Now This is OUR FDA!

The FDA (Food and Drug Administration) they're reviewing information from outside the US as well as responding to problem within the US. This is what we want the FDA to do. When we questioned the FDA of the policy for topical Ibproven and suggested that the FDA simply fine someone who doesn't dot their "i"s and cross their "T"s. We were told by the that FDA doesn't have that power. When we saw that the US News and World Report and Wall Street Journal said that the FDA was warning users of the Alli weight loss products we began our search.

What we found was this: "Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. Thirty of the 32 reports occurred outside the United States. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. Hospitalization was reported in 27 of the 32 cases."

"...FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed. Consumers should consult their health care professional if they are experiencing symptoms possibly associated with the use of orlistat and development of liver injury, particularly weakness or fatigue, fever, jaundice or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite. FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA's MedWatch Adverse Event Reporting program using the information at the bottom of the page."

When the FDA responded to our queries they said they don't have the power to fine companies and that companies need to comply with their rules and regulations. They didn't address the issue of whether or not they received complaints in reference to topical ibproven use which doesn't seem to fit their definition of a new drug in our estimation. We're still waiting and seeing what they're response to those specific questions.