The drugmaker issued the recall last week after tests showed that bottles in which the tablets were packaged were defective and could allow the product to come into contact with water, which could mean patients “may not receive a fully effective dose.”
Company spokeswoman Emily Baier told in-Pharmatechnologist.com the problem was the result of changes to production equipment at one of the firm’s packaging facilities in Germany.
“A new packaging line was used for this lot. The line experienced jams near the labeler...in some cases jammed bottles were cut due to a sharp edge on the labeling machine.”
She also said that Boehringer has already made changes to the manufacturing line to correct the problem.
“Modification of the equipment was completed to spring mount the guide part of the labeling machine. Additionally, the spring is controlled by a sensor that initiates an emergency stop for defined conditions.”
Boehringer advised patients which have Pradaxa from the lot in question – number 201900 – to exchange it at their pharmacy. It also warned against stopping the treatment altogether as this would increase the risk of ischemic stroke.
Although limited in scope, the Pradaxa recall will be unwelcome news for Boehringer which has faced media questions over the product’s safety.
According to the New York Times the drug has been linked to 500 deaths in the US where it has been on the market for two years. The article suggests that unlike warfarin the blood thinning effects of Pradaxa are hard to reverse because no antidote is available.
One 2011 study suggested that rather than any increased safety risk, the deaths associated with Pradaxa could be due to a lack of caution from physicians prescribing the drug, particularly to older people or those with kidney problems who are at higher risk of bleeding.
Later same year the US Food and Drug Administration (FDA) asserted that bleeding rates associated with Pradaxa were no higher than those linked to warfarin. Similar findings were presented by Boehringer during the American Heart Association's Scientific Sessions 2012 earlier this month.