A Whole Hog of Problems

China’s recent African swine fever outbreak has left many within the US’ congressional body concerned. The reason? China remains its main source of heparin (an anticoagulant used in the treatment of angina and renal impairment) and with 440 million of the world’s supply of 770 million pigs, 80 percent of the world’s heparin supply is produced in China. 

African swine fever is highly contagious and  with no known cure, poses a threat to drugmakers who rely upon pig intestines to produce their heparin products. A bipartisan group of six congressional leaders expressed their concerns to Norman Sharpless, the FDA’s Acting Commissioner.

The FDA only allows heparin derived from pig intestines to be used in medicines entering the US market, as bovine-derived heparin has an increased potential to be contaminated with oversulfated chondroitin sulfate (OSCS), bovine spongiform encephalopathy or products harmful to human health, like filler. However, the US’ reliance on porcine-derived heparin increases the risk of shortages of the drug and in 2018, the regulatory authority suggested that heparin could be produced using cow lungs, though the idea is yet to be adopted by the industry.

The FDA has already listed Baxter Healthcare and Pfizer as two companies suffering from heparin shortages since November 2017 (though neither company has expressed concern about the swine fever outbreak and its implications for heparin production). In 2008, 80 dialysis patients died due to fatal allergic reactions caused by OSCS contamination of the anticoagulant drugs administered to them during treatment. Baxter Healthcare subsequently recalled both its multi-dose and single-dose heparin from the market as a precautionary measure and has previously cited Hurricane Maria as a cause of drug shortages as they have manufacturing facilities based in Puerto Rico. The Caribbean island was significantly affected by the category five hurricane in 2017.

Fresenius, a German health care company which provides patients with products for dialysis, announced that it was limiting its allocations of heparin due to the potential risk of a falling supply of the raw ingredient. Though company sources its heparin from multiple sources, it predicts that shortages in China’s supply of the API will have widely felt implications. 

China’s National Bureau of Statistics reported that the nation’s supply of pigs has fallen by 40 million and predict that it will take years to bring the deadly outbreak under control. According to estimates China could lose up to 200 million pigs to culling or death from the disease (1).

There is currently no evidence to indicate that China’s ongoing swine fever crisis is impacting the US supply of heparin. However, in a letter penned to the FDA by the congress, the group explain that the country’s supply of the drug is already “stressed”(2). They predict a six to nine-month delay before the implications of the shortage are felt.