Health Highlights, Dec. 10, 2020

Below are newsworthy items compiled by HealthDay staff:

First Non-Prescription, At-Home COVID-19 Test Approved by FDA

The first over-the-counter COVID-19 home test kit for Americans was approved by the U.S. Food and Drug Administration on Wednesday.

LabCorp’s Pixel COVID-19 Test Home Collection Kit — authorized for use by people 18 and older without a prescription — enables users to collect a nasal swab sample at home and then send the sample to the company for testing. The kit can be bought online or in a store.

Positive or invalid results are given over the phone by a healthcare provider, while negative results are provided online or by email.

“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” Dr. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in an agency news release.

“While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing.”

Sildenafil and Trazodone Tablets Recalled After Being Packaged Together

Sildenafil and trazodone tablets have been recalled by pharmaceutical distributor AvKare because the drugs were “inadvertently packaged together” when they were bottled by a third-party vendor, according to the company.

Sildenafil is the active ingredient in Viagra, used to treat erectile dysfunction, and trazodone is used to treat major depression.

The recall is for 100 milligram (mg) sildenafil tablets, lot 36884 with an expiration date of 03/2022, and 100 mg trazodone tablets, lot 36783 with an expiration date of 06/2022, CNN reported.

Avkare said it doesn’t know of any patients being harmed by the recalled products, CNN reported.

For more information about the recall, consumers can contact AvKARE at 1-855-361-3993.

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