Listing 

20 Dec 2004: Iressa® (gefitinib) ISEL study results [by AstraZeneca]
The analysis of the primary endpoint of the ISEL trial showed that Iressa® (gefitinib) did not significantly prolong survival in advanced non-small cell lung cancer patients compared to placebo.

20 Dec 2004: Lamcital® (lamotrigine) – new safety information [by GlaxoSmithKline]
GlaxoSmithKline has updated the Warnings and Precautions, Dosage and Administration and the Interactions sections of the product labelling information for Lamictal®. These revisions are based primarily on clinical data obtained from a recently completed clinical pharmacology study of the interaction between lamotrigine and an oral contraceptive preparation.

13 Dec 2004: Efexor® (venlafaxine) – Response to the Medicines and Healthcare products Regulatory Agency (MHRA) [by Wyeth]
This letter is a respond from Wyeth to the UK MHRA's requests for revised labelling for Efexor® (venlafaxine) and Efexor XR (venlafaxine substained release).

03 Nov 2004: Rosuvastatin (Crestor®) – new prescribing information [by AstraZenca]
AstraZeneca has updated the product labelling information for Crestor® including new dosage recommendations and the findings of pharmacokinetic studies that showed a 2-fold increase in plasma concentration of rosuvastatin in Asian subjects (including Japanese, Chinese, Indian and Malay) compared to Caucasian subjects.

01 Oct 2004: MSD's voluntary withdrawal of Vioxx® (rofecoxib)
This is a voluntary withdrawal by MSD based on the possible increase in risk of cardiovascular events (heart attack and stroke) in patients taking Vioxx® (rofecoxib) long-term.

05 Apr 2004: HSA alerts on an illegal Jamu product labelled as “Pil Ajaib Cap Emas, Penguat Urat Saraf” found adulterated with potent western medicinal ingredients
The Pharmacovigilance Unit of HSA has received two adverse drug reactions reports of Cushing's syndrome suspected to be associated with the usage of Pil Ajaib Cap Emas. It was found to be adulterated with indomethacin and dexamethasone.