It can occur when we grill meat or when the oil exceeds the ‘smoke point’ and put our health at risk. It is nitrosamine, a substance considered carcinogenic and which can be contained – within certain limits – even in some substances. Precisely for this reason, Pfizer recalled from the market five batches of Accupril, a drug for high blood pressure, as a precaution, after discovering that they contained nitrosamines in quantities greater than those that can be taken every day without risk. The problem would not concern Italy and Europe because the lots in question would have been distributed only in the United States and Puerto Rico.
What is the withdrawn drug used for
Accupril is a drug based on the active ingredient Quinapril Hydrochloride, belonging to the category of ACE inhibitors and is used in the treatment of systemic arterial hypertension and congestive heart failure. In more than thirty years of use, the medicine has been shown to be safe and Pfizer has stated that it is not aware of any adverse events related to its use. In a statement, the company says it believes the risk / benefit profile of the products remains positive based on currently available data. Although long-term ingestion of N-nitroso-quinapril may be associated with a potential increased risk of cancer in humans, there is no immediate risk for patients taking this drug. Patients currently taking these products should consult with their doctor about alternative treatment options.
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The choice of withdrawal
Why then the withdrawal of the drug? The decision to withdraw the lots containing a high quantity of Nnitroso-quinapril was taken by the company in total autonomy, without any imposition by external agencies (such as the Food and Drug Administration). Furthermore, it is not linked to an immediate risk for patients. The nitrosamine in question, in fact, can cause damage only if taken for a long period of time. Accupril batches have been withdrawn precisely to minimize the possibility that something like this could happen as only in these batches traces of contamination with excessive amounts of nitrosamines have been identified.
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Which lots are withdrawn
The five batches withdrawn are: DR9639 Accupril 10 mg expiring on March 31, 2023; DX8682 Accupril 20 mg due March 31, 2023; DG1188 2022 Accupril 20 mg expiring on May 31, 2022; DX6031 Accupril 40 mg expiring March 31, 2023 and CK6260 2022 Accupril 40 mg expiring May 31 2022. Pharmacies are invited to immediately suspend the dispensing of these lots which will be stored in a safe area and prepared for withdrawal according to the normal procedures in force. .
What is nitrosamine
Small amounts of nitrosamines are present in water and some foods including cured meats and dairy products. Their consumption within certain limits, therefore, does not represent a risk. The speech changes when the concentration of these substances becomes greater. In particular, there was a higher than normal level of Nnitroso-quinapril inside the medicine, which is dangerous at high doses. “Nitrosamines – explains Saverio Cinieri, president of the National Medical Oncology Association (Aiom) – are organic compounds and their danger is linked to the nitrite ion of which we remember the news of years ago when in Umbria salamis and hams were stored precisely with nitrites and an increased risk of stomach cancer was found in those populations that was higher than the national average ”.
Nitrosamines in drugs
By law, nitrites are now no longer used for the preservation of cured meats and there is a European regulation of 2021: “We are going to test the nitrosamine content in medicines and whether this organic compound is present in a greater than those that are the limits of the European law, then the drug must be withdrawn from the market because evidently there was a problem during production “, continues Cinieri who specifies:” The fact remains that those contained in drugs still have infinitesimal values, that is, below these threshold values we need not worry “.
Precautions in the kitchen and when shopping
Beyond this news that is now increasing attention on nitrosamines, these substances can also cause damage to health in our kitchens. “Especially now that the summer season arrives – continues Cinieri – we must be careful that during the grilling the meat is not burned because molecules that can be carcinogenic are formed inside the crunchy part. Also be careful not to exceed the so-called ‘smoke point’ with oil that develops toxic substances and then cigarette smoke which contains nitrosamines along with many other carcinogenic substances ”. Attention also when shopping: “Especially in some areas of central-southern Italy – explains President Aiom – some sell fruit and vegetables on the paved road. Even if they are valid products from the point of view of flavor and quality, they must be washed with a little more attention because the nitrosamines from the asphalt settle on fruit and vegetables ”.
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