Valsartan complications from now-recalled pills contaminated with NDMA may include cancer or liver damage. Even pills that have not been recalled can still cause liver damage as a side effect.
Patients who came down with liver damage from taking Valsartan or cancer from taking Valsartan may have standing to sue the Valsartan pharmaceutical companies. If successful, Valsartan lawsuit plaintiffs may recover large monetary damages to compensate them for all their expenses related to their injuries, including pain and suffering.
In this article, our personal injury lawyers will discuss the following Valsartan topics:
1. Valsartan side effects
The primary purpose of Valsartan is to lower blood pressure. But like all medications, Valsartan may cause unintended consequences. (Scroll down to section 2 for information on how Valsartan can cause liver damage.)
The more common Valsartan side effects include:
- nausea
- abdominal pain
- loose stools
- tiredness
- coughing
- headaches
- dizziness
- impotence
- high potassium (hyperkalemia)
- compromised renal function
- throat swelling (angioedema)
Other potential side effects are:
- vomiting
- no appetite
- increased thirst
- weight gain
- blood in urine and/or decreased urine
- pain in the lower back or side
- lightheadedness, especially when getting up
- fainting
- weakness
- irregular heartbeat
- trouble breathing
- face, calf and/or finger swilling
- numbness and/or tingling in feet, hands, or lips
- cold sweats
It is rare (but possible) for users to experience the following possible side effects:
- sore throat
- swelling of the feet, hands and/or mouth
- sudden onset of trouble breathing or swallowing
- voice hoarseness
- chills
- fever1
Some Valsartan side effects like gastric distress are merely annoying and inconvenient. But others like shortness of breath can be very serious. Patients should consult their doctor whenever they experience any unintended reaction. There are several other blood pressure medications that the doctor could switch the prescription to that may cause fewer side effects.
Patients who have been injured by Valsartan may have viable legal claims against the pharmaceutical company if it failed to disclose the side effect in its marketing or packaging materials:
Relevant evidence would include the marketing or packaging materials (if any) the patient received with the pills. Other relevant evidence would include the patient’s medical records and expert medical testimony linking the Valsartan to the patient’s injuries.
2. Liver damage from Valsartan
Patients who have trouble metabolizing Valsartan may suffer acute liver damage. The liver is a vital organ located in the upper middle and right abdomen that performs the following vital functions:
- creating bile to aid digestion
- filtering out toxins
- breaking down proteins, fats, and carbohydrates
- storing vitamins and minerals
- making blood proteins
- aiding in the creation of blood clots
When people develop acute liver injuries from Valsartan, it usually occurs within only eight weeks of starting the meds. Acute liver damage has similar symptoms to hepatitis, such as:
- jaundice (yellowing of skin and eyes)
- no appetite
- weight loss without dieting
- tiredness
- flu-like symptoms
- dark urine
- pale-colored bowel movements
- abdominal aches
Acute liver injury that goes untreated can turn into cholestasis, which is when bile flow from the liver gets reduced or blocked. Cholestasis has the same symptoms of acute liver injury listed above in addition to:
- nausea
- excessive itching2
In short, while Valsartan may be helpful to some patients, it can prove toxic to others whose livers have trouble metabolizing it. Valsartan patients with any of the above symptoms should seek medical help immediately.
2.1. Valsartan with NDMA
Valsartan that has been contaminated with the genotoxin N-nitrosodimethylamine (NDMA) can also cause liver damage. In high enough doses, NDMA causes complete liver failure. In China, a student died 15 days after drinking from a water cooler spiked with NDMA.3
Apparently, Zhejiang Huahai Pharmaceuticals in Linhai, China had been manufacturing Valsartan contaminated with NDMA for probably several years. These batches have now been pulled off the market, but the damage may be done for people who already ingested the recalled Valsartan.4
Symptoms of overexposure to NDMA overexposure are:
- dizziness
- jaundice
- headaches
- nausea and vomiting
- cramps in the abdomen
- fever
- compromised liver, kidney and/or lung function, and
- enlarged liver5
Scroll down to section 4 for information on suing pharmaceutical companies for causing liver damage from Valsartan.
3. Cancer from Valsartan
It is suspected that NDMA probably causes cancer in humans. As discussed above, potentially millions of patients have ingested Valsartan contaminated with unsafe levels of NDMA, and consequently many might have developed or may still develop cancer.
A Danish study from 2018 shows that Valsartan contaminated with NDMA increased cancer risks by 9% among patients in Denmark. The study’s takeaways include:
- Scientists inject animals with NDMA in order to make them develop cancer so they can study the disease;
- There was an especial increase in uterine and colorectal cancer among the Danish patients;
- People who eat processed meat — which contains NDMA — have a higher risk of gastrointestinal cancer;
- There may be more NDMA in recent Valsartan prescriptions than in earlier ones;
- Currently-healthy people who took contaminated Valsartan may still develop cancer in the future6
Among the more common cancers NDMA may cause include:
- colorectal cancer
- pancreatic cancer
- lung cancer
- liver cancer
- kidney cancer
- stomach cancer
- bladder cancer
Cancers caught in their earliest stage (State I) are typically the easiest to treat and cure. But many people do not notice or check out their symptoms until the cancer has metastasized (Stage IV).
Advanced cancer is often impossible to cure, and doctors instead try to slow the growth while managing the patients’ pain. Typical cancer treatments include:
- surgery
- gamma knife surgery
- radiation
- chemotherapy
- targeted therapy
- immunotherapy
- bone-marrow transplant
- cryoablation
- radiofrequency ablation
- clinical trials
Scroll down to the next section to learn how cancer patients can sue pharmaceutical companies for giving them Valsartan contaminated with NDMA.
4. Suing for injuries
Patients who developed liver damage or any type of cancer after taking now-recalled blood pressure meds may have grounds to sue the pharmaceutical company. Common legal claims are:
- negligence
- defective manufacturing
- failure to warn
Since there are so many Valsartan users, it is likely that their lawsuits will be joined into a Valsartan MDL (short for multi-district litigation). MDLs are a way to streamline the litigation process and hopefully expedite a global settlement among all the plaintiffs. Ultimately, the plaintiffs’ attorneys are fighting for the highest possible settlement to cover:
- medical bills (including home nursing care);
- pain and suffering
- lost wages
- loss of future earnings
If the plaintiff dies before the lawsuit resolves, the plaintiff’s estate can continue litigating the matter. Additionally, the plaintiff’s family may try to bring a wrongful death lawsuit against the pharmaceutical company.
Call a personal injury attorney…
If you suffered serious side effects after taking impure medications, we want to help. For a free consultation and case evaluation, call us at any time. Just call soon before your Valsartan statute of limitations passes.
Legal References
- Diovan, RXlist.com; Valsartan (oral route), mayoclinic.org; Valsartan, WebMD.com.
- Valsartan, LiverTox: Clinical and Research Information on Drug-induced Liver Injury, NIH.
- Stefan Van Assche, “Fudan University student sentenced to death for poisoning roommate“, Thatsmags.com (February 18, 2014).
- Zhejiang Huahai Pharmaceutical 11/29/18, FDA Warning letter; Valsartan products under recall – Updated April 11, 2019, FDA.gov.
- Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA.gov (January 2014).
- Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and risk of cancer: Danish nationwide cohort study, BMJ 2018;362:k3851 (September 12, 2018).