FDA Recalls another Blood Pressure Drug Due to Risks of Developing Cancer
The Valsartan lawsuit targets various pharmaceutical manufacturers who produce blood pressure drugs containing the ingredient valsartan. After a report discovered that the ingredient could lead to the development of cancer, the FDA started recalling many drugs used for controlling blood pressure in patients with heart problems. The FDA’s report highlighted this decision to recall medication that shared the same active ingredient.
The decision is based on the variants containing traces of N-nitrosodimethylamine, a carcinogenic impurity that is harmful to humans. However, it’s an organic compound that is formed as a result of the manufacturing process for a variety of different products, such as lubricants and liquid rocket fuel.
In September, the FDA revealed that they discovered another ingredient in valsartan that could possibly be a carcinogen. At the time, their latest tests showed that they found another impurity, N-Nitrosodiethylamine, which is a suspected animal and human carcinogen.
Recalling another Popular Blood Pressure Medication
In recent developments, the FDA made the decision to recall irbesartan, which is also a popular blood pressure medication, after discovering that it has contaminants that could potentially cause cancer. While testing the drug, the administration found that the pills have traces of N-Nitrosodiethylamine, a material used to make liquid rocket fuel so it’s considered a byproduct of pesticide manufacturing, as well as fish processing.
Irbesartan helps in blocking angiotensin, a potent blood-based chemical that makes the muscles surrounding blood vessels to contract. When the chemical binds with angiotensin II receptors, the vessels can constrict and result in higher blood pressure.
As of yet, the FDA is trying to test all known angiotensin II receptor blockers (ARBs) for carcinogenic impurities. They designed a different test after discovering that certain ingredients from China-based Zhejiang Huahai Pharmaceuticals contained the impurity.
After conducting an inspection of their facility, the administration placed the company on an alert in late-September, which would prevent any active medications and finished pharmaceuticals from entering the U.S.
Aurobindo is the producer that supplies the ingredient to ScieGen for their products and after the Valsartan Lawsuit gained attention, the company recalled the entire irbesartan lot suspected of containing NDEA that they supplied to the U.S.
Testing from the FDA and the Aurobindo laboratories confirmed that there was NDEA in some of the irbesartan lots that they provided to the U.S.
The Risk of Actually Developing Cancer
There still a lack of clarity as to the severity of the risk that patients can develop cancer from using the recalled irbesartan or valsartan medication. At the time of the valsartan recall, FDA’s research showed that there was a minimal risk.
They estimated that if around 8,000 patients took the highest available dose of valsartan from a batch contaminated by NDMA, daily for a period of four years, they would face one more case of developing cancer over their lifetimes. But since most heart patients take a far lower dosage, they face far lower risks.
Other Valsartan and Irbesartan Medications
According to the FDA, the recall affects a mere 1 percent of all the irbesartan medications available in the U.S. market. This implies that not all drugs that contain the active ingredient were recalled. Since there are plenty of blood pressure drug variants containing valsartan or irbesartan, patients might be able to transition to another version of the medication.
The Recalled Tablets
FDA recalled tablets that were produced in 75, 150 and 300 mg doses by the company ScieGen Pharmaceuticals Inc. These drugs are packed in bottles with 30 and 90-count sizes and have the label ‘Westminster Pharmaceuticals and Golden State Medical Supply, Inc.’.
As of now, the FDA is recommending heart medication users to consult with their doctors about replacements or alternatives before completely discontinuing the use of drugs that they currently have, even if they are suspicious that their tablets are part of the recalled medications.
This is mainly because there’s a higher risk of a patient suffering from harm by discontinuing use suddenly. If patients wish to stop using their medication, it’s essential that they find a suitable alternative before they do so. If you’re suspicious about your medication, you can check the FDA’s page to know as to whether the blood pressure drugs you have are part of the recall.
What should I do?
If you or a loved one took blood pressure medication like irbesartan or valsartan and later developed complications like liver, kidney or lung cancer or liver damage, please contact our attorneys for a confidential discussion of your rights and next steps.