Filing a Benicar Lawsuit
In 2010, the United States Food and Drug Administration (FDA) announced that it was evaluating data from two clinical trials that indicated the blood-pressure medication, Benicar, had a higher risk of death than other medications, prompting many to consider filing a Benicar lawsuit against Daiichi Sankyo, Inc., the drug’s manufacturer. In addition to the investigation into the results of the clinical trials, in 2013, the FDA also ordered the manufacturer of the drug to add a warning label regarding the risk of a serious intestinal condition.
What is Benicar?
Benicar, also known as Olmesartan, is prescribed to patients with high blood pressure in adults and children who are at least six years old and is often given in combination with other medications. The drug works by keeping blood vessels from narrowing, increasing blood flow and lowering blood pressure. It is not recommended for pregnant or nursing women (http://www.drugs.com/benicar.html). Benicar is in a class of drugs known as angiotensin II receptor blockers (ARBs), and since 2010, four safety communications have been issued for the drug by the FDA.
In an effort to determine whether Benicar would slow the progression of kidney disease, two clinical trials were conducted, comparing the advantages to Benicar to a placebo. Both studies found, unexpectedly, that there was an increase in death caused by heart attack, stroke or other cardiovascular incident in the Benicar-treated patients compared to those who were given placebo (http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm215222.htm#sa). In 2011, The FDA determined that the benefits of Benicar outweigh the risks of death from cardiovascular events and that physicians should continue to prescribe the drug (http://www.fda.gov/drugs/drugsafety/ucm251268.htm). Those with a family member who have died after taking Benicar, however, are looking into the possibility of a Benicar lawsuit.
Risk of Cancer
In 2010, another warning was issued by the FDA regarding Benicar after a published study said that the drug had been linked to a small increased risk of cancer. A study of over 60,000 patients who had been using ARBs long-term found new cancer occurrences in 7.2 percent of the patients studied, compared to only six percent of those not receiving the drug. The FDA reported that they would investigate the study and determine whether the cancer diagnosis was related to the use of the drug or were isolated incidents. The FDA recommended that physicians continue to use Benicar, despite the study’s report, prompting some patients to consider a Benicar lawsuit.
In 2013, the FDA ordered that the makers of Benicar add a warning to the label of the drug regarding the risk of a severe intestinal problem that could develop months to years after starting the drug therapy. Sprue-like enteropathy causes severe, chronic diarrhea with substantial weight loss (http://www.fda.gov/drugs/drugsafety/ucm359477.htm). Celiac sprue is commonly known as Celiac disease and is a chronic disorder of the digestive tract. Patients diagnosed with the disease are unable to process gluten, which is commonly found in wheat, rye and barley products. Although the disease is rarely fatal, it can be life-altering and debilitating. Patients may be at risk for lymphoma or adenocarcinoma of the intestine (http://emedicine.medscape.com/article/171805-overview#aw2aab6b2b4aa). Because there is no cure other than eliminating gluten from the diet, a difficult process as wheat flour is a common ingredient in many products found throughout the world, a patient who develops the disease after taking ARBs may consider a Benicar lawsuit.
When a product is suspected as causing injury or death, a product liability case may be in order. If you or a loved one have developed intestinal problems after taking Benicar, or if a loved one has died of a cardiovascular incident after taking the drug, you may be eligible for a Benicar lawsuit. Contact our office today to learn more about what rights you may have.