In July 2018, the U.S. Food and Drug Administration (FDA) joined dozens of health and safety agencies around the world in issuing valsartan recalls after discovering the presence of carcinogens in the blood pressure drug. The FDA has stated the cancer-causing substances likely were introduced into valsartan tablets due to changes to the drug’s manufacturing process, and some valsartan products may have been contaminated for as long as four years.
Since the initial recall on valsartan, other sartan drugs have also been recalled for similar contaminations. All sartans fall into a class of drugs known as angiotensin II receptor blockers (ARBs). The large number of recent recalls has led to a national shortage of ARBs. The recalls have also led to thousands of people filing valsartan lawsuits over claims that the contamination contributed to their cancer.Did your recalled valsartan drug lead to cancer? Claim your free case evaluation today
Why Valsartan Was Recalled
At the heart of the valsartan contamination are four separate probable carcinogens that have been discovered in various batches of the drug. Not every valsartan tablet contains all of these contaminants. To see if a particular valsartan brand or product has been recalled due to one of these potential human carcinogens, you can search the FDA’s Angiotensin II Receptor Blockers (ARB) Recall Database.
Initial valsartan recalls identified the unexpected presence of NDMA, with speculation that changes to the manufacturing process had cross-contaminated the medication. Valsartan brands from only three companies—Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals—were included in the first recall of valsartan. During the next several months, the recall was expanded to include additional drugs and companies.
NDMA is not currently produced in the United States, according to the U.S. Environmental Protection Agency (EPA). In the past, it has been used in the production of rocket fuel, lubricants and copolymers.
Shortly after discovering one impurity in valsartan, a second potentially cancer-causing substance was found. NDEA is a synthetic oil that is sometimes added to gasoline and lubricants as a stabilizer.
It is not entirely clear how valsartan and other ARBs became contaminated with NDEA. The most likely answer lies with the manufacturing process. Like NDMA, NDEA may be the result of the complex chemical reactions that occur during the drug manufacturing process.
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
NMBA appears only to have been found in certain losartan lots made by Camber Pharmaceuticals. No NMBA has been detected in valsartan or irbesartan, but the FDA is continuing to monitor for it.
NMBA is a compound that is found in some types of tobacco. It is unclear how it was introduced into the ARB production process.
In June 2019, a fourth probable human carcinogen was found in valsartan tablets made by Novartis AG and other drug manufacturers. DMF, a solvent, is used to break down raw materials that go into some drugs. However, DMF is supposed to be completely removed from the drug prior to it being dispensed to patients.
Valisure, an online pharmacy, discovered the high levels of DMF in valsartan medications. Although high, the levels of DMF were within the FDA’s acceptable limits. The online pharmacy petitioned the FDA and asked the agency to reevaluate the intake levels at which they deem the DMF safe. No medications have been recalled because of DMF.
Valsartan Recall Timeline
- First valsartan recalls issued by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals due to NDMA contamination
- Valsartan recall expanded to include NDMA-contaminated pills from Camber Pharmaceuticals/Hetero Labs, Torrent Pharmaceuticals and RemedyRepack
- Valsartan recall expanded to cover NDEA contamination
- FDA halts valsartan imports from Zhejiang Huahai Pharmaceuticals’ Chuannan factory in China
- RemedyRepack recalls of valsartan medications expanded
- ScieGen issues recall of irbesartan (an ARB similar to valsartan) due to NDEA contamination
- Mylan issues valsartan recall due to NDEA
- Teva Pharmaceuticals expands valsartan recall due to NDEA
- Sandoz issues recall for losartan (an ARB drug similar to valsartan) due to NDEA
- Mylan expands valsartan recall due to NDEA
- FDA lowers acceptable limits for NDMA and NDEA in ARB drugs
- Torrent issues losartan recall due to NDEA
- Aurobindo recalls valsartan due to NDEA
- Torrent twice expands losartan recall
- Solco Healthcare issues irbesartan recall due to NDEA
- Macleods Pharmaceuticals issues losartan recall due to NDEA
- FDA lowers acceptable limits for NMBA in ARB drugs
- Torrent expands losartan recall to include contamination by a new carcinogen, NMBA
- Torrent again expands losartan recall due to NMBA
- Teva issues recall of losartan due to NMBA
- Vivimed issues losartan recall due to NMBA
- Teva expands losartan recall due to NMBA
- Macleods expands losartan recall due to NMBA
- Fourth probable carcinogen (DMF) found in ARB drugs
- Torrent expands losartan recall a fifth time
Companies That Have Issued Valsartan Recalls
Several valsartan manufacturers have issued recalls for small amounts of valsartan drugs, and others have expanded their recalls to cover thousands or even millions of bottles.
Some of these companies supplied products to other distributors or operate under other names. For example, in the United States, Camber Pharmaceuticals operates as Hetero Labs. Some distributors received valsartan from multiple suppliers.
The following table provides an overview of the number of lots each pharmaceutical company has recalled. Note that the number of bottles per lot differs by company.
Valsartan Recall: List of Companies
# Valsartan Lots Recalled
|Aurobindo Pharma USA, Inc.||135|
|Camber Pharmaceuticals Inc.||25|
|Teva Pharmaceuticals USA||221|
|Torrent Pharmaceuticals Limited||109|
|Source: FDA List of Recalled Angiotensin II Receptor Blockers (ARBs)|
Common Valsartan Manufacturers
Not all valsartan medications are included in the recall, only those supplied by the Chinese company Zhejiang Huahai Pharmaceuticals and the Indian company Hetero Labs Limited (Camber Pharmaceuticals). As a result, Diovan lawsuits and legal actions against other valsartan-containing drugs produced by Novartis are not currently being filed.
In September 2018, the FDA halted imports from Zhejiang Huahai’s Chuannan factory, located in China, due to the contaminated valsartan.
Amlodipine Valsartan Recall
Since the initial voluntary recall, the valsartan recall list has expanded to include other valsartan-containing products—such as valsartan/hydrochlorothiazide and valsartan with amlodipine—from a number of different companies.
Valsartan Recall FAQs
Are All Valsartan Drug Products Recalled?
No. Only certain lots of valsartan made in India and China have been recalled. The FDA has a searchable database that lets you search by the drugmaker’s name, type of medicine, drug lot number and drug expiration date.
Note that products with expiration dates prior to July 2018 were not included in the recall, meaning that expired drugs that have not been properly disposed of could still be problematic if somebody takes them. Future products that contain the active pharmaceutical ingredient valsartan may also be added to the recall if they are discovered to contain NDMA.
What Should I Do if my Valsartan Prescription Was Recalled?
There are three things you should do if your valsartan prescription is included in one of the recent recalls:
Talk to your doctor: Your doctor may be able to give you a new prescription to replace the contaminated one or provide another treatment option. You should never discontinue a prescription medication without talking to your healthcare provider.
Contact the drug company: Each company has different procedures for processing recalls. Depending on the company, they may instruct you to dispose of the medication or return it for proper disposal. You may also be eligible for a refund for the cost of the medicine.
Talk to a lawyer: You have a legal right to safe medications. We can help you find a reliable lawyer to review your case and your options for compensation.
How Likely am I to Develop Cancer if I Take Contaminated Valsartan?
Cancer risk from the trace amounts of carcinogens found in contaminated valsartan is still unknown. The FDA estimates that about 1 out of every 8,000 people who take valsartan contaminated with one of these carcinogens is likely to develop cancer. However, the FDA has stressed that the actual risk a patient faces from a contaminated ARB is much lower than the agency’s estimates. The number of people affected by these contaminations may not be known for some time.
The chemicals involved in the valsartan recall have been linked to several types of cancer. If you have taken contaminated valsartan and been diagnosed with one of these cancers, you should talk to one of our lawyers right away.Talk to Our Valsartan Attorneys
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