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.