The Chief Pharmaceutical Inspectorate (GIF) has announced an urgent withdrawal from the marketplace of 4 series of popular drug with magnesium – Magne B6. The reason for the decision are the results of stableness studies that showed besides low levels of vitamin B6 release, which could endanger patients' health.
Which series have they withdrawn?
The decision concerns 4 series Magne B6 film-coated tablets (Magnesii lactas dihydrocus + Pyridoxini hydrochloridum), 48 mg Mg2+ + 5 mg, pack 60 tablets, GTIN 05902502992744. The MAH is Opella Healthcare Poland sp. z o.o. based in Warsaw.
The following series were immediately withdrawn from the market:
- GV380Date of expiry: 06.2025
- GV381Date of expiry: 06.2025
- GV382Date of expiry: 06.2025
- HV006Date of expiry: 12.2025
The withdrawal concerns the full area of Poland and entered into force on the date of notification of the decision.
Reason for the decision: insufficient release of vitamin B6
The Communication of the Chief Pharmaceutical Inspector explains that the reason for the withdrawal is too low levels of pyridoxine hydrochloride release (i.e. vitamin B6), found in stableness studies. This substance has a key function in the preparation due to the fact that helps absorb magnesium in the body.
The deficiency of adequate release of vitamin B6 may so mean that the medicine does not work according to the declared therapeutic efficacyas a consequence may pose a real hazard to patients’ health.
"The Chief Pharmaceutical Inspector has identified a real hazard to patients' wellness due to the deficiency of expected efficacy of the medicinal product under consideration", says the authoritative Communication.
Sales ban and work to destruct the product
According to Article 67 paragraphs 1 and 2 of the Pharmaceutical Law Acta medicinal product that does not meet the established quality requirementscan not be further marketed or utilized in patients. In that case, it is subject to mandatory destruction, unless the withdrawal decision provides for otherwise applicable and in this case such a anticipation has not been allowed.
The importance of GIF decisions for patients and pharmacies
GIF decision has immediate legal effect and means that:
- Pharmacy must immediately retreat the specified series from the sale.
- Patients holding withdrawal packs should not usage them..
- The entities liable for distribution must ensure the disposal of the withdrawn product in accordance with applicable regulations.
For patients this means that it is essential verification of series numbers of packages held and possible consultation with your doctor or pharmacist on alternate magnesium preparations.
Background: Magne B6 – popular, but now under the microscope
Magne B6 is 1 of the most recognizable medicines available without a prescription, utilized to treat magnesium deficiency, muscle spasms and chronic fatigue. The combination of magnesium and vitamin B6 was intended to increased bioavailabilitywhich made the preparation more effective than regular dietary supplements.
The withdrawal of up to 4 series of this medicine is serious informing signalfor both patients and the full pharmaceutical industry. It besides shows how crucial they are continuous quality checks, even for long-term preparations on the market.
What's next?
Bye. lack of information on the possible withdrawal of subsequent series or full product Magne B6. The GIF may take further action depending on the results of subsequent tests and reports from the manufacturer. However, it is worth noting that stability checks are a standard procedure and their aim is to guarantee maximum patient safety.
GIF recalls that in case of any safety concerns, patients may report adverse reactions to the Committee for Medicinal Products Registration Officeand search information from pharmacies and doctors.
More here:
GIF popular medicine Magne B6. Does not meet quality standards
