Heparin Vials Recalled by Baxter
Baxter announced a voluntary recall of all remaining lots of various heparin related drugs and heparin flush products. The initial recall was announced January 17, 2008 as a precautionary measure as reports came in of adverse patient reactions that were higher than normal.
The FDA and Baxter have earlier concluded that a widespread removal of heparin from the market, could endanger the patients, many of whom rely on the drug. The heparin lots that were recalled previously include 1000 units/mL 10 mL and 30 mL multi-dose vials.
The recall will now include the remaining lots of the product and:
- heparin sodium injection 5000 units/mL 10mL multi-dose vials
- heparin sodium injection 10,000 units/mL 4mL multi-dose vials
- heparin sodium injection 1000 USP units/mL
- 5000 USP units/mL, and 10,000 USP units/mL single-dose vials
- all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials
The recall DOES NOT include: Baxter’s heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.According to the FDA, sufficient amount of heparin is now available from other suppliers, so that this voluntary recall by Baxter will not affect the drug’s availability on the market.
Some of the common symptoms that patients have been experiencing in association with these recalled drugs have been stomach pain, nausea, vomiting, diarrhea, dizziness and decreased or low blood pressure. If you have experienced any of these symptoms and are currently on these medications, talk with your health care professional immediately for further instructions.
Medical facilities have been instructed to discontinue the use and remove their remaining inventory of the products mentioned.
Source: Baxter
- Are you concerned that there may be a shortage of heparin in the weeks to come?
Dear MedHeadlines,
Heparin can cause serious side affects and severe allergic reactions. the drugs manufactures in the UK have guidelines which should be strictly followed, unfortunately evidence suggests these guidelines are not being followed and severe reactions are going unnoticed. Nausea, vomiting, diarrhea etc and heparin induced thrombocytopenia were the symptoms my grandmother had before her death. She was on LMW Heparin from the UK , these symptoms started days after the heparin was started. Unfortunately the British doctors did not recognise this as being an adverse effect of this medication. Last month the Coroner HM Leeming, opened an inquest into my grandmother death four year after she had died. Her death certificate has now been changed to include Heparin induced thrombocytopenia gastro intestinal haemorrhage and acute diarrhoeal illness. Maybe you are now getting more reports of adverse reactions to heparin because it is being highlighed in the USA and people are now more aware of the symptoms.
Over the last few years I have done a lot of research on heparin and these reactions are well documented in clinical studies throughout the world.
It was quite obvious to me that my grandmother had had a severe reaction to this drug yet it has taken me four years to finally prove it.
An alert needs to go out to all countries which supply heparin. The amount of adverse reactions being reported in the UK is far lower than in the US but these reactions can only be reported if UK Doctors are aware of the symptoms and treatment of these adverse reactions to heparin.
Yours
Mrs Jill Orrell ( Lancahire UK)