Beware of Unfounded Ozempic, FDA Warns

— Agency seized thousands of unsuitable units already

by Kristen MonacoSenior Personnel Author, MedPage At the moment December 22, 2023

The FDA continues its investigation into unsuitable semaglutide (Ozempic) merchandise — that must aloof aloof be available for purchase — and has already seized thousands of units, the company introduced Thursday.

In its warning, the FDA instructed wholesalers, retail pharmacies, healthcare practitioners, and sufferers to take a look at the product they’ve received and no longer distribute, expend, or promote merchandise labeled with lot number NAR0074 and serial number 430834149057.

The investigation particularly pertains to the 1-mg injectable, labeled under the trace title Ozempicwhich is indicated for form 2 diabetes. The GLP-1 receptor agonist is also available in 0.5-mg and a pair of-mg doses for diabetes, moreover to a 2.4-mg dose for weight reduction under the logo title Wegovy.

Each and every the drug merchandise and the needles are deemed unsuitable, bringing their sterility and quality into inquire and rising the possibility for serious infection. So a ways, the FDA knows of 5 detrimental occasions from the lot, though none had been deemed serious and had been in step with the gastrointestinal occasions associated with semaglutide.

Any detrimental occasions associated with the drug desires to be reported to FDA’s MedWatch Security Recordsdata and Detrimental Match Reporting Program.

To defend a ways from unsuitable merchandise, the FDA truly handy retail pharmacies easiest purchase Ozempic thru authorized distributors of Novo Nordisk and compare photos of the merchandise. As for sufferers, they must aloof easiest attach the drug with a sound prescription thru direct-licensed pharmacies and verify the product for signs of counterfeiting sooner than expend.

Concerns with unsuitable semaglutide accumulate persevered throughout the 365 days as the blockbuster drug shot to status. Support in June, maker Novo Nordisk warned of unsuitable semaglutide that was reportedly sold at a sound U.S. retail pharmacy that truly contained insulin glargine in its put of the GLP-1 agonist.