We all turn to advanced medications in our hour of need to solve problems that could prove life-threatening if left unaddressed, but sometimes, the very drug we looked to for help turns out to be harmful instead. Defective and dangerous drugs have no place in our pharmaceutical industry, and when they cause injury or death to those who use them - the victims have legal recourse to seek damages in a mass tort.
Valsartan has been used for years to counteract hypertension, but it has recently been recalled due to potentially dangerous side effects, including a high risk of certain cancers. We at Consumer Alert Now are here to provide you with full information on Valsartan and other dangerous or high-risk drugs so that you understand the risks and understand your rights. We can help connect you with a personal injury lawyer who will assess your case and explain to your legal options, possibly enabling you to join a class action suit for those injured by Valsartan.
To learn more and to speak with a Consumer Alert Now representative, feel free to contact us at 310-695-5724 anytime 24/7 nationwide!
What Is Valsartan? And What Does It Treat?
Valsartan is an antihypertensive drug that often goes by the brand name Diovan. It has no other common names besides these two: Diovan & Valsartan, which is unusual since most drugs have 5 to 10 or more different labels. However, there are other similar drugs on the market that may also be dangerous under certain circumstances, such as losartan and irbesartan. All of these drugs are angiotensin II receptor blocker (ARB) medications.
Valsartan, in particular, prevents your blood vessels from narrowing as much as they otherwise would, which helps keep down your blood pressure. This drug has been used to reduce hypertension in both adults and children (six years and up), and it can also be prescripted to help fight congestive heart failure, and cardiomyopathy, which is a hereditary disease that affects heart muscle.
Valsartan relaxes your blood vessels to allow freer flow of blood throughout your body. This makes heart attacks and strokes less likely to occur in users. And it also makes them likely to be less severe if they do occur, which makes survival rates higher. Valsartan is not usually the first medication of choice, but it may be prescribed in place of other drugs if those drugs have annoying side effects (like a dry cough) or alongside other drugs to bolster the positive effects.
Basic Drug Use Facts To Know About Losartan
All drugs have potential negative side effects, and losartan is certainly no exception. The most common side effect is simply dizziness, which is not normally serious. But it can also cause an allergic reaction in some patients, which may lead to difficulty breathing, swelling of the throat, tongue, and face, and hives. In rare cases, it can also lead to kidney failure.
Common side effects include headaches, dizziness, diarrhea, flu-like symptoms, back and joint pain, stomach pain, and coughing. More serious symptoms include shortness of breath, lack of urination, abnormal swelling, unusual weight gain, vomiting, lightheadedness, feeling disoriented, heavy thirst, low appetite, a general feeling of bodily weakness, unusual heartbeats or fluctuations, and a reduced heart rate and low pulse.
Those with kidney or liver disease should never take valsartan. You should avoid this drug if on a low-salt diet, if you have had an allergic reaction to any blood-pressure drug in the past, and if you are or may soon become pregnant. Valsartan could cause your unborn baby injury or death if you use it during the 2nd/3rd trimester of pregnancy. Women taking this drug should be informed by their doctor to use birth control and that the drug will enter breast milk (and so should not be used if nursing.) No one under the age of six should ever be prescribed valsartan.
It is critical to always follow your prescribed dose. The prescribing doctor may increase or decrease the dose. You should take the capsules at the same times each day in liquid or tablet form. It doesn’t matter whether or not you consume food while taking this medication.
When taking valsartan, blood pressure can get somewhat low. And you will need to frequently check your blood pressure and/or your kidney function. You should notice a lowering of high blood pressure within two to four weeks of beginning to take the medication, and if you don’t - you should immediately talk to your doctor.
NEVER drink alcoholic beverages while on valsartan or it could exacerbate side effects and knock your blood pressure down to dangerously low levels. NEVER take potassium supplements or salt-substitute supplements while on valsartan. Also, avoid other drugs that valsartan may interact with, such as cyclosporine, lithium, rifampin, ritonavir, aspirin, and ibuprofen.
Cancer Risk Rises With Some Forms Of Valsartan
Not all forms of valsartan have been shown to be dangerous, but many have and have, therefore, been recalled by the FDA. In 2018, the FDA recall was issued on various generic forms of valsartan and valsartan HCTZ. The reason was that “impurities” were found to have been in these drugs for years, which have been shown to increase the risk of certain cancers.
Taking recalled forms of valsartan puts you at higher risk of cancer of the liver, kidneys, stomach, intestines, colon, bladder, and pancreas. It also increases the risk of non-cancerous (but very serious) liver and kidney damage. Certain other antihypertensive drugs were recalled along with valsartan, and valsartan has now been recalled in 22 different countries around the world.
The main contaminant discovered in some batches of valsartan is called by a very long name (N-Nitrosodimethylamine), but NDMA for short. It has been labeled by the FDA as a probable cause of cancer in human beings based on certain lab-test results. The defect was thought to be introduced due to changes in the way in which the drug was being manufactured, and again, not all versions of valsartan were affected. So while caution is needed, the problem is not with the drug itself necessarily but with the presence of impurities that weren’t supposed to have been in it, to begin with. The FDA issued an initial recall and then later expanded it until over a dozen manufacturers of valsartan were affected, with a few other companies voluntarily issuing their own recall as well.
The risk of cancer from NDMA found in some valsartan is real, and enough to convince the FDA and 21 other nations around the world to take action. Yet, as the lab tests involved high dosages given to rodents, the exact level of risk is an unknown at this point. The NDMA is toxic and increases in toxicity with the dosage level and the longer you use it. NDMA has been shown to cause liver damage in human beings. NDMA occurs naturally and as a result of industrial processing. For example, you will find it in rocket fuel and industrial lubricants and as a byproduct of making rubber and pesticides. There’s little doubt that NDMA is harmful and is rightly labeled a dangerous impurity when found in valsartan drugs.
However, this shouldn’t create an overreaction against ARB drugs in general or even against all valsartan. There is no evidence of cancer being caused by these drugs even after nearly 150,000 patients were included in relevant clinical trials whose results were published in the peer-reviewed medical journal Medicine in 2016. It should be crystal clear that is is the impurity NDMA and not valsartan itself that is the issue.
I Received A Valsartan Recall Letter. Now What?
You may have been taking some form of valsartan and then received a recall letter. What should you do next? First of all, realize that you are not alone. This is the largest Class-1 FDA recall ever issued and it is for one of the most commonly prescribed antihypertensive medications used in the US. Considering that a third of American adults suffer from some level of high blood pressure, it is not that surprising that two million people have received a valsartan recall letter through Humana toward the end of 2018.
The second thing to remember is NOT to suddenly stop taking your medication without talking to your doctor first. Your doctor may be able to switch you over to a different hypertension medication, but you could put yourself in greater danger by suddenly ceasing your daily dosages on your own initiative than by continuing to take it until prescribed a substitute. Also, note that Consumer Alert Now is NOT a substitute for a physician or medical practice, and we do not give out medical advice as such. We simply alert the consumer to the information he or she needs to know and then refer him or her to see a doctor or a lawyer (or both).
Going to a brand name form of valsartan may be a good solution, at least in the short term, if you doctor suggests. For it was certain generic valsartan companies that were involved in the recall. If you did not receive a valsartan recall letter, it may be that your version of valsartan was not sourced from a supply contaminated with NDMA. To be sure, however, you should visit the FDA website or talk to your prescribing physician - just in case you didn’t receive a recall letter but should have. And by the same token, check with these same sources of information to double check that a recall letter you did receive was not sent to you by accident.
Also note that, as the FDA has been feverishly working with the drug companies involved in the recall to prevent such impurities from entering any future batches of valsartan, there probably won’t be any additional recall letters before long.
Some may fear that drugs similar to valsartan or that contain (but do not simply consist in) valsartan are not safe. But this fear is unfounded. Amlodipine is safe. Entresto, containing valsartan and sacubitril, was not recalled. And valsartan products made by Sandoz and Novartis in the US were not affected, even though those outside the US may have been since the US and non-US products have different sources for their active ingredients. Also, brand-name valsartan like Diovan was not affected. Check the name of the drug on the medication label and the name of the pharmaceutical company manufacturing it to compare to the FDA website’s list of drugs affected by the recall or to discuss the matter with your doctor or pharmacist.
Switching To A Valsartan Alternative
If you need to switch from valsartan to a replacement medication, make sure you do so in an orderly, safe fashion. After all, these medications treat high blood pressure and heart failure and it is as important to find the right replacement drug as it is to avoid the impurities found in certain forms of valsartan.
If you aren’t going to switch to a different version of valsartan, then you may need a different ARB (angiotensin receptor blocker.) That gives you seven other possibilities on the market today aside from valsartan. Losartan, irbesartan, and olmesartan are among the most common alternatives. Each patient’s needs and propensity to side effects of different drugs will vary, so there is no single solution. A new medical exam and consultation with your doctor will be necessary to find the right drug.
Also, the new product might affect your blood pressure differently than did valsartan. You might have to adjust the dosage, at the direction of your physician, after using the new drug for a while. You should keep a log recording your blood pressure level at different times of day along with the timing and dosage of all medications taken. Show this to your physician so he or she can adjust your new prescription till it is right for you.
Have You Been Injured By Valsartan?
If you have not only received an FDA recall letter for your valsartan medication but also have been diagnosed with cancer or severe liver/kidney damage after taking the drug, you may have grounds for a lawsuit. If a loved one of yours has died due to such injury after taking valsartan products, you may qualify to file a wrongful death suit.
Cancers that can qualify for a valsartan lawsuit include colon, liver, rectal, intestinal, kidney, and stomach cancer. Some other cancers, like breast or lung cancer, would likely not qualify. You are entitled to full compensation for any injury or loss sustained due to the negligence of pharmaceutical companies manufacturing valsartan. This can include medical expenses, loss of income, physical pain and mental stress, and loss of consortium in the case of wrongful death.
The lawsuit would likely be on the basis of a defective product since the drug was contaminated with NDMA in some cases. NDMA is a known human carcinogen, and its presence has been verified in certain batches of generic versions of valsartan. This contamination may have taken place for many years before the FDA caught it, and the full extent of it is not known. Therefore, you do not absolutely have to have a recall letter to file a lawsuit, though that piece evidence certainly helps.
Class Action Valsartan Lawsuits Filed Already
Many individual and class action lawsuits have already been filed against drug companies that manufacture valsartan since the closing months of 2018, and new ones continue to pop up all the time. You may be able to join an existing class action suit, file an individual suit, or even start a new class action suit.
The very first class-action lawsuit filed over valsartan was filed by Elizabeth and John Duffy in New York State against both manufacturers and distributors of the drug due to the presence of the NDMA impurity. Solco Healthcare and Prinston Pharmaceutical were targeted, as were Walgreen and Throggs Neck Pharmacy. The suit was filed not only on behalf of the immediate plaintiffs but was also meant to represent others who were affected by valsartan in a similar way.
Soon afterward, Robin R. filed another class action valsartan recall lawsuit over the NDMA contamination. This lawsuit brought up the point of certain generic valsartan manufacturers promoting their products for years as being essentially equivalent to the brand-name drug Diovan, while in fact, they were not producing and distributing the generic drugs in strict accord with federal and state regulations - which led to the NDMA impurities and increased cancer risk. The lawsuit alleges that the defendants showed negligence by ignoring clear warning signs that sub-standard operation was afoot. Specifically, the use of a Chinese company in inadequate facilities in China to do the actual manufacturing is alleged to have led to the problem. It is thought that contamination occurred in these Chinese factories as early as 2015, or even 2012 in some cases. This is cited as consumer fraud since these kinds of sub-standard manufacturing conditions were not revealed to consumers.
Another valsartan lawsuit was filed by Eric Erwin specifically against Prinston Pharmaceutical, Solco Healthcare, Teva Pharmaceutical, and Huahai. This suit is also based on the same Chinese connection in the very same factories as the suit filed by Robin R. And a third suit to the same effect was filed by Dominic Stimma in New Jersey.
A final example is a lawsuit filed by James Jones in Missouri. He alleged consumer fraud, negligence, breach of contract and warranties, improper merchandising, and unjust enrichment. This suit sought to enforce strict liability.
It is still too early to tell how many and which manufacturers and distributors will be affected by valsartan lawsuits, how large of a judgment may result on average per victim, or how long the lawsuits will take to be fully settled. It is also possible that other forms of cancer will be connected to the NDMA impurity, opening the way for even more valsartan lawsuits. Although most damages are based on NDMA exposure, NDEA (N-Nitrosodiethylamine) and NMBDA (N-Methylnitrosobutyric acid) are other possible contaminants in some batches of valsartan.
These kinds of class action lawsuits often take years to settle and end up involving many thousands of plaintiffs. The amount awarded to each plaintiff may vary but can include all relevant medical expenses, cancer treatment expenses, loss of income and of earning ability, pain and suffering, mental anguish, and punitive damages.
Can I Afford A Valsartan Lawyer? And How Do I Find One?
Understand that class action attorneys working on recall drug cases will work on a contingency basis. That is, they will only collect payment if they win you compensation. They normally do not charge upfront fees but simply take a percentage of the settlement as their compensation. Thus, anyone can “afford” to join a valsartan lawsuit. You don’t have to lose out on your rightful compensation due to lack of ability to hire an expensive lawyer.
Next, you need to simply locate and contact a law firm that handles valsartan cases for a free, no-obligation assessment. They will ask you to tell your story and ask you basic questions about what type of valsartan drug you took, for how long, what injury you have suffered, and whether or not you received an FDA recall letter in the mail. If they believe you “have a case,” they will walk you through the next steps in filing a suit or joining an existing one.
Looking For A Top-tier Valsartan Lawyer Near Me?
We at Consumer Alert Now are not a law firm, nor do we pretend to be one. We do not work for any law firm either - we work for you, the consumer. Our job and our passion are to alert you of the presence and effects of dangerous drugs and medical products on the US market and give you the ability to respond appropriately.
However, Consumer Alert Now does connect you to the right lawyer! We have great familiarity with the legal industry in the area of medical recall-related lawsuits and we can give you a list of the best valsartan lawyers in your area. Call our defective drug attorney anytime 24/7, at 800-511-0747 for nationwide support! We can connect you to a lawyer familiar with the laws of your state and with federal law.