The Medicines and Health products Regulatory Agency (MHRA) has issued a medicines defect alert for Accord’s sugar free Diazepam 2mg/5ml oral solution.
Accord-UK has informed the MHRA that important safety warnings for the excipient Propylene glycol are missing from the patient information leaflet (PIL) used in the above batches, including the batches waiting QP certification. The warnings should be present in accordance with the current annex to the excipient guidelines.
“Additionally, the warnings for sorbitol need updating although similar warnings are already present. The product is not subject to recall due to supply and shortage considerations,” the regulator has said in its latest update.
The drug manufacturer has added following excipient warnings to the PIL for future batches.
- Diazepam oral solution contains 409mg Propylene glycol per 5ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol. If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.
- Diazepam oral solution contains 1.91g to 2.58g of sorbitol per 5ml solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine. Sorbitol may cause gastrointestinal discomfort and mild laxative effect. Calorific value 2.6 kcal/g sorbitol.
Diazepam 2mg/5ml Oral Solution Sugar Free (Accord-UK Ltd) (PL 0142/0103)
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The following batches have been packed and are waiting QP certification
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Healthcare professionals are suggested to provide necessary information to the patients on the issue. “There is no risk to product quality as a result of this issue, therefore the associated batches are not being recalled at this time. The product is not subject to recall due to supply and shortage considerations,” the MHRA said.
“Accord-UK have confirmed that they will be providing hard copies of the updated PIL to wholesalers and pharmacies so that any remaining stock in the dispensary can be supplemented with the updated PIL information,” it said.