Cancer Risk Triggers Recall on Blood Pressure Drug
The manufacturer of the blood pressure and heart failure drug Valsartan has issued a recall after potentially carcinogenic impurities were discovered in the drug. This most recent recall is part of ongoing efforts to voluntarily pull affected batches of the drug from the market over the last eight months.
According to the FDA, the recall, which will continue until June, involves about 660,000 million tablets from three batches of drugs produced by Synmosa with the code numbers:
Additionally, the impurity was found in drugs produced by the Synpac-Kingdom company, extending the recall to Disartan 80mg. That portion of the recall affects 577,000 tablets in two batches with the code numbers:
Currently, all active pharmaceutical ingredients (API) made at certain Japanese facilities are barred from entering the United States due to an import alert issued by the FDA in September 2018.
If you are taking medication that you believe could be from any of these batches or you have concerns about your blood pressure medication’s safety, you should contact your doctor immediately. Do not stop taking your medication until you have spoken to your doctor.
What’s the Problem with Valsartan?
The recall was issued after trace amounts of N-nitrosodimethylamine (NDMA), a probable carcinogenic chemical compound, were identified in Valsartan. Some batches of Valsartan alternatively contained N-nitrosodiethylamine (NDEA), which is also a probable carcinogen.
The impurities were discovered by the FDA and are believed to have occurred during a side reaction of one step in the compound’s synthesis.
According to FDA testing on the drug, the impurity concentrations in valsartan exceed the acceptable intake levels for NDMA and NDEA. The risk for developing cancer when talking Valsartan is low, even with the impurity, and according to FDA scientists, if 8000 people took the highest valsartan dose (320 mg) from the contaminated batches every day for four years, only one additional case of cancer would likely develop.
Still, the recall was issued and officials and medical professionals are concerned about the safety of the drug.
Awareness of Side Reactions Could Eliminate Problems with Drug Assessments
At least one person familiar with how the impurity likely developed believes chemists evaluating reaction conditions should have considered the risk of a side reaction. With more awareness from manufacturers and better training for regulatory officials, situations such as this could be preventable.
Many are hoping the incident serves as a wake-up call to regulators.
Others, including Ed Price, chief executive officer of the API and drug-substance manufacturer SEQENS North America, believes that based on current evaluation standards, the side reaction would have been discovered before the drug went to market.
According to Price, over the last 10 years or so the FDA has made the analytical requirements for blood pressure medications stricter. The FDA has also published three gas chromatography/mass spectrometry methods that make it easier in today’s market to detect both NDMA and NDEA.
This, of course, assumes that any new drug would be put through a complete testing trial, which isn’t always the case when new drugs that are similar to already approved drugs are brought to market.
In the meantime, those taking Valsartan should speak to their doctors about whether their medication has been affected by the recall before taking any further measures.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.