- FDA recommends health professionals prescribe no more than 325 mg of acetaminophen per dose
- FDA advisory panel to consider OTC status of NSAIDs
- FDA advisory committees vote against changing naproxen label to highlight a lower CVD profile
- Consumer trust intact as McNeil brands like Tylenol return back to shelf
- USPLabs agrees to recall and destroy dietary supplement following FDA actions
NEW YORK Sales of liquid Tylenol formulations, both adult and children, totaled $104.5 million across food, drug and mass (minus Walmart) for the 52 weeks ended May 17, according to Information Resources Inc. Internal analgesics tablet sales of Tylenol SKUs (across the top 20 brands) generated another $480.9 million. That’s more than $500 million in annual revenue, not including Walmart, potentially impacted by a future Food and Drug Administration decision. That’s not even representative of all acetaminophen sales.
So it’s a pretty significant market that’s at stake here. Whatever recommendations the Food and Drug Administration decides to implement around acetaminophen, it will be less damaging to the sale of acetaminophen at the end of the day than consumer perception, or misperception as the case may be, around the safety of the category.
In a nutshell, McNeil is communicating to the consumer that the safety of their banner brand is not in question when the medicine is used as directed. Administer more than the recommended dose, and that’s when you run the risk of liver-related adverse events. Otherwise, use of acetaminophen is safe.
And that’s an important message to be communicating. Because no matter what the FDA decides, an agency ruling will impact all acetaminophen suppliers and retailers, and that impact will be cycled through within one year. But if the consumer walks away from news reports covering the acetaminophen story thinking that acetaminophen is no longer safe, that will have a negative impact that will last much longer than just one year.