Benicar and the FDA
The drug Benicar was originally approved by the FDA to treat hypertension and high blood pressure in 2002.
In July of 2013, the FDA followed this up with a Drug Safety Communication warning that Benicar can cause a number of severe medical complications, that can lead to symptoms like chronic diarrhea, weight gain, and gastrointestinal issues. The FDA approved changes to the label of these drugs to include warnings about these Benicar side effects.
Several studies have shown a link between olmesartan medoxomil and several gastrointestinal problems, such as gastrointestinal problems, Celiac-like symptoms, sprue-like enteropathy, villous atrophy and fetal toxicity, including a study published by Mayo Clinic researchers in 2012. Numerous case studies have been published in recent years.
Benicar Side Effects and Complications
Side effects and complications linked to Benicar include:
- Gastrointestinal Problems
- Celiac-like Symptoms
- Sprue-like Enteropathy
- Villous Atrophy
- Fetal Toxicity
- Excessive Weight Loss
- Chronic Diarrhea
- Celiac disease Mis-Diagnosis
Daiichi Pays $39 Million For Illegal Kickbacks
Less than two years after the Benicar warning label update, the U.S. government filed charges against Daiichi alleging that Daiichi violated the False Claims Act by paying kickbacks to induce physicians to prescribe their drugs. The lawsuit specifically notes that Daiichi paid the physicians to prescribe Benicar, Tribenzor and Azor. The Anti-Kickback Statute is in place to prevent improper payments and gifts from compromising a physicians judgment. Daiichi had been providing kick-backs to doctors prescribing Benicar for seven years according to the lawsuit!
Daiichi eventually settled the anti-kickback Benicar lawsuit for $39 million. U.S. Attorney Carmen Ortiz for the District of Massachusetts took a hard stance against Daiichi and other pharmaceutical companies, stating
“Drug companies are prohibited from using lavish entertainment and padded speaker program payments to induce physicians to prescribe their drugs for beneficiaries of federal health care programs. Settlements like this one show that the government will continue to pursue health care companies that use kickbacks to promote their products.”
Safer Benicar Alternatives
Benicar falls into a class of drugs called ARBs (angiotensisn II receptor antagonist). ARBs are a drug class that treat high blood pressure. There are many alternative drugs that are ARBs that do not cause severe gastrointestinal side effects. Below are a list of alternative ARBs that doctors would have had the option to prescribe instead of Benicar if they and their patients had been aware of the risks associated with Benicar:
- Cozaar (losartan)
- Micardis (telmisartan)
- Diovan (valsartan)
- Avapro (irbesartan)
- Edarbi (azilsartan)
- Kanarb (fimasartan)
- Teveten (eprosartan)
- Atacand (candesartan)
Severe Side Effects of Benicar
- Chronic Diarrhea: Diarrhea multiple times per day, every day. Usually takes months to develop.
- Severe Abdominal Pain: Serious abdominal pain requiring hospitalization.
- Vomiting: Frequent, unexplained vomiting.
- Weight Loss: Malnutrition causing weight loss of 10% to 40% of total body weight.
- Gallbladder Complications: Removal of gallbladder due to sludging or a low ejection fraction. Symptoms worsen after gallbladder removal.
- Dehydration: Due to the amount of liquid lost from constant diarrhea.
- Acute Kidney Failure: Due to dehydration as a result of chronic diarrhea.
- Pancreas Complications: Removal of the pancreas. Symptoms worsen after removal of the pancreas.
- Heart Attack: Due to electrolyte embalances secondary to malabsorption.
- Sprue-like enteropathy: Blunting or flattening of the villi in the small intestine.
- Duodenitis: Inflammation of the duodenum (first part of small intestine). Thickening of the small intestine.
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