FDA investigates liver injury claims from weight-loss medication users
NEW YORK This agency pulls no punches. The merest blip of a post-marketing serious adverse event report, and the agency is acting sooner than later. Because when you get right down to it, out of all the prescriptions for Xenical (approved for sale April 1999), out of all the people who have tried Alli when the ingredient orlistat was switched over the counter (in February 2007), there have been as many adverse events reported in the United States around orlistat and liver injury as there have been Boston Red Sox championships in the past 70 years: two.
That may be cause for concern. Because it taints the use of a product already approved for sale over-the-counter (and prescription-only in the case of Xenical) with a broad brush labeled “safety concern.” And with so few serious adverse event reports, that may be an unfair label causing some consumers who could benefit from the use of a product like alli not to try the product at all. And if these types of announcements become common, with so few serious adverse events to justify them, it could have the effect of making a public numb to any announced safety concerns.
Taking the other side, why might this be a good thing?
First, there is no actual recall here. Rather it’s a frank communication that a possible danger flag around the use of a product regulated by the FDA may be raised. And while this may certainly place the respective healthcare manufacturers on the defensive, it’s an indicator that the agency will aggressively live up to its mission statement — the protection of the American public.
There have been a host of criticisms around the agency’s ability to deliver on that promise leading up to this year. Contaminated prescription blood thinners and contaminated peanut butter are only the most recent examples of an agency with a somewhat tarnished safety reputation.
It’s good because actions such as these restore faith in the reputation of what is still considered the premier healthcare regulator in the world. And that’s important for all of the healthcare and food products around which there is no (or at least practically nonexistent) safety concern.
The challenge for those companies being called to the mat by FDA is educating the public around what the real issues are. In this case, it’s communicating to consumers that there has been no recall, and that the FDA is still recommending people use the products as directed. It’s communicating to consumers that safety concerns rank pretty high, with both the agency and the healthcare manufacturer. It’s communicating to consumers that those medicines available for sale over-the-counter are still real medicines, and that consumers need to follow usage directions.
Finally, it’s communicating to consumers that this is what they’ve asked for — the ability to make a healthcare decision with all the facts laid bare so that they and the healthcare professionals they look to for guidance can truly make a discerning decision about what’s right for them.
‘The Biggest Loser’ wellness coach launches weight-control supplement line
NEW YORK Jillian Michaels, renowned wellness coach from NBC’s “The Biggest Loser,” on Friday announced the launch of her line of weight-control supplements in partnership with ThinCare International.
“I have always been an advocate of supplements for boosting metabolic function and supporting weight loss,” stated Michaels, “My new QuickStart Rapid Weight Loss System is designed to help you overcome the two greatest obstacles to successful weight loss — appetite control and fat burning.”
“We are extremely happy to be working with Jillian Michaels,” said Gina Daines, spokesperson for ThinCare. “[Michaels] is a true icon and this product line is the biggest thing to hit the diet shelves in years.”
The entire Jillian Michaels supplement line includes: Maximum Strength Calorie Control, Maximum Strength Fat Burner, Triple Process Total Body Detox & Cleanse Plus Probiotic Replenishment and QuickStart Rapid Weight Loss System, which contains both the Fat Burner and the Calorie Control products.
The line launches Aug. 21 in GNC and will roll out nationwide over the next month.
Jillian Michaels’ products will be sold at GNC, Walmart, Walgreens, CVS, Rite-Aid Target and most chain grocery stores, the company stated.
Wound-Be-Gone receives APMA Seal of Approval
ELK GROVE VILLAGE, Ill. Wake Pharma US on Thursday announced that it has been awarded the American Podiatric Medical Association Seal of Approval for its Wound-Be-Gone.
Wound-Be-Gone is an over-the-counter gel that enhances wound healing in varied clinical settings with both acute and chronic wounds. The mechanism of action is related to a decrease in inflammatory mediators due to the active scavenging of oxygen free radicals, the company stated.