Navigation Links
New Standards Set for Heparin and Glycerin

Stricter testing is aimed at keeping tainted drugs, products off U.S. market

WEDNESDAY, Feb. 4 (HealthDay News) -- In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration is adopting stricter standards for heparin and glycerin -- two widely used drug products at the center of recent contamination episodes.

The new standards were created by the U.S. Pharmacopeia (USP) Convention, a nonprofit health organization that sets public standards for prescription and over-the-counter medicines and other health-care products made or sold in the United States.

"These are ongoing changes for our standards for heparin, and for glycerin that might be contaminated with toxins called ethylene glycol and diethylene glycol," said USP Chief Science Officer Dr. Darrell R. Abernethy. "The reason is to protect the public health."

Starting in November 2007, there were hundreds of severe reactions among patients receiving heparin, a blood thinner, and most were patients on kidney dialysis. Some 200 people died from the reactions, Abernethy said.

"There was almost certainly a contaminate put in the heparin in China that caused these reactions," he said. "It was done in such a clever, devious way that it passed our standards."

The contaminated heparin from China was tainted with over-sulfated chondroitin sulfate, which is made from the dietary supplement chondroitin and mimics heparin's blood-thinning properties, Abernethy explained.

The USP had to fix the standard so that adulterated heparin would not be allowed to come into the United States, Abernethy said. In a first step, the USP did a "quick fix" last year, which dealt with the immediate problem from China.

Now, there will be a permanent change in the standard that takes effect in August. After that time, manufacturers and importers of heparin will have to use the new standard to test their products before they can be sold in the United States. The new standard includes a specific chemical identification of heparin that spots the chemicals in the heparin more precisely than was done before, Abernethy said.

Glycerin is a chemical used to sweeten products such as toothpaste and pancake syrup, while ethylene glycol and diethylene glycol are poisonous. Switching ethylene glycol, which is used in antifreeze, as a cheap substitute for glycerin goes back as far as 1937 when more than 107 people were killed in the United States by ethylene glycol used as a liquid base for an antibiotic, Abernethy said.

Recently, there have been cases of ethylene glycol or diethylene glycol contamination in toothpaste from China found in the United States and Panama. The latest case occurred in November, when 34 Nigerian children died after being given a tainted teething drug, according to the FDA.

With that background, the FDA asked the USP to improve the standard for glycerin, to exclude ethylene glycol or diethylene glycol from glycerin, Abernethy said.

Before this change, manufacturers were only required to spot test their products for these chemicals. Now manufacturers will have to test for these chemicals in all the glycerin that comes into their plants, Abernethy said. The new standard takes effect in May.

"The approach that the FDA is using to enforce these standards for heparin and glycerin means that these impurities should not happen again," Abernethy said.

Dr. David L. Katz, director of the Yale University School of Medicine's Prevention Research Center, said he wasn't convinced that these new standards will keep all tainted drugs or other products out of the country.

"In a world of global commerce, perfect defenses against tainted or adulterated drugs are achievable, but at costs few would be willing to pay," Katz said. "It would require high-volume inspection, strict quality-control standards, and a massively costly surveillance effort to let the good products through, while unfailingly filtering out the bad."

"Are higher quality standards and more scrutiny for heparin and glycerin a perfect defense against drug adulteration? Surely not," Katz said. "But they are a good step in the right direction."

More information

For more on drug safety, visit the U.S. Food and Drug Administration.

SOURCES: Darrell R. Abernethy, M.D., Ph.D., chief science officer, United States Pharmacopeia, Rockville, Md.; David L. Katz, M.D., M.P.H., director, Prevention Research Center, Yale University School of Medicine, New Haven, Conn.

Copyright©2009 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. HHS Secretary Recognizes Products of HITSP Standards Work
2. CNA/NNOC Criticizes SEIU Trusteeship: Cites Concerns for Erosion of RN and Patient Care Standards
3. Interleukin Genetics Submits Plan to Regain Compliance with Continued Listing Standards
4. Hospital diabetes care standards not met by US academic medical centers
5. NECs new M155 Messenger Sets New Standards in Mobile Messaging
6. Healthcare Organizations Launch Collaborative Initiative to Test HIPAA Transactions Against Proposed 5010 Standards
7. USP and NIBSC to collaborate on improved quality standards for biological medicines
8. Annals colonoscopy study underscores importance of quality standards
9. URAC Announces Revised Case Management Accreditation Standards and Measures
10. Innovatech Labs, Assisting Companies in Adhering to Halogen-Free Manufacturing Standards Aimed at Protecting the Environment
11. Accreditation to the International Standards Organization for Quality Management Granted to First U.S. Lab
Post Your Comments:
(Date:11/25/2015)... ... ... “While riding the bus, I saw a passenger in a wheelchair drenched from ... a convenient and comfortable way to protect them from bad weather, so I invented ... during cold or inclement weather. In doing so, it ensures that the user remains ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible for advancing care ... disease. The Periwinkle Pioneers, nominated by the public, will receive special recognition throughout ...
(Date:11/25/2015)... ... November 25, 2015 , ... An unlikely combination ... in a way for homeless people to have a more dignified and comfortable ... initiative whereby they are repurposing plastic bags into sleeping mats for the homeless. ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... focused on providing comprehensive solutions involving adult stem cell therapies to patients with ... deemed the “Regenestem” name as a Registered Trademark (RTM). , Organizations are required ...
(Date:11/24/2015)... ... 2015 , ... Genesis Chiropractic Software helps practice owners automate ... between the practice owner and the patient that automatically manages all five aspects ... Click here to learn more. , According to Dr. Brian ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , November 25, 2015 Kitov ... ) (TASE: KTOV), a biopharmaceutical company focused on the ... various clinical conditions, today announced the closing of its ... Shares ( ADSs ), each representing 20 ordinary shares ... 3,158,900 ADSs. The ADSs and warrants were issued in ...
(Date:11/25/2015)... , Nov. 25, 2015 Allergan ... pharmaceutical company, and Rugen Therapeutics, a start-up  biotechnology ... for unmet CNS disorders and funded by the ... they have entered into an exclusive collaboration to ... for Autism Spectrum Disorders (ASD) and Obsessive Compulsive ...
(Date:11/25/2015)... Israel , November 25, 2015 ... "New Investors"), pursuant to which BioLight and the New ... IOPtima Ltd. subsidiary ("IOPtima") via a private placement. The ... of its innovative IOPtimate™ system used in the treatment ... approval pathway process for the IOPtimate™ system with the ...
Breaking Medicine Technology: