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      4 The Portugal News • 17 Nov 2018

      Portugal addresses Nolotil painkiller scare




      Portugal’s national drugs authority has this week issued its take on a prescription-only painkiller                     N N N N N  CARRIE-MARIE
      linked to the deaths of ten British and Irish expatriates, and holidaymakers in neighbouring Spain.                           BRATLEY
                                                                 bulletin on its website that  It did not specify how many, if any,  2009, a Spanish study had
                                                                 recommended care in the use of  of those cases were foreign  already warned of the danger of
                                                                 medicines such as Nolotil.   nationals, namely Britons or  Britons being medicated with
                                                                 In Portugal, medicines sold  northern Europeans.          Nolotil”.
                                                                 containing metamizole are    To minimize the risk of      It said the study, conducted by
                                                                 Nolotil, Dolocalma and       agranulocytosis associated with  researchers at the Internal
                                                                 Metamizol Cinfa.             the use of metamizole, Infarmed  Medicine Unit of the Costa del
                                                                 Nolotil is prescribed for acute  recommends its use is restricted  Sol Hospital in Marbella and
                                                                 and severe pain, including   to “a maximum of 7 days”, and in  published in the Revista Clínica
                                                                 spasmodic pain and tumour    the case of longer use, “the blood  Española, titled ‘Agranulocytosis
                                                                 pain, and high fever, which does  count values should be  from Metamizole: A Potential
                                                                 not respond to other antipyretic  monitored”.             Problem for the British’, had
                                                                 treatment. It is available over-the-  Among other recommendations,  concluded that in Spain,
                                                                 counter in Mexico, India, Brazil,  it also advised particular  “agranulocytosis from
                                                                 Russia, but is banned in the US,  attention to the prescription of  metamizole is an adverse effect
                                                                 Sweden, Japan, Australia and  such medicinal products in  that occurs more frequently in the
             anned in the UK and    to the non-use of metamizole in  much of Europe.          elderly patients, and advised  British, therefore its use should
              Sweden, Nolotil, a pain  patients “in whom it is not  Addressing the recent reports,  prescribing physicians and other  be avoided”.
              reliever whose main   possible to perform controls”,  Infarmed stressed that    health professionals to “pay  In a recent statement,
      Bcomponent is                 such as “fluctuating populations”,  “Metamizole has been used for  particular attention to the  manufacturers Boehringer
      Metamizol, is commonly        interpreted by some as a ban on  the treatment of pain and fever for  prevention and / or early  Ingelheim said there is “no
      prescribed in Portugal and    prescribing the drug to tourists.  about 40 years” in Portugal, and  detection of this or other  scientific evidence” Nolotil
      Spain.                        Its manufacturer, Boehringer  acknowledged “the use of    undesirable effects”.        causes the side effects
      In August, Spain’s drugs and  Ingelheim, denied a ban, saying  medications containing this  Despite the recent scare  mentioned in relation to “genetic
      sanitary products regulator   it was merely “reinforcement that  substance may cause an  surrounding the drug, Infarmed  peculiarities”, meaning specific
      AEMPS was reported by The     it should only be used with a  adverse reaction -         noted that “these medicinal  populations are not affected, but
      Times to have “confirmed it had  prescription”.            agranulocytosis - which,     products maintain a positive risk-  added it “regrets the deaths and
      launched an investigation into  The AEMPS’ investigation came  although severe, is very rare”.  benefit relationship, provided  will continue to monitor and
      concerns that northern        after Spanish medical translator  Agranulocytosis is an acute  that all conditions, including the  evaluate, in collaboration with
      Europeans may be more at risk  Cristina Garcia del Campo   condition involving a severe and  indications for use of metamizole  health authorities, any safety
      of side effects” than others.  lobbied for a probe after   dangerous drop in the white  and the above precautions (listed  issues potentially associated
      The AEMPS also updated the    discovering a link between blood  blood cell count.       in the SPC and FI of this    with their medicines”.
      metamizol datasheet in light of  poisoning in several British and  Infarmed said that in Portugal, a  medicinal product) are met.”  Infarmed stressed that patients
      the investigation, and issued a  Irish tourists and the drug.  total of 11 cases of     Infarmed concluded by saying it  who have been prescribed
      recommendation that the drug  The Times also said that over  agranulocytosis potentially  will “continue to monitor and  metamizole “should not
      be taken responsibly, “for short-  “100 British and Irish expatriates  associated with the use of  disseminate all relevant  discontinue treatment”.
      term treatments, sold with a  and holidaymakers in Spain   metamizole were reported to the  information on this subject in  It said a doctor should be seen
      prescription, and before it is  have suffered devastating side  pharmaco-vigilance system  coordination with the other  immediately “if there are signs
      issued, detailed blood tests  effects after taking the drug”,  between 2008 and 2018, “with a  partners and with the European  and symptoms of blood
      should be performed in order to  such as blood poisoning and  frequency of 1 to 2 cases per year  Medicines Agency”.  dyscrasia, such as general
      avoid risk factors for        amputations.                 (which is within the expected  A report in Portuguese     malaise, infection, persistent
      agranulocytosis”.             On Wednesday, Portugal’s drugs  frequency of one very rare  newspaper Observador has   fever, bruising, bleeding or
      Another recommendation refers  watchdog Infarmed issued a  reaction)”.                  meanwhile recalled that “in  paleness”.
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