If you have been diagnosed with high blood pressure, a condition that affects around 116 million Americans according to Cleveland Clinic data, it is important to note that the U.S. Food and Drug Administration (FDA) has issued a warning regarding a specific medication for this condition. This medication has the potential to cause long-term health issues of a different nature.
On December 6, the FDA issued a recall for Nebivolol Tablets, produced by Aurobindo Pharma USA Inc., a company located in East Windsor, NJ. This recall comes in the wake of recent recalls on lisinopril and ramipril. The FDA has not disclosed the exact quantity of Nebivolol Tablets affected by the recall.
Nebivolol, classified as a type of beta-blocker, is the generic form of the hypertension drug Bystolic. While it is most commonly prescribed to regulate the heart and circulatory system, beta-blockers can also be used to treat conditions of the brain and nervous system, according to the Cleveland Clinic. In fact, in 2022 alone, nebivolol was prescribed over 3 million times, as reported by a pharmaceutical trade outlet.
The medications that have been recalled were distributed in 30-count bottles of tablets with a dosage of 2.5 milligrams (mg). These medications can only be obtained with a prescription. To identify whether a product is affected by the recall, consumers can refer to the information provided on the drug’s label.
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- Lot numbers: NB0224001A and NB0224001B
- Expiry date: April 2027
- National Drug Code (NDC): 59651-137-30
The recall was initiated after deviations from Common Good Manufacturing Practice (CGMP), which ensures quality control, were found. It was discovered that the blood pressure controlling tablets contained high levels of N-Nitroso Nebivolol, a cancer-causing impurity known as a Nitrosamine.
Nitrosamines are organic compounds that can be detected at low levels in various sources, including our water and food supply, such as meat, vegetables, and dairy products, as revealed by an FDA investigation. In a concerning development, an extensive recall of a widely used class of antidepressant medications was initiated after elevated levels of nitrosamines were found in over 230,000 bottles. These medications belong to the category of selective serotonin reuptake inhibitors (SSRIs).
According to the FDA, exposure to certain nitrosamines above acceptable levels and over long periods of time may increase the risk of cancer. However, it is important to note that the effect of nitrosamines on cancer risk would only occur with prolonged ingestion of high levels. The FDA also states that individuals who consume nitrosamines at or below the acceptable intake limits on a daily basis for 70 years are not expected to have an increased risk of cancer.
Other scientists are expressing concern about the increasing problem of nitrosamine contamination in medications, as they are not fully convinced of the compound’s safety. According to a study published in the Journal of Pharmaceutical Analysis in 2023, the presence of N-nitroso compounds, especially N-nitrosamines, in pharmaceutical products has raised global safety concerns. These compounds have significant genotoxic and mutagenic effects, making them highly toxic and capable of damaging DNA. Even in trace amounts, nitrosamine impurities can increase the risk of cancer incidence.
When used on its own or in conjunction with other medications, this drug affects the way certain parts of the body, including the heart, respond to nerve impulses. As a result, the heart beats at a slower rate and blood pressure decreases. This decrease in blood pressure leads to an increase in the amount of blood and oxygen that reaches the heart.
The FDA advises against abruptly stopping your medication if it has affected your personal stock. It is important to have a discussion with your healthcare provider before making any decisions. Your healthcare professional has a comprehensive understanding of your health and medical history, and can guide you in making the most suitable choices for your care.