The U.S. Food and Drug Administration has announced that a company recalled nearly 581,000 bottles of the blood pressure medication prazosin hydrochloride.
According to the Associated Press, the recall was initiated “over concerns it may include a cancer-causing chemical.”
- The FDA’s page for the recall says it was voluntarily initiated.
- It’s a nationwide recall initiated by Teva Pharmaceuticals USA, Inc., of New Jersey.
- In addition to blood pressure, the medication is used for nightmares and post-traumatic stress disorder sleep problems, the AP reported.
- The recall is for Prazosin Hydrochloride, capsules, 1mg, 2 mg and 5 mg USP. Prescription only.
Why Was the Blood Pressure Medication Recall Initiated?
The reason given for the recall is “CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.”
The recall derives from N-nitrosamine impurities, according to the AP.
The FDA revealed that the agency “has classified the affected lots of the recalled drug as a Class II risk,” CBS News reported, because “some of the medication may have nitrosamine impurities that are considered potentially carcinogenic.”
In 2024, the FDA issued guidance relating to “steps manufacturers of active pharmaceutical ingredients (APIs) and drug products should take to detect and prevent unacceptable levels of nitrosamine impurities in pharmaceutical products.”
What Are Nitrosamine Impurities?
According to the FDA, the agency “has been investigating the presence of impurities, called nitrosamines, in some types of medications. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines.”
The FDA noted: “Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time, but a person taking a drug that contains nitrosamines at-or-below the acceptable daily intake limits every day for 70 years is not expected to have an increased risk of cancer.”
How Many Americans Have High Blood Pressure?
According to the FDA, “nearly half, more than 119 million, American adults have high blood pressure. But only about 1 in 4 of those people have their condition under control.”
Many people “develop high blood pressure when they are in their late 30’s or early 40’s, and it occurs more frequently as people age,” the FDA says.
However, more children are developing high blood pressure due to obesity, the FDA reports.
(Photo by Yuri CORTEZ / AFP) (Photo by YURI CORTEZ/AFP via Getty Images)
“Blood pressure is defined as the force of blood pushing against the walls of the arteries as the heart pumps blood. High blood pressure – also known as hypertension – is a disease in which blood flows through blood vessels (arteries) at a higher-than-normal pressure,” the FDA wrote.
According to the FDA high blood pressure can kill. “High blood pressure puts you at an increased risk for heart disease, heart failure, and stroke, among other things,” notes the FDA.
“There are several types of medications that treat high blood pressure,” the FDA wrote.
