A generic drug packager has issued a valsartan combination recall for three different medications for blood pressure. This valsartan combination recall affects those medications that the manufacturers believe could include small amounts of a potentially cancer-causing impurity.

Anyone currently taking combination valsartan drugs should pay attention to the news since more recall details are emerging each month. Many companies are concerned about the potential risk with contamination, since the contaminants are carcinogens.

People taking these valsartan medicines on a daily basis might not realize they could be increasing their cancer risk by taking the drugs as prescribed. The latest valsartan combination recall could affect patients all over the U.S. since it adds to the total number of recalls that have already impacted valsartan-containing drugs.

All of the recalled drugs in the valsartan combination recall are blood pressure medications that contain valsartan. Some of them combine valsartan with other cardiovascular drugs.

Valsartan Contamination

Valsartan has been subject to numerous recalls by several drug companies since July when a report revealed that the valsartan could have been contaminated by NDMA or NDEA.

More recently, Mylan Pharmaceuticals recalled 104 lots of three different medications in the valsartan combination recall. These include combination tablets with valsartan and hydrochlorothiazide, valsartan and amlodipine, and valsartan tablets. Testing of the drugs identified in the valsartan combination recall identified trace amounts of NDEA, a potential human carcinogen.

Hydrochlorothiazide and amlodipine alone are not subject to the recall, but because of their combination with valsartan, these medications have been named in the medication notice.

Getting a doctor’s advice about what to do next rather than stopping the medication regime suddenly is recommended if you are a person taking drugs listed in the recall. Alternative medications are available for those who might have been taking drugs under the valsartan combination recall.

Although the level of risk due to this impurity it is not yet known, many of these drugs have been recalled in order to remove the risk to consumers.

Contamination Source

Currently, the Food and Drug Administration is investigating the cause of the contaminated drugs.

To date, the contamination has been traced to a small factory in India and a larger factory in China. Similar manufacturing processes were used to make the drugs included in the valsartan combination recall and valsartan was supplied from those factories to generic drug companies around the world.

Testing at those factories identified NDMA, a potential human carcinogen. FDA testing revealed that a second contaminant, NDEA, was also in certain valsartan drugs, including those named in the valsartan combination recall.

Numerous pharmaceutical companies have already taken an action to announce recalls of valsartan, losartan, and Irbesartan. These blood pressure medications work by relaxing or widening blood vessels and lowering a patient’s blood pressure.

Potential contamination with impure valsartan could increase a patient’s risk of developing cancer in the future. The FDA has shared reports that the company supplying the contaminated drugs included in the most recent valsartan combination recall has been placed on import alert, which means that their products are no longer being shipped to the United States from factories abroad.