News Briefs for June 2015

FDA Cautions Against Use of Over-the-Counter Homeopathic Asthma Products

The Food and Drug Administration (FDA) has issued a warning to patients with asthma about over-the-counter products for the condition labeled as homeopathic. These products may promise to be “natural” solutions for asthma and are often promoted as being safe and effective.[1] The FDA cautions that asthma is a serious condition that must be treated and managed appropriately to avoid serious harm to patients, and that FDA-approved prescription (as well as some over-the-counter) products are safe and effective ways to treat asthma. Consumers should not rely on products labeled as homeopathic, and can identify such products not only by the label but also by the active ingredients being “listed in terms of dilution (e.g., ‘LM1’ ‘6X’ or ‘30C’).”

First Biosimilar Approved in United States

In March, the Food and Drug Administration approved filgrastim-sndz (ZARXIO), the first biosimilar product to be approved in the U.S.[2] Biosimilars are essentially generic versions of biologic drugs, medications that are derived from living organisms. ZARXIO, a biosimilar to the biologic filgrastim (NEUPOGEN), is approved for preventing infections in patients receiving chemotherapy for cancer and leukemia, among other uses. Public Citizen released a report in 2014 showing that brand-name biologic companies had been using their political clout to resist the introduction of biosimilars to the market.[3] But the approval of the first biosimilar signals a start to competition that is likely to decrease costs for these usually expensive medications.[4]

References

[1] Food and Drug Administration. Over-the-counter asthma products labeled as homeopathic: FDA statement - consumer warning about potential health risks. March 19, 2015. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439014.htm. Accessed March 23, 2015.

[2] Food and Drug Administration. FDA approves first biosimilar product Zarxio. March 6, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Accessed March 19, 2015.

[3] Public Citizen. Competition inhibitors: How biologics makers are leveraging political power to maintain monopolies and keep prices sky-high. December 18, 2014. http://www.citizen.org/documents/report-biologics-industry-leverages-political-power-to-maintain-monopolies-and-inflate-prices.pdf. Accessed March 19, 2015.

[4] Carome M. Public Citizen highlights efforts by biologics industry to maintain monopolies. Worst Pills, Best Pills News. 2015;21(3):2. /newsletters/view/949. Accessed March 19, 2015.