The Icelandic Medicines Agency has suspended the sale and prescribing of the antibiotic Staklox as a precautionary measure
9th February 2023
The Danish Medicines Agency has reported that some patients in Denmark who received the antibiotic Dicillin (capsules) from the company Sandoz from September 2022 to January 2023 have developed infections caused by antibiotic-resistant bacteria.
-Automatic translation
A specific batch of the antibiotic Dicillin, sold in Denmark, was found to be contaminated with the same bacteria. A similar drug is sold in Iceland under the name Staklox, but it is in capsules from the same manufacturer.
The Icelandic Medicines Agency has suspended the sale of Staklox in Iceland while the matter is under investigation. The Icelandic Medicines Agency has also recalled the product from individuals who have been prescribed the product. The reason for the recall of Staklox in Iceland is that one person in Iceland who had taken the drug in July 2022 developed an infection by the same bacteria that was diagnosed in Denmark.
Those who are taking the medicine Staklox are asked to return the medicine to the nearest pharmacy as soon as possible. A generic medicine from another manufacturer, Dicloxacillin Bluefish, will be supplied instead to individuals free of charge. Icelandic Medicines Agency.
Physicians in Iceland are also asked to prescribe other antibiotics if possible to maintain supplies of the generic. There are adequate supplies of other antibiotics that can be used as a replacement for Staklox, such as Keflex.
It has not yet been confirmed whether Staklox capsules were contaminated with the bacteria detected in Denmark. If it turns out, we point out the following:
The bacteria can in some cases colonize the digestive tract and become part of the person's microbiota, but it is not known how often this occurs.
The bacteria is not easily transmitted between people through normal contact but can be transmitted through close contact and fecal-oral transmission, as can other enteric infections.
The bacteria do not progress automatically to infection because much of similar bacteria are already present in the digestive tract.
However, bacteria in the digestive tract can still cause infections, especially urinary tract infections.
There is no evidence that this particular bacteria is more prone to infections than other bacteria of the same species.
Tests have revealed that despite the identified antibiotic resistance, this bacterium is susceptible to many other antibiotics, so various treatment options are available.
It is important to inform if a person has taken contaminated Staklox because it helps to select suitable antibiotics if infections occur.
It is important to inform if a person has taken contaminated Staklox if he/she is admitted to a medical institution because of the possibility that the pathogen spreads within an institution.
Further information:
Notice from the Danish Medicines Agency from 7 February 2023
News from the Icelandic Medicines Agency from 9 February 2023
News from the Statens Serum Institut in Denmark from 6 February 2023
The Chief Epidemiologist