admin September 18th, 2007
Johnson and Johnson and the FDA have informed healthcare professionals of the risks of sudden death, QT prolongation and Torsades de Pointes(TdP) in patients treated with haloperidol, especially when given intravenously, or at doses higher than recommended. They report:
There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.
More at the FDA.
admin September 5th, 2007
The MHRA’s Drug Safety Update is out. This month:
- 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
Link to PDF.
admin September 3rd, 2007
The National Patient Safety Agency (NPSA) has issued a rapid response report Risk of confusion between non-lipid and lipid formulations of injectable amphotericin.
The National Patient Safety Agency (NPSA) is alerting all healthcare staff involved in the use of intravenous amphotericin of the potentially lethal results if non-lipid and lipid formulations of the drug are confused. These different formulations are used for the treatment of systemic fungal infections. The NPSA is aware of two recent deaths and a number of near misses reported to the National Reporting and Learning System (NRLS) and other similar incidents internationally.
admin September 3rd, 2007
Following consultation with the MHRA and other European regulators, the manufacturer of the osteoarthritis drug lumiracoxib (Prexige), is writing to health professionals to inform them of new restrictions on the prescribing of lumiracoxib. Concern was raised worldwide after rare reports of serious liver reactions; mostly relating to daily doses that are higher than licensed in the EU.
The new measures include regular liver monitoring for patients taking lumiracoxib. In addition, lumiracoxib should not be used in patients with current liver disease or those thought to be at possible risk because of their previous history or other medicines.
The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis will be further evaluated by European Regulatory Authorities in September. Any updated advice will be issued following that evaluation.
Read on…