| VIRACEPT | | MHRA | 01-Sep-08 | MHRA has issued drug updates:
Fentanyl patches: serious and fatal overdose from dosing errors, accidental exposure, and inappropriate use
Viracept: update on carcinogen contamination (ethyl mesylate)
Natalizumab (Tysabri): progressive multifocal leukoencephalopathy
Intrathecal drug pumps: missing propellant
Caffeine for apnoea of prematurity: correction
Recall of reagent for paracetamol levels |
| VIRACEPT | | Health Canada | 21-Aug-08 | OTTAWA - Following up on a Public Communication issued September 10, 2007, Health Canada wishes to inform Canadians and Canadian health care professionals that Health Canada and Pfizer Canada have agreed on an acceptable ethyl methanesulfonate limit for Viracept, a drug used in the treatment of HIV/AIDS.
Health Canada would like to assure Canadians that the Viracept product now available on the Canadian market has the acceptable ethyl methanesulfonate limits so that the precautions relating to its use in non-pregnant HIV infected adults and children no longer apply.
Health Canada would also like to remind Canadians of its advice against the use of Viracept in pregnant women due to safety concerns regarding ethyl methanesulfonate during pregnancy.
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| VIRACEPT | | FDA | 10-Sep-07 | Pfizer issued a Dear Healthcare Professional Letter to inform healthcare professionals of the presence of ethyl methanesulfonate (EMS), a process-related impurity in Viracept and to provide guidance on the use of Viracept in pregnant women and pediatric patients.
FDA has asked Pfizer to implement new specifications to limit the presence of EMS in Pfizer-manufactured Viracept products marked in the United States.
For pediatric patients who are stable on Viracept-containing regimens, FDA and Pfizer agree that the benefit-risk ratio remains favorable and those patients may continue to receive Viracept.
Pediatric patients who need to begin HIV treatment should not start regimens containing Viracept until further notice.
Pregnant women who need to begin antiretroviral therapy should not be offered regimens containing Viracept until further notice.
As a precautionary measure, pregnant women currently receiving Viracept should be switched to an alternative antiretroviral therapy while Pfizer and FDA work to implement the long term EMS specification for Viracept.
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| VIRACEPT | | Health Canada | 10-Sep-07 | Pfizer and Health Canada wish to notify you of the presence of low levels of ethyl methanesulfonate (EMS), a process-related impurity in VIRACEPT (nelfinavir mesylate) and to provide guidance on the use of VIRACEPT in patients, including pregnant women and pediatric patients.
At this time, physicians should consider the risks and benefits of prescribing VIRACEPT to their HIV-infected adult patients, given the information provided below.
The levels currently deemed acceptable for long-term exposure to EMS suggest a theoretical lifetime increased cancer risk in adults of less than 1 case per 100,000 patients exposed.
Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments.
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| VIRACEPT | | MHRA | 03-Sep-07 | MHRA has issued drug updates:
Hormone-replacement therapy: updated advice
Tibolone: benefit-risk balance
Desmopressin nasal spray: removal of nocturnal enuresis indication
Pabrinex: allergic reactions
Corticosteroids: early psychiatric side-effects
Duloxetine: marketed as Cymbalta and Yentreve for different disorders |
| VIRACEPT | | MHRA | 01-Aug-07 | MHRA has issued drug updates:
Gadolinium-containing contrast agents and nephrogenic systemic fibrosis
Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false glucose reading
a1-adrenoreceptor antagonists and intraoperative floppy iris syndrome
Cabergoline: risk of cardiovalvulopathy
Linezolid: restriction of indication
Dopamine agonists and pathological gambling, increased libido, and hypersexuality
Antidepressants and risk of suicidal behaviour
Isotretinoin for severe acne
Smoking-cessation aids |
| VIRACEPT | | MHRA | 06-Jun-07 | The MHRA in conjunction with the EMEA, with assistance from Roche Registration Ltd, are recalling all batches of Viracept products irrespective of whether they have been supplied direct from Roche or as parallel distributed stock.
Recipients are requested to quarantine stock, including part packs and return to your original supplier.
Additional information is available in the Q&As sheet (see download document).
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