What blood pressure medicine did the FDA recall?

Blood pressure medicine

If you take medication to treat high blood pressure, you should check the medication label once more.

 

And if you feel like the phrase “blood pressure medication recall” is thrown around of late, you’re not wrong.

 

Since December 2018, the FDA recalled valsartan, losartan, and irbesartan, all blood pressure medications.

 

The latest was just a few days ago, and we’d be surprised if more recalls didn’t happen in the near Future.

 

Mid-February Losartan Recall:

 

On February 25th, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide (HCTZ) 100mg/25mg combination tablets by Macleods Pharmaceuticals, according to a safety announcement posted on the FDA’s official site.

Losartan was recalled because it contains N-nitrosodiethylamine, or NDEA.  NDEA has been designated as a likely human carcinogen; therefore, it could cause cancer.  NDEA is a byproduct of pesticide manufacturing and fish processing, and is also used to make liquid rocket fuel.

 

First Blood Pressure Medication Recall (12/20/18):

 

The blood pressure medication recalls first began in mid December.  Specifically, on December 20th the FDA alerted “patients and health care professionals to Torrent Pharmaceuticals’ voluntary recall of two lots of losartan potassium 100 mg tablets” (1)

This was also due to N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.

Importantly, not all Losartan tablets were recalled.  Only the tablets that “tested positive for NDEA above the acceptable daily intake of 0.27 ppm” were recalled (2).

 

Recalls Continued:

 

Following Torrent’s recall of losartan, Aurobindo Pharma announced a voluntary recall on January 2nd of this year.  The recall was of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets.

Similarly to the December recall, Aurobindo’s recall was due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan.

 

Between the last recall (2/25/19) and the first related recall (12/20/18), various losartan and irbesartan tablets were recalled by Torrent Pharmaceuticals, Solco Healthcare LLC, Teva Pharmaceuticals, and other pharmaceutical companies.

 

Ok, you get the point.  The recalls are all because of NDEA.

 

But What is NDEA?

 

Why is NDEA so bad?

With all the pharma recalls centered around high NDEA levels, it’s important to know what this tricky compound is, and why its so bad for you.

NDEA is short for N-nitrosodiethylamine. According to PubChem, NDEA is best described as a “synthetic light-sensitive, volatile, clear yellow oil that is soluble in water, lipids, and other organic solvents”.  The oil is used as a gasoline and lubricant additive, antioxidant, and stabilizer for industry materials.

Both PubChem and the NCI (National Cancer Institute) state that NDEA “is considered to be reasonably anticipated to be a human carcinogen” (3).

Yup, a human carcinogen.

Proof in the Studies:

Various studies show the compound’s harmful effects.

For instance, in December 2015, researchers from Aligarh Muslim University discovered that high doses of NDEA can cause significant injury to the liver and red blood cells in rats (4).  In turn, this injury leads to liver damage and liver cancer.

Another study published by the American Association for Cancer Research found similar results for NDEA exposure.

The researchers examined over 4000 rats that had chronically ingested NDEA.  The results confirmed prior worries.  “Even quite low dose rates of the test agents caused a variety of nonneoplastic liver abnormalities (e.g., hyperplastic nodules, or shrinkage of hepatocytes) at a frequency roughly proportional to the dose rate” (5).

Liver damaged was easily linked to very low exposures of NDEA in the rats.

The researchers also stated, “a dose of 1 ppm of NDEA or NDMA in the drinking water will cause about 25% to develop a liver neoplasm, a dose of 0.1 ppm will cause about 2.5% to do so, and a dose of 0.01 ppm will cause about 0.25% to do so, etc., with no indication of any “threshold (6).

Liver neoplasm= liver cancer.  And just 1 ppm of NDEA caused 25% of rats to get cancer.

Long-term studies of the compound’s ill effects haven’t been completed as of yet, but the FDA is still clear about the importance of avoiding NDEA altogether.

 

Conclusion:

Bottom line?

If you’re taking blood pressure medication, or considering taking it, be sure to do your research on relevant blood pressure medicine brands beforehand.  See if the medication your considering has any levels of NDEA.

Look into the medical company’s history.  Have they ever initiated a voluntary recall of a medicine before?

These questions should help you make the right decision on blood pressure medication.

Challenges with Medicine:

The recent NDEA recalls touch on an important part of science, and medicine in particular.  The field is constantly evolving, and as we strive for solutions subsequent challenges inevitably come up.

As mentioned earlier, NDEA is used in a variety of settings, including with gasoline, manufacturing, and other industrial processes.

NDEA likely facilitates and improves these processes.  But, exposure to the compound in other settings (i.e. drug tablets) isn’t guaranteed to be safe.  Rather, health implications of NDEA are largely unknown.

 

Ying-yang!

 

 

 

Have any questions?  Drop in the comment box below!

 

 

 

References:

 

(1,2)  //www.fda.gov/drugs/drugsafety/ucm613916.htm

(3) //pubchem.ncbi.nlm.nih.gov/compound/n-nitrosodiethylamine#section=Top

(4) //content.sciendo.com/view/journals/intox/8/1/article-p1.xml

(5, 6)  //cancerres.aacrjournals.org/content/51/23_Part_2/6415

Leave a Reply

Your email address will not be published. Required fields are marked *