Benicar, also known by the generic name olmesartan, received FDA marketing approval in 2002, and is classifed as an angiotensin II receptor antagonist drug intended to lower blood pressure, improve blood flow and prevent dangerous narrowing of the blood vessels. It is typically prescribed to patients six years of age and older who have been diagnosed with hypertension, and is can also be prescribed in conjunction with other blood pressure drugs.
Olmesartan is designed to block a substance found in the human body that promotes tightening of the blood vessels. By relaxing those vessels, the drug reduces blood pressure and boosts circulation and oxygenation of the heart.
Important facts about Benicar
Patients taking Benicar have long been advised to maintain a close relationship with their physician while taking the drug and to schedule regular checkups to ensure that the drug is functioning as intended. Women who are pregnant should not take the drug, as it has the potential to cause serious harm to unborn babies. The lightheadedness and dizziness that some patients have reported after taking Benicar have resulted in warnings against driving or using heavy machinery while taking the drug.
More serious complications have also been reported by patients taking olmesartan for hypertension. Benicar side effects including vomiting, chronic and severe diarrhea and extreme weight loss. Many of those who have suffered such effects have required lengthy hospitalization and extended recovery times. In a substantial number of cases, dangerous malnutrition and dehydration occurred. For this reason, lawyers have begun exploring the possibility of filing lawsuits against Daiichi Sankyo, Benicar’s manufacturer.
Mayo Clinic study and subsequent FDA labeling mandate
Recent research published by the Mayo Clinic has drawn attention to a likely link between Benicar usage and the onset of sprue-like enteropathy, a painful, debilitating condition that has affected many users of olmesartan. Sprue-like enteropathy is characterized by very serious gastrointestinal manifestations that can include dramatic weight loss and chronic diarrhea. It is often that case that sprue-like enteropathy is mistaken for Celiac disease, delaying accurate diagnosis and appropriate treatment. This can result in lasting harm to patients who have placed their faith in the safety of Benicar as a means to address their blood pressure issues.
The Mayo Clinic study followed 22 patients who took Benicar and also suffered severe gastrointestinal problems similar to those experienced by patients with Celiac disease. Fourteen of those patients had such extreme symptoms that hospitalization was necessary. These patients ultimately tested negative for Celiac disease and did not find relief by following a gluten-free diet, a typical treatment protocol for Celiac sufferers. Once they stopped taking Benicar, however, each of the 22 patients being monitored experienced cessation of their gastrointestinal problems and were able to regain the weight they had lost.
On the heels of the Mayo Clinic study, the U.S. Food and Drug Administration issued a warning in the form of a Safety Announcement in which it approved changes to the labeling of olmesartan medoxomil, sold under the names Benicar, Benicar HCT, Tribenzor, Azor and generic versions. Going forward, labels would reflect the increased risk of sprue-like enteropathy posed by the drug. The agency also pledged to continue its evaluation of this category of drugs and to report any additional material findings.
Potential for onslaught of Benicar lawsuits
Benicar has gained widespread acceptance among doctors since its introduction in 2002, and in 2012 alone, over 10 million prescriptions for the medication were written. Given the drug’s substantial use as a treatment for hypertension, it stands to reason that the number of patients affected by serious gastrointestinal side effects will only escalate. It is also important to note that there is often a delay in the onset of sprue-like enteropathy and its accompanying symptoms. It is not unusual for the condition to develop months or even years after Benicar use begins.
For these reasons, lawyers across the country are beginning to review potential Benicar lawsuits. Investigations into the lengthy delay in warning the public about the risk of sprue-like enteropathy and the associated danger of dehydration, malnutrition and weight loss are underway and injury victims are coming forward in greater numbers than ever before.
Determinations are being made concerning possible causes of action against Daiichi Sankyo and assessments of damages to individual plaintiffs are ongoing.
If and when Benicar lawsuits commence, plaintiffs may be able to recover compensation that could cover:
- Past, present and future medical expenses
- Physical pain and suffering
- Emotional distress
- Lost wages
- Physical rehabilitation
Benicar lawyers prepare for litigation
In addition to securing financial recovery for individuals, Benicar attorneys are currently investigating possible claims against the drugmaker are also motivated by the opportunity to hold a negligent manufacturer accountable and to help deter others from engaging in similarly hazardous conduct.
Dangerous drug lawsuits generally involve claims that pharmaceuticals with manufacturing or design defects were negligently marketed and sold the the public, were promoted without adequate warning of known risks or were actively touted as being much safer than they actually were. Benicar lawyers are beginning to build arguments on behalf of injury victims based on the fact that they (and their doctors) did not receive sufficient warning of the very real danger of sprue-like enteropathy.
While the eventual size and scope of Benicar litigation has yet to be determined, it does appear likely that the popularity of the drug among prescribing physicians and its increasingly demonstrable link to serious gastrointestinal harm will give rise to a significant number of lawsuits in the coming months and years.
- Mayo Clinic, Olmesartan (Oral Route) Side Effects, http://www.mayoclinic.org/drugs-supplements/olmesartan-oral-route/side-effects/drg-20065169
- U.S. Food and Drug Administration, Olmesartan (marketed as Benicar) Information, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm215245.htm
- U.S. Food and Drug Administration, FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil, http://fda.gov/Drugs/DrugSafety/ucm359477.htm
- Hufffington Post, Benicar: FDA Issues Warning On Blood Pressure Drugs Over Diarrhea, Weight Loss Risks, http://www.huffingtonpost.com/2013/07/03/benicar-warning-blood-pressure-drugs-fda-azor-tribenzor_n_3540900.html