The Food and Drug Administration has recently announced a recall of some medicines that contain valsartan, a medicine used for the treatment of high blood pressure and heart failure. The drug has been recalled because of the detection of an NDMA impurity that could cause cancer in patients who were consuming the drug.
Keep in mind that all valsartan products have not been affected by the FDA recall. There are some generic versions that contain the NDMA impurity and do not meet the safety standards as set by the FDA.
The FDA has set up a task force to further investigate the nature of the impurity and its potential impact. Any new developments and information will be managed by this task force. The task force comprises of chemists, doctors, pharmacists, communication specialist, toxicologists, and lab technicians.
The recall was initiated after Prinston Pharmaceuticals Inc. contacted the FDA in June 2018. The company informed the FDA that its valsartan formulations contained the valsartan active ingredient manufactured by Zhejian Huahai Pharmaceutical Co. Zhejiang was the one to detect the impurity – the presence of a chemical known as N-nitrosodimethylamine (NDMA). NDMA is known to cause cancer if found at risky levels in water and some food items. Even though it is believed that the level of NDMA in Zhejiang’s valsartan is in trace amounts, it still does not meet the FDA standards.
Once the FDA had obtained and verified this information, they further identified 13 other manufacturers who were supplying valsartan to more than 20 drug companies in the US. Immediate action was taken to determine if any of their products contained NDMA and three companies were identified in July 2018. The investigation is still ongoing, and there is a possibility that the FDA may discover more manufactures whose valsartan products may contain NDMA. Patients who are on valsartan should regularly monitor any recalls so that they are aware if their formulation is also affected by the NDMA impurity.
It is believed that this NDMA impurity was introduced because of a change in the manufacturing process at Zhejiang Huahai Pharmaceuticals. Companies that were using the valsartan ingredient from this company are the ones who have been affected by the recall.
Please note that all valsartan formulations are not affected by the recall. Companies that are manufacturing and marketing valsartan but have not used the valsartan ingredient manufactured by Zhejiang Huahai Pharmaceuticals are not affected by the recall.
Specifically, these are the companies that are currently affected by the FDA product recall:
- Prinston Pharmaceutical
- Major Pharmaceuticals
- Teva Pharmaceuticals
- Remedy Repack
- A-S Medication Solutions LLC
- Bryant Ranch Prepack Inc.,
- H J Harkins Company Inc.
- dba Pharma Pac
- Proficient Rx LP,
- Northwind Pharmaceuticals
- Camber Pharmaceuticals
- NuCare Pharmaceuticals
Companies not affected by the recall and whose valsartan formulations can still safely be consumed by patients include:
- Alembic Pharmaceuticals Ltd
- Allergan Inc.,
- American Health Packaging,
- Amneal Pharmaceutical LLC,
- AphenaPharma Solutions,
- Apotex Corp,
- Aurobindo Pharma Limited,
- Cardinal Health,
- Carillion Materials Management,
- Gavis Pharmaceuticals LLS
- Cadista Pharmaceuticals
- Lucid Pharma
- Macleods Pharmaceuticals
- Novartis Pharmaceuticals
- Novel Laboratories
- Ohm Laboratories
- Par Pharmaceutical
- PD-Rx Pharmaceutical
- Preferred Pharmaceuticals
- Proficient Rx
- Sandoz Inc
- Unichem Pharmaceuticals
Important Information for Patients
who have been consuming valsartan for the treatment of hypertension need to:
- Continue taking their medicine and should confirm if their formulation is the one that has been recalled.
- If yes, they should continue to take the drug but contact their healthcare provider immediately for an alternate prescription.
- If patients are unsure if their product is the one under recall, they should speak to their pharmacist immediately.
It is important not to panic. Not only are there several valsartan products still available in the market that are not affected by the recall, but healthcare providers can also provide alternate drugs to control the patient’s medical condition if required.
Estimated Level of Exposure So Far
The FDA is still reviewing the long-term impact of the NDMA purity on patients who have been consuming the recalled valsartan products. Based on animal studies NDMA can be considered a human carcinogen. Exposure to higher than acceptable levels could increase the patient’s risk of cancer.
As per toxicology reports and scientific evaluations, if 8000 patients took the maximum daily dose of valsartan (320 mg) for four years, there would be one additional case of cancer of the lifetime of these 8000 patients beyond the average rate of cancer among other Americans who had not consumed valsartan. This is an estimation of the highest possible level of NDMA exposure. However, it is important to keep in mind that patients who have consumed the defected valsartan products did not take this high a dose and were not exposed to these levels of NDMA.
Hammers for Your Valsartan Lawsuit
The legal team at Schneider Hammers understands the feelings of patients who have been taking valsartan for several years and who have been affected by the recall. We are here to defend your rights and ensure that you get the compensation you deserve. Call our office today if you have been diagnosed with cancer and if you believe that it might be due to the NDMA purity in your valsartan tablets. Even if you are suffering from any side effects, please contact your healthcare provider immediately and if they confirm that it is due to your hypertension medicine, give us a call, and we will determine if you have a claim against the company that manufactures and markets your particular valsartan products.
If you are concerned about the potential impact of the NDMA purity on your health, we recommend that you visit your doctor as soon as possible. The FDA is not recommending that you discontinue your valsartan treatment even if your particular formulation is in the list of recalled products. However, you must see your doctor immediately and get an alternate prescription either for another valsartan non-recalled formulation or another drug for the treatment of hypertension and heart failure.
If you are experiencing any of these side effects, these could be due to the impact of NDMA on your health. Talk to your doctor immediately if you are suffering from:
- Liver problems
- Kidney problems
- Lung problems
Remember, the NDMA effect could include the risk of liver cancer and liver damage. You need to talk to a healthcare provider immediately. You should also speak to our lawyers at Schneider Hammers so that they can help you recover the financial losses you might be incurring due to increased medical expenses because of these side-effects or long-term impact on your health.
Even though there is no group lawsuit being filed against the companies affected by the recall, there is a very high possibility that such a lawsuit might happen if more valsartan products are found to be affected by the impurity or if more patients suffer from side-effects or are diagnosed with cancer. We are here to help you if you decide to take legal action against the valsartan manufacturers. We believe that the patients are victims of these companies and deserve to be compensated for their suffering.
Our lawyers will evaluate the specifics of your case and will determine if you have a claim. If you do and if there is a lawsuit filed against the manufactures, we will ensure you get compensation for all the medical expenses that you incurred during the process of diagnosis, testing, and treatment. We will also seek compensation for the pain and suffering that resulted due to the problems with the valsartan products.
Many patients who have suffered severe symptoms because of their intake of valsartan and who have been too sick to go to work can also file a claim to recover their lost wages. Talk to our lawyers today, and they will tell you how you can do that. They will also tell you how you can claim any other economic losses that you might have incurred because of the valsartan impurity.
The legal team at Schneider Hammers is here to help you get through this tough time. We understand that hypertension and heart disease is already difficult to live with. There are so many life changes that you already have to manage because of this tough medical condition. The last thing you need is an added risk of cancer and difficult symptoms to deal with while consuming your daily medicine. We believe that you have every right to fight for justice.
Pharmaceutical companies who do not focus on quality and who buy low-cost raw material from suppliers in China and India to reduce their manufacturing costs do not realize that they are playing with the lives of real human beings. We will demand justice for you, and we will make sure you get the compensation you deserve.
Call the offices of Schneider Hammers today at 678-846-6900, and we will be happy to assist you. Our lawyers have over four decades of experience and have won millions in compensation for clients. We have been serving clients in Georgia for many years, and we are confident that we can provide you with the legal guidance and we can defend your rights in the court of law. Don’t hesitate. Call and schedule an appointment today.