EMA pulls an opioid from the 1950s used to treat dry cough – Endpoints News

The Eu­ro­pean Med­i­cines Agency said Fri­day that it’s pulling from all Eu­ro­pean mar­kets phol­co­dine-con­tain­ing med­i­cines, which are an opi­oid used in adults and chil­dren for the treat­ment of dry cough and in com­bo with oth­er drugs as a treat­ment for cold and flu.
The de­ci­sion to pull the med­i­cines comes as the EMA points to the re­sults from the re­cent ALPHO study, which show that use of phol­co­dine dur­ing the 12 months pre­ced­ing anes­the­sia is linked to a risk of an ana­phy­lac­tic re­ac­tion re­lat­ed to the neu­ro­mus­cu­lar block­ing agents (NM­BAs) used (with an ad­just­ed OR of 4.2, and a 95% con­fi­dence in­ter­val of 2.5 to 6.9).
“Health­care pro­fes­sion­als should con­sid­er ap­pro­pri­ate treat­ment al­ter­na­tives and ad­vise pa­tients to stop tak­ing phol­co­dine-con­tain­ing med­i­cines,” EMA said.
Com­pa­nies mar­ket­ing phol­codines had to con­duct the ALPHO study fol­low­ing a pre­vi­ous safe­ty re­view from 2011.
“As no ef­fec­tive mea­sures have been iden­ti­fied to min­imise this risk, phol­co­dine med­i­cines are be­ing with­drawn from the EU mar­ket,” EMA added Fri­day, telling pa­tients on phol­codines to con­tact their doc­tors or phar­ma­cists and they will pre­scribe an­oth­er drug.
A 2013 re­view of the ev­i­dence link­ing phol­co­dine ex­po­sure to NM­BA hy­per­sen­si­tiv­i­ty not­ed that when phol­co­dine was with­drawn from the Nor­we­gian mar­ket in March 2007, the coun­try saw a “fall in phol­co­dine and sux­am­etho­ni­um sen­si­ti­za­tion rates and al­so in the in­ci­dence of NM­BA ana­phy­lax­is.” But EMA said those stud­ies did not con­vinc­ing­ly es­tab­lish a causal link be­tween phol­co­dine use and ana­phy­lax­is from NM­BA use.
Used as a cough sup­pres­sant since the 1950s, phol­co­dine-con­tain­ing drugs are au­tho­rized in Bel­gium, Croa­t­ia, France, Ire­land, Lithua­nia, Lux­em­bourg and Slove­nia. Phol­co­dine is of­ten used in com­bo with oth­er drugs, made avail­able as syrups, oral so­lu­tions, and cap­sules un­der var­i­ous trade names and as gener­ics, in­clud­ing Dimetane, Bio­ca­lyp­tol and Bron­ca­lene.
“For pa­tients sched­uled to un­der­go gen­er­al anaes­the­sia with NM­BAs, health­care pro­fes­sion­als should check whether pa­tients have used phol­co­dine-con­tain­ing med­i­cines in the last 12 months and main­tain aware­ness about po­ten­tial pe­ri­anaes­thet­ic ana­phy­lac­tic re­ac­tion re­lat­ed to NM­BAs,” EMA said.

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