The Ministry of Health warns of 3 counterfeit batches of influenza vaccination
The Ministry of Health and Community Protection has warned of three counterfeits of the original product used for vaccination against seasonal influenza virus (H3N2 and H1N1).
The health facilities and health care practitioners at the state level were informed to take the necessary action in this regard.
The ministry confirmed, in a circular issued yesterday, that the three counterfeit operations are: EUH2174AC, EUHO71AB, EOHO71ABk, and their expiration date is June 2022.
And it requested to report in case of any side effects via its electronic link on the side effects of the drug, or via the email of the drug control department.
It also requested to inform it and the local authorities in the event of the presence of counterfeits, and not to purchase the product from unreliable sources, and to limit dealing with the approved agent.
And she stressed the need to obtain vaccinations from approved centers in the country, noting that "counterfeit product operations did not enter the country through the official import system."
According to the ministry, the original manufacturer (Sanofi) confirmed that it did not produce or distribute the aforementioned batches, and that the variable data (batch number and expiration dates) for these products do not match its manufacturing records, which means that the product is not original.
The Ministry recommended adding special warnings and precautions in the internal bulletin of the medicinal product «Tecfidera» used to treat relapsing multiple sclerosis (MS), to reduce the risk of disease (PML), and to prevent the use of the product for patients suffering from suspected or confirmed PML.
The reporting of progressive multifocal leukoencephalopopathy (PML) in patients with lymphopenia confirmed the lymphocyte count of 0.8 x 109 / liter who were treated with the said drug, indicating that PML was previously reported only in moderate to severe lymphopenia.
The Ministry stated that the product is registered in its drug administration, stressing that treatment with Tecfidera should not be started in patients who suffer from severe lymphocytes (lymphocyte count less than 0.5x109 / liter).
The Ministry warned that if the number of lymphocytes is less than the normal range, a comprehensive evaluation of the possible causes must be made before starting treatment with the drug, indicating that patients who suffer from severe lymphocytosis that persist for more than six months should stop taking it.
She stated that if a patient develops PHIL, Tecfidera should be permanently discontinued immediately.
• The Ministry stressed the need to obtain vaccinations from approved centers in the country.
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