One thing can be said for Daiichi Sankyo. It is very forthcoming about the side effects of its controversial blood pressure medication, Benicar – at least, all but one. If one visits the product’s home page at benicar.com, one will see a nearly complete laundry list of possible side effects – all easily accessible, without the need to click through any links. However, there is one thing missing.
Among the side effects listed: fetal injury or death, low blood pressure and accompanying dizziness, kidney disorders, dehydration, unusual fatigue, difficulty urinating, elevated heart rate, seizures, confusion, restlessness, muscular pain or cramping and nausea and vomiting. Then, in a separate paragraph, the following: “Serious side effects may also include severe, chronic diarrhea with considerable weight loss, which may develop months to years after starting BENICAR or BENICAR HCT.”
Although those are indeed the symptoms of sprue-like enteropathy, the condition is not specifically mentioned anywhere on the Benicar website. This means that any prospective patient would be clueless and have no starting point from which to possibly do a bit of online research on “sprue-like enteropathy” in order to figure out just what the condition is and what the implications are. Of course, once a patient begins experiencing diarrhea and dramatic weight loss, the damage is done.
What is interesting is that the dangers of sprue-like enteropathy were noted by the FDA in 2013. At that time, the regulatory agency began requiring a label warning. Perhaps Daiichi-Sankyo is following the letter of that requirement, but it’s still vague.
Sprue-like enteropathy is a condition that mimics celiac disease. The difference is that while the latter is the result of gluten intolerance, the former has no apparent cause, other than Benicar. By mentioning the possibility of these symptoms without identifying sprue-like enteropathy by name, the company is in essence attempting to dodge responsibility. After all, how many patients would actually start taking the medication if they new exactly what sprue-like enteropathy was and how dangerous it can be? After all, there are many reasons why someone might experience diarrhea – and not all of them are serious. Likewise, there are a number of conditions that can cause weight loss.
But you have to give Daiichi-Sankyo some credit. At least the company is warning the public about the possibility of experiencing those particular symptoms, even if the literature has avoided mentioning the cause of those symptoms by name.
How serious is sprue-like enteropathy? It can require hospitalization, and can even be fatal. In simple terms, it reduces the surface area of the intestinal walls, making it more difficult for the body to absorb nutrients from food during the digestive process. Essentially, the patient can literally starve to death. Despite the fact that the connection between Benicar and sprue-like enteropathy was established in 2013, the prescription drug went on to generate approximately $5.5 billion in revenues over the course of 2013 and 2014.
Small wonder that Daiichi-Sankyo wants to minimize the dangers of such a profitable drug.