FDA Issues a Recall Warning over Concerns That Some Drugs Containing Contaminated Valsartan
In July 2018, the FDA (Food and Drug Administration) began recalling drugs containing valsartan. The federal agency stated that the medication to treat heart failure and high blood pressure contained a toxic chemical. The chemical N-nitrosodimethylamine (NDMA) compound has known carcinogenic properties.
What is Valsartan?
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.
The FDA approved valsartan for the use in numerous generic medications to treat left ventricular dysfunction, left ventricular failure, heart failure, and hypertension. The medication as prescribed in varying doses and is sometimes combined with hydrochlorothiazide (HCTZ) for the treatment of hypertension.
NDMA Linked to Valsartan
Recently, Chinese drug manufacturer Zhejiang Huahai Pharmaceutical issued a release stating that N-nitrosodimethylamine had been discovered in their generic valsartan products. The pharmaceutical company was supplying the impure medication containing NDMA to drug companies in the United States including Major Pharmaceuticals, Teva Pharmaceuticals Industries Ltd. and Solco Healthcare.
Once the contaminated products were acquired, these drug companies processed the medication and distributed tainted valsartan pills and tablets to the American pharmaceutical market. For years, these companies have made the drug available to consumers.
What is N-nitrosodimethylamine?
Information supplied by the International Agency for Research on Cancer (IARC) reveals that N-nitrosodimethylamine (NDMA):
- Is a highly toxic organic chemical compound;
- Is used in various products from liquid rocket fuel to softeners and lubricants;
- Can be created through a chemical reaction during the manufacturing process;
- Has been classified as a manufacturing byproduct created when making rubber tires, formulating pesticides and processing fish;
- Has been detected in trace amounts in some foods that can be released through a chemical reaction while the food is being processed;
- Can be created when salting, browning or grilling some meats.
Researchers have identified N-nitrosodimethylamine has been linked to cancer in animals that formed cancerous tumors in the respiratory tract, kidney and liver. NDMA is also associated with nasal cancer, lung cancer, kidney cancer, colorectal cancer, gastric cancer and liver cancer and might likely cause other cancerous conditions in all organs. Because of the animal testing results, scientists have label NDMA as a probable human carcinogen, making them highly dangerous to everyone.
A Voluntary Recall
On July 13, 2018, the FDA released a safety communication warning announcing that pharmaceutical medications containing contaminated valsartan would be voluntarily recall from the medical marketplace. The federal agency released a list of other medications containing unadulterated valsartan that were not being pulled from the pharmaceutical marketplace.
The products that were recall were processed and distributed by specific drug companies.
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
Drug Law Center
According to the FDA, “it is possible that not all valsartan-containing products repackaged by these companies are impacted by the recall. The FDA continues to evaluate valsartan -containing products and will update the list of products included in the recall and the list of products not included in the recall as more information becomes available.”
An FDA Update
On July 27, 2018, the Food and Drug Administration updated their recall information concerning consumer use of impure valsartan-containing medications. The agency states that:
“The amounts of NDMA found in the recalled batches of valsartan exceeded these acceptable levels. The agency wanted to put some context around the actual potential risk posed to patients who used versions of valsartan that may have contained high levels of NDMA. Based on records from the manufacturer of the recalled valsartan, some levels of the impurity may have been in the valsartan-containing products for as long as four years. FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people. This assessment led to FDA’s decision to have these batches recalled.”
On August 2, 2018, the FDA released their next update of the list of products added to the recall and stated that:
“FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients (APIs) are not at risk of NDMA formation. The agency reminds manufacturers to thoroughly evaluate their API manufacturing processes, and changes to those processes, to detect any unsafe impurities. If a manufacturer detects new or higher levels of impurity, they should take action to prevent changes to the product’s safety profile.”
U.S. Joints 22 Other Countries’ Recall
In July 2018, the FDA (Food and Drug Administration) finally joined 22 other countries in North America (Canada), Asia and Europe in recalling medications containing contaminated valsartan. The FDA Director of the Center for Drug Evaluation and Research Dr. Janet Woodcock stated that:
“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.”
FDA commissioner Dr. Scott Gottlieb said the federal agency is investigating the dangers of the drug and remains:
“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. We will identify lapses in the quality of drugs and problems with their manufacturing that had the potential to create risks to patients, we are committed to taking swift action to alert the public and help facilitate the removal of the products from the market.” The doctor also stated that “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.”
Reported Adverse Events
Taking the angiotensin II receptor blocker valsartan (Diovan) to control heart failure, post heart attack conditions and hypertension can produce side effects that include:
- Back pain,
- Blurred vision,
- Cold symptoms including sore throat, sneezing, stuffy or runny nose, and coughing,
- Dizziness and lightheadedness,
- Flu symptoms,
- Joint pain,
- Nausea and diarrhea,
- Stomach pain,
- Swelling around the eyes or lips,
- Tiredness and fatigue,
- Unexpected weight loss,
- Upper respiratory infections,
More serious side effects involve:
- Chest flutters, pounding heart beats, loss of appetite, increase thirst, confusion weakness,
- High potassium response including a tingling sensation, muscle weakness, week pulse, or slowed heart rate.
- Rapid weight loss
- Shortness of breath occurring with just mild exertion,
- Unusual increase urinating volume.
The FDA recommends that patients speak with their doctors about the medications they are taking before discontinuing any drug without their doctor’s permission. The American Heart Association says that quitting a medication without supervision could be dangerous to the patient’s health.
According to the American Academy of Family Physicians, doctors should “advise patients to contact the health care professional who prescribed the medication or the pharmacist who dispensed it if their prescription is included in the recall to discuss their treatment. This could include prescribing another valsartan product not affected by the recall or an alternative treatment option …”
Do You Have Questions About Your Legal Options Related To The Valsartan Recall?
Attorneys at the Drug Law Center are currently reviewing all types of cases related medical complication associated with Valsartan. If you or a family member experienced serious medical side effects or developed cancer after taking Valsartan, contact our office for a free review of your legal rights and options for a financial recover. All consultations are free and confidential.