• Heparin Safety Issue – Possible Cause Identified
• FDA investigates link of botox to deaths

Heparin Safety Issue – Possible Cause Identified
After a period of frantic searches and investigations, the suspected contaminant which trigger the near-crisis type of safety concerns with heparin seemed to have been identified.

The investigators were now pointing their finger at the substance called chondroitin sulphate. The newly appointed USFDA director for CDER -  Dr Janet Woodcock – explained about the role of chondroitin sulphate and its extraction process which was believed to have triggered the safety concerns. Chondroitin sulphate is common health supplement but its “oversulphated” version is very closely related to heparin and appeared to mimic heparin in standard tests. The substance made up 2% to 50% of the total content of heparin active pharmaceutical ingredient in some of the samples tested at the Changzhaou SPL plant in China where heparin has been sourced. 

This safety saga has nearly caused a global paralysis in healthcare services like heamodialysis and heart surgeries where heparin is an essential component of the treatment. This incident must have trigger the healthcare policy makers in re-examining the dependence of our global drug supply and the vulnerability of the global sourcing of active pharmaceutical ingredients.

FDA investigates link of botox to deaths
Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children given the drugs for muscle spasms have died, the government warned Friday.
 
The Food and Drug Administration's warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.

In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.

Botox is best known for minimizing wrinkles by paralyzing facial muscles — but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have.

However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.
http://www.fda.gov/cder/drug/early?comm/botulinium?toxins.htm