Monthly Archives: December 2007

Varenicline (brand name Champix) European wide review

EMEA have issued a warning about suicidal ideation and suicide attempts associated with varenicline [PDF]: The European Medicines Agency (EMEA) has concluded that updated warnings to doctors and patients are needed to increase awareness of cases of suicidal ideation and … Continue reading

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Withdrawal of lumiracoxib

EMEA have withdrawn lumiracoxib from the European market due to its effects on the liver [PDF]: The liver safety of lumiracoxib has been monitored continuously since its launch in 2005. In August 2007, the product information was updated with contraindications … Continue reading

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Carbamazepine: Dangerous & fatal skin reactions

Carbamazepine’s propensity to skin rashes is well known, with 5-20% of patients developing skin rashes which can lead to drug withdrawal. It is also associated relatively rarely with more serious skin reactions such as exfoliative dermititis, Stevens Johnson syndrome (SJS) … Continue reading

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Reducing Paediatric medication errors

The use of medicines in children is a dangerous activity. Physical and physiological differences between children and adults, and the comparative lack of data for drug use in children makes decisions about dosing complex. Often specifically licensed childrens preparations are … Continue reading

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FDA review of omeprazole and esomeprazole

The FDA has completed its review of the safety of omeprazole and esomeprazole, in the wake of two studies that appeared to show higher rates of cardiac events in those treated with the proton pump inhibitors (PPIs). Both of these … Continue reading

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Recent Research Findings

The following are three posters this unit recently presented at ISOP 2007 in October of this year: Cox AR, Anton C, Marriott JF, Ferner RE. The paradox of low prescribers who are high reporters: correlates of spontaneous reporting of adverse … Continue reading

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Challenges for the FDA:The Future of Drug Safety

The National Academies Press has published Challenges for the FDA:The Future of Drug Safety, Workshop Summary, which is the result of a one-day symposium in March of this year. The text is free online.

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MHRA Annual Conference 2008

The MHRA Annual Conference will be held in Birmingham this year.

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Salmeterol in children

The NPC draw attention to a FDA document on the safety of salmeterol in children, and provide extensive links on material to help prescribers.

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The safe dispensing of medicines

The NPSA have issued two booklets about the safe dispensing of medicines. 1. A guide to the design of the dispensing environment. 2. A guide to the design of dispensed medicines. A BMJ news report summerises the key points as: … Continue reading

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