The FDA has recently recalled a number of blood pressure medications in the US that contain valsartan. Valsartan treats hypertension. This sudden step by the FDA is on the basis of concerns that valsartan may cause cancer.
The FDA has found a carcinogenic element, the N-nitrosodimethylamine (NDMA) in the drugs. As of July 13, 2018, the FDA took immediate action to stop doctors from prescribing these medications. The companies facing the recall are all those selling the generic formulation of valsartan.
22 other countries have also issued recalls including Germany, Finland, Norway, Sweden, Hungary, The Netherlands, Austria, Ireland, Bulgaria, Italy, Spain, Portugal, Belgium, France, Poland, Croatia, Lithuania, Greece, Canada, Bosnia, Bahrain, and Malta.
Valsartan is classified as an angiotensin II receptor blocker. It treats hypertension, heart failure, and heart attacks. There are several formulations available including 40mg, 80mg, 160mg, and 320mg tablets. Valsartan is not for patients who suffer from severe congestive heart failure. The drug is also not for patients who suffer from hyperkalemia, renal impairment, aortic or mitral valve stenosis or hereditary angioedema.
Several pharmaceutical companies have been affected by this recall. Major Pharmaceuticals which manufactures and markets Valsartan tablets, 80mg USP and 160mg USP; Teva pharmaceuticals which manufactures and markets Actavis (valsartan and valsartan-hydrochlorothiazide tablets); and Prinston Pharmaceutical which markets valsartan 40mg, 80mg, 160mg and 320mg tablets and valsartan-hydrochlorothiazide 80mg, 160mg, and 320mg tablets.
Other companies facing a recall include AvKARE, Remedy Repack, A-S Medication Solutions LLC, Bryant Ranch Prepack Inc., H J Harkins Company Inc. dba Pharma Pac, Proficient Rx LP, etc. The Environmental Protection Agency has stated that NDMA is not produced in pure form or commercially in the US. However, in India and China, that is clearly not the case. It is believed that the substances were supplied by a company in China called Zhejiang Huahai Pharmaceuticals. The recall notice was issued as soon as the company notified authorities of the impurity.
Important Information for Patients
Please note that all drugs containing valsartan are not under recall. Only the companies listed on the FDA’s website are the ones whose valsartan products have been recalled. Patients can still continue to take valsartan products produced and marketed by Alembic Pharmaceuticals Ltd., Allergan Inc., American Health Packaging, Amneal Pharmaceutical LLC, Aphena Pharma Solutions, Apotex Corp, Aurobindo Pharma Limited, AvPAK, Camber Pharmaceuticals, Cardinal Health, Carillion Materials Management, Gavis Pharmaceuticals LLS, Cadista Pharmaceuticals, Lucid Pharma, Lupin, Macleods Pharmaceuticals, Northwind Pharmaceuticals, Novartis Pharmaceuticals, Novel Laboratories, Ohm Laboratories, Par Pharmaceutical, PD-Rx Pharmaceutical, Preferred Pharmaceuticals, Proficient Rx, Sandoz Inc., and Unichem Pharmaceuticals.
Please do not discontinue your drugs without first checking the name of the pharmaceutical company.
- As it is, the FDA is advising patients not to stop taking valsartan altogether as hypertension patients cannot abruptly stop their medicines. However, patients are being advised to talk to their healthcare provider immediately for alternative drugs that would have the same efficacy but lower risk of side effects.
Patients who are on valsartan need not worry as the FDA is actively working on finding alternate therapeutic solutions for patients who will be affected by these shortages.
- Patients who still require an effective and safe blood pressure medication will have access to other drugs that do not have a carcinogenic element to them.
The FDA is currently in the process of evaluating the impact of these drugs on patients.
- But till the FDA’s investigation is complete, these drugs will not be available.
Possible side effects of the carcinogenic containing valsartan include the risk of liver cancer, liver tumors, and liver damage.
- Some symptoms that patients on valsartan from Indian and Chinese companies should be on the lookout for include fever, nausea, dizziness, headache, jaundice, cramps, vomiting, liver dysfunction, kidney dysfunction, and lungs dysfunction. If you experience any of these symptoms, call your healthcare provider immediately so that they can prescribe you an alternate valsartan formulation.
There are certain things that all affected patients should keep in mind.
- First, not all valsartan formulations contain the NDMA impurity. It is important for patients to take a look at the drug name and the company name on their packaging before taking any action. If you are unable to find that information or are still unclear, please talk to your pharmacist or your healthcare provider.
Second, patients should not worry that there are no alternative therapeutic options.
- Your doctor will definitely be able to prescribe an alternate drug. They will be in the best position to figure out whether you need another medication or switch to another type. Please do not take any action on your own without consulting your doctor first.
The FDA Is still evaluating the long-term risks associated with the NDMA impurity.
- Please do not panic until they have reached a conclusion. However, if you have noticed any symptoms mentioned above, speak to your doctor immediately.
Call Burnetti PA For Your Valsartan Lawsuit
At Burnetti, P.A., we have been serving clients for over 25 years. We are currently in the process of defending patients who have become a victim of these carcinogenic drugs. If you have been recently diagnosed with cancer or if you have recently suffered side effects that are due to valsartan, please call our office immediately.
We understand that such a diagnosis can be life-changing for people, but we are here to help you through this time. By filing a lawsuit, we will help you recover money for medical expenses and lost wages. If you have lost a family member because of cancer caused by valsartan, we are here to help you find the financial support you need to meet funeral expenses.
Our lawyers are here to help you during this traumatic time in your lives. Consultation is absolutely free. We provide results to all our clients. We sympathize with the patients who have suffered the consequences of these pharmaceutical practices. Let our experienced lawyers help you determine whether you have a claim against the companies that market valsartan. We will ensure that all patients who are victims of this unacceptable situation get the justice they deserve.
Our lawyers will try to help you recover monetary damages to compensate for the following any:
- Medical expenses
- Pain and suffering that is the result of valsartan related carcinogenic effects.
- Loss of wages due to a negative impact on your health from the use of valsartan.
- Other economic losses that you may have incurred because of damages
- Punitive damages, if applicable.
Even though at this point in time there are no group lawsuits in process against valsartan manufacturers, but you should be aware that this type of litigation can take years to be addressed and resolved. If there are sufficient patients who have been affected by the negligence of these pharmaceutical companies, together they can take action against the parties responsible. Call us today, and we can see if you have a valid claim.
It is evident that the process of ensuring the quality of generic medicines needs to be improved to prevent such things from happening in the future. Suppliers from India and China need to be closely monitored. Companies should only purchase material from genuine and reliable suppliers. If they don’t, they put the lives of many people at risk. This is not only true for valsartan but for many other generic drugs available in the market. A system needs to be in place to gauge the quality of the material they use.
An Attorney Will Be By Your Side
Our team is here to help you if you have any concerns or questions. If you or someone in your family has been using a valsartan formulation, the first thing you need to do is call your healthcare provider to get an alternate prescription. Do not discontinue your medicine without speaking to them first. Get an alternate prescription so that your hypertension stays in control. Evaluate if you are suffering from any of the symptoms that could indicate an impact of the NDMA contaminated formulation. If yes, call us, and we will see whether you have a valid claim against the pharmaceutical company that has manufactured your particular formulation. Contact Burnetti Law today for more information.