Valsartan (Diovan) is a popular medication prescribed by doctors to treat congestive heart failure (CHF) and high blood pressure. The drug is classified as an ARB (angiotensin receptor blocker) that is used to extend life longevity after a patient suffers a heart attack. Doctors prescribed valsartan to patients who have previously suffered from heart failure because the medication is known to relax blood vessels and improve circulatory issues and blood flow. The medication helps to lower high blood pressure and can prevent kidney problems, heart issues and stroke.
In July 2018, the FDA (Food and Drug Administration) recalled the popular medication after it was discovered that the drug was formulated with a chemical linked to cancer. The federal agency was slow to respond and only recalled drug after 22 other countries had already taken action to remove the medication from their pharmaceutical shelves. The FDA states that traces of the chemical N-nitrosodimethylamine (NDMA) compound were discovered in products that had been recalled.
N-nitrosodimethylamine is a known carcinogenic substance that has been linked to cancer. Previously, scientists used the organic compound to create antioxidants, lubricant additives and liquid rocket fuel. Currently, medical science only uses the semi-volatile organic chemical for research purposes. The food industry uses NDMA in cured, smoked and cooked food products because the water-soluble product has no odor and no taste. However, the toxic carcinogenic chemical is harmful to the liver and other organs in humans and has caused the development of cancer and rents.
The FDA Took Action
On July 13, 2018, the federal agency issued a Safety Communication Warning to alert patients, healthcare professionals and the public of a voluntary recall involving products containing N-nitrosodimethylamine, including valsartan. The FDA states that products are removed from use because of impurities and the chemical’s probable carcinogenic effects. However, the agency is conducting an ongoing review but remains committed in ensuring every one safety.
FDA Commissioner Dr. Scott Gottlieb states that the federal agency “is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they are manufactured.” The doctor also stated that:
“When we identify lapses in the quality of drugs and problems with their manufacturing that have a potential to create risks to patients, we are committed to taking swift action to alert the public and help facilitate the removal of products from the market. As we seek the removal of certain drug products today, are drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”
The FDA’s Center for Drug Evaluation and Research spokesperson Janet Woodcock stated that:
“The presence of [N-nitrosodimethylamine (NDMA)] was unexpected and is thought to be related to changes in the way the active substance was manufactured.”
“We have carefully assessed the valsartan-containing medication sold in the United States, and we have found that the valsartan sold by these specific companies does not meet are safety standards. This is why we have asked these companies to take immediate action to protect patients.”
Additionally, the US Environmental Protection Agency (EPA) has concluded that N-nitrosodimethylamine chemical compound is a probable human carcinogen that can increase the potential risk of a human developing cancer. The harmful chemical has been detected in certain food products and water supplies at levels that are considered relatively safe.
It is my Valsartan Medication Affected?
To ensure your safety, the FDA recommends that you contact your health care provider to determine if the medication you are currently taking has been recalled. However, the federal agency recommends that you do not discontinue the medication until your doctor has prescribed replacement because the drug may be treating a serious medical condition that could be affected if you stop taking the medication.
The determine if your drug was recalled, identify the company name on the prescription bottle that manufactures your medication. If the information is not there, contact your pharmacist who can assist you in identifying the drug maker.
If the medication you are currently taking has been recalled, contact your doctor and discuss any other available treatment option. Your doctor may be able to prescribe and alternative treatment drug or a different valsartan medication that is not part of the recall. The FDA has released a list of recalled drugs containing the toxic chemical and an additional list of products that contain valsartan that are not part of the recall.
The FDA Recall Involves Numerous Drug Makers
July 2018 Voluntarily Recall Valsartan Medication
| Drug Company | Recalled Medicine |
|---|---|
| Major Pharmaceuticals | Valsartan – 80 mg and 160 mg tablets |
| Solco Healthcare LLC | Valsartan – 40 mg, 80 mg, 160 mg, 320 mg |
| Actavis – Teva Pharmaceuticals USA | Valsartan – 40 mg, 80 mg, 160 mg, 320 mg |
| A-S Medication Solutions LLC | Valsartan – 80 mg, 160 mg |
| Bryant Ranch Prepack Inc | Valsartan 80 mg, 320 mg |
| H J Harkins Company | Valsartan – 160 mg |
| Northwind Pharmaceuticals | Valsartan – 80 mg, 160 mg, 320 mg |
| Quality Care Products LLC (Lake Erie Medical) | Valsartan – all doses |
| NuCare Pharmaceuticals | Valsartan – all doses |
| Proficient Rx | Valsartan – all doses |
| Actavis – Teva Pharmaceuticals USA | Valsartan w/ hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg |
| AvKARE | Valsartan w/ hydrochlorothiazide (HCTZ) 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg |
| A-S Medication Solutions LLC | 80 mg, 160 mg & valsartan w/ hydrochlorothiazide (HCTZ) 160 mg/12.5 mg, 320 mg/25 mg |
Source: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf
Injured Patients Report Adverse Events
Taking the angiotensin II receptor blocker valsartan (Diovan) to control heart failure, post heart attack conditions and hypertension has been known to produce side effects that include:
- Upper respiratory infections,
- Flu symptoms,
- Tiredness and fatigue,
- Dizziness and lightheadedness,
- Headaches
- Nausea and diarrhea,
- Sore throat, sneezing, stuffy or runny nose, cough and other cold symptoms,
- Blurred vision
- Swelling
- Stomach pain
- Joint pain
- Back pain
- Palpitations
- Vomiting
- Unexpected weight loss
- Swelling around the eyes or lips
More serious side effects involve:
- Rapid weight loss
- Unusual increase urinating volume
- Shortness of breath occurring with just mild exertion,
- High potassium response including a tingling sensation, muscle weakness, week pulse, or slowed heart rate.
- Chest flutters, pounding heart beats, loss of appetite, increase thirst, confusion weakness,
- The sensation of passing out.
Exposure to the toxic chemical is thought to increase the patient's potential risk of developing cancer of the liver, G.I. tract, kidney and colon. If you have been exposed to medications containing the highly toxic N-nitrosodimethylamine (NDMA) chemical compound, you should speak to your doctor right away and consider taking immediate legal action against the drug maker who manufactured, promoted, marketed and sold the defective drug. However, time is of the essence. You must file all the necessary documents and paperwork in the proper courthouse before the state or federal statute of limitations expires.
Canada, Europe and Asia Involved in the Recall
Before the United States FDA pulled dangerous products from the medical marketplace, 22 other countries in Europe and Asia had already recalled valsartan products including Canada, Taiwan, Hong Kong and China. Not long ago, the Zhejiang Huahai Pharmaceutical Co. notified drug regulators that NDMA residue had been discovered in many products they manufacture including valsartan medications. The company has sold approximately $50 million worth of valsartan supplies that contained the toxic chemical in 2017 and generated more than $20 million in sales involving valsartan-containing medications.
Contact an Attorney Right Away if You Have Been Prescribed Valsartan
If you, or a loved one, have been prescribed a recalled valsartan medication made by Solco Healthcare or Teva Pharmaceuticals, contact the defective drug injury attorneys at Rosenfeld Injury Lawyers LLC today at (888) 424-5757. Schedule a no obligation, free consultation to discuss the validity of a claim for compensation. We can provide legal assistance even if you have not experience symptoms are developed cancer. The medication your taking now could cause serious medical issues in the months or years ahead.
Our law firm accepts all personal injury cases, wrongful death lawsuits and defective medication injury compensation claims through contingency fee agreements. This arrangement will postpone payment of all our legal services until after we have successfully resolved your case through a negotiated settlement or jury trial award. We offer every client a “No Win/No-Be” guarantee, meaning if we are unable to secure compensation on your behalf, you owe us nothing. Let us begin working on your case now.
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