The recall of popular blood pressure drug valsartan is being expanded following the discovery of a cancer-causing substance in medications made by additional manufacturers in China and India.
Meanwhile, consumers are questioning the effectiveness of the earlier recall, with some expressing frustration in their attempts to get replacement drugs.
At issue is N-nitrosodimethylamine (NDMA), regarded as a probable cancer-causing substance. In July, it was detected in batches of valsartan using ingredients supplied by a Chinese company, Zhejiang Huahai Pharmaceuticals.
Now the U.S. Food and Drug Administration (FDA) says that NDMA has been found in ingredients supplied by a second company, Zhejiang Tianyu Pharmaceuticals. In addition, the recall is being extended to some valsartan products made by Hetero Labs Limited, in India, labeled as Camber Pharmaceuticals Inc.
A complete FDA list of recalled valsartan medications is available here.
Don’t stop taking it
Health officials emphasized that patients should not simply stop taking their valsartan. Instead, they should check with their physician, who may prescribe an alternative, or with their pharmacist, who may be able to supply a version that has not been recalled.
Valsartan is used to treat high blood pressure and heart failure — both serious diseases that can have dire consequences if left untreated.
“There is no immediate risk to patients. Patients should not stop taking any valsartan medicines without consulting their doctor or pharmacist,” the European Medicines Agency said in an advisory. EMA is the European equivalent to the FDA.
Lower NDMA concentration
EMA also said that the NDMA levels detected in batches of valsartan from Zhejiang Tianyu are much lower than levels seen in the active substance from Zhejiang Huahai, which triggered the earlier recall.
The FDA said levels of NDMA was also lower in the results from Hetero Labs of India.
“Test results from Hetero Labs shows the amount of NDMA found in its valsartan API exceeds acceptable levels; although it is generally lower than the amount discovered in the API manufactured by Zhejiang,” the FDA said in its August 9 update.
Consumers have complained that they have met with little or no help in trying to get replacements for their valsartan.
One consumer said his mail-order pharmacy, PillPack, notified him of the recall but offered no advice, other than to contact his physician.
Nothing further happened and, for whatever reason, the doctor’s office said it was not contacted by PillPack. Instead, it forwarded a prescription for a different drug to a local pharmacy. PillPack then sent an email “confirming” that valsartan would be included in its next monthly shipment.
Other consumers said they had received conflicting advice from their physicians and pharmacists.