Diethylene glycol, killer on the prowl

Nigerian death toll rises in tainted infant teething drug

The latest victims to greed are the smallest among us…….

Over 45 babies have died in Nigeria from the tainted teething syrup, "My Pikin Baby Teething Mixture". The medicine is contaminated with diethylene glycol, causing kidney failure in the children who died.

The National Agency for Food, Drug Administration and Control (NAFDAC) has shut down the manufacturer of "My Pikin", Lagos-based Barewa Pharmaceuticals, as well as a company called Tranxell Ltd, which is believed to have supplied chemicals to Barewa and possibly to other local drugs manufacturers.

Diethylene-glycol-contaminated products have had a long history in dealing death. This chemical, which is used in antifreeze, is sometimes added illegally as a cheaper sweetener or thickening agent with deadly results.
So deadly in fact, that the catastrophic deaths following its first use in medicines led to the passage of the 1938 Federal Food, Drug, and Cosmetic Act.

In 1937 more than 100 U.S. citizens, many of them children, died when diethylene-glycol was added to an antibiotic to make the liquid form, Elixir Sulfanilamide.

And their deaths were painful as noted in a grieving mother’s letter to President Franklin D. Roosevelt:

"The first time I ever had occasion to call in a doctor for [Joan] and she was given Elixir of Sulfanilamide. All that is left to us is the caring for her little grave. Even the memory of her is mixed with sorrow for we can see her little body tossing to and fro and hear that little voice screaming with pain and it seems as though it would drive me insane. ... It is my plea that you will take steps to prevent such sales of drugs that will take little lives and leave such suffering behind and such a bleak outlook on the future as I have tonight."

According to the World-wide Organization of the Health during the 1980's and 1990's more than 600 people were killed by this type of contamination.

Furthermore it continues still today and is becoming more prevalent. In 2007, Diethylene glycol was found in contaminated toothpaste manufactured in China. Over a hundred people died in Panama. That same year The New York Times reported that about 900,000 tubes turned up in the United States, including correctional facilities, juvenile detention centers, and some hospitals, as well as discount stores.

In today’s global economy ingredients can be manufactured anywhere and consumers rely on companies to look out for their safety. Authentication of raw materials is essential to ensure the safety of consumers and mitigate the risks of contamination to the finished product.

Track and Trace versus Inspection and Authentication Technologies?

In a comparison of Track and Trace versus Inspection and Authentication technologies it is apparent that Track and Trace solutions such as RFID, bar coding, holograms, tracing and pedigree products are not a one-size-fits-all solution to protecting the domestic and global pharmaceutical supply chain.

Track and Trace products might be sufficient, when employed throughout the Supply Chain to protect it from Drug Diversion which is one source of counterfeit activity, but these Track and Trace technologies cannot provide full protection for the product within the package. For example, how can anyone expect a Track and Trace product to determine if, either in the manufacturing or distribution process, the wrong ingredient was purposely or accidentally added into the product? Pedigree or Serialization may help, after a threat has propagated to the general public and was detected by other means, to help backtrack to the source of the problem. But by then it may be too late and the consumer will have already suffered.…

Only through the use of Inspection and Authentication technology such as XStream Systems’ XT250 Pharmaceutical Authentication System can those within the drug supply chain immediately inspect and authenticate the product within the container. Don’t let problems reach the general public. Stop the issues in their tracks.

For more information on XStream Systems and the XT250™ Pharmaceutical Authentication System, visit their website at www.xstreamsystems.net.

Heparin Contaminant found in 11 Countries!

China is continuing to deny their part in the contamination of the Heparin supply and the related deaths. They have even gone so far as to imply that the contamination could have occurred in a US plant. There is no denying on their part now, as the countries affected have climbed to 11 including: Australia, Canada, China, Denmark, France, Germany, Italy, Japan, the Netherlands, New Zealand and the United States.

With this latest revelation, China has at least accepted responsibility for the contaminant (oversulfated condroitin sulfate, or OSCS), but denies this resulted in the over 800 adverse reactions and the 81 deaths the FDA has attributed to it in the U.S. alone. FDA has conducted testing which has linked the OSCS to the adverse reactions observed. Additionally, The FDA has traced the lots in question to 12 Chinese companies involved in the heparin’s manufacturing.

Worldwide, the heparin recalls have expanded to include recalls from numerous companies that use heparin in a variety of medicinal products: Baxter (heparin); B.Braun (heparin solutions); Covidien (pre-filled syringes); American Health Packaging (heparin sodium vials); Hospira (heparin syringes, vials, and bags); AstraZeneca (heparinized saline); Sanofi-Aventis (Clexane drug); Rotexmedica (heparin products); Opocrin (heparin API); Sierra Pre-Filled Inc.(heparin lock and normal saline flushes); G. Bichsel AG (heparin products); and Arseus NV -Fagron (heparin).

The FDA has updated their testing to include two screening tests and is currently working with US Pharmacopeia, a non-profit organization dedicated to safety in the pharmaceutical industry on further testing.

Clearly, the magnitude of these recalls echo the need for more encompassing and rapid screening tests in the pharmaceutical arena. As the saga continues, manufacturers and suppliers should ask the question – Am I doing everything possible to ensure my supply is secure?

As the number of deaths stemming from the Heparin tragedy increases, so must our vigilance to make sure this does not happen again.

Heparin Contamination and Recalls

We at XStream Systems have been monitoring the Heparin contamination and recall situation very closely. Each day we are uncovering more stories on the who, what, when, where, and why.

Aside from the precautionary recalls of the product from the market, and the normal spin on the topic by the media, there really is a problem with a number of the lots of medication.

Adding to recent stories on other contaminated products, China is again accused in this case. Here is a link to a summary of the heparin situation so far. This article points out that China is waking up to the issue.

Sadly, the number of U.S. deaths is up to 19.