Patients with high blood pressure can expect a more severe shortage of the medications they take to manage their condition. Last week, Torrent Pharmaceuticals Ltd. announced an expansion to the already gigantic losartan recall currently in place.
Drug and Device Watch details the initial cause of the losartan recall in the article titled “FDA Controversial Advice: Take Probable Carcinogens During Blood Pressure Medication Recall.” The initial recall was issued after carcinogenic compounds were found in products used to manufacture the medications.
Sweeping Recall of Blood Pressure Medications
The medications at the center of this ongoing losartan recall are all part of a class of drugs called angiotensin II receptor blockers (ARBs), which are used to treat high blood pressure. This class of drug is the top choice for doctors to treat hypertension. It is also frequently prescribed for complications relating to Type 2 diabetes.
Over the past several months, drug manufacturers have recalled dozens of ARBs for contamination with one or more of the following cancer-causing compounds:
- N-Nitrosodimethylamine (NDMA)
- N-Nitrosodiethylamine (NDEA)
- N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
The massive recalls apply to both brand name and generic ARBs containing:
- Losartan-containing products
To date, there have been more than 75 individual recalls of ARB medications since the problem first appeared in 2018.
After the FDA discovered probable human carcinogens in ARBs, the agency investigated the manufacturing process of the contaminated drugs. They discovered a common theme. An unexpected chemical reaction among the raw materials that contaminated the final product with carcinogens.
Almost all losartan products were manufactured by the same process until recently when the FDA investigation prompted an update to the agency’s guidelines. The update was specific to manufacturing standards of blood pressure medications. The recalls removed an enormous portion of the drugs from the market. Now, changing the manufacturing process will take time.
Newest Losartan Recall Announcement
The most recent losartan recall is from Torrent Pharmaceuticals. This is not their first entry of appearance in the losartran recall saga. Since August 2018, the company has expanded its list of products in the losartan recall no fewer than seven times.
This single company issuing more than half a dozen recall expansions in as many months is the perfect example of how confusing this expansive process has been for high blood pressure patients. As of April 19, Torrent Pharmaceuticals announced its newest wave of recalled losartan products:
- 36 lots of losartan potassium tablets
- 68 lots of losartan potassium/hydrochlorothiazide tablets
That is a total of 104 additional lots of recalled blood pressure medication that are now on the U.S. Food and Drug Administration’s (FDA) master list of drugs in the losartran recall.
Like all the other ARBs pulled from the market, Torrent is recalling these lots because they have detectable levels of carcinogenic compounds. In this case, the active pharmaceutical ingredient contains N-Methylnitrosobutyric acid (NMBA).
At this time, consumers have not made any adverse reports to the FDA in connection to these contaminated medications, but the tablets in these lots contain higher than FDA-accepted levels of contaminants and must be recalled. Victims of exposure to the medication may be forthcoming. The cancers associated with the drugs in the losartan recall are primarily lung and liver cancers, with some compounds also capable of causing blood disorders.
A Shortage in Blood Pressure Medications
The widespread problem with the manufacturing process, combined with the huge consumer demand for these drugs, provides conditions ripe for a medication shortage. Since these medications are intended to treat serious conditions, it is simply not an option for patients to stop taking them if they expect to maintain their health. Medical providers and pharmacists all over the country have been scrambling to find alternative treatments to keep their patients safe.
In 2016, doctors wrote 60 million prescriptions for losartan drugs. Around 14 million Americans filled prescriptions for a drug containing losartan, and 3.6 million filled prescriptions for irbesartan. Assuming each of those prescriptions were for a unique individual, those numbers represent almost 21 percent of the nation’s population.
Many Americans rely on this class of drugs to manage their health. That led to the FDA fast-tracking approval of a new generic ARB product. This was done with the intent to relieve the shortages. As of this month, there are 40 blood pressure medications on the FDA’s list that are free from contamination.
Who is at Risk and the Odd Advice from the FDA
As mentioned above, a significant portion of the American population uses ARB drugs. Patients affected by the losartan recall include those with a diagnosis of high blood pressure (hypertension). Some patients with a diagnosis of Type 2 diabetes complicated by nephropathy (kidney damage) may also feel the effects.
Because each of these conditions is quite serious, the FDA is urging consumers to continue taking the contaminated product until their doctor changes their treatment. According to the agency’s repeated warnings throughout this losartan recall, the risks associated with going without treatment far outweigh the risk of developing cancer while taking the drug.
The FDA stands by that risk/benefit analysis so steadfastly that the agency issued a statement allowing for the continued distribution of some losartan products known to be contaminated. The FDA expects the safe supply of blood pressure medication to bounce back within about six months. Their recommendation is that taking the drugs containing a certain level of contamination for that period is not a significant increase in the risk the patient will develop cancer.
Consumers who regularly take losartan products have been unwittingly exposed to carcinogenic substances in their medication for four years, which is long before the FDA identified the contamination. The agency has not published a calculation disclosing how much the risk increases over years of exposure. It is safe to assume, however, that there is even more risk than we know.
In April 2019, the FDA did announce new testing practices for manufacturers to more efficiently detect carcinogenic impurities in these medications. The hope is the avalanche of losartan recalls is nearing an end.
What to Do if You Take ARBs
If you take an ARB that is included in the losartan recall, there is no doubt you have concerns about your health. Never stop taking a prescribed medication without consulting your healthcare provider. In the meantime, consider the following:
- Cross-reference your prescription with the FDA’s list of 40 safe medications.
- Patients taking losartan should continue taking the prescription, because stopping it immediately could endanger health.
- If you have had an adverse experience due to the medications included in the losartan recall, report it to the FDA’s MedWatch Adverse Event Reporting program.
- If you have suffered harm related to taking a losartan product, contact an attorney to learn about your rights as a consumer.
Americans have every right to expect that prescription medications will treat their ailments, not cause them serious harm. The thought that a medication made to improve health could cause cancer is beyond alarming.
Legal Support for Consumers
The FDA, drug manufacturers, and international regulators have all failed the American consumer by allowing contaminants to risk their health. It is inevitable that these failures have caused harm to consumers.
At Drug and Device Watch, we have followed this losartan recall every step of the way. As victims come forward, our team of attorneys is here to help. We can offer support, advice, and guidance for protecting your rights.
If you or someone you love is being treated for adverse events due to a losartan product, contact us for a free consultation. Call 1-888-458-6825, or fill out our online form.