Azor generic 2016 series#

Mini-Sentinel and CMS Medicare assessments of ICD-9 codes for celiac disease showed that at a 2-year minimum exposure, which correlates with the long latency observed in literature and case reports, olmesartan users had a higher rate of celiac disease diagnoses in claims and administrative data than users of other ARBs. Mini-Sentinel and CMS Medicare data were assessed for celiac disease (as a marker for enteropathy and other gastrointestinal symptoms) after exposure to ARBs. The signal of sprue-like enteropathy with olmesartan was further investigated for a possible ARB class effect using active surveillance data. Some of these patients were later found to have villous atrophy associated with olmesartan use. In May 2013, an article describing patients with villous atrophy and negative serologies for celiac disease reported that some patients without definitive etiologies for villous atrophy were characterized as having unclassified sprue. 3 Eighteen patients had follow-up intestinal biopsies histologically demonstrating recovery or improvement of the duodenum after discontinuation of olmesartan.

Azor generic 2016 series#

In June 2012, Mayo Clinic researchers published a case series of sprue-like enteropathy associated with olmesartan 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. All patients improved clinically after discontinuation of olmesartan, and a positive rechallenge was seen in 10 of the cases. FDA’s evaluation found clear evidence of an association between olmesartan and sprue-like enteropathy.įDA identified 23 serious cases in FAERS presenting as late-onset diarrhea with significant weight loss and, in some cases, with intestinal villous atrophy on biopsy. The current olmesartan drug labels include diarrhea in the Adverse Reactions section.įDA evaluated adverse event reports received by FDA’s Adverse Event Reporting System (FAERS), published literature case series, 3-4 information from FDA’s Mini-Sentinel pilot of the Sentinel Initiative, and information from the CMS Medicare database. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) that was approved on April 25, 2002, for the treatment of hypertension, alone or with other antihypertensive agents. Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan.įDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs. Discontinuation of olmesartan has resulted in clinical improvement of sprue-like enteropathy symptoms in all patients. If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started.

The enteropathy may develop months to years after starting olmesartan, and sometimes requires hospitalization (see Data Summary). Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. FDA has approved changes to the labels of these drugs to include this concern. Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.