Other safety alerts
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| The United States: FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia |
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Subsequent to the notice dated 5 January 2012 regarding the FDA statement on a recently terminated clinical trial with Doribax (doripenem), FDA had concluded that Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the US under the name Primaxin). Based on FDA’s analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA had approved changes to the Doribax drug label that describe these risks.
Doribax is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this unapproved use. Healthcare professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators. Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including kidney infections called pyelonephritis.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm387971.htm
In Hong Kong, Doribax for Inj 500mg (HK57638) is registered by Johnson & Johnson (Hong Kong) Ltd (J&J) and it is a prescription only medicine. According to the registered package insert, ventilator-associated pneumonia is one of the approved indications. This indication is also being approved in other drug regulatory authorities such as EMA and MHRA. Related news had been released by FDA and Health Canada, and was posted on the Drug Office website on 6 January and 1 February 2012 respectively. A letter to inform healthcare professionals was issued on 6 January 2012. As reported on 4 March 2014, J&J already issued “Dear Healthcare Professional Letter” on 24 February 2014 to inform healthcare professionals about the discontinuation of the product and remark another treatment alternative for consideration. The arrangement for return and refund of the product was also notified. The Department of Health will keep vigilant against any updates of the drug.
Ends/ Friday, March 07, 2014
Issued at HKT 15:00
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