In an unorthodox statement last week, the U.S. Food and Drug Administration (FDA) said it does not object to manufacturers continuing to distribute a slew of drugs involved in a wide-reaching blood pressure medication recall. Their announcement is in response to public concerns of a shortage of blood pressure medicine since the recall includes dozens of individual products from many different pharmaceutical companies.
There are so many recalled products, in fact, that the FDA has actually published a list of drugs that are NOT included in the recall to make it easier for consumers to recognize which drugs are affected.
Widespread Blood Pressure Medication Recall
Over the last several months, the FDA has added product after product to their recall because each one has been found to have of trace amounts of either:
- N-Nitrosodimethylamine (NDMA)
- N-Nitrosodiethylamine (NDEA), or
- N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
These three compounds are probable carcinogens, meaning they increase the risk of cancer. The FDA identified levels of these contaminants in three kinds of blood pressure drugs:
- Losartan-containing products
The drugs in the widespread blood pressure medication recall are part of a large class of drugs called angiotensin II receptor blockers (ARBs) which work by relaxing and widening blood vessels to lower blood pressure.
Not all ARBs contain the carcinogenic compounds. However, so many of this class of drug are included in the recall that the FDA has published four separate lists for consumers to navigate the danger:
- The list of recalled drugs containing valsartan
- The list of recalled drugs containing irbesartan
- The list of recalled drugs containing losartan-containing products
- The list of ARBS that have not been recalled
FDA Investigations Snowball the Massive Recall
The FDA began an investigation of the manufacturing process by which these drugs are made after identifying three companies producing five drugs contaminated with the carcinogens NDMA and NDEA. The agency hired dozens of chemists to review pharmaceutical companies and monitor their manufacturing processes.
Their investigation revealed the chemical process of combining raw materials under certain reaction conditions creates the carcinogens and contaminates the final pharmaceutical product. It also revealed a third cancer-associated compound, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) present in these blood pressure drugs.
ARBs manufactured domestically and abroad, and under both branded and generic pharmaceutical names, may contain the carcinogens.
Most pharmaceutical companies that make the three commonly prescribed blood pressure medications used the same chemical process to make the drugs. The FDA updated its current good manufacturing processes (CGMPs) for ARBs to avoid the conditions that allow carcinogens to remain in the final product.
Controversial FDA Advice for Consumers
On March 20, 2019, the FDA issued a statement announcing that it does not object to manufacturers continuing to distribute certain drugs involved in the blood pressure medication recall, even though they are known to the agency to contain the carcinogen NMBA.
The FDA is having to walk a fine line between their knowledge that these blood pressure medications may cause cancer and their repeated warnings that stopping these medications is dangerous. This is, of course, very confusing for patients. Presumably, the considerable news coverage the blood pressure medication recall has generated has led to the FDA’s statement addressing concerns of a drug shortage.
USA Today has published several articles about this recall, updating their audience every time the FDA added a new product to the list of dangerous drugs. In a follow-up piece about the dangers patients face if they stop taking their medication, USA Today pointed out the types of blood pressure drugs in this recall are usually a doctor’s first choice of treatment for high blood pressure.
Since this class of drug is the first line of therapy for patients with high blood pressure, the drugs are not only widely used by consumers, but also may leave physicians scrambling to find other safe treatments for their patients since the FDA has deemed the majority of ARBs unsafe.
The enormous scope of the blood pressure medication recall may very well mean a shortage of the products on the short list of safe ARBs.
This being the state of things, it’s not surprising the FDA decided to issue a statement addressing the possible shortages. Considering the possibility of a shortage, essentially, began with the FDA investigations and subsequent recalls. Not surprisingly, the agency is receiving backlash on their recent statement.
Why Would the FDA Advise Americans to Consume Carcinogens?
Essentially, the FDA says it’s safer for consumers to take the possibly carcinogenic drugs than to stop taking their blood pressure medication altogether. The risks of stopping blood pressure medication are quite serious and include:
- Heart attack
According to the FDA, taking the contaminated pills for the period of time it will take to overcome the medication shortages will not carry a “meaningful” increased risk of cancer. They expect the supply of contaminant-free ARBs to bounce back in about six months.
The FDA statement also specifies manufacturers may only distribute the recalled losartan drugs containing NMBA between 0.96 parts per million (ppm) and 9.82 ppm. They say taking losartan with NMBA at 9.82 ppm carries a lower increased risk of cancer than a lifetime of taking the drug with the maximum acceptable threshold of 0.96, which indicates that these certain recalled products are just as safe over the short-term as those products that have not been recalled.
What is the Risk to Consumers?
The primary reason so many products are included in the blood pressure medication recall is because these products have been on the market for four years. The FDA’s calculated risk of advising consumers to take the medication with impurities carries the hugely important disclaimer that the risk is only acceptable over the short-term.
Americans who take medication for high blood pressure have been exposed to carcinogens in their medication, not for the short term, but for four years.
Regarding the actual risk to consumers over these four years, the FDA noted that the drug would cause one additional case of cancer in 8,000 patients who took the highest possible dosage of 320 mg of valsartan. The additional case would be one more than the usual rate of about 38 percent.
I.e. using this drug, 3,041 people would get cancer instead of the 3,040 who would get it without the drug.
Though that statistic seems reassuring, there is:
- No similar calculation to quantify the risk for consumers exposed to NDEA
- No similar calculation to quantify the risk for consumers exposed to NDMA
- No similar calculation regarding irbesartan or losartan-containing products
- No information available about the frequency with which consumers would have received contaminated prescriptions since sources of the medicine can vary with where the consumer filled the prescription.
The cancers associated with NDEA are liver and lung cancer, the biggest risk being damage to the liver.
What to Do if You Take Blood Pressure Medication
First, as the FDA advises, you should not stop taking your medication without consulting your physician. Abruptly stopping your blood pressure medication can be dangerous or even life-threatening.
If you take one of the many drugs in this blood pressure medication recall, speak with your doctor or pharmacist about alternatives. Be sure to ask them about the carcinogen content present in any particular prescriptions you normally take. There are still safe ARBs on the market, though their availability is limited.
It is possible that your doctor may prescribe you a different class of drug such as an ACE inhibitor instead of your usual ARB so you don’t run into problems with the expected shortages.
Consider Contacting a Dangerous Drug Attorney
If you or a loved one has developed cancer while also taking ARBs to manage blood pressure or another medical condition, speak to an attorney to evaluate your experience. You may have a claim for monetary compensation for your illness, as well as any related medical bills or lost wages.
To find out more, contact the dangerous drug attorneys at Drug and Device Watch. Your initial consultation is free and confidential. Schedule your consultation by submitting our online form, or by calling us at 1-888-458-6825.