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Advanz Pharma alerts MHRA to patient information error

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Advanz Pharma alerts MHRA to patient information error

The pharmaceutical company Advanz Pharma has reported that some batches of its MacroBID 100mg Prolonged-Release Capsules contain patient information leaflets that are missing details about possible side-effects.

The company told the Medicines and Healthcare products Regulatory Agency that eight batches – 21001, 21002, 21003, 22001, 22002, 22003, 22006 and 22007 – have leaflets missing the following information: 

Section 4. Possible Side effects

  • Scarring due to damaged lung tissue may occur
  • In rare cases, it may cause liver failure which may be fatal
  • Damage to bone marrow causing deficiency of the red blood cells (anaemia)

The PSNC said there is no risk to the product’s quality and efficacy and the affected batches are not being recalled but urged pharmacists “to exercise caution” and provide “a copy of the Summary of Product Characteristics when dispensing this medication to patients".

The PSNC, meanwhile, reminded contractors that any NHS prescriptions they submit for payment for original FreeStyle Libre Sensors after the end of this month will not be processed because of manufacturer Abbott Laboratories Ltd’s decision to discontinue them in the UK by December 31.

“This means that the original sensors will be deleted from Part IXA of the Drug Tariff from January 2023,” the negotiator said.

“Only devices listed in the Appliances section in Part IX (Parts IXA, IXB and IXC) of the Drug Tariff are allowed on NHS prescriptions.”

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