• FDA Update re: interaction of ceftriaxone with calcium-containing products
• Raptiva/Efalizumab suspended by FDA, US MAH Initiated Phased Withdrawal
• Erlotinib (Tarceva®) Associated with gastrointestinal perforation, SJS and corneal perforation or ulceration
• FDA Update re: interaction of ceftriaxone with calcium-containing products
FDA notified healthcare professionals of an update to a previous alert that addresses the interaction of ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates. At the request of FDA, the manufacturer of ceftriaxone (Roche) conducted two in vitro studies to assess the potential for precipitation of ceftriaxone-calcium when ceftriaxone and calcium-containing products are mixed in vials and in infusion lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of ceftriaxone-calcium using varying ceftriaxone and calcium concentrations, including concentrations in excess of those achieved in vivo. Based on the results from these studies, FDA now recommends that ceftriaxone and calcium-containing products may be used concomitantly in patients >28 days of age, using the precautionary recommendations noted because the risk of precipitation is low in this population. FDA had previously recommended, but no longer recommends, that in all age groups ceftriaxone and calcium-containing products should not be administered within 48 hours of one another. For more information: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Ceftriaxone
• Raptiva/Efalizumab suspended by FDA, US MAH Initiated Phased Withdrawal
Since the reported risk of PML or progressive multifocal leucoencephalopathy being associated with psoriais drug efalizumab, both EMEA and HSA have issued the suspension of of sales for the product. In April, the US FDA has directed the suspension of the sales of the product marketed by Genentech in the US. Genetech will discontinue the product from US market from 08-Jun-09.
On 26 Feb 2009, HSA has requested for Merck Pte Ltd to suspend the sales of its product, Raptiva® in Singapore. HSA and its Pharmacovigilance advisory committee has reviewed the risk-benefit profile of Raptiva® and concluded that the benefits of Raptiva® in the treatment of plague psoriasis no longer outweigh its risks due to safety concerns including the occurrence of Progressive Multifocal Leukoencephalopathy (PML). Both EMEA and Health Canada have also recommended the suspension of the marketing authorization for Raptiva®. Patients who are taking Raptiva® should not stop treatment abruptly but consult their doctors as soon as possible to assess the most appropriate replacement treatment. Prescribers are advised not to issue any new prescriptions for Raptiva® and should review the treatment of patients currently taking the drug.
• Erlotinib (Tarceva®) Associated with gastrointestinal perforation, SJS and corneal perforation or ulceration
On 15 Apr 2009, HSA included in it’s website Roche’s update to healthcare professionals on the increased risk of developing gastrointestinal perforations in patients receiving erlotinib (Tarceva®). Additionally, there have also been very rare occurrences of bullous, blistering and exfoliative skin conditions suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis as well as corneal perforation or ulceration in patients receiving Tarceva®. Tarceva® treatment should be discontinued in patients who develop gastrointestinal perforation, severe bullous, blistering or exfoliative skin conditions or acute/worsening ocular disorders such as eye pain.
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