg/day. “The long-term neurobehavioral effect of exposure to delta-9-tetrahydrocannabinol on the developing brain is unclear,” they write. “Mothers should be cautious using cannabis during pregnancy and breastfeeding.”

Source: Baker T, Datta P, Rewers-Felkins K, Thompson H, Kallem RR, Hale TW. Transfer of inhaled cannabis into human breast milk. Obstet Gynecol. [e-pub April 6, 2018.]

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VACCINE HESITANCY

Why do parents resist childhood vaccinations?

Although parental resistance to childhood vaccinations, known as vaccine hesitancy and vaccination apathy, is often attributed to misinformation and exaggerated fear of complications, new research implicates a host of other factors over recent decades, including drug scandals and a lack of political priority placed on disease prevention dating back to the 1960s. Researchers traced measles vaccine hesitancy in Canada from 1963 to 1998, just before publication of a widely publicized but fraudulent study falsely linking the measles-mumps-rubella vaccine to autism. They found the roots of vaccine hesitancy in various social and political events in the 1960s, including the thalidomide disaster of 1962, the emergence of new styles of parenting, second-wave feminism, and the popularity of alternative medicine. In later decades, vaccine hesitancy was fueled by a growing emphasis on individual rather than collective responsibility for health promotion, and a national and international focus on children's rights and child health, which led many young parents to question the wisdom of childhood vaccinations. “Lack of sustained training in the rapidly changing science of immunology left Canadian health care practitioners with limited knowledge to provide guidance when asked to explain the benefits of vaccination to anxious parents,” says coauthor Heather MacDougall.

Sources: MacDougall H, Monnais L. Vaccinating in the age of apathy: measles vaccination in Canada, 1963-1998. CMAJ. 2018;190(13):E399-E401. Vaccine apathy fueled by decades of misinformation. University of Waterloo. News release. April 9, 2018.

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CHILDHOOD ECZEMA

Emollient bath additives fail to soothe

Combined with topical corticosteroids and other medications, complete emollient therapy is a mainstay of treatment for childhood eczema, also known as atopic eczema. Applied directly to the skin, used as soap substitutes, or added to bath water, emollients are thought to decrease moisture loss from skin and protect the skin from irritants. But according to a recent study involving 483 children ages 1 to 11 years who met diagnostic criteria for atopic dermatitis in the United Kingdom, adding emollients to bath water is neither beneficial nor cost-effective.

Children in the intervention group were prescribed emollient bath additives to be used regularly for 12 months. Those in the control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and caregivers were given standardized instructions on how to wash participants. The primary outcome was eczema control measured weekly by the patient-oriented eczema measure (POEM) for 16 weeks. Secondary outcomes were eczema severity over 1 year, generic quality of life, utilization of resources, and type and quantity of topical corticosteroid or topical calcineurin inhibitors prescribed.

The results showed no statistically significant difference in weekly POEM scores between the two groups over 16 weeks. In addition, no differences were found in secondary outcomes, economic outcomes, or adverse reactions.

The authors conclude that the evidence showed no clinical benefit to the use of emollient bath additives in the standard care of children with eczema. They call for more investigation into the effectiveness of leave-on emollients and soap substitutes. Commenting on the expense of emollient therapy, they note that bath additives are estimated to contribute to up to one-third of the costs of eczema treatment in the United Kingdom.

Source: Santer M, Ridd MJ, Francis NA, et al. Emollient bath additives for the treatment of childhood eczema (BATHE): multicentre pragmatic parallel group randomised controlled trial of clinical and cost effectiveness. BMJ. 2018;361:k1332.

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OTC PRODUCTS

FDA cracks down on caffeine

To protect consumers from the dangers of highly concentrated caffeine products, the FDA has issued a directive stating that dietary supplements containing pure or highly concentrated caffeine in powder or liquid forms are considered unlawful when sold in bulk quantities directly to consumers. These products contain up to thousands of recommended servings per container and have been linked to the deaths of at least two otherwise-healthy people.

According to the FDA, a half cup of highly concentrated liquid caffeine can contain approximately 2,000 mg of caffeine, and a teaspoon of a powdered pure caffeine product can contain about 3,200 mg of caffeine. The recommended safe serving of highly concentrated or pure caffeine products is about 200 mg. Less than two tablespoons of some formulations of powdered, pure caffeine could kill an adult; even smaller amounts could be fatal to children. Because the risk of overuse and misuse is particularly high when highly concentrated caffeine is sold in bulk quantities, the FDA seeks to remove these products from the market.

Consumers have been known to mix dangerously high amounts of caffeine into workout cocktails for an extra energy boost. Warn patients who use caffeine products about the dangers and teach them to precisely measure and consume only the very small recommended doses.

Sources: FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine. U.S. Food & Drug Administration. News release. April 13, 2018. Guidance for industry: highly concentrated caffeine in dietary supplements. U.S. Food & Drug Administration. www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm604318.htm.

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