A Couple of the Bigger Stories out of the FDA this Week

Here's a couple of the bigger stories out of the FDA this week.... and my personal commentary on one...

Class I Recall of Coumadin 5mg Tablets

Bristol-Meyers Squibb is recalling a single lot of brand name Coumadin (warfarin sodium) 5mg tablets because a tablet was found to be a higher potency than expected. Warfarin is a high alert drug, even small amounts can cause significant inhibition of clotting.



Non-Sterile Boston Scientific Products Stolen

Boston Scientific reported a shipment of urology and women's health equipment stolen. The shipment was marked sterile, but was en route to a facility to be sterilized. If the stolen products are sold and used, there is a risk of infection. Lot numbers of affected products are available on the official press release.

FDA Pushing to Remove Unapproved Drugs Marketed for the Treatment of STDs

The FDA is working on removing a few unapproved drug products from sale on the internet and in some retail store that claim to cure or prevent sexually transmitted diseases. The products are not FDA approed and may contain products that are prescription drug analogues (similar to active ingredients of prescription drugs) or herbal remedies and supplements with little to no proof of efficacy.

• Medavir - Maybe I'm not looking hard enough, but I can't find an ingredient list for this at all, so I can't imagine anyone wanting to use a product they might be allergic to, but have no way of finding out what the active ingredients are. Second, people should always be aware when medications promise "no side effects"
• HerpaFlor - This product contains Tea Tree Oil, which acts as a poison when taken internally. No wonder is kills the herpes virus...
• Viruxo - The major active ingredient is Bioperine, which is apparently derived from the same plant that we get black pepper from. It also contains L-Lysine, a synthetic form of a naturally occurring amino acid that supposedly disrupts viral RNA replicaion. More than anything, Lysine may alter serotonin levels in the brain... so much for the lack of side effects. 
• C-Cure - I'm not even sure where to talk. The website says the chlamydia is caused by a parasite, so I'd be naturally untrusting of a drug that isn't even sure which type of pathogen it's supposed to be fighting. (Chlamydia is caused by the bacteria Chlamydia trachomatis, for those interested). The website also says that blood tests for STDs are wrong and silly, and it's much more intelligent to google the symptoms and see if they match... To tell you the truth, this entire website is so silly, you should really see it for yourself.... C-Cure. Take a look at the picture of the bottle....... And, to "protect your privacy" you will NEVER SEE AN ORDER CONFIRMATION....
• Never an Outbreak - First off, they claim their product is safe even if the tamper evident seal is broken. Only their two employees touched it. The reason those seals became required is because a disgruntled lunatic spiked the load after it hit the shelves. Maybe your UPS guy doesn't like you...It is a multi-step process. One of the steps is INTENDED to raise your blood pH above 7.45, because the virus can't replicate at that pH. It's also important to note that metabolic alkalosis can cause muscle spams, nausea and vomiting as well as neuralgia. The other part of the treatment, DMSO is used to help other topical medications cross the skin into the blood stream. This can cause toxicity if the user isn't aware what's being carried into their blood stream. 

Moral of the story, use your brains, people. No, the FDA isn't perfect, but they actually are trying to help you out by keeping tabs on this stuff. 


Cheers,
C. Samuels