FDA: Tysabri users may have increased risk of developing deadly brain infection
NEW YORK New cases of a deadly brain infection have turned up in patients using a multiple sclerosis drug.
The Food and Drug Administration announced late last week that several patients using the drug Tysabri (natalizumab) had developed progressive multifocal leukoencephalopathy. Also known as PML, the disease results from a brain infection caused by the JC virus, which is present in most adults but kept in check by the immune system. PML most often occurs in patients with advanced AIDS and those taking some immunosuppressant drugs, causing irreversible decline in brain function and death.
Tysabri, made by Elan Corp. and Biogen Idec, is approved for treating MS and Crohn’s disease, though no cases of PML have occurred in Crohn’s disease patients. The FDA approved the drug in 2004, but has confirmed 13 cases of PML worldwide in patients using it, though the FDA said it would not require changes to Tysabri’s prescribing information or risk management plan.
Organix hair care brand
NEW YORK Vogue International has been making waves in the hair care segment with its Organix hair care brand, which launched in 2007.
The brand, spotted on shelf at a CVS store in Manhattan, will have an even bigger year in 2010 as it will be partnering with Walt Disney to promote Tim Burton?s new “Alice in Wonderland” film, featuring Johnny Depp as the Mad Hatter.
Meanwhile, the hair care brand is seeing some impressive sales. According to data provided by Information Resources Inc., sales of its Organix Mocha Espresso shampoo and conditioner are up 148.4% and 172.7%, respectively, at food, drug and mass (excluding Walmart) for the 13 weeks ended June 28.
NAD: Align advertising claims are supported
NEW YORK News such as this really showcases how far the dietary supplement has come in just a few short years. This NAD program was formed and supplemented by the Council for Responsible Nutrition and has proved so popular that the association is looking into extending the program.
It’s important because this program accomplishes three objectives to the betterment of the industry — it vets legitimate dietary supplement manufacturers and the claims they make around their products by way of clinical trials; it cautions those supplement manufacturers who have all intentions of being responsible players in the market but are just a tad too aggressive in some of their marketing claims; and it outs all of those “dietary supplement” marketers who make egregious, impossible-to-support claims for what they really are — the sheisters who give supplements a bad name with all of their lose-100-lbs.-without-ever-getting-off-the-couch testimonials and herbal cancer cure-alls.
And what does it all mean? It means that through industry initiatives like this coupled with Food and Drug Agency enforcement of dietary supplement Good Manufacturing Practices and pre-market notification of new dietary ingredients, tomorrow’s consumer will have a lot more confidence that the supplement they’re taking to better their health will actually do what the company selling that supplement says it does.