The Food and Drug Administration (FDA) has updated the public on their ongoing investigation into the contamination of generic heart medication. A third type of toxin has been identified in certain lots of the drugs. Additionally, several companies have expanded their recalls of pills tainted by unwanted impurities that could cause cancer.
The FDA outlined possible causes of the contamination and promised to act swiftly to locate and remove all affected pills from the market. So far, thousands of lots of Valsartan, Losartan, and Irbesartan have been recalled. Though the risk of the toxins is thought to be low, more than 60 million Americans take 1 of these 3 drugs every day.
Known as angiotensin II receptor blockers, or ARBs, these popular heart medications are used to treat high blood pressure and heart disease. For people who take 1 of these drugs, the general guidance is to keep taking medication as directed. Do not change your routine without consulting first with your doctor or pharmacist.
Which Companies Expanded Their Recalls of ARBs?
The FDA maintains an up-to-date list of the recalls, complete with lot numbers and other identifying information. In the latest update, Torrent Pharmaceuticals and Aurobindo Pharma expanded their recalls after detecting tainted pills:
- Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets.
- Aurobindo recalled an additional 38 lots of Valsartan and Amlodipine/Valsartan tablets.
If consumers have concerns, they are encouraged to reach out to their physician. Contact information is also listed for affected manufacturers. Those who have experienced a problem or had an adverse reaction to their medication may report it to the FDA's MedWatch Adverse Event Reporting program.
What Impurities Have Been Detected in Heart Medication?
In the latest update, the FDA said that Hetero Labs Ltd. of India announced a recall of 87 lots of Losartan potassium tablets. Medications produced by Hetero are distributed in America by Camber Pharmaceuticals. The contamination in these batches of Losartan has been identified as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA).
NMBA is the third nitrosamine impurity identified by investigators in generic ARBs. Nitrosamines are a type of chemical compound that are thought to cause cancer in humans. Along with NMBA, 2 other nitrosamines have been detected: N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications,” said FDA Commissioner Scott Gottlieb. In response to the crisis, Gottlieb said scientists have developed more sophisticated methods to test for nitrosamines. What they have discovered is that:
“[T]he nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s [active pharmaceutical ingredient], and may also result from the reuse of materials, such as solvents.”
As of now, it remains unclear whether or not additional types of toxins will be discovered. In the wake of these recalls, scrutiny of the worldwide production of generic drugs has increased greatly. This is important, because it appears that under-regulated manufacturing processes could easily have led to the production of heart medication with such dangerous impurities.
Serious Red Flags at Facilities with Contamination
In 2016, days before inspectors from the U.S. Food and Drug Administration arrived at a Hetero Labs facility, employees began shredding documents. What were they shredding in such a hurry? From closed circuit footage the FDA inspectors reviewed, it appeared signed records of their manufacturing process were systematically destroyed. And that wasn’t all.
The inspection identified a number of potentially hazardous issues in their manufacturing process. They found equipment was not properly maintained, yet it was listed as “CLEANED.” Serious complaints about their products were not investigated thoroughly. Records of their processes were incomplete and inconsistent.
When questioned, facility managers were aware of these issues, but did not think they were important. They failed to explain a number of observations made by the investigators. Why had records been destroyed? Why were irregularities in the process not examined? Why did quality control personnel fail to follow-up on duties they promised to in writing?
When it comes to manufacturing drugs, every safe-guard put in place is there because small changes in the process can have unforeseen results. The FDA inspection of Hetero Labs identified many blind-spots generated by their lax protocols. By disregarding the standard procedures for monitoring production, it seems Hetero Labs left the door open to disaster.
Along with this complex and massive recall, the FDA has a backlog of foreign drug manufacturers to inspect. Clearly, there is no time to waste.