Did Roseanne Influence New FDA Warnings for Ambien?

5/2/19 – – The Food and Drug Administration this week slapped tougher warnings of dangerous, sometimes deadly side effects on bottles of Ambien and other sleep medications. Doctors are being advised to use heightened caution when prescribing these popular insomnia remedies.

I’ve never taken Ambien, but I’m losing some sleep over the timing of the FDA’s action.

While accounts of people exhibiting odd behavior after taking Ambien have been around for years, the medication’s risks were thrust into the headlines around this time last year when comedian Roseanne Barr blamed the side effects of Ambien for her hateful late-night tweet disparaging Obama administration advisor Valerie Jarrett. If you recall, media coverage of the incident exploded after Sanofi, manufacturers of Ambien, responded with this provocative tweet: “While all pharmaceutical treatments have side effects, racism is not a known side effect of any Sanofi medication.”

In The Crisis Preparedness Quotient I criticize Sanofi’s decision to engage Rosanne as an unfortunate example of what I call self-inflicted collateral brand damage, or crises by association. I was pretty tough on Sanofi, predicting that the spotlight they chose to make brighter would create additional problems for its very profitable Ambien brand.

Maybe the timing of this week’s strengthened FDA warning had nothing to do with the Roseanne vs. Sanofi encounter. I suspect it did. Either way, it’s worth reprising my September 17, 2018, blog post, which was prompted by continuing media attention, titled, ” The Unfortunate Side Effects of Sanofi’s Response to Rosanne.”

For crisis communicators, it’s a cautionary tale:

9/17/18 – – Even if you follow the best practices of crisis prevention, your brand may still get pulled into an ugly situation you did nothing to create. In Chapter 20 of The Crisis Preparedness Quotient – Measuring Your Readiness to Weather a Reputational Storm (“Dealing with Collateral Brand Damage”), we examine these predicaments I call “crises by association.”

The mother of all such unwelcome product spotlights has to be the Jonestown Massacre, a mass suicide in 1978 at a cult colony in Guyana, South America. Nine hundred men, women and children, following the orders of their charismatic leader Jim Jones, drank a deadly brew of cyanide, sedatives and Kool-Aid. From this tragic incident came the phrase “drinking the Kool-Aid,” used to describe an individual who blindly believes a particular assertion or goes along with a questionable point of view.

I was reminded of Kool-Aid’s “crisis by association” in May 2018, when the sleep medication Ambien found itself in the middle of a storm created by comedian Roseanne Barr. Here’s the discussion of the incident from Chapter 20:        

ABC abruptly cancelled the hit TV series Roseanne after comedian Roseanne Barr tweeted a hateful description of Obama administration advisor Valerie Jarrett. An apologetic Roseanne, attempting to explain her indiscretion, posted this: “It was 2 in the morning and I was ambien tweeting.” Sanofi, manufacturers of the prescription sleep medication Ambien, fired off a tweet of its own: “While all pharmaceutical treatments have side effects, racism is not a known side effect of any Sanofi medication.”

Sanofi’s concern with the popularization of the phrase “Ambien tweeting” is understandable. But its provocative response — probably considered clever by some inside the company — thrust the product from supporting cast to leading role in the controversy. News reports immediately began focusing on the unpleasant side effects of Ambien, actually lending credibility to Roseanne’s claim. Featured in the stories were FDA warnings of hallucinations and suicidal thoughts, as well as, “decreased inhibition (e.g., aggressiveness and extroversion that seemed out of character), bizarre behavior, agitation and depersonalization.” At that time, a number of people commented to me, “Wow, I never knew that stuff was so dangerous.”

It would have been far wiser for Sanofi — rather than seeing its response as a platform for addressing racism — to have issued a statement affirming Ambien’s safety and effectiveness when prescribed and used properly. Full stop. Reinforcing the focus on “side effects” (the phrase was used twice in a two-sentence statement), the company unnecessarily heightened interest in the most negative aspects of the brand.

The unfortunate ramifications of Sanofi’s response strategy were demonstrated recently in the New York Post. The tabloid reported on an interview between Roseanne and Dr. Oz., in which the maligned comedian told The Dr. Oz Show audience:

“I’ve done weird things on Ambien . . . I think a lot of people have, too. I’ve heard from thousands of people about it. One guy got up and cooked a turkey and ate it, so that was like four hours if you think about it, and didn’t remember it in the morning . . . I Ambien eat like Tiger Woods Ambien drove. It is a weird drug.”

I’m sure Sanofi is not happy with the continuing discussion of Ambien tweeting, Ambien eating and Ambien driving. Nor can the company be thrilled with Roseanne Barr getting media attention as an unauthorized spokesperson for the medication. This self-inflicted escalation underscores the wisdom of guidance provided in Chapter 20: “Minimizing collateral brand damage is the goal for communicators navigating such storms. ‘Don’t make things worse’ should be a strategic priority.”


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