The FDA on Thurs­day up­dat­ed its list of drugs in short­age to in­clude the se­da­tion drug mi­da­zo­lam, which along with oth­er seda­tives is be­ing used to treat COVID-19 pa­tients re­quir­ing me­chan­i­cal ven­ti­la­tion.

The up­dat­ed list­ings for five man­u­fac­tur­ers note an in­creased de­mand for mi­da­zo­lam and may just be the be­gin­ning of what’s to come for oth­er se­da­tion drugs too.

Michael Ganio

Michael Ganio, se­nior di­rec­tor of phar­ma­cy prac­tice and qual­i­ty at the Amer­i­can So­ci­ety for Health-Sys­tem Phar­ma­cists, told Fo­cus via email: “We have mul­ti­ple re­ports of in­creas­es in pur­chas­es and uti­liza­tion of seda­tives like mi­da­zo­lam, fen­tanyl, and propo­fol to treat COVID-19 pa­tients who re­quire me­chan­i­cal ven­ti­la­tion.”

Stat News’ Phar­malot re­port­ed on this in­creas­ing de­mand for seda­tives ear­li­er this week, not­ing there has been a 51% in­crease in de­mand so far this month for half a dozen dif­fer­ent seda­tives and anes­thet­ics.

“The amount of seda­tives saved from for elec­tive surg­eries is not enough to equal the in­creased use of seda­tives for me­chan­i­cal­ly ven­ti­lat­ed pa­tients, es­pe­cial­ly con­sid­er­ing the amount of seda­tives need­ed and the du­ra­tion these pa­tients are on ven­ti­la­tors,” Ganio added.

He al­so not­ed that hos­pi­tals na­tion­wide are prepar­ing for a surge in cas­es of COVID-19 and they are at­tempt­ing to ac­quire the sup­plies and med­ica­tions nec­es­sary to meet the needs of those pa­tients.

A Pfiz­er spokesper­son told Fo­cus via email: “We cur­rent­ly have am­ple sup­ply of sev­er­al pre­sen­ta­tions of Mi­da­zo­lam but are ex­pe­ri­enc­ing high de­mand for the prod­uct. As of to­day, Pfiz­er’s man­u­fac­tur­ing and dis­tri­b­u­tion net­work con­tin­ues to op­er­ate with­out sig­nif­i­cant dis­rup­tion. We’ve iden­ti­fied a list of med­i­cines that are crit­i­cal to treat­ing pa­tients with COVID-19 dur­ing this time. For many of these crit­i­cal med­i­cines, we have am­ple sup­ply. For some, the un­prece­dent­ed surge in de­mand for these prod­ucts is lim­it­ing our abil­i­ty to ful­ly sat­is­fy cus­tomer or­ders in the short-term. We are mak­ing every ef­fort to ad­vance the or­der­ing of ad­di­tion­al ma­te­ri­als, in­crease our pro­duc­tion of the most es­sen­tial prod­ucts, ex­pe­dite or­ders to cus­tomers, es­pe­cial­ly those in high-im­pact ar­eas, and al­lo­cate cus­tomer or­ders to en­sure the most ap­pro­pri­ate dis­tri­b­u­tion.”

In ad­di­tion to the seda­tives, the un­proven but po­ten­tial COVID-19 treat­ment hy­drox­y­chloro­quine sul­fate is al­so list­ed as cur­rent­ly in short­age. Last week, FDA al­so re­leased guid­ance on re­port­ing drug short­ages dur­ing the pan­dem­ic.

FDA Drug Short­age List

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US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.