May 27, 2015 was a busy day at the FDA and a good day for two competing pharmaceutical companies. Allergan’s Viberzi, as well as Valeant’s Xifaxan medications were both approved by the agency to treat IBS-D, or irritable bowel syndrome with diarrhea.
Patients suffering from irritable bowel syndrome must contend with frequent agonizing bouts of lower stomach distress. The pain can be intense and is amplified by the combination of cramping and excess gas and bloating. Those that suffer from IBS-D endure the same symptoms, as well as the added complications of diarrhea.
Allergan pushed the marketing of Viberzi hard. It hired a renowned world champion paratriathlete to try to mitigate the embarrassment that patients feel when speaking with their doctors about their digestive troubles. It worked with a population health management specialist to help develop tools for doctors to monitor their patients taking the medication. It even created and deployed an online IBS-D toolkit for patients.
What it didn’t do was account for the possibility of patients without gallbladders taking the drug and dying.
Now the FDA has issued a Safety Communication warning that a review by the agency “found these patients have an increased risk of developing serious pancreatitis that could result in hospitalization or death.” The Safety Communication goes on to recommend against the use of Viberzi in this patient population and urges medical professionals to find “alternative treatment options,” as the “symptoms of pancreatitis have occurred with just one or two doses” of the medication.
Bad news for Allergan. Great news for Valeant, as well as a whole host of other over-the-counter, or OTC gastrointestinal medications including Pepto-Bismol and Gas-X.
In addition to staying out of the FDA’s crosshairs, Valeant’s Xifaxan has generated significantly more revenue than Allergan’s drug. 2016 saw $94.3 million going into Allergan’s coffers from sales of Viberzi. That number seems impressive until one learns that Xifaxan sent $251 million to Valeant – in three months.
The tale of these two drugs is still being written, however, as the FDA says it is working with Allergan to address concerns over the safety of its medication. In the meantime, Allergan’s legal team is no doubt steeling itself for the onslaught of activity sure to come over the apparent harm its medication has caused.