Danish medicines authority recalls antibiotic used by 35,000 people
The Danish Medicines Agency, Lægemiddelstyrelsen, said on Monday that persons using the antibiotic medicine Dicillin, produced by Sandoz, should return it to pharmacies to be replaced.
The medicines authority issued the instructions in a press statement on Monday after multi-resistant bacteria known as CPO were detected in nine cases in patients who have taken the antibiotic.
The nine cases were detected over a four-month period.
Around 35,000 people in Denmark were prescribed the antibiotic between September and December last year, according to the Danish Patient Data Authority (Sundhedsdatastyrelsen).
The Medicines Agency is therefore recalling the antibiotic, which is taken in 500 milligram capsules.
“It’s important that you don’t stop your treatment if you are taking antibiotics. So patients to take 500mg Dicillin from Sandoz should go to their pharmacy to get a different, equivalent preparation,” the agency writes in the statement.
Multi-resistant bacteria are resistant to treatment with several types of antibiotic.
CPO or carbapenemase-producing organisms are a group of bacteria that are resistant to several different types of antibiotics. They can be difficult to treat, according to information from the Danish Health Authority.
The risk of becoming seriously ill due to CPO is low for a healthy person, but people who are already ill or vulnerable can be at increased risk.
Manufacturer Sandoz has recalled all Dicillin packets, news wire Ritzau writes. Tests will be undertaken to determine whether the problem relates to a single batch or larger amount of the product.
“Pharmacies have been informed of the matter and are ready to exchange the medicine. Good alternatives are available and there will be no extra cost for the individual patient,” the Danish Medicines Agency states.
Patients do not need to obtain a new prescription from their doctor.
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The medicines authority issued the instructions in a press statement on Monday after multi-resistant bacteria known as CPO were detected in nine cases in patients who have taken the antibiotic.
The nine cases were detected over a four-month period.
Around 35,000 people in Denmark were prescribed the antibiotic between September and December last year, according to the Danish Patient Data Authority (Sundhedsdatastyrelsen).
The Medicines Agency is therefore recalling the antibiotic, which is taken in 500 milligram capsules.
“It’s important that you don’t stop your treatment if you are taking antibiotics. So patients to take 500mg Dicillin from Sandoz should go to their pharmacy to get a different, equivalent preparation,” the agency writes in the statement.
Multi-resistant bacteria are resistant to treatment with several types of antibiotic.
CPO or carbapenemase-producing organisms are a group of bacteria that are resistant to several different types of antibiotics. They can be difficult to treat, according to information from the Danish Health Authority.
The risk of becoming seriously ill due to CPO is low for a healthy person, but people who are already ill or vulnerable can be at increased risk.
Manufacturer Sandoz has recalled all Dicillin packets, news wire Ritzau writes. Tests will be undertaken to determine whether the problem relates to a single batch or larger amount of the product.
“Pharmacies have been informed of the matter and are ready to exchange the medicine. Good alternatives are available and there will be no extra cost for the individual patient,” the Danish Medicines Agency states.
Patients do not need to obtain a new prescription from their doctor.
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