Heparin Sodium: History and Background
Heparin Sodium, a drug used to prevent blood clots in patients, was first approved for the market by the FDA in 1972. Its primary manufacturer is Baxter International, and its production is handled by the Wisconsin-based group Scientific Protein Laboratories LLC (SPL). Heparin is an anticoagulant used to thin the blood in surgery, dialysis, and to prevent blood clots in bedridden patients.
Recent Reports Find Negative Side Effects for Heparin
The adverse effects of Heparin first came into light towards the end of 2007. In the beginning of 2008, the FDA reported over 350 instances of adverse effects due to Heparin since the end of 2007. Following this report, Baxter International announced its intentions to recall its multi-dose vials of Heparin. In March of 2008, Baxter expanded its recall to all multi-dose, single-dose, and diluted solutions of Heparin.
According to the FDA reports, approximately 500 patients have suffered from the adverse side effects of Heparin, and at least 21 have died as a result of the drug. One widely-publicized instance of Heparin’s dangerous effects was that of actor Dennis Quaid. In this case, the actor’s newborn twins were accidentally given an excessive dosage of Heparin, a mistake which nearly caused the infants’ deaths. Dennis Quaid and his wife have sued the maker's of Heparin, Baxter Healthcare Corp. for not doing enough. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital.
The Blame Game
It is suspected that during the production of Heparin in one of SPL’s Chinese factories, a contaminant was put into the drug’s active ingredient. Additionally, it has been discovered that the production factories in China were not up to sanitation code. The blame for this lack of inspection falls not only on SPL and Baxter International, but also on the FDA, who admitted to breaking its own policy by not inspecting these locations.
Recent Reports Find Negative Side Effects for Heparin
The adverse effects of Heparin first came into light towards the end of 2007. In the beginning of 2008, the FDA reported over 350 instances of adverse effects due to Heparin since the end of 2007. Following this report, Baxter International announced its intentions to recall its multi-dose vials of Heparin. In March of 2008, Baxter expanded its recall to all multi-dose, single-dose, and diluted solutions of Heparin.
According to the FDA reports, approximately 500 patients have suffered from the adverse side effects of Heparin, and at least 21 have died as a result of the drug. One widely-publicized instance of Heparin’s dangerous effects was that of actor Dennis Quaid. In this case, the actor’s newborn twins were accidentally given an excessive dosage of Heparin, a mistake which nearly caused the infants’ deaths. Dennis Quaid and his wife have sued the maker's of Heparin, Baxter Healthcare Corp. for not doing enough. The lawsuit also says the company should have recalled the large-dosage vials after overdoses killed three children at an Indianapolis hospital.
The Blame Game
It is suspected that during the production of Heparin in one of SPL’s Chinese factories, a contaminant was put into the drug’s active ingredient. Additionally, it has been discovered that the production factories in China were not up to sanitation code. The blame for this lack of inspection falls not only on SPL and Baxter International, but also on the FDA, who admitted to breaking its own policy by not inspecting these locations.
