Contaminated Blood Thinning Drug Linked To Allergic Reaction Outbreak
Baxter International issued a recall notice for its blood thinning drug heparin in February 2008 after it was linked to hundreds of cases of allergic reactions in the United States.
According to reports by the Food and Drug Administration, there have been at least 785 cases of serious injury reported among heparin users, including at least 19 deaths.
The Food and Drug Administration is currently conducting an investigation to determine the cause of the outbreak of allergic reactions among patients taking heparin.
The investigation has revealed that as much as 20% of the heparin in the vials produced by Baxter is actually an unknown contaminant which was undetectable by regular tests.
Heparin is a blood thinning drug that is used during heart bypass surgery or kidney dialysis.
About half of the heparin that is used in the U.
S.
is manufactured by Baxter.
The active ingredient in the drug is manufactured using an enzyme found in pig intestines.
The Centers for Disease Control and Prevention and the FDA began receiving reports of a high number of allergic reactions among patients taking heparin beginning in January 2008.
A subsequent investigation revealed that reports of heparin side effects had risen to more than 30 times their normal level over the course of just a few months.
Symptoms reported by patients included difficulty breathing, vomiting, nausea, elevated heart rate and a rapid drop in blood pressure which can be fatal.
Baxter was forced to issue its first heparin recall soon afterward when the allergic reaction outbreak with linked with nine lot numbers of the heparin it manufactures.
After the FDA began to tie reports of heparin side effects to lot numbers beyond those that were initially pulled, Baxter was forced to issue a complete heparin recall.
Health authorities in both Germany and Japan have also called for heparin recalls in the weeks since the outbreak of allergic reactions was first reported in the U.
S.
Although Japanese officials say that their recall is only a precautionary measure, at least 80 cases of allergic reactions associated with heparin have already been reported in Germany.
Even more disturbingly, these heparin side effects reports concerned vials that were not manufactured by Baxter, raising the prospect that the problems with the drug could have an even large scope than was initially estimated.
The FDA is investigating the Chinese plant where the active ingredient in heparin is manufactured to determine the source of the heparin contamination.
Some experts have raised the possibility that this ingredient could have been mixed with the contaminant discovered by researchers in an attempt to boost production.
The FDA is also investigating whether a recent outbreak of illnesses among Chinese pig, or the use of "crude heparin" produced by on some farms by untrained workers could also be the cause of the contamination.
The heparin allergic reactions outbreak has renewed concerns about the safety of importing Chinese-manufactured drug into the U.
S.
"I don't think the pharmaceutical industry knows what it's doing in China, and I don't think the U.
S.
government knows what it's doing in China," says Michael Santoro, a business expert who has written about the relationship between the drug industry and China.
According to reports by the Food and Drug Administration, there have been at least 785 cases of serious injury reported among heparin users, including at least 19 deaths.
The Food and Drug Administration is currently conducting an investigation to determine the cause of the outbreak of allergic reactions among patients taking heparin.
The investigation has revealed that as much as 20% of the heparin in the vials produced by Baxter is actually an unknown contaminant which was undetectable by regular tests.
Heparin is a blood thinning drug that is used during heart bypass surgery or kidney dialysis.
About half of the heparin that is used in the U.
S.
is manufactured by Baxter.
The active ingredient in the drug is manufactured using an enzyme found in pig intestines.
The Centers for Disease Control and Prevention and the FDA began receiving reports of a high number of allergic reactions among patients taking heparin beginning in January 2008.
A subsequent investigation revealed that reports of heparin side effects had risen to more than 30 times their normal level over the course of just a few months.
Symptoms reported by patients included difficulty breathing, vomiting, nausea, elevated heart rate and a rapid drop in blood pressure which can be fatal.
Baxter was forced to issue its first heparin recall soon afterward when the allergic reaction outbreak with linked with nine lot numbers of the heparin it manufactures.
After the FDA began to tie reports of heparin side effects to lot numbers beyond those that were initially pulled, Baxter was forced to issue a complete heparin recall.
Health authorities in both Germany and Japan have also called for heparin recalls in the weeks since the outbreak of allergic reactions was first reported in the U.
S.
Although Japanese officials say that their recall is only a precautionary measure, at least 80 cases of allergic reactions associated with heparin have already been reported in Germany.
Even more disturbingly, these heparin side effects reports concerned vials that were not manufactured by Baxter, raising the prospect that the problems with the drug could have an even large scope than was initially estimated.
The FDA is investigating the Chinese plant where the active ingredient in heparin is manufactured to determine the source of the heparin contamination.
Some experts have raised the possibility that this ingredient could have been mixed with the contaminant discovered by researchers in an attempt to boost production.
The FDA is also investigating whether a recent outbreak of illnesses among Chinese pig, or the use of "crude heparin" produced by on some farms by untrained workers could also be the cause of the contamination.
The heparin allergic reactions outbreak has renewed concerns about the safety of importing Chinese-manufactured drug into the U.
S.
"I don't think the pharmaceutical industry knows what it's doing in China, and I don't think the U.
S.
government knows what it's doing in China," says Michael Santoro, a business expert who has written about the relationship between the drug industry and China.