Another Blood Pressure Drug Valsartan Recalled for Possible Cancer RiskFebruary 6, 2019
According to a new, updated report from USA Today, the Food and Drug Administration is now investigating the causes of impurities known to be carcinogenic in multiple blood pressure and heart medications. Aurobindo Pharma USA, Inc voluntarily recalled 80 lots of valsartan tablets containing N-nitrosodiethylamine (NDEA)—classified as a possible human carcinogen. Patients taking the drug are advised to contact their physician to find an alternative medication however are warned not to stop taking the drug until a suitable substitute is prescribed.
A pattern of problems has surfaced following factory inspections of facilities in China and India related to blood pressure/heart medication drugs valsartan, losartan and irbesartan. In some cases, these drugs were used in combination with other drugs, while in others they were used alone. The most recent recalls of these blood pressure drugs include:
- Eight lots of irbesartan, manufactured by Zhejiang Huahai Pharmaceuticals were recently recalled due to possible cancer risks.
- Teva Pharmaceuticals voluntarily recalled two blood pressure drugs in November 2018 over cancer concerns.
- Torrent Pharmaceuticals, an India-based drug company, recently recalled eight lots of losartan potassium tablets in addition to the two recalled in December 2018. The medication, which is used for blood pressure as well as diabetic kidney disease, was found to contain unacceptable levels of N-nitrosodiethylamine—a known human carcinogen.
- Hetero Labs, also in India, was forced to recall several commonly-prescribed blood pressure drugs since last July, including irbesartan, valsartan and losartan.
- Sandoz Inc. recently recalled Losartan Potassium hydrochlorothiazide when the impurity N-nitrosodiethylamine as found in the drug, causing cancer concerns. Affected Losartan tablets were those with the lot number JB8912, expiration date June 2020.
- Prinston Pharmaceuticals recalled one lot of irbesartan tablets and seven lots of irbesartan HCTZ tablets due to high levels of NDEA—the ingredients for the drug came from China’s Zhejiang Huahai Pharmaceuticals.
- In August, an expanded recall of valsartan was announced by the FDA due to concerns of cancer-causing impurities.
FDA Examining Backlog of Foreign Drug Plants
The FDA is currently attempting to examine a backlog of “unchecked foreign drug plants” amid the ever-increasing overseas pharmaceutical industry. Although N-nitrosodiethylamine is a substance which can occur naturally in drinking water, it is more often found in air pollution and industrial processes and has been classified as a probable human carcinogen by the International Agency for Research on Cancer.
Does the FDA Stamp of Approval Guarantee Safety for Consumers?
In an interview with USA Today, the commissioner of the FDA, Scott Gottlieb, said these recalls of blood pressure medications in the United States reflect an agency goal of ensuring no impurities are present in our prescription medications. While we certainly want to believe that an FDA stamp of approval means the prescription medications we take are safe, unfortunately, this is not always the case. In fact, according to a 2017 CNN report, as many as one-third of the drugs approved by the FDA between 2001 and 2010 were involved in some level of “safety event” after being marketed to consumers.
During that time period, manufacturers were forced to add 61 black box warnings to medications to call attention to serious or life-threatening risks and of 222 novel therapeutics which garnered FDA approval, there were 123 post-market safety events involving 71 products which required FDA action. Three of the new prescription medications were subsequently withdrawn from the market.
Which Drugs are Most Likely to Be Recalled?
The CNN report found that drugs used to treat mental illnesses, as well as those which were approved under an accelerated approval process had higher numbers of adverse events than other prescription drugs. The majority of the prescription drugs required 1,000 or fewer patients in a drug trial to receive FDA approval—although FDA officials say “blockbuster drugs” which are prescribed to large numbers of people are typically tested on a larger population prior to approval.
How Many Problems are Associated with Newly Approved Prescription Drugs?
The International Journal of Health Services found that more than two million serious, adverse drug reactions occur each year in the United States, causing an estimated 100,000 deaths. Many drug safety issues come to light only after the drugs receive FDA approval. In fact, in the first 16 years following a drug approval by the FDA, there are 27 market withdrawals and black box warnings issued for every 100 newly-introduced drugs. Drugs which are withdrawn have a median time from FDA approval to removal from the market of about five years.
Helping Clients Who Have Suffered Injury from a Dangerous Drug
The CDC estimates that as many as 1,000 deaths each day are the result of high blood pressure; as many as 7 out of 10 U.S. adults with high blood pressure use medications to treat the condition. With numbers this high, the blood pressure drug recalls are particularly alarming. Clients who have suffered injury as a result of taking a dangerous blood pressure drug—or other prescription drug—can be limited in their ability to meet related medical expenses, however USClaims can help. The pre-settlement funding offered by USClaims can help your clients pay the unexpected expenses related to their dangerous drug injuries in anticipation of a court judgment or settlement. Call 1-877-USCLAIMS today for the information you and your clients need and deserve.