Here are some safety advisory and news for your speed update.

•    HSA Issued Professional Advisory to Limit Use of Rosiglitazone Products
•    HSA Recall News: Peg-Intron® REDIPEN Injection
•    European Regulators Rule out Narcolepsy Links with GSK’s Pandemrix

•    HSA Issued Professional Advisory to Limit Use of Rosiglitazone Products
The HSA's PV Advisory Committee & panel of experts has recommended to limit the use of OHGA containing rosiglitazone due to shift in risk/benefit profile of the drug. This was prompted by published evidence linking the potential increased risk of myocardial ischaemic events. Similar advisory has been issued by USFDA; but the European agency EMEA has decided to suspend the marketing authorization of all rosiglitazone products instead. In Singapore, approved rosiglitazone-containing products are Avandia®, Avandamet® & Avandaryl®.- all marketed by GSK.
Avandia was once a blockbuster diabetic remedy & GSK’s 2nd biggest product line. Sales have plummeted dramatically since the safety concerns erupted. Worldwide sales in 2009 was about USD1.2 billion, but was USD3.2 billion in 2006.

•    HSA Recall News: Peg-Intron® REDIPEN Injection
SOL Limited (Singapore Branch), a subsidiary of Merck& Co. Inc, agreed to a voluntary recall, to the pharmacy/retailer level, of all strengths of Peg-Intron® REDIPEN Injection as a precautionary measure due to a potential defect in the glass cartridge component of the product delivery system.  As a result of this defect, a limited number of REDIPEN units may have a potential risk for contamination since the container seal may be compromised.  With effect from 18 Sept 2010, all sales of Peg-Intron® REDIPEN Injections have been suspended and all existing stocks of all the affected batches will be recalled. Until unaffected units of Peg-Intron ® REDIPEN become available, healthcare professionals are advised NOT to initiate Peg-Intron ® treatment on NEW patients and to consider switching existing patients to alternative therapies.

•    European Regulators Rule out Narcolepsy Links with GSK’s Pandemrix
The Committee for Medicinal Products for Human Use (CHMP), on behalf of the European Medicines Agency (EMA), has concluded that the available data are insufficient to demonstrate a causal relationship between GlaxoSmithKline's (GSK) Pandemrix and the observed cases of narcolepsy. CHMP has further concluded that any temporary restriction on the use of Pandemrix is not considered warranted.
GSK claimed that over 30 million doses of Pandemrix have been administered throughout Europe, to date, with the most recent EMA Pharmacovigilance Report concluding that the benefit-risk profile of the three centrally-approved H1N1 vaccines, including Pandemrix, continues to be positive.

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