A global healthcare company Baxter International has stopped selling its heparin blood-thinning products, due to under suspicion for 21 deaths and hundreds of allergic reactions in America.
According to the officials, half of Heparin's raw ingredients derived from the lining of pigs' intestines and comes primarily from China.
The FDA acknowledged that it didn’t inspect a Chinese plant that supplies the active ingredient for Baxter's heparin before approving it because the agency mergd the plant's name with a different company.
Baxter recalled its multidose vials of heparin on Jan. 17, but had not recalled its single-dose individual vial products and a device containing heparin called a Hep-Lock, because there have been no reports of allergic reactions in patients using it.
Heparin is vital in many medical and surgical procedures.
Dr. Sidney Wolfe of worstpills.org said, "I don't understand why it takes deaths and serious injuries to a large number of Americans before the FDA wakes up this is clearly a wake up call."
The underlying cause of the allergic reactions is still unknown.
Michael Rogers, director of the FDA's division of field investigations said, "We're concerned about what we've observed but can't make links to the adverse events."
The only Baxter products remaining on the market that contain heparin are premixed bags of IV solutions, but there have been no adverse events reported.
The financial impact of the recall on Baxter will be minimal. Baxter had $11.3 billion in revenue last year. Heparin sales were just $30 million for the year.
Drugmakers must recheck their supply chains.
