Benicar Safety
Two recent studies have prompted safety reviews of olmesartan (Benicar), but hypertension experts attending the European Society of Hypertension (ESH) European Meeting on Hypertension in June 2010 did not appear to be particularly concerned about possible risk of cardiac death. See
ROADMAP presented; hypertension experts react to FDA review of olmesartan safety. (You may be asked to register for free access to the story about ROADMAP study.)
Hypertension experts thought the supposed increased risk of cardiac death from olmesartan in the ROADMAP and ORIENT studies could be due to chance. They noted that the drug has proven no real danger since it went on the market in 2002. The
FDA is evaluating data from the two studies.The US FDA also announced this month that it will be conducting a safety review of olmesartan after a paper about a
meta-analysis, published in
Lancet Oncology, suggested that angiotensin receptor blockers, as a class of drugs, may be linked to a small increase in cancer risk. There was no increased risk of death from cancer.
Most patients included in the
meta-analysis, 86 percent, were taking
telmisartan (Micardis), so the applicability of this analysis
to other or all ARBs is not known. The data analyzed was
limited to only four FDA-approved ARBs (telmisartan, losartan, valsartan, and candesartan), and
none of the data was based on use of olmesartan, irbesartan or eprosartan.The German drug maker of Micardis noted that the meta-analysis relied mainly on
data from a combination of Micardis with an angoitensin-converting enzyme (ACE) inhibitor called
ramipril. The manufacturer of Micardis does not recommend this combination. The drug maker also pointed out that
no analysis was provided for the available data from the trial arms using each compound separately. In its safety alert,
the FDA says it has "not concluded that ARBs increase the risk of cancer." The agency is
reviewing information related to this safety concern and will update the
public when additional information is available. At this time, FDA believes the
benefits of ARBs continue to outweigh their potential risks.
FDA DesignationsCIR is frequently asked if the FDA has approved the medications used with inflammation therapy. All the IT medications have been FDA-approved for use in the United States. See the
FDA website for verification.
On March 26, 2006, the FDA designated Minocycline as an orphan drug for the treatment of sarcoidosis.
On August 9, 2006, the FDA designated Clindamycin as an orphan drug for the treatment of sarcoidosis.
An application to the FDA requesting designation of olmesartan medoxomil as an orphan drug has not been approved. See
FDA Status of Inflammation Therapy Medications.
StatisticsFrom time to time, CIR is asked if there are any clinical studies regarding inflammation therapy or if there are any statistics regarding the efficacy of this treatment. The only statistics available are those that were gleaned from a retrospective questionnaire filled out by a small group of selected members of the Autoimmunity Research Foundation website community. See
Clinical Studies and Inflammation Therapy.
