Listing 

23 Jun 2006: Lamotrigine (Lamictal®) and risk of oral clefts [by GlaxoSmithKline]
GSK updates on an emerging safety data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry which suggests an association between lamotrigine (Lamictal®) and non-syndromic oral clefts in infants exposed to lamotrignine monotherapy during the first trimester of pregnancy.

21 Jun 2006: Infliximab (Remicade®) and risk of hepatosplenic T-cell lymphoma [by Schering Plough]
Schering Plough informs about post-marketing adverse event reports of a rare subtype of Non-Hodgkins Lymphoma (NHL) known as hepatosplenic T-cell lymphoma in adolescent and young adult patients with Crohn's disease treated with infliximab (Remicade®). This subtype of lymphoma has been reported in six Crohn's disease patients between the age of 12 to 19 years and one from a 31-year-old patient.

22 Feb 2006: Safety update and product labelling changes for Tequin® (gatifloxacin) [by Bristol-Myers Squibb]
Serious cases of both hypoglycaemia and hyperglycaemia have been reported with Tequin® (gatifloxacin). In light of the post-marketing experience, the company has recommended a contraindication on the use of Tequin® in patients with diabetes mellitus.

14 Feb 2006: Literature reports on the possible risk of serious renal and cardiovascular toxicity following Trasylol® (aprotinin) administration to patients undergoing coronary artery bypass grafting surgery (CABG) [by Bayer]
Bayer informs about two recently published observational studies of the possible risk of serious renal and CV toxicities following Trasylol® (aprotinin) administration to patients undergoing coronary artery bypass grafting surgery (CABG). An observational study published in The New England Journal of Medicine reported that Trasylol® may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition) has reported that Trasylol administration may increase the risk for renal toxicity although not for cardiovascular or cerebral toxicity.

09 Jan 2006: Rare reports of macular oedema observed with rosiglitazone (Avandia® or Avandamet®) therapy [by GlaxoSmithKline]
GSK updates on very rare post-marketing reports of new onset and worsening diabetic macular oedema in patients receiving rosiglitazone (Avandia® or Avandamet®) and the associated risk factors.