Status: 21.09.2023, 05:29 a.m.
By: Emanuel Zylla
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Due to probably too high amounts of a carcinogenic substance, a well-known pharmaceutical company has to carry out a recall of its antihypertensives.
Holzkirchen – Around 20 million people in Germany, one in three adults, suffer from high blood pressure. Anyone taking medication for hypertension should now check whether the product prescribed to them is affected by the current drug recall of a blood pressure reducer from 1A Pharma. According to the Federal Office for Safety in Health Care (BASG), the reason for the recall is that the drugs could have elevated nitrosine levels.
The BASG further writes on its website that the Holzkirchen-based pharmaceutical supplier had already informed its supplied customers on September 13 that in a batch "the nitrosamine quantities may be above the permissible acceptable daily dose". Therefore, the affected product had to be recalled.
Recall from pharmaceutical supplier: This drug for high blood pressure is affected
These are the 10 milligram lisinopril tablets from 1 A Pharma. The ACE inhibitor is used to treat high blood pressure (arterial hypertension) and heart failure and its symptoms.
Here is the most important information about the recall and the affected batch of the provider:
| Drug | Lisinopril 1A Pharma 10 mg - tablets |
| Licence number | 1-24983 |
| Central pharmaceutical number | 2445002 |
| Marketing authorisation holder | 1 A Pharma GmbH |
| Batch number | KS6053 |
| Expiry date | 31.12.2023 |
| Risk class | 2 |
| Callback to the level | Pharmacies |
| Business figure BASG | INS-640.001-4463 |
Recall of hypertensive tablets due to nitrosamine, a carcinogenic substance
According to a 2014 study, "mutations and cancer" are caused during the metabolism of nitrosamine in the body. The carcinogenic effect had been proven in 90 percent of the nitrosamines examined in animal experiments. On the other hand, it is still uncertain whether nitrosamine is just as harmful to humans.
According to the European Food Safety Authority (EFSA), nitrosamines are also found in many foods, such as beer, fish, cured meat products or cheese. However, this is done with limit values and in very small quantities. Certain nitrosamine compounds in food are suspected of being able to cause cancer and damage DNA in humans, EFSA warns. However, nitrosamines can also be found in children's toys, where they are also potentially harmful to health.
According to the German Federal Office for Safety in Health Care (BASG), 1 A Pharma GmbH has launched a recall for its antihypertensive tablets. (Symbolic image) © Prashant ZI Prashant Sahu/Imago
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There are also applicable limits for the use of nitrosamine in medicines, according to the Federal Institute for Drugs and Medical Devices (BfArM). "These have been set on the basis of internationally agreed standards and are based on lifelong admission. In principle, patients should not be exposed to an additional lifetime risk of cancer of more than 0.001 percent due to nitrosamines in medicines," writes the BfArM on its website. (zy
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