Cancer Risk Prompts Blood Pressure Drug Recall

Under pressure from the Food and Drug Administration, Lupin Pharmaceuticals agreed to stop selling Quinapril, a popular blood pressure drug.

blood pressure drug

“Everyone is exposed to some level of nitrosamines,” officials stated. “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.” Patients taking Quinapril should discuss their treatment plan and/or alternative medicines with their doctors.

Lupin said it stopped making the drug in September 2022 and was working with distributors to arrange for the return of the recalled product lots.

Nitrosamine Contamination Nitrosamines are among the most common and deadly industrial by-products. Nitrosamines like NDMA (N-Nitrosodimethylamine) often appear in a wide variety of products, ranging from processed meats to rocket fuel.

Most of these chemicals are forever chemicals, meaning they are extremely stable and the body cannot naturally remove these toxic substances. So, the safe exposure levels are extremely low. There is no definitive nitrosamine/cancer link. However, according to the FDA, there is a probable link if someone is exposed to acceptable levels or for a long period of time. A probable link is enough for a New York personal injury attorney to prove causation, which in this case is a connection between nitrosamine and cancer by a preponderance of the evidence.

The burden of proof is low in these claims. However, drug companies have almost unlimited resources. These companies earned over $550 billion in 2021, allowing these companies to retain high-priced lawyers and expert witnesses. Therefore, dangerous drugs and other such claims usually involve bitter fights.

Will FDA Recall Blood Pressure Drug?

The FDA only recalls dangerous drugs and devices as a last resort.

Furthermore, the FDA cannot unilaterally recall dangerous products. The FDA can only publicly pressure companies to voluntarily recall hazardous products or add additional warnings to them.

Your Legal Options

We mentioned the two most common legal options in dangerous drugs and other such cases above: failure to warn and defective products. A few other legal theories, such as public nuisance and inherently dangerous activities, are available in some cases.

Public nuisance claims short-circuit one of the most common defective product defenses. These companies argue that since government inspectors proclaimed they were safe, their products cannot be defective as a matter of law. This defense often doesn’t hold up in court. As discussed above, the FDA often approves drugs, foods, and devices for financial reasons instead of safety reasons.

In New York and most other states, plaintiffs may bring one of two defective product actions in court:

  • Design Defect: Powerful drugs can have powerful side effects that are sometimes worse than the original illness. However, that doesn’t stop companies from selling such products.
  • Manufacturing Defect: NDMA contamination is a manufacturing defect. Certain drugs, like Zantac, that are stored at room temperature for too long become tainted with NDMA. Usually, manufacturers are responsible for all defects that occur before the product appears in retail.

    Contact Napoli Shkolnik today for a free legal consultation.