Hikma to ease U.S. hydromorphone shortage; FDA gives nod to Terumo BCT to boost anticoagulant stocks

Generics maker Hikma is looking to ease the U.S. shortage of hydromorphone with increased production as the FDA gave its OK to Terumo BCT to shore up short supplies of anticoagulant solution.

Hikma said it released more than 5 million 2-ml vials of the injectable opioids to hospitals in June and expects to release another 3 million vials this month.

Despite the ongoing opioid crisis in America, stocks of the injectable painkiller used to treat patients in hospitals, clinics and hospices has been in short supply due to manufacturing issues. The shortage for medical institutions that rely on the drugs has been magnified by government regulations aimed at preventing the illegal sale of the addictive drugs.

Pfizer, a major manufacturer of small syringes and vials of the painkillers, has previously said it expects "full recovery date" for supplies to be reached by early 2019.

"We continue to prioritize the manufacture of opioid products affected by this shortage including fentanyl, meperidine, morphine and hydromorphone to provide hospitals and doctors with the medicines they need to best treat their patients," Daniel Motto, EVP of Hikma’s U.S. injectables division, said in a statement.

Back in 2015, makers of injectable drugs like Hikma, Baxter and Hospira (now owned by Pfizer) came under fire for taking advantage of drug shortages to increase their prices and profits. The drugmakers defended the price hikes by pointing to the cost of upgrades at manufacturing facilities.

In a separate move to relieve drug shortages in the U.S., the FDA approved Terumo BCT’s sodium citrate 4% anticoagulant solution produced in the U.K. and commonly used during apheresis procedures to collect plasma that is then used to treat serious conditions.

Sodium citrate has been on the regulatory agency’s shortage list for more than a year. Terumo BCT said the newly approved sodium citrate will be available in the U.S. later this summer.