Takeda’s US subsidiary launched its proton pump inhibitor dexlansoprazole last February under the name Kapidex. No one thought they’d have to find a new name a year later.
But shortly after the launch, the company began getting reports of dispensing errors. Some were due to prescription misreading, others to simple, honest mistakes. The two drugs causing all the confusion were AstraZeneca’s Casodex (bicalutamide) and Actavis’ Kadian (morphine sulfate extended-release), treatments for prostate cancer and chronic pain, respectively.
The number of incident reports was actually quite small: less than 20 out of over a million prescriptions. Still, Takeda decided not to take any chances and expedited reporting to the FDA. They released sales reps into the healthcare professional population to increase awareness of the name confusion, published announcements in journals—and saw a decrease in incidents.
Before the company could breathe a sigh of relief, though, the numbers started climbing again. That’s when Takeda’s conversation with the FDA took on a new urgency. “The FDA recognized the fact that lots of patients have come to rely on this medication,” said Robert Spanheimer, Takeda’s VP of medical and scientific affairs in North America. “Both parties knew how important it was to not have gaps in patient care.”
So Takeda swiftly came up with a list of possible names and sent them off to the FDA for review. After some back-and-forth, they agreed on Dexilant.
Name changes can be confusing for consumers as well as professionals, so as early as next week the company will send out an army of reps to educate pharmacists and pharmacy technicians about the switch—which is just the name, by the way. The formula and approved indications are the same, Spanheimer stressed.
What’s really interesting about this story isn’t the name switch; it’s the fact that the FDA and a pharma company worked together harmoniously—and quickly—to nip a potential fiasco in the bud. All those promises of a more efficient FDA seem to be the real deal….For now, at least.