A spate of drug recalls related to a potential carcinogen has tested public faith in regulatory oversight. Now, one company is pulling two lots of an injectable sedative—currently on the FDA's drug shortage list—over fears of cross-contamination, racking up its second recall in about three months.
Fresenius Kabi USA will voluntarily recall two lots of its 200-microgram/50-milliliter dexmedetomidine sodium chloride injection (dexmedetomidine HCL) after investigations alerted the drugmaker to potential traces of lidocaine.
Fresenius has not received any reports of patient side effects but said trace amounts of lidocaine in its dexmedetomidine injectable—used as a sedative in ventilated ICU patients and non-intubated patients before surgery—could trigger anaphylaxis in those with a lidocaine allergy, leading to a potentially fatal reaction. The lots in question were distributed across the U.S. to wholesalers, distributors, hospitals and pharmacies between June of last year and April 2020, according the FDA's recall listing.
To make matters more complicated, injectable dexmedetomidine found its way onto the FDA's drug shortage list in April. Fresenius has two doses of the anesthetic—including the 200-micogram/50-milliliter dose subject to the recall—on backorder due to increased demand. Meanwhile, Accord Healthcare, Hikma Pharmaceuticals, Pfizer and other companies are also struggling to keep up supplies of the ICU sedative.
Surgical anesthetics and painkillers—many of which are used to treat patients with COVID-19—have become increasingly scarce in U.S. hospitals as the pandemic saps supplies. In April, the FDA cited shortages of anesthesia drugs propofol and midazolam due to increased demand.
That same week, the U.S. Drug Enforcement Administration gave its blessing to ramp up shipments of midazolam to the U.S. and added a suite of painkillers and sedatives to its increased production list, including fentanyl, ketamine, diazepam and more.
The Fresenius recall also comes at a time when faith in drug oversight has been tested by the ongoing COVID-19 pandemic and after repeated recalls on carcinogen contamination.
In late May, the FDA urged five manufacturers to pull their extended-release metformin products, broadly used to treat diabetes, after confirming trace amounts of N-Nitrosodimethylamine (NDMA), a likely human carcinogen, in samples of the drug. Actavis, Lupin and Marksans all had products hit by the recall, along with Amneal and Apotex, which launched their own voluntary recalls of the tainted diabetes meds.
Soon after, CEO of independent testing laboratory Valisure, David Light, warned U.S. senators that the COVID-19 outbreak would likely hamper the FDA's ability to oversee quality control on foreign-made drugs. Valisure had pushed for an earlier metformin recall, which itself followed a spate of other NDMA-related recalls of the stomach drug Zantac and its generics, and a class of blood pressure drugs known as sartans.
And in June, Pfizer voluntarily pulled two batches of its menopause drug Duavee, known as Duavive abroad, from U.K. shelves after identifying problems in the drug's packaging that might have compromised its effectiveness. That recall came two weeks after Pfizer pulled 11 lots of Duavee in the U.S. and two in Canada.
Plus, it's not Fresenius Kabi's first recall this year, either. Back in April, the German-based drugmaker pulled 13 lots of the anti-inflammatory Ketorolac Tromethamine Injection after eight vials were found to contain carbon, silicon, oxygen and polyamide particulates.