TWO common drugs used in the treatment of diabetes have been withdrawn from the Bahrain market, due to concerns about their effectiveness.
Glynase 5mg Tablet and Diatab 5mg Tablet are generic medication, but were deemed to fall below the standards of the treatment on which they were based.
The decision was announced by the National Health Regulatory Authority (NHRA) yesterday, after being notified by the Saudi Food and Drug Authority (SFDA).
“These two drugs are common drugs used for treating diabetes and the issue is that they are generic,” NHRA chief executive Dr Maryam Al Jalahma told the Gulf Daily News.
“Generic drugs undergo continuous testing for their bioequivalence, which means that they are equivalent in their efficiency and safety as the original drug.
“Since we have a report from the Gulf Alert System by the SFDA that they tested the bioequivalence of these drugs not matching the original, the drugs had to be withdrawn from the market until the manufacturing company redevelops the drug to match the original.”
Despite the decision Dr Al Jalahma reassured patients about the safety of the medication.
“This doesn’t mean the drug was harmful, but it is not as efficient in controlling diabetes as the original or could have more side effects compared with the original,” she said.
“Agents have been contacted to withdraw the drug.
“Usually generic drugs are given approvals for manufacturing after they do tests proving their bioequivalence.
“But we do post-marketing analysis by taking samples from the market to ensure that their bioequivalence is the same as when they were approved.
“If found otherwise it will be withdrawn, which is what has been done now.”
Glynase 5mg Tablet is manufactured by Julfar and Diatab 5mg Tablet is manufactured by Spimaco Pharmaceutical, but both are scientifically known as Glibenclamide.
“Alternative drugs are available and patients should consult with the doctor or pharmacist to find out options to replace these drugs,” said the NHRA.
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