Title Povlačenje nekih lijekova iz medicinske upotrebe: uzrok i posljedice Title (english) Withdrawal of some medicines from medical use: cause and consequences Author Franka Hunjet Mentor Živka Juričić (mentor)Committee member Živka Juričić (predsjednik povjerenstva)Committee member Lidija Bach-Rojecky (član povjerenstva)Committee member Karmela Barišić (član povjerenstva)Granter University of Zagreb Defense date and country 2021-09-03, Croatia Scientific / art field, BIOMEDICINE AND HEALTHCARE Abstract Tijekom povijesti, a posebno u razdoblju početaka razvoja farmaceutske industrije, postojalo je mnogo primjera lijekova koji
su odobreni za stavljanje u promet, a poslije se otkrilo kako imaju teške, a neki i smrtonosne štetne posljedice. Takvi lijekovi
su povučeni s tržišta uz veliki odjek u javnosti. Danas je takvih primjera vrlo malo, a teži se potpunom rješavanju toga
problema.
Dietilstilbestrol odobren je za stavljanje na medicinsko tržište 1938. godine, a tek 1971. godine znanstvenici su povezali pojavu
neplodnosti, spontanih pobačaja, raka dojki, raka grlića maternice i još nekih teških nuspojava zabilježenih kod pacijentica, s
primjenom DES-a tijekom trudnoće. Također, primjećene su i štetne posljedice kod djece, i ženske i muške, koja su bila
izložena DES-u unutar maternice. Slijedile su brojne tužbe i veliko nezadovoljstvo javnosti.
Rofekoksib je stavljen u promet 1999. godine, a povučen od strane proizvođača 2004. godine nakon što se otkrilo da njegova
primjena uzrokuje povećani rizik od infarkta miokarda i moždanog udara. Koristio se za liječenje akutnih i kroničnih simptoma
osteoartritisa i akutnih bolova zbog čega je bio vrlo popularan te propisan više od 80 milijuna ljudi diljem svijeta. Nakon
njegovog povlačenja, zabilježen je pad primjene i ostalih lijekova ove skupine kao rezultat zabrinutosti da bi se i na njih moglo
odnositi pitanje sigurnosti kao i za rofekoksib.
Cerivastatin odobren je 1997. godine, a zbog zabilježenih povećanih pojava rabdomiolize kod pacijenata koji su ga koristili,
proizvođač ga je 2001. godine dobrovoljno povukao s tržišta. Dogodio se pad primjene ostalih statina, lijekova bitnih za
snižavanje ukupnog i LDL kolesterola i sprječavanje štetnog učinka nepovoljnih kardiovaskularnih događaja. Povlačenje
odobrenog i široko korištenog lijeka kao što je cerivastatin, zbog ozbiljnih nuspojava opasnih po život, ugrozilo je povjerenje
javnosti u sustav medicinske skrbi.
Drotrekogin alfa (aktivirani) na tržište je stavljen 2001. godine kao jedini lijek s primjenom isključivo za pacijente s teškom
sepsom i septičkim šokom. Povučen je 2011. godine nakon što brojna ispitivanja nisu uspjela potvrditi učinkovitost lijeka
pokazanu u izvornom ispitivanju, što je povećalo skepticizam javnost prema medicini i farmaciji.
Abstract (english) Throughout history, especially in the early days of the pharmaceutical industry, there have been many examples of drugs
approved for placing on the market, and it was later discovered that they have severe, and some of them even fatal adverse effects. Such drugs have been withdrawn from the market with a great public response. Today, there are very few such examples, and efforts are being made to completely solve this problem.
Diethylstilbestrol was approved for marketing in 1938, and it was not until 1971 that scientists linked the occurrence of
infertility, miscarriages, breast cancer, cervical cancer and some other severe side effects reported in patients to the use of DES during pregnancy. Adverse effects were also observed in children, both female and male, who were exposed to DES within the uterus. Numerous lawsuits and great public discontent followed.
Rofecoxib was placed on the market in 1999 and withdrawn by the manufacturer in 2004 after its use was found to cause an increased risk of myocardial infarction and stroke. It has been used to treat acute and chronic symptoms of osteoarthritis and acute pain which is why it has been very popular and prescribed to more than 80 million people worldwide. Following its withdrawal, there has been a decline in the use of other drugs in this group as a result of concerns that they could be as unsafe as rofecoxib. Cerivastatin was approved in 1997, and due to the increased incidence of rhabdomyolysis in patients who used it, the manufacturer voluntarily withdrew it from the market in 2001. There has been a decline in the use of other statins, drugs essential for lowering total and LDL cholesterol and preventing the harmful effects of adverse cardiovascular events. Withdrawal of an approved and widely used drug such as cerivastatin, due to serious life-threatening side effects, has jeopardized public confidence in the health care system.
Drotrecogin alfa (activated) was placed on the market in 2001 as the only drug to be used exclusively for patients with severe sepsis and septic shock. It was withdrawn in 2011 after a number of trials failed to confirm the drug’s effectiveness shown in the original trial, increasing public skepticism toward medicine and pharmacy.
Keywords
dietilstilbestrol
rofekoksib
cerivastatin
drotrekogin alfa
sepse
statini
trudnoća
estrogen
koksibi
Keywords (english)
diethylstilbestrol
rofecoxib
cerivastatin
drotrecogin alfa
sepsis
statins
pregnancy
estrogen
coxibs
Language croatian URN:NBN urn:nbn:hr:163:483865 Study programme Title: Pharmacy Type of resource Text File origin Born digital Access conditions Open access Terms of use Created on 2022-03-25 13:17:03
