In July of 2021, the FDA announced that it was looking into the recall of Amlodipine due to possible NDEA impurities. The NDEA impurities were related to the antidepressant clonazepam. This article will discuss the specifics surrounding the recalled Amlodipine lawsuit and the implications for the manufacturer.
An Amlodipine Lawsuit
In a nutshell, the NDEA lawsuit refers to the generic version of the blood pressure medication clonazepam, known as Acomplia. It was manufactured by AstraZeneca and is one of the valsartan medications used for treatment of hypertension.
The FDA was alerted in June of 2021 after two men developed serious side effects from using the Acomplia, which included confusion, memory loss, hallucinations, and hypotension. As a result, the manufacturer issued a voluntary recall of all amlodipine products containing Acomplia.
The FDA notified all pharmaceutical manufacturers and suppliers of the recalled drugs.
The agency also provided them with instructions for handling the drugs and advised them on the correct storage and use. Unfortunately, many of the drugs that contained Acomplia had already been subjected to leakages prior to the recall. Based on these leakages, as well as analysis of the actual levels of Acomplia in recalled samples, the FDA decided to ban all Acomplia products, including valsartan and hydrochlorothiazide.
While valsartan and hydrochlorothiazide are commonly used to treat various cardiovascular conditions, the FDA found that these drugs contained unreported amounts of Acomplia and other undeclared AEDs, such as phenytoin and warfarin. Because these drugs had already been subject to leakages before the recall, and the levels of Acomplia and other drugs in recalled samples were still significantly higher than standards set by the FDA, the agency announced the ban on all Acomplia products.
Although the FDA cited many reasons for the recall, only one manufacturer was being charged with negligence.
The company responsible for producing the pills, Genivia, was charged with several counts of violating federal drug regulations, as well as misbranding and advertising impurities. The company has settled all claims against it and agreed to a full refund of all paid products.
The company faces a total of four lawsuits in connection with this case, and it is unknown if or when it will be able to resume manufacturing. In addition to the monetary charges, however, the FDA is threatening to shut down the facility that manufactured the medications if the company cannot prove that it will not sell any tainted drugs once again.
A similar tablet produced by a different company was the subject of a separate lawsuit.
The generic name for this tablet was Metafate, and the generic name for the ingredient used in the tablets, calcium channel blocker, was Thioctic. This case was settled out of court, without the defendants providing any admission of wrongdoing.
In this settlement, the company admitted it did intend to use the inappropriate names for the tablets (and did so improperly), but still went ahead with the sale. The company is appealing the court’s decision.
The FDA is also currently involved in a number of other, smaller recalls.
A batch of diabetes drugs was recalled last fall due to benzhydrine being mixed with the medications it was intended to contain. There were no immediate reports of serious injury resulting from the mix, but the FDA is still investigating the incident. Other drugs have been recalled due to impurities in the fillers used to manufacture the drugs.