As one of the top ten most prescribed drugs of 2020, Losartan is the generic name for the brand name medication Cozaar and is approved as a common treatment for hypertension. An astonishing 108 million adults in the United States are either diagnosed with hypertension or are taking medication for hypertension. As part of the class of angiotensin ii receptor blockers or ARBs, Cozaar blood pressure medication was first approved by the U.S. Food and Drug Administration (FDA) in 1995.
Losartan, the generic, was approved in April of 2010 to treat high blood pressure as well as diabetic kidney disease. Losartan also helps to reduce the risk of stroke in patients with hypertension and treats hypertensive patients with diabetic nephropathy. Losartan is also used to treat patients with an enlarged heart muscle. Losartan is broken down in the body, or metabolized, by a process that occurs primarily in the liver. Doctors do not recommend taking Losartan during pregnancy because it is excreted in breast milk and could cause a potential risk to an unborn baby. Losartan should be kept out of the reach of children and at room temperature.
Recently, the FDA criticized several popular blood pressure medications including Losartan, Valsartan and Irbesartan because of contamination with impurities like N-nitrosodimethlyamine (NDMA) and N-methylnitrosobutric acid (NMBA) and the risk of harm of the contamination on patient’s health. NDMA and NMBA are classified as probable human carcinogens. When impurities were found in these medications, many manufacturers initiated voluntary recalls of medication. Since that time, many of the recalled medications, including Losartan, became the subject of lawsuits.
What are the Possible Side Effects of Cozaar?
Cozaar, the brand name medication, and Losartan, the generic, are ARBs or angiotensin receptor blockers. They are effective because they relax blood vessels so that blood can flow more freely within veins and arteries. As a result, users experience lower blood pressure. Most commonly, Losartan and Cozaar are used to treat hypertension and to ensure people with diabetes have healthy kidneys. The drugs are also used to lower the risk of stroke.
There are possible side effects of taking any prescription drugs. The possible side effects of Losartan include nasal congestion, back pain, cough, dizziness, lightheadedness, nausea and vomiting, fever, dark-colored urine, difficulty concentrating, shortness of breath, rapid or irregular heartbeat, palpitations and upper respiratory infection among several others. In order to mitigate the side effect of dizziness, try to remember to get up slowly from a seated or lying position. Losartan and Cozaar can cause high potassium levels, so your doctor should be notified if you faint or have a slow or irregular heartbeat. Additionally, patients should check with their doctor prior to using salt substitutes that contain potassium or taking potassium supplements. Even though these medications are used to treat kidney problems, they can cause kidney damage in some patients with chronic kidney disease. Rarely, taking Losartan results in allergic reaction. As a result, most doctors monitor patient kidney function while taking these medications. For a complete list of side effects and adverse effects, talk to your health care professional.
Losartan has drug interactions with aliskiren, lithium and drugs that increase the level of potassium in the blood (like ACE inhibitors and birth control pills containing drospirenone). Losartan can also interact negatively with over-the-counter or nonprescription nonsteroidal anti-inflammatory drugs (NSAIDs) like naproxen and ibuprofen, more commonly known as Advil or Aleve. If you take Losartan or Cozaar, you should take the medication at the same time each day in order to maximize the benefit of the medication. If you skip a dose of the medication, do not try to make up your missed dose by doubling up on medication, just try to take the next dose as soon as you remember. If you suspect that you took an overdose of medication, please contact the poison control center or seek medical help.
Why was Losartan Recalled?
In the summer of 2019, the U.S. Food and Drug Administration (FDA) learned that there were unacceptable levels of various substances in generic ARBs, including Losartan and Valsartan sold in the United States. As a result, several companies issued a voluntary recall of Losartan. There were additional lots affected in subsequent recalls. The recalls involve both lots of Losartan potassium/hydrochlorothiazide tablets and lots of Losartan potassium tablets. Some of the affected lots were manufactured by drug makers Torrent Pharmaceuticals Limited, Camber Pharmaceuticals and Zhejiang Huahai Pharmaceuticals.
Losartan was recalled after trace amounts of N-methylnitrosobutytic acid (NMBA) were discovered in the medication. NMBA is a probable human carcinogen as characterized by the International Agency for Research on Cancer. All of the lots of Losartan that were recalled contain levels of probable human carcinogens at higher than the acceptable intake per day, as calculated by the FDA. As a result of taking this medication, users may experience an increased cancer risk.
There were also recalls of another high blood pressure medication, Valsartan. This high blood pressure medication was found to have NDMA contamination. NDMA is another probable human carcinogen.
The FDA has recommended that people should continue to take their ARBs even if they have been recalled because ARBs treat serious medical conditions. Your doctor can recommend alternative medical therapy to replace the recalled medication. According to the CDC, having other cardiovascular diseases, such as hypertension (high blood pressure) or stroke, may increase your risk of severe illness from COVID-19, also known as the novel coronavirus.
The Environmental Protection Agency (EPA) has determined that exposure to NDEA and other probable human carcinogens can lead to multiple types of cancer including:
- Liver cancer
- Colon cancer
- Stomach cancer
- Intestinal cancer
- Prostate cancer
- Esophageal cancer
- Non-Hodgkin’s Lymphoma
- Multiple Myeloma
- Pancreatic Cancer
All of the recalls were voluntary and none of the labs at issue have received reports of adverse events related to the contamination of their subject medication.
How Does the Losartan Recall Effect Me?
Please visit www.fda.gov or search FDA the list of recalled angiotensin ii receptor blockers for more information and to discover if your particular lot number was part of the voluntary nationwide recall. Remember to always discuss changes in medication with your healthcare provider. Your doctor may be able to prescribe an alternative treatment for your high blood pressure. If you have a recalled product, you can return it to your pharmacy. Do not flush the medication down the drain or dispose of the medication in the trash. The pharmacy will return the medication to its supplier and issue a replacement medication to fulfill your prescription.
Is There a Losartan Recall Lawsuit?
In short, yes. There are currently multiple lawsuits filed across the country by consumers who took Losartan and were subsequently diagnosed with cancer. These lawsuits, both personal injury mass tort claims and class actions, alleging that specific batches of Losartan were contaminated with a probable human carcinogen during the manufacturing process and ultimately caused cancer. In other words, that the pills had a manufacturing defect and improper labeling that did not warn of the dangers associated with taking the medication. The class-action lawsuit was filed in New Jersey and names pharmaceutical companies as the parties responsible for the increased risk of cancer. There are time limitations called statutes of limitation that limit the amount of time in which you can seek damages so time is of the essence.