Daiichi Sankyo Inc., the company that manufactures Benicar and other blood pressure medications, is facing accusations that the drugs can cause severe diarrhea and other injuries.
One plaintiff, George Williams, had been hospitalized repeatedly over the past four years.
The lawsuits were filed in New Jersey last month and accuse Daiichi of producing a drug that causes severe diarrhea, nausea, malnutrition and dehydration. Daiichi is based in New Jersey and has already been on the receiving end of a 2013 FDA safety communication which warned that Benicar may be linked to gastrointestinal conditions such as spruce-like enteropathy and celiac disease. At the time, the agency reported that there was “clear evidence of an association” and, after 23 serious cases of gastrointestinal problems were indentified, changed Benicar’s label to reflect this. Patients who had taken the drug for two or more years were also warned that they had a higher chance of developing problems.
This week’s lawsuits accuse Daiichi of manufacturing a defective product. One plaintiff, George Williams, had been hospitalized repeatedly over the past four years with symptoms allegedly linked to Benicar, and now requires a feeding tube to eat. He has also developed cataracts as a result of treatments for his diarrhea.
The FDA Adverse Event Reporting System (FAERS) report, submitted on July 3, 2013, which identifies the risks posed by Benicar, notes that:
“In June 2012, Mayo Clinic researchers published a case series of spruce-like enteropathy associated with olmesartan [the drug branded as Benicar] in 22 patients whose clinical presentation was similar to that of the FAERS cases: Patients in the Mayo Clinic case series developed diarrhea, weight loss, and villous atrophy while on olmesartan, and drug discontinuation resulted in clinical improvement.”
A May 2013 article published in The American Journal of Gastroenterology also reported results in line with the FAERS evaluation. It seems that the cards are stacked against Daiichi, and more lawsuits are expected to follow this week’s filings.
The FDA has simple advice for patients who may be affected: contact your doctor right away. Every case is different, and the best thing to do is seek help as soon as possible.