FDA Warns That Popular Blood Pressure Drug Can Cause Severe Diarrhea Reply

The FDA is warning that the widely-used antihypertensive agent olmesartan (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) may cause severe diarrhea. According to an FDA safety announcement, olmesartan “can cause intestinal problems known as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss.” The warning is being added to the label of drug products containing olmesartan. Olmesartan is a member of the class of drugs known as angiotensin II receptor blockers (ARBs).

The FDA said that it has found no evidence that other angiotensin II receptor blockers increase the risk for sprue-like enteropathy.

The FDA recommends that physicians tell their patients taking olmesartan to contact them if they develop severe, chronic diarrhea with substantial weight loss. Symptoms may take months or years to develop after initiation of olmesartan therapy. The FDA advises physicians to look for other causes of the symptoms, including celiac disease. Olmesartan should be replaced with another antihypertensive agent if no other cause is found.

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Two FDA Officials Quarrel Over Safety Of Angiotensin Receptor Blockers 1

Two FDA officials are quarreling in public about their different views about the safety of angiotensin-receptor blockers (ARBs), according to a story by Thomas Burton in Friday’s Wall Street Journal.

One official, Thomas Marciniak, contends that ARBs may increase the risk of cancer. Marciniak has been a vocal critic of FDA’s efforts to assess drug  safety. In the past he has raised questions about other major drugs, including prasugrel, rosiglitazone, and rivaroxaban. But Marciniak’s boss, Ellis Unger, who is the acting director of the office of new drugs, told the WSJ  that Marciniak’s concerns are a “diversion.”

Click here to read the full story on Forbes.

 

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European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System 1

The European Medicines Agency said last week that it was initiating a review of the combined use of agents that block the renin-angiotensin system (RAS). The three classes of RAS-blocking drugs (ACE inhibitors, ARBs, and direct renin inhibitors) are used to treat hypertension and congestive heart failure.

The EMA said that the review was being performed to address concerns that combined RAS-blocking drugs could increase the risk for hyperkalemia, hypotension, and kidney failure when compared with a single agent.  A recent meta-analysis of 33 clinical studies published in the British Medical Journal concluded that “although dual blockade of the renin-angiotensin system may have seemingly beneficial effects on certain surrogate endpoints, it failed to reduce mortality and was associated with an excessive risk of adverse events… The risk to benefit ratio argues against the use of dual therapy.”

Franz Messerli, senior author of the BMJ meta-analysis, applauded the EMA action and said that “as usual the FDA is dragging its feet.”

Click here to read the full story on Forbes.

 

 

 

Study Warns Against Dual Blockade of Renin-Angiotensin System In Heart Failure And Hypertension 1

The enormous success of ACE inhibitors in hypertension and heart failure spurred hope that adding a second drug to block the renin-angiotensin system would yield improved outcomes. Although definitive evidence supporting dual blockade of the renin-angiotensin system has never been found, more than 200,000 patients in the US currently receive  this therapy. Now a large new meta-analysis suggests that dual blockade results in no improvement in mortality but is associated with an increase in important adverse events.

In a paper published online in BMJ, Harikrishna Makani and colleagues at Columbia University and New York University performed a meta-analysis of more than 68,000 patients who were enrolled in clinical trials comparing dual blockade of the renin-angiotensin system with monotherapy. They found no significant difference between the groups for all cause mortality or cardiovascular mortality, although dual blockade was associated with a signifcant 18% reduction in hospital admission for heart failure:

Click here to read the full article on Forbes.

 

Acute Kidney Injury Associated With Dual Antihypertensive Therapy And NSAIDs Reply

Adding a non-steroidal anti-inflammatory drug (NSAID) to dual antihypertensive therapy (a diuretic plus either an ACE inhibitor or an angiotensin receptor blocker) is associated with an increase in risk for kidney injury, according to a large new retrospective study published in BMJ.

Click here to read the complete story on Forbes.