Other safety alerts
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| The United Kingdom: Mycophenolate mofetil (CellCept) and mycophenolic acid: risk of hypogammaglobulinaemia and risk of bronchiectasis |
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Mycophenolate mofetil (brand leader: CellCept) is licensed in combination with ciclosporin and corticosteroids to prevent acute transplant rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. It is also used off-label in other specialties, such as rheumatology, gastroenterology, respiratory medicine, and dermatology. Mycophenolate mofetil is a prodrug that is completely converted to the active pharmacological form mycophenolic acid (MPA). MPA has potent cytostatic effects on both B-lymphocytes and T-lymphocytes.
A review by European regulators concluded that mycophenolate mofetil in combination with other immunosuppressants can cause hypogammaglobulinaemia in adults and children, which can be associated with recurrent infections. This conclusion was based on published reports, clinical trial data, and reports from clinical practice. Switching from mycophenolate mofetil to an alternative immunosuppressant resulted in serum immunoglobulin G (IgG) levels returning to normal in some cases.
The review also concluded that mycophenolate mofetil in combination with other immunosuppressants can cause bronchiectasis in adults and children (sometimes years after starting mycophenolate mofetil treatment). The risk of bronchiectasis may be linked to hypogammaglobulinaemia or to a direct effect of MPA on the lungs. Patients who developed bronchiectasis usually presented with a persistent productive cough and, in some cases, recurrent upper or lower respiratory tract infections. The diagnosis was confirmed by high resolution computed tomography of the chest. In some of these cases, switching from mycophenolate mofetil to another immunosuppressant improved respiratory symptoms. Mycophenolate mofetil is also known to cause pulmonary fibrosis.
To date, the MHRA has received 13 Yellow Card reports of hypogammaglobulinaemia and 12 Yellow Card reports of bronchiectasis associated with mycophenolate use. Bronchiectasis can occur after years of mycophenolate mofetil treatment, so the link to mycophenolate mofetil may not be made.
When using mycophenolate mofetil or any other medicine containing mycophenolic acid (MPA) as its active ingredient, healthcare professionals are advised of the following:
- Measure serum immunoglobulin levels if recurrent infections develop.
- In cases of sustained, clinically relevant hypogammaglobulinaemia, consider appropriate clinical action. Take into account the potent cytostatic effects of MPA on B-lymphocytes and T-lymphocytes
Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms, such as cough and dyspnoea
Please refer to the following website in MHRA for details:
https://www.gov.uk/drug-safety-update/mycophenolate-mofetil-cellcept-and-mycophenolic-acid-risk-of-hypogammaglobulinaemia-and-risk-of-bronchiectasis
In Hong Kong, there are 17 registered pharmaceutical products containing mycophenolate mofetil or mycophenolic acid. All of them are prescription-only medicines. So far, the Department of Health (DH) has not received any relevant adverse reaction (ADR) report of the drug. In view of the MHRA's announcement, a letter to healthcare professional will be issued to draw their attention to the matter and urge them to report any ADR related to the drug. The matter will be discussed in the meeting of the Registration Committee of the Pharmacy and Poisons Board. The DH will remain vigilant on the safety updates of the drug.
Ends/ Thursday, January 29, 2015
Issued at HKT 18:00
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