| HEPARIN | | FDA | 07-Apr-10 | Laboratory studies performed at the request of the FDA have shown that Heparin Sodium, USP made under the new United States Pharmacopeia (USP) Monograph ("new heparin") has approximately 10% less blood-thinning (anticoagulant) activity compared to heparin prepared using the previous (â¬oeoldâ¬) USP Monograph.
The results of these studies reinforce FDAâ¬(TM)s previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient and consider the clinical circumstances where the potency decrease may require dosage adjustments and more frequent monitoring.
FDA notified healthcare professionals and patients of a change to heparin, effective October 1, 2009, which will include a new reference standard and test method used to determine the potency of the drug and able to detect impurities that may be present in heparin.
The change, which will also harmonize the USP unit dose with the WHO International Standard unit dose, will result in approximately a 10% reduction in the potency of the heparin marketed in the United States.
This may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important.
Healthcare providers should be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
There will be simultaneous availability of heparin manufactured to meet the â¬oeold⬠and â¬oenew⬠USP monograph, with potential differences in potency.
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| HEPARIN | | Health Canada | 26-Nov-09 | OTTAWA - Health Canada is informing health care professionals and Canadians of recent changes to heparin manufacturing standards in the United States that will result in a decrease in the potency of certain heparin products by about 10 per cent.
Heparin is a common anti-clotting drug mainly used in health care settings such as hospitals.
Most heparin products on the Canadian market use the same potency standard as is used in the U.S. As a result, the changes to the U.S standard will also affect heparin products available in Canada.
Given that heparin dosage and treatment is determined on a case-by-case basis using frequent blood testing, the change in potency is not expected to have a significant impact in most situations where heparin is used.
Patients requiring heparin may notice they are receiving a higher-than-usual dose or number of units of heparin because of the reduced potency of the product.
This monitoring may include blood testing that is commonly used to check heparin treatment, and will likely be temporary as the newer product replaces the old product on the market.
As in the U.S., there will be a transition period in Canada of approximately two years starting in December 2009 when products manufactured under both the old and new systems will be available at the same time.
Health Canada issued a Notice to Hospitals on November 25, 2009 with more specific recommendations and information on when this transition will be implemented in Canada.
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| HEPARIN | | FDA | 01-Oct-09 | The U.S. Food and Drug Administration (FDA) is alerting healthcare providers of a change to the United States Pharmacopeia (USP) monograph for heparin, effective October 1, 2009.
Manufacturers will not begin shipping heparin products manufactured and tested according to the new USP monograph until October 8th or later.
This changeâ¬"largely in response to the 2007-2008 heparin contamination problemâ¬"will include a new USP reference standard and test method that is used to determine the potency of the drug.
The monograph change will also harmonize the USP unit dose with the WHO International Standard (IS) unit dose.
The change in heparin potency may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important.
The change in heparin potency is expected to be less clinically significant when it is administered subcutaneously due to the low and highly variable bioavailability of heparin when administered by this route.
Healthcare providers should also be aware of the decrease in heparin potency as they monitor the anticoagulant effect of the drug; more heparin may be required to achieve and maintain the desired level of anticoagulation in some patients.
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| HEPARIN | | MHRA | 01-Apr-09 | Wockhardt UK have informed us that some of the batches involved are presented in Wockhardt (unbranded) livery.
Wockhardt UK have informed us that two additional batches are involved which have been added to the attached appendix.
A very low level (0.6%) of over sulphated chondroitin sulphate (OSCS) has recently been identified in the active raw material used in the manufacture of 31 batches of CP Pharmaceuticals and Wockhardt UK heparin sodium injections distributed in the UK.
This was identified using a more sensitive test method than was previously available.
There is no evidence that this very low level of OSCS is associated with the anaphylactoid reactions reported following use of heparin with OSCS levels of 17 to 21% after i.v. administration, which were observed outside of the UK during 2007/8.
Nonetheless Healthcare Professionals are advised to exercise particular caution when using the affected batches.
MHRA will continue to liaise with Wockhardt UK to ensure that affected batches of products remain in the supply chain for as short a time as possible.
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| HEPARIN | | MHRA | 09-May-08 | Further to our Class 4 Drug Alert EL(08)A/3 issued on 24 April 2008 we wish to advise Parallel Importers that we are concerned about higher levels of contamination in some lots of Clexane syringes which have been supplied to some overseas markets.
In our previous notification we stated that the Commission of Human Medicines (CHM) recommended the continuation of supply of batches of Clexane pre-filled syringes contaminated with low levels (below 5%) of Over Sulphated Chondroitin Sulphate (OSCS).
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| HEPARIN | | MHRA | 24-Apr-08 | MHRA has recently been informed that some batches of Enoxaparin Sodium (Clexane) pre-filled syringes with low levels of Over-Sulphated-Chondroitin-Sulphate (OSCS) have been distributed in the UK over a period of 4 to 6 weeks.
In the interim period, precautionary advice is being issued to minimise any risk of adverse reactions.
Withdrawal of the contaminated Clexane products could lead to a shortage of low molecular weight heparins.The Commission on Human Medicines has considered the matter and has recommended the continued supply of this product despite the low level contamination.
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| HEPARIN | | FDA | 28-Mar-08 | Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant.
To date, Covidien has not received any adverse event reports related to this issue.
See the manufacturers press release for the list of specific lots of the product affected by the recall.
Use of the recalled product should be discontinued immediately.
Patients should contact their physician if they experience any problems associated with the use of the product.
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| HEPARIN | | Health Canada | 28-Mar-08 | Background On January 18, 2008, Baxter Healthcare and the U.S. FDA notified American healthcare professionals of a recall of all of their multi-dose and single-use vials of heparin, due to an increase in reports of allergic adverse reactions.
The last reported number in U.S. is approximately 785 adverse reactions and 19 deaths associated with use of certain heparin lots in which the contaminant was found.
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| HEPARIN | | Health Canada | 25-Mar-08 | The contaminant, oversulphated chondroitin sulphate, has also been found in heparin products in the United States and Australia.
Health Canada is continuing its testing of heparin products from all Canadian companies and will continue to update Canadians as needed.
Patients should be monitored during and immediately following heparin administration for signs of allergy or anaphylactic reaction.
Adverse reaction reports to Health Canada do not show an increase in adverse reactions, including allergic reactions, related to heparin.
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| HEPARIN | | FDA | 21-Mar-08 | B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API).
The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada.
This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant.
FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.
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