Issues with Blood Pressure Medications
Hello, doctor.
I have been taking antihypertensive medication, and I happened to use a batch of valsartan from a Taiwanese manufacturer that has been associated with carcinogenic issues.
Later, my doctor told me to switch to the original valsartan.
I am puzzled as to why I was prescribed the generic version when the original medication was available.
I have also been taking this problematic batch of medication for a while...
What should I do?
Tian Xiansheng, 40~49 year old female. Ask Date: 2018/07/20
Dr. Xiao Yongxun reply Family Medicine
Dear Mr.
Tian:
1.
According to reports, the antihypertensive medication Valsartan has reached the end of its patent period, allowing many domestic and international pharmaceutical companies to manufacture and sell it.
Consequently, many pharmaceutical companies in our country not only produce synthetic Valsartan but also import foreign-synthesized Valsartan for tablet packaging.
As a result, there are various brand names (e.g., Diovan®, Daianxo®, Valsart®, etc.), which are collectively referred to as generic drugs by the National Health Insurance Administration and various medical institutions.
Of course, the Food and Drug Administration has established quality management standards to maintain therapeutic efficacy.
Due to the high competition among generic drugs, prices naturally decrease.
Additionally, due to the long-term operational difficulties of our national health insurance, there are restrictions on the growth of drug costs, and even drug reimbursements may be cut.
Consequently, many hospitals opt for cheaper generic drugs for physicians to prescribe.
The problematic Valsartan in question has been imported from China for many years and was recently found to have manufacturing issues, leading to its removal from the market.
2.
Reports indicate that the problematic Valsartan contains NDMA, which has been found to have hepatotoxicity in animal studies, potentially harming the liver and increasing the risk of liver cancer; however, there is currently no evidence of this in humans.
Therefore, it has been classified as a Group B2 carcinogen by the U.S.
Environmental Protection Agency, meaning "possibly carcinogenic to humans."
3.
I believe that since your attending physician has switched your medication to the original manufacturer’s product, it is best for you to focus on controlling your hypertension for now; there is no need to worry about uncertainties.
As there is currently no evidence of carcinogenicity in humans, aside from changing medications, the medical community does not have specific preventive measures or recommended solutions.
4.
If you have further questions, please discuss them with your attending physician.
Reply Date: 2018/07/20
More Info
Valsartan is a medication primarily used to treat high blood pressure and heart failure. It belongs to a class of drugs known as angiotensin II receptor blockers (ARBs). By blocking the action of angiotensin II, a substance in the body that causes blood vessels to constrict, Valsartan helps to relax blood vessels, thereby lowering blood pressure and improving blood flow. This mechanism is particularly beneficial for patients with hypertension and those suffering from heart failure, as it can help reduce the workload on the heart.
Your concerns regarding the safety of Valsartan, especially in light of recent reports about certain batches containing impurities, are entirely valid. In 2018, some generic formulations of Valsartan were found to contain N-nitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen. This led to widespread recalls and heightened scrutiny of the manufacturing processes of these medications. The presence of NDMA was linked to manufacturing issues, particularly in certain facilities, and not all Valsartan products were affected.
When your doctor switched you from a generic version of Valsartan to the original brand, it was likely a precautionary measure to ensure your safety and to provide you with a medication that has been rigorously tested and monitored for quality. Brand-name medications, like Diovan (the original formulation of Valsartan), are often subject to stricter regulatory oversight compared to some generic versions, especially those produced in regions where manufacturing practices may not be as closely monitored.
If you have been taking a potentially contaminated batch of Valsartan, it is understandable to feel anxious about the implications for your health. However, it is important to note that while NDMA has been shown to cause cancer in animal studies, there is currently no direct evidence linking the consumption of contaminated Valsartan to cancer in humans. The risk is considered to be low, especially if the exposure was short-term and the levels of NDMA were within the acceptable limits set by health authorities.
In terms of what you should do next, it is crucial to follow your doctor's advice and switch to the original brand of Valsartan. This change should help alleviate any concerns you have about the quality and safety of your medication. Additionally, maintaining regular check-ups with your healthcare provider is essential. They can monitor your blood pressure and overall health, ensuring that the medication is effective and that you are not experiencing any adverse effects.
If you have lingering concerns about the previous medication, discussing these with your doctor can provide peace of mind. They can offer further insights into the safety of the medications you have taken and any necessary follow-up tests or monitoring that may be appropriate.
In summary, while the concerns surrounding certain batches of Valsartan are serious, the best course of action is to adhere to your doctor's recommendations, switch to the original brand, and maintain open communication with your healthcare provider about any health concerns you may have. Your health and safety are paramount, and your doctor is there to support you in managing your condition effectively.
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