| MYCOPHENOLATE MOFETIL | | FDA | 14-Aug-09 | Roche notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with CellCept.
The WARNINGS and ADVERSE REACTIONS sections of the CellCept Prescribing Information have been revised to reflect this new safety information.
PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination.
Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor).
In some cases, PRCA was found to be reversible with dose reduction or cessation of CellCept therapy.
In transplant patients, however, reduced immunosuppression may place the graft at risk.
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| MYCOPHENOLATE MOFETIL | | FDA | 14-Jul-09 | The FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy.
These immunosuppressant drugs are used to protect against the rejection of certain organ transplants.
The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf).
Monitoring for this serious risk and early intervention by the health care provider is critical.
Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy.
FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation.
The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDAs MedWatch Adverse Event Reporting program.
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| MYCOPHENOLATE MOFETIL | | MHRA | 06-Jul-09 | MHRA Safety Update.
Clopidogrel and proton pump inhibitors: interaction
Abacavir: risk of myocardial infarction - update from epidemiological studies
Use of long-acting ß-agonists in chronic obstructive pulmonary disease
Mycophenolate mofetil: pure red cell aplasia
Hydroxycut range of food supplements: risk of liver damage
Priadel Liquid: potential for dosing errors
Clarification: ACE inhibitors and angiotensin II receptor antagonists - use during breastfeeding |
| MYCOPHENOLATE MOFETIL | | Health Canada | 04-Jun-09 | Hoffmann-La Roche Limited (Roche), in consultation with Health Canada, has informed Canadian healthcare professionals of important new safety information regarding reports of a type of anemia called pure red cell aplasia (PRCA) in patients treated with CellCept® (mycophenolate mofetil).
CellCept is authorized for the prevention of organ rejection in adults receiving kidney, heart or liver transplants, and in children and adolescents (2-18 years) receiving kidney transplants.
Cases of PRCA have been reported in patients treated with CellCept in combination with other anti-rejection drugs.
There may be a risk to the transplanted organ if anti-rejection medications, such as CellCept, are reduced in dosage or discontinued.
Patients taking CellCept and any other prescribed anti-rejection medications should not discontinue or change their medication without discussion with their transplant physician.
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| MYCOPHENOLATE MOFETIL | | FDA | 24-Mar-09 | FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend.
By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle.
Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend.
FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward.
FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.
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| MYCOPHENOLATE MOFETIL | | MHRA | 04-Mar-09 | MHRA has issued drug updates:
Methylphenidate: updated guidance on safe and effective use in ADHD
Atomoxetine: risk of psychotic or manic symptoms
Antipsychotics: use in elderly patients with dementia
Exenatide (Byetta): risk of severe pancreatitis and renal failure
Bisphosphonates: atypical stress fractures
Efalizumab (Raptiva): recommendation to suspend marketing authorisation
Patient-controlled analgesia extension sets: risk of inadequate pain relief
Effects of MRI on implantable drug pumps
Oral bowel cleansing solutions: risk of harm |
| MYCOPHENOLATE MOFETIL | | FDA | 16-May-08 | FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy.
MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic.
In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection.
However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme.
Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected.
MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy.
FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure.
See the FDA Healthcare Professional Information Sheet containing considerations and recommendations for clinicians prior to prescribing MMF or MPA to women of childbearing potential.
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| MYCOPHENOLATE MOFETIL | | FDA | 10-Apr-08 | Novartis informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the Myfortic prescribing information.
The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with Myfortic.
Roche Laboratories informed healthcare professionals of changes to the WARNINGS and ADVERSE REACTIONS sections of the CellCept prescribing information.
The changes are based on postmarketing data regarding cases of Progressive Multifocal Leukoencephalopathy (PML) in patients treated with CellCept.
FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.
PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines.
FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information.
FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.
FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information.
As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public.
Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.
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| MYCOPHENOLATE MOFETIL | | MHRA | 03-Dec-07 | MHRA has issued drug updates:
Recombinant human erythropoietins: new prescribing advice
Rosiglitazone and pioglitazone: cardiovascular safety
Dosulepin: measures to reduce risk of fatal overdose
ACE inhibitors and angiotensin II receptor antagonists: not for use in pregnancy
Short-acting ß agonists: myocardial ischaemia
Varenicline: possible effects on driving, and psychiatric illness*
NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Aprotinin: suspension of Marketing Authorisations
Lumiracoxib: suspension of Marketing Authorisations
Strontium ranelate: risk of severe allergic reactions
Talc for pleurodesis: risk of adverse events |
| MYCOPHENOLATE MOFETIL | | FDA | 29-Oct-07 | Prescribing information for Mycophenolic Acid (marketed as Myfortic Delayed Released Tablets) revised to include information that use of drug during pregnancy is associated with increased risks of pregnancy loss and congenital malformations.
See the MedWatch alert for Myfortic (mycophenolic acid).
Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, and kidney.
Based on postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil during pregnancy, the pregnancy category for CellCept has been changed from Category C (risk of fetal harm cannot be ruled out) to Category D (positive evidence of fetal risk).
Labeling changes include the following sections: BOXED WARNING, WARNINGS/Pregnancy and Pregnancy Exposure Prevention, PRECAUTIONS/Information for Patients, and ADVERSE REACTIONS/Postmarketing Experience.
Within one week of beginning CellCept therapy, women of childbearing potential should have a negative serum or urine pregnancy test.
In addition, women of childbearing potential (including pubertal girls and peri-menopausal woman) taking CellCept must receive contraceptive counseling and use effective contraception.
Healthcare professionals and patients should be aware that CellCept reduces blood levels of the hormones in the oral contraceptive pill and could theoretically reduce its effectiveness.
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