FDA’s biotin warning: Was it enough to educate physicians, patients about the risks?
A recent study in JAAD found that after the FDA’s 2017 warning about how biotin can interfere with laboratory tests, researchers found that biotin risks and the FDA warning were not discussed frequently in scholarly articles.
The study found that out of the 119 articles surveyed, 25 (21%) mentioned biotin risks and only six (5%) mentioned the FDA warning. In addition, of the top 1% of the most reviewed biotin products on Amazon in November 2018, none listed the FDA warning on the label. The articles that did cite biotin risks and warnings were generally not published in high-impact journals. The study authors suggest developing CME activities to publicize FDA warnings about commonly used dermatologic medications to educate physicians on the risks of biotin.
Read more about how biotin can falsely lower results for troponin, a biomarker used in diagnosing heart attacks in this month’s issue of Dermatology World.
DW Insights and Inquiries: Dupilumab’s growing pains
Dupilumab has been a valuable addition to dermatologists’ therapeutic palette in managing atopic dermatitis (AD). The biologic agent was released in 2017, indicated for moderate-to-severe AD, and is now approved for patients who are at least 12 years old. I suspect that most clinicians would agree that when AD cannot be adequately controlled with topical agents (steroids, calcineurin inhibitors, or phosphodiesterase inhibitors) or phototherapy, dupilumab is the systemic treatment of choice, supplanting methotrexate, cyclosporine, or mycophenolate mofetil. Other agents, not yet approved or available for AD, include JAK inhibitors, anti-IL-13 inhibitors (lebrikizumab, tralokinumab), PDE4 inhibitors (apremilast), and the anti-pruritic anti IL-31 agent (nemolizumab).
Dupilumab is a fully human monoclonal antibody that reduces TH2 inflammation by blocking the shared receptor subunit for interleukin (IL)-4 and IL-13, thereby inhibiting signaling of both cytokines. The diminished quality of life (QoL) in AD, combined with its societal economic burden, drives the impetus for refined therapeutic options. Dupilumab has greatly improved QoL for many afflicted AD patients. In a randomized phase 3 clinical trial including 251 adolescents (mean age 14.5 years) with moderate-to-severe atopic dermatitis, Simpson et al demonstrated that dupilumab 200 or 300 mg every two weeks and 300 mg every four weeks resulted in a significant treatment response versus placebo following 16-week treatments, with an acceptable safety profile. This study supports the use of dupilumab in adolescents, just as prior reports confirm its efficacy in adults. Keep reading!
2020 kicks off with revised ICR coding guidelines
Updates to intermediate and complex repair coding guidelines went into effect Jan. 1, 2020. To help with accurate reporting of intermediate and complex repairs, use the Academy’s coding tool to find the proper code to ensure reimbursement, and to familiarize yourself with the revised guideline requirements. Learn more and check out the Academy’s new coding tool.
Join the Academy’s skin cancer measure testing project
The Academy is seeking participants for its new skin cancer measure testing project. Your participation will help build better dermatology measures for clinical practice, DataDerm™, and MIPS. These outcome measures will help you see which patients with skin cancer are improving.
Participants will be asked to provide data on five quality measures on skin cancer, including process and outcome measures addressing appropriate surgical margins, post-operative complications, dysplastic nevi biopsies, biopsy site photos, and tracking of recurrence.
FDA warns about respiratory problems with gabapentin
A recent communication from the U.S. Food and Drug Administration (FDA) warned that life-threatening breathing difficulties can occur in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system, as well as those with underlying respiratory conditions and the elderly. In response, the FDA is requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects. Drug manufacturers will also be conducting clinical trials to further evaluate the abuse potential of combining gabapentinoids with opioids.
Read about dermatologists who have experience and research in treating patients with gabapentin and pregabalin for chronic itch in Dermatology World.
The data submission period for MIPS-eligible clinicians who participated in the 2019 Quality Payment Programs is now open. Data can be submitted and updated until 8 p.m. EDT March 31, 2020. To submit 2019 MIPS data, physicians can go to the Quality Payment Program website and sign in using QPP access credentials. Physicians can submit 2019 MIPS data or review the data reported on your behalf by a third party. To learn more about how to submit data, review resources in the QPP Resource Library.
For more information and resources for 2019 MIPS reporting, visit the Academy's MIPS reporting resource center. If you're reporting using DataDerm™, the 2019 MIPS Reporting Module can still be purchased by calling the Academy's Member Resource Center at 866-503-SKIN (7546).
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