Germany’s heparin supply shows signs of contamination
WASHINGTON Baxter’s supply of heparin, which was recently discovered to be contaminated, may not be the only contaminated doses being used in the world, according to the Associated Press.
Dialysis patients in Germany have gotten sick after using a version of the blood thinner manufactured by a German company called RotexMedica GmbH. In reaction to this, the Food and Drug Administration has urged all U.S. suppliers of heparin to start using high-tech tests to make sure their products are free of the contaminant.
“We’re concerned about, worldwide, this contaminant in heparin and making sure it stays out of the heparin supply,” the FDA’s chief medical officer, Janet Woodcock, said. “With this testing method, there’ll be a way to protect the heparin supply.” The contaminant has caused allergic-type problems with breathing and low blood pressure.
Baxter’s rival, APP Pharmaceuticals remains contaminant-free and is now the sole maker of the injections.
St. Charles Pharmaceuticals receives grant for research on new analgesic
NEW ORLEANS St. Charles Pharmaceutical has announced that it has received funding for the first year of three for a research grant from the National Institute of Neurological Disorders and Stroke.
St. Charles Pharma is a Louisiana based company that will use the award, technically a Cooperative Small Business Phase II SBIR Grant for Translational Research, to fund the research of SCP-123, which the company is working hard to place into clinics. The award will also work in funding the preparation of the application to be submitted to the FDA.
SCP-123 is an analgesic that treats neuropathic pain, and according to published reports, offers greater pain reduction, reduced side effects and has the potential to also treat acute, migraine, post-operative and pediatric pain.
“We are excited. Dr. Narducy and his research team have now raised $6 million in NIH grant funding to support the Company’s drug development efforts,” John Koerner, St Charles’ chairman, stated. “If all goes well, SCP-123 could fill a large, unmet medical need and become a drug of first choice—a blockbuster—for the treatment of neuropathic pain. This grant award is a big plus toward mitigating development risk and making it all happen.”
FDA issues warnings to makers of misbranded STD drugs
ROCKVILLE, Md. The Food and Drug Administration on Thursday issued six warning letters to five U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet indicated for the prevention and treatment of sexually transmitted diseases.
“The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective,” stated Janet Woodcock, deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. “STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs.”
Some of these products, directed at U.S. consumers, falsely claim to have “FDA Approval” and some claim to be “more effective” than conventional medicine, the regulatory agency stated. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus.
Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.
The products claim to prevent or treat a variety of STDs, including herpes, chlamydia, human papilloma virus, cervical dysplasia and HIV/AIDS.
Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products, the agency stated. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.