The Spanish Agency for Medicines and Healthcare Products (AEMPS) announced the withdrawal of a batch of the stomach protectant Omeprazole Altan. The news spread widely in the media as the active ingredient of this relatively popular drug was withdrawn even though the warning did not affect the daily version of the treatment. So no need to run to the medicine cabinets, it’s not about the tablets we keep at home.

Hospital use.
The withdrawn drug is not the tablet version of this compound we are used to. The withdrawn drug is marketed as a powder for intravenous infusion and is administered by medical personnel.

Given this situation, the drug withdrawal focuses on healthcare professionals tasked with managing the drug distribution chain of healthcare centers, so it’s not a warning to consumers, so the massive repercussions that caused the withdrawal draw attention. in the media.

unknown impurities
The received lot corresponds to a format for hospital use, Omeprazole Altan is a powder of 40 milligrams for infusion solution, so its circulation is limited. The agency has ordered that all distributed units of the affected lot 22C0169 with expiration date of 03/31/2023 be withdrawn from the market.

preventive withdrawal.
According to the warning made public yesterday by AEMPS, the reason for the withdrawal is given as “the possibility of testing for unknown impurities before the end of the useful life of the lot in question will result in an outside specification”.

Beyond that, no information has emerged about the potential effects of these “impurities” or the situations in which they could cause harm. The absence of possible harmful effects indicates that this is a precautionary withdrawal. Also, the agency’s message does not exclude the possibility of false positives.

There are risks from errors in drug manufacturing (as in the case of food). Surveillance is therefore one of the core tasks of pharmaceutical institutions and does not end with the approval of a treatment, it extends to the manufacturing stage and beyond. In other words, it focuses not only on the creation of the medicinal product, but also on its production. In no case is there zero risk, but extreme oversight is always preferable.

Other recent withdrawals.
Such withdrawals are not exceptional. Without going any further, last week AEMPS ordered the withdrawal of three more batches corresponding to two different drugs. One of these drugs is for hospital use, and the other is for withdrawal from detecting leaks in a serum’s packaging.

Omeprazole is a regular in our medicine cabinets.
Omeprazole is a very popular drug in tablet version, making it clear that society is concerned about possible problems in its manufacture. It is a compound that works by reducing the amount of acid produced by the stomach. It belongs to the category of drugs known as “proton pump inhibitors”.

The compound is used to treat a variety of conditions such as gastroesophageal reflux, the stomach effects of Zollinger-Ellison syndrome, and ulcers. It is also used (with other medicines) to treat and prevent the recurrence of ulcers caused by a certain type of bacteria (H. pylori).

Side effects.
Possible side effects associated with this drug may include constipation, gas, nausea, diarrhea, vomiting, or headache. Given the severity or persistence of any symptoms, with or without a health warning, it is advisable to see a doctor as well as before any serious symptoms appear.

Transparency and alert.
Transparency is key in an alarm system, but it’s also important to consider the risks involved. Misinterpretation of warnings to health officials can lead to inappropriate decisions, such as discontinuing a treatment we need to fight a disease.

In this case, the fact that the news is about two very different versions of the same drug in its application, one of which is common in our homes, fuels the fire and facilitates a misunderstanding that may cause some doubts in users. .

Image | Alexander Gray