Blood Pressure Medication Recall: the Issues

Recent Blood Pressure Medication Recall of Valsartan and Other Drugs - In June of this year, an online pharmacy filed a petition with the FDA, claiming to have found yet another cancer-causing chemical in blood pressure medications which fall under a blood pressure medication recall. The chemical dimethylformamide (DMF) was found in the common blood pressure medication valsartan, potentially triggering yet another valsartan recall. Novartis, the company which manufactures a brand name version of valsartan stated DMF is not found in its medications. This latest announcement follows a long string of blood pressure medication recalls, since the first batch was recalled more than a year ago.

Recently, the large pharmaceutical firm Teva Pharmaceuticals announced they would be recalling six more lots of the losartan potassium tablets—four 100 mg. strength and two 50 mg. strength. These particular cancer-causing blood pressure medications were sold exclusively to Golden State Medical Supply, Inc who then re-packaged the medications under their own label, selling them in bottles of 30 tables, 90 tablets and 1,000 tablets. In April, Teva initiated a voluntary blood pressure medicine recall of 35 lots of losartan potassium USP tablets—29 lots of 100 mg. strength, and six lots of 25 mg. strength.

According to company officials, the high blood pressure medication recall was due to the detection of an impurity of active pharmaceutical ingredient. The week before, Torrent Pharmaceuticals Limited recalled an additional 36 lots of losartan potassium tablets USP and 68 lots of losartan potassium/hydrochlorothiazide tablets USP. The high blood pressure medication recall was expanded to the “consumer level” due to traces of the same impurity found in the drugs. This was the fourth blood pressure medication recall since December 2018 of blood pressure medications manufactured by Torrent.  

These latest recalls of cancer-causing blood pressure medications among a long line of blood pressure medications pulled from shelves due to the detection of trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA), which has been classified as a substance which could potentially cause cancer. In February Camber Pharmaceuticals instigated a high blood pressure medication recall of 87 lots of losartan, and in January, Macleod’s Pharmaceutical instigated a blood pressure medication recall of losartan, after detecting NDEA, also classified as a “probable human carcinogen.” There have been many other high blood pressure medication recalls over the past year.

Voluntary Recalls by Teva Pharmaceuticals and Aurbindo Pharma USA - Teva is the latest firm to issue a high blood pressure medication recall of all amlodipine/ valsartan combination tablets as well as all amlodipine/valsartan/hydrochlorothiazide combination tablets. Teva says the medications were recalled as a result of the presence of N-nitroso-diethylamine (NDEA) which has been classified as a probable carcinogen. The contaminated ingredient was manufactured by Mylan in India.

The same contamination was detected by EU authorities which made the decision to suspend the use of Mylan’s valsartan in Europe. Mylan is the latest manufacturer to have their blood pressure drugs affected by NDEA or NDMA contaminants, after impurities were found in the Chinese firm Zhejiang Huahai Pharmaceuticals and Indian firms Hetero Labs and Aurobindo Pharma Limited (for losartan and irbesartan). In late December, Aurobindo Pharma Limited announced it was taking 80 lots of its amlodipine valsartan, valsartan HCTS and valsartan tablets from the market.

Why Did These Recalls Happen? In each case of a high blood pressure medication recall, a recalled drug was contaminated with NDMA or NMBA—chemicals which are believed to cause cancer in human beings. Some research also suggests that NDEA can cause blood cell damage and liver damage. NDEA is used to make rocket fuel and is also created by certain chemical reactions, and as a byproduct of industrial processes, such as the manufacture of pesticides, the making of rubber tires and fish processing. The FDA says the risk of getting cancer from the small amounts of NDEA and NDMA in the blood pressure drugs is small, although the amount of NDMA found in the recalled valsartan drugs exceeds acceptable levels.

Drug manufacturer records show the impurities could have been in the valsartan products for up to four years. The common thread among all these recalls is that the drugs or the drug ingredients were made in India or China. Since the 1990s, many American drug companies have used overseas factories to manufacture their drugs, and, in fact, as much as 40 percent of all finished medications are manufactured outside the United States. Nearly 8 out of 10 active pharmaceutical ingredients which are made into medications at other plants are also manufactured overseas.

The FDA is actively investigating how the drugs became contaminated; inspectors believe the contaminated compounds were unintentionally created through a chemical reaction. Experts advise anyone taking these recalled drugs to continue to do so, however, you should definitely contact your doctor or pharmacist. The threat from the contaminated drug could be less than the threat of discontinuing the drug. Your doctor or pharmacist will help you find a good alternative to your cancer-causing blood pressure medication.   

What Drugs Were Involved in the Recalls? There were many drugs involved in the blood pressure medication recall. There has been a valsartan recall, a losartan recall, an amlodipine recall, an irbesartan recall and a hydrochlorothiazide recall. Teva Pharmaceuticals and Aurobindo Pharma USA are just a couple of the manufacturers involved in these widespread high blood pressure medication recalls.

What are the Dangers of Valsartan and Other High Blood Pressure Medications? Valsartan is off patent and is used as a component in other generic medications, however, not all medications which contain valsartan are involved in the recall. The presence of the NDMA and NDEA in the recalled blood pressure medications was “unexpected,” according to the FDA, and believed to be related to changes in the way the active substance was manufactured. Nearly a year ago, twenty-two other countries issued recalls involving 2,300 valsartan batches which were sent to many different countries.

Those who have been taking valsartan, losartan, amlodipine, irbesartan and hydrochlorothiazide are now concerned about their risk of cancer. Patients also wonder whether they should only request brand name medications rather than risking generic medications, and if they should have any specific tests done.  It is important to know that not all medications which contain valsartan are included in the high blood pressure medication recall, because not all valsartan-containing medications were linked to the NDMA and NDEA impurities.

The medication Entresto, which is manufactured by Novartis and contains valsartan and sacubitril is not affected by the recall. The actual long-term risks associated with the NDMA and NDEA impurities are still somewhat unknown, although the amount of the impurities consumed could play a role in these risks. In other words, the dosage and the length of time the drug with the impurities was taken has an effect on the potential cancer risks.

The impurities have been found to affect the liver, causing liver fibrosis or scarring as well as liver tumors and liver cancer in rats, so it is assumed to be toxic to humans as well, however the rats were given the impurities in large quantities. The FDA told USA Today that the effects of taking the tainted medications could range from “limited” to “life threatening,” depending on the dose, the length of time the drugs were taken, and the individual’s health issues. The long-term health risks are largely unknown at this time.

It is important to note that a Danish study done in 2018 found that NDMA exposure can potentially cause liver cancer, stomach cancer, colon cancer, rectal cancer and pancreatic cancer. Historically, NDMA has been chosen as a method of homicide on occasion.  One example of this occurred in 1978, when a chemistry teacher attempted to murder his wife by mixing NDMA into her blackberry jam—he was convicted of attempted murder by a German Court. It is important to note that the NDMA levels used in that case were much, much higher than those found in the recalled blood pressure medications.

Are There Valsartan Lawsuits? There have already been valsartan lawsuits filed by patients who took contaminated valsartan. Patients who took these tainted drugs are claiming the companies made and sold drugs which were unsafe or defective. Elizabeth and John Duffy took contaminated valsartan and later filed a valsartan cancer lawsuit in New York against Solco Healthcare, Prinston Pharmaceutical, Walgreens, and Throggs Neck Pharmacy—all Valsartan manufacturers. The Duffy lawsuit alleges patients were misled and would not have bought the drugs if they knew they were contaminated and that valsartan-tainted drugs are worthless because they are contaminated with a carcinogen, therefore, not fit for human consumption.

A similar valsartan recall lawsuit was filed in New Jersey by patient Eric Erwin, against Prinston Pharmaceutical Inc., Solco Healthcare, Huahai US Inc., and Teva Pharmaceuticals, as well as the drug manufacturer, ZHP. There are more valsartan cancer lawsuits already filed and being filed. It is almost certain there will be all of the following in the near future: irbesartan lawsuit, irbesartan class action, amlodipine lawsuit, amlodipine class action, valsartan cancer lawsuit, valsartan class action, losartan cancer lawsuit, losartan class action, hydrochlorothorazide lawsuit, and hydrochlorothorazide class action.

Lawsuits such as these will likely ask for medical expenses, including any costs of cancer treatment or other necessary treatments resulting from the tainted medications, lost income due to illness, such as time off work or unemployment, future lost income, pain and suffering, mental anguish and emotional distress, and possibly even punitive damages. Those who want to file a valsartan lawsuit or other type of lawsuit for tainted blood pressure medication, should check to see if the FDA has their particular medication on the recall list and, if so, should check with their doctor for an alternative medication. It is advisable to keep careful records, including all medical and insurance records. You should keep the recalled valsartan, losartan, irbesartan, amlodipine or hydrochlorothorazide medication, as it could be evidence in the case. Finally, you should speak to a valsartan lawsuit attorney as quickly as possible to determine your best course of action.

How a Valsartan Lawsuit Lawyers Can Help - If you or a loved one have been harmed by tainted valsartan or other similar drugs, you may want to consider filing a valsartan lawsuit, a losartan lawsuit, an irbesartan lawsuit, an amlodipine lawsuit or a hydrochlorothorazide lawsuit. Speaking to a Sullo & Sullo valsartan lawyer can be very beneficial to your future. You may be entitled to receive damages after taking a recalled high blood pressure drug. We are highly experienced losartan cancer attorneys who will answer your questions related to your irbesartan recall lawsuit, helping you navigate the issues associated with an amlodipine lawsuit. Contact a Sullo & Sullo hydrochlorothorazide lawyer today, for highly qualified legal assistance with your amlodipine recall lawsuit.

Blood Pressure Medication Recall List - High blood pressure medications which had been recalled as of last October included those sold by Teva Pharmaceuticals labeled as Major Pharmaceuticals, Prinston Pharmaceutical Inc. labeled as Solco Healthcare LLC, Teva Pharmaceuticals USA labeled as Actavis, AvKARE (Teva/Actavis), RemedyRepack Inc. (Prinston/Solco), A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Bryant Ranch Prepack Inc. (Teva/Actavis), H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco), Northwind Pharmaceuticals (Teva/Actavis), Hetero Labs, Inc. labeled as Camber Pharmaceuticals, Inc., NuCare Pharmaceuticals Inc. (Prinston/Solco), RemedyRepack, Inc. (Hetero/Camber), AvKARE (Hetero/Camber), Preferred Pharmaceuticals, Inc. (Hetero/Camber), Torrent Pharmaceuticals Limited, and RemedyRepack, Inc. (Torrent). Since that time there have been many more high blood pressure medication recalls. Additional information about the specific recalled products, including doses, lot numbers and expiration dates, is detailed on the FDA's website, which can be accessed at this site:

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