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Ashley Quigley of Portland, left, takes the blood pressure of Samsam Dahir of Portland. (Shawn Patrick Ouellette / Portland Press Herald photo team via Getty Images)
Do you have an idea of what is in this blood pressure medications? Take away the "I" from an idea and you've got a NDEA. That's the chemical that seems to have some contaminated lots of blood pressure medications.
NDEA is short for N-nitrosodiethylamine. PubChem describes NDEA as a "synthetic light-sensitive, volatile, clear yellow oil that is soluble in water, lipids, and other organic solvents," which is "used as a gasoline and lubricant additive, antioxidant, and stabilizer for industry materials." The description also mentions NDEA emitting "toxic fumes" when heated to a high enough temperature and used in the lab to cause liver tumors for experiments. Then, there is this sentence: "it is considered to be reasonably anticipated to be a human carcinogen."
Yes, this last sentence is not written in the most definitive manner. Imagine telling your significant other, "you are "Nonetheless, it is safe to say that there are cancer-related concerns about NDEA.
Apparently, trace amounts of NDEA have appeared in irbesartan tablets sold by Sciegen Pharmaceuticals, Inc. NDEA is not normally supposed to be part of such medications. So trace amounts would be contamination or an impurity. This impurity has prompted the company to voluntarily recalling specific lots of irbesartan tablets (USP 75 mg, 150 mg, and 300 mg dosage forms), According to the U.S. Food and Drug Administration (FDA).
Here is the renin-angiotensin system that helps regulate the constriction of blood vessels and blood pressure. (Photo by: Encyclopaedia Britannica / UIG via Getty Images)
Irbesartan is an angiotensin II receptor blocker (ARB). Although it seems like a movie, Angiotensin II is actually a hormone thatngiotensinogen. Renin, a hormone produced by your kidneys, then converts angiotensinogen into angiotensin I. Next, an enzyme called angiotensin-converting enzyme (ACE) produced by your lungs converts angiotensin I into angiotensin II. Angiotensin II then can bind your receptors in your blood vessels throughout your body, causing your blood vessels to tighten. This process helps regulate blood flow throughout your body. However, high blood pressure can occur when your blood vessels are too narrow, which can occur when vessel walls get too stiff or thickened. ARBs such as irbesartan can block these angiotensin II receptors, thus relaxing and widening your blood vessels. That is why doctors use ARBs to control high blood pressure and improve blood circulation for patients with weaker hearts.
If this seems a bit like already seen all over again, it can be considered to be. A couple months ago, the FDA had announced that Torrent Pharmaceuticals Limited was voluntarily recalling a different type of ARB, valsartan. The recall included valsartan tablets and those combined with Amlodipine and hydrochlorothiazide. In this case, the impurity was N-nitrosodimethylamine (NDMA), another chemical that "is reasonably anticipated to be a human carcinogen. " Zhejiang Huahai Pharmaceuticals had manufactured these medications.
Should you be "reasonably anticipated" to worry about this news? "Trace amounts" alone is probably not of huge concern. Scientists use much higher concentrations of the chemicals to induce tumor growth in the laboratory. It is not completely clear how much exposure to NDEA or NDMA can lead to cancer in humans, and the threshold is likely to vary. However, the larger issue would be cumulative exposure over time. If you are exposed to these chemicals or other factors, could you add the effect? That's why you want to minimize such "impurities" in your medications as much as possible.
These 2 recalls highlight the importance of monitoring manufacturing processes and supply chains for medications. Impurities could not be used in every process. If you are outsourcing any part of these processes, make sure that After all, finding a chemical in your medication that can be expected to be a human carcinogen and is normally found in gas, is not a gas.
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Ashley Quigley of Portland, left, takes the blood pressure of Samsam Dahir of Portland. (Shawn Patrick Ouellette / Portland Press Herald photo team via Getty Images)
Do you have an idea of what is in this blood pressure medications? Take away the "I" from an idea and you've got a NDEA. That's the chemical that seems to have some contaminated lots of blood pressure medications.
NDEA is short for N-nitrosodiethylamine. PubChem describes NDEA as a "synthetic light-sensitive, volatile, clear yellow oil that is soluble in water, lipids, and other organic solvents," which is "used as a gasoline and lubricant additive, antioxidant, and stabilizer for industry materials." The description also mentions NDEA emitting "toxic fumes" when heated to a high enough temperature and used in the lab to cause liver tumors for experiments. Then, there is this sentence: "it is considered to be reasonably anticipated to be a human carcinogen."
Yes, this last sentence is not written in the most definitive manner. Imagine telling your significant other, "you are "Nonetheless, it is safe to say that there are cancer-related concerns about NDEA.
Apparently, trace amounts of NDEA have appeared in irbesartan tablets sold by Sciegen Pharmaceuticals, Inc. NDEA is not normally supposed to be part of such medications. So trace amounts would be contamination or an impurity. This impurity has prompted the company to voluntarily recalling specific lots of irbesartan tablets (USP 75 mg, 150 mg, and 300 mg dosage forms), According to the U.S. Food and Drug Administration (FDA).
Here is the renin-angiotensin system that helps regulate the constriction of blood vessels and blood pressure. (Photo by: Encyclopaedia Britannica / UIG via Getty Images)
Irbesartan is an angiotensin II receptor blocker (ARB). Although it seems like a movie, Angiotensin II is actually a hormone thatngiotensinogen. Renin, a hormone produced by your kidneys, then converts angiotensinogen into angiotensin I. Next, an enzyme called angiotensin-converting enzyme (ACE) produced by your lungs converts angiotensin I into angiotensin II. Angiotensin II then can bind your receptors in your blood vessels throughout your body, causing your blood vessels to tighten. This process helps regulate blood flow throughout your body. However, high blood pressure can occur when your blood vessels are too narrow, which can occur when vessel walls get too stiff or thickened. ARBs such as irbesartan can block these angiotensin II receptors, thus relaxing and widening your blood vessels. That is why doctors use ARBs to control high blood pressure and improve blood circulation for patients with weaker hearts.
If this seems a bit like already seen all over again, it can be considered to be. A couple months ago, the FDA had announced that Torrent Pharmaceuticals Limited was voluntarily recalling a different type of ARB, valsartan. The recall included valsartan tablets and those combined with Amlodipine and hydrochlorothiazide. In this case, the impurity was N-nitrosodimethylamine (NDMA), another chemical that "is reasonably anticipated to be a human carcinogen. " Zhejiang Huahai Pharmaceuticals had manufactured these medications.
Should you be "reasonably anticipated" to worry about this news? "Trace amounts" alone is probably not of huge concern. Scientists use much higher concentrations of the chemicals to induce tumor growth in the laboratory. It is not completely clear how much exposure to NDEA or NDMA can lead to cancer in humans, and the threshold is likely to vary. However, the larger issue would be cumulative exposure over time. If you are exposed to these chemicals or other factors, could you add the effect? That's why you want to minimize such "impurities" in your medications as much as possible.
These 2 recalls highlight the importance of monitoring manufacturing processes and supply chains for medications. Impurities could not be used in every process. If you are outsourcing any part of these processes, make sure that After all, finding a chemical in your medication that can be expected to be a human carcinogen and is normally found in gas, is not a gas.
