With the United States facing a high number of drug shortages, a Chinese company may help to boost the supply of one in particular, the chemotherapy agent cisplatin.

The U.S. Food and Drug Administration is working with the Chinese drugmaker Qilu Pharmaceutical to import the widely used cancer drug. The Canadian pharmaceutical company Apotex will distribute the medication in 50-milligram vials, CNN reported.

Health care providers can begin ordering the drug on Tuesday.

“The FDA recognizes the importance of a stable, safe supply of critical drugs used in oncology, especially those used in potentially curative or life-extending situations,” said FDA Commissioner Dr. Robert Califf on Twitter late Friday. “Today, we’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs.”

Califf stressed that in these situations regulators carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients.

“The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages,” he added.

The near-record number of drug shortages has had a big effect on cancer treatments, with about two dozen chemotherapy drugs in active shortage this spring, CNN noted, citing data from the University of Utah Drug Information Service.

Lawmakers criticized the FDA for falling behind on inspections of international facilities in a hearing last month, but the agency said much of the shortages were due to economics.

Platinum-based drugs, like cisplatin (Platinol), are prescribed for 10% to 20% of all cancer patients, according to the U.S. National Cancer Institute.

Cisplatin has a cure rate of over 90% when used to treat testicular cancer, the FDA said. It also treats bladder, cervical, ovarian, lung, gastric, breast, and head and neck cancers.

Dr. Amanda Fader, a professor at the Johns Hopkins School of Medicine, said Friday that the severe shortage of cisplatin and carboplatin are affecting hundreds of thousands of patients, CNN reported.

“Substitutions are sometimes required,” she said. “Many of these drugs may carry worse side effect profiles or different dosing schedules that require two to three times longer to administer.”

Importing foreign medications has helped in the past, Fader noted.

“The drugs do need to pass the same rigorous inspections and requirements as conventionally FDA-approved drugs, so that process does take time,” Fader said.

More information

The American Cancer Society has more on cancer treatment.


Source: HealthDay

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