Paroxetin este un medicament cu actiune antidepresiva, anxiolitica, ce poate fi administrat si in tratamentul tulburarii obesiv compulsive si in atacurile de panica. Apartine unei clase farmaceutice de antidepresive numite inhibitori selectivi ai recaptatii serotoninei.
Desi initial se considera ca fiind un medicament relativ sigur, studii noi efectuate au prezentat ipoteza ca administrarea de paroxetin in cursul sarcinii poate sa creasca riscul de aparitie al malformatiilor cardiace. Ulterior publicarii acestor rezultate au fost realizate si alte studii, dintre care 4 studii care au inclus un numar mare de femei insarcinate ce au luat paroxetin in timpul evolutiei sarcinii, studiile urmarind apoi copiii nascuti din acestea sarcini pana la varsta de 9 ani.
O colectie de extrase din articole relevante pentru subiect.
Paroxetin si pericolele asociate lui
Paroxetin este un medicament cu actiune antidepresiva, anxiolitica, ce poate fi administrat si in tratamentul tulburarii obesiv compulsive si in atacurile de panica. Apartine unei clase farmaceutice de antidepresive numite inhibitori selectivi ai recaptatii serotoninei.
Desi initial se considera ca fiind un medicament relativ sigur, studii noi efectuate au prezentat ipoteza ca administrarea de paroxetin in cursul sarcinii poate sa creasca riscul de aparitie al malformatiilor cardiace. Ulterior publicarii acestor rezultate au fost realizate si alte studii, dintre care 4 studii care au inclus un numar mare de femei insarcinate ce au luat paroxetin in timpul evolutiei sarcinii, studiile urmarind apoi copiii nascuti din acestea sarcini pana la varsta de 9 ani.
Nu s-a observat un risc crescut de dezvoltare a unor malformatii sau a altor defecte ce ar fi putut fi atribuite administrarii de paroxetin. De aceea, specialistii sunt inca rezervati in catalogarea acestui medicament ca avand potential teratogen.
Pericolele mult mai reale ale paroxetinului sunt, insa, altele. Administrarea acestui antidepresiv, dar si a altor substante din aceasta clasa farmaceutica si a antidepresivelor triciclice in timpul sarcinii, mai ales in ultimul trimestru, poate determina dezvoltarea sindromului de abstinenta la bebelus. Acesta nu se poate adapta vietii extrauterine, mai ales in primele zile postpartum.
Cele mai frecvente simptome ale sevrajului aparute in urma administarrii de antidepresive pe perioada sarcinii includ: dispnee, hipertonie musculara, iritabilitate, tulburari ale somnului, dificultati de alimentatie si tremor. Se pare ca simptomele enumerate pot sa apara la orice doza de paroxetin, insa sunt cu atat mai grave cu cat dozele sunt mai crescute.
Un alt pericol indus de administrarea de paroxetin in timpul ultimului trimestru de sarcina este reprezentata de aparitia hipertensiunii pulmonare la nastere. Pentru a se stabili care este impactul antidepresivelor, dar si al bolii depresive a mamei netratatate, asupra fatului, au fost mai multe studii tip cohorta.
Rezultatele lor au fost suprinzatoare deoarece au aratat ca efectele pe termen lung ale bolii asupra fatului sunt mai importante decat cele ale terapiei: copii nascuti din mame cu depresie, care nu au fost tratate pe durata sarcinii au avut un anumit grad de retard intelectual care ii impiedica sa aibe rezultate scolare satisfacatoare, comparativ cu copii nascuti din mame care au fost sub un tratament antidepresiv efectuat strict sub supraveghere medicala, care aveau rezultate mai bune.
In cazul in care sunteti insarcinata si ati fost in tratament cu antidepresive sau inca le mai luati, cel mai bine este sa discutati cu medicul aceasta problema. Tratamentul va fi oprit sau mentinut in functie de riscurile si beneficiile asupra sanatatii dumneavoastra precum si a dezvoltarii fatului. In cazul in care depresia este lasata netratata exista un risc crescut de pierdere a sarcinii, aparitia preeclampsiei, a nasterilor premature si a greutatii mici sau foarte mici la nastere.
http://www.voceapacientului.ro/index.php?cnt=detalii-articol-tratament-nou&pid=103
Femeile insarcinate ce utilizeaza inhibitori selectivi ai recaptarii serotoninei ISRS (antidepresive orale) cresc riscurile ca nounascutii sa dezvolte hipertensiune pulmonara persistenta. Hipertensiunea pulmonara este o afectiune ce apare la aproximativ 2 din 1000 de nounascuti si in cele mai multe cazuri pune in pericol viata copilului.
Nounascutii femeilor care au utilizat in timpul sarcinii sertralina, citalopram, paroxetina si fluoxetina (ISRS – antidepresive orale) au avut un risc semnificativ crescut de a dezvolta hipertensiune pulmonara. Dr Kieler coordonatorul studiului publicat in luna ianuarie in British Medical Journal mentioneaza ca riscul absolut de a dezvolta boala a fost crescut la 3 copii din 1000 de nounascuti.
Analiza efectuata la reputatul Institut Karolinska din Stockholm a inclus 1 600 000 de nounascuti in perioada 1996-2007 din care au fost selectate 11 000 de cazuri la care terapia antidepresiva a fost utilizata in fazele timpurii ale sarcinii si 17 000 de cazuri in care a fost utilizata in fazele mai tarzii ale sarcinii.
Utilizarea ISRS in fazele mai avansate ale sarcinii a produs chiar o crestere mai mare a riscului de a dezvolta hipertensiune pulmonara – o dublare a acestui risc comparativ cu femeile ce nu au utilizat ISRS.
Conform autorilor studiului acest risc pare sa fie unul ce apartine clasei de substante si nu unei molecule anume, dar mecanismul exact prin care se produce aceasta crestere a riscului nu a putut sa fie identificat. Se presupune ca serotonina (al carui nivel e crescut de aceste substante) s-ar depune in plamanul nounascutului si ar induce o constrictie a vaselor pulmonare, dar sunt necesare si alte studii care sa certifice acest aspect precum si riscurile identificate in acest studiu.
Duc antidepresivele la deces (post)neonatal sau la alte complicatii dupa nastere?
Inhibitorii selectivi ai recapatarii serotoninei (SRRI) au fost cosiderati responsabili de multe dintre complicatiile aparute dupa nastere. Tocmai de aceea, antidepresivele sunt interzise in sarcina, administrarea lor fiind considerata de catre multi ca „o sabie cu doua taisuri”.
Totusi, un studiu la care au participat 30.000 de femei din Danemarca, Finlanda, Islanda, Norvegia si Suedia a aratat ca, cel putin in cadrul acelei cercetari, nu a gasita nicio legatura intre antidepresive si riscul decesului neonatal sau postanatal. Ce am mai putea spune decat ca adevarul se afla intotdeuna la mijloc?
O problema dificil de abordat de medicul clinician o reprezinta tratamentul depresiei in timpul sarcinii, deoarece intreruperea tratamentului poate duce la o recidiva uneori severa a bolii, in vreme ce continuarea lui prezinta riscuri pentru fat.
Pana in prezent, datele nu au aratat ca medicamentele ISRS ar produce malformatii. Singurele probleme au aparut la utilizarea in ultimul trimestru de sarcina, deoarece pot determina hipertensiune pulmonara persistenta sau sindrom de abstinenta la nou-nascuti.
In Martie 2012, Agentia Daneza a Medicamentului (DKMA) a publicat rezultatele unui amplu studiu care a investigat riscul malformatiilor la copiii expusi la inhibitori ai recaptarii serotoniei in prima parte a vietii intrauterine. Studiul s-a bazat pe un registru national specializat, care contine date despre 950.000 de copii, dintre care 11.000 au fost expusi la ISRS in timpul sarcinii.
Concluzia studiului a fost ca prevalenta malformatiilor de orice tip este crescuta la copiii ai caror mame au primit agenti de tip ISRS la inceputul sarcinii comparativ cu copiii neexpusi (3,1% vs. 2,4%). Nu s-a putut stabili cu suficienta siguranta daca un anume tip de malformatie a fost in mod specific crescut. Efectul pare a fi unul de clasa, nefiind decelate diferente semnificative intre diferite tipuri de agenti ISRS.
Nu se cunoaste mecanismul potential teratogen si nu este exclus faptul ca femeile tratate cu medicamente serotoninergice sa difere de cele netratate in anumite privinte care sa fie in realitate responsabile de prevalenta crescuta a acestui tip de reactii adverse.
Datele au fost deja comunicate pacientilor si medicilor din Danemarca, iar Autoritatea Daneza a reamintit recomandarea sa conform careia decizia de a trata medicamentos depresia la femeile insarcinate trebuie luata numai de un specialist in psihiatrie si doar dupa evaluarea atenta a celorlalte optiuni terapeutice.
Rezultatele au fost prezentate si Agentiei Europene a Medicamentului (EMA), urmand ca in a doua parte a anului, EMA sa se pronunte asupra masurilor ce trebuie luate in vederea asigurarii unei balante beneficiu-risc pozitive la administrarea ISRS in timpul sarcinii.
Sarcina
Siguranta antidepresivelor însarcina este un considerent important pentru femeile tratate cu ISRS. O sintezareferitoare la îngrijirea sanatatii mentale in perioada prenatala depasestescopul articolului de fata, dar la ora actuala exista suficiente date publicatein literatura de specialitate ce pot veni în sprijinul luarii deciziilor.27ISRS nu par sa creasca riscul de malformatii dupa expunerea în timpul primuluitrimestru; exceptia face paroxetina, care se asociaza cu o accentuare cu 1,5 ariscului de malformatii congenitale cardiace. Clasa ISRS, administrata dupa 20de saptamâni de gestatie, poate fi corelata cu un risc crescut de hipertensiunepulmonara persistenta la nou-nascut, iar toate antidepresivele prescrise în altreilea trimestru de sarcina pot produce, la nou-nascut, simptome dediscontinuitate, mai ales iritabilitate, desi ele sunt, de regula, usoare siauto-limitate. Prin urmare, ghidurile clinice recomanda ca paroxetina sa fieoprita în sarcina si, desi ISRS nu sunt contraindicate, sa se ia înconsiderare utilizarea antidepresivelor triciclice, care se stie ca au, inacest caz, riscuri mai mici.
http://www.mhra.gov.uk/home/groups/pl-p/documents/websiteresources/con2022700.pdf
A series of new studies suggests that birth defects are more common in babies whose mothers took paroxetine early in their pregnancy.
The most recent study followed a group of women and recorded the outcomes of their pregnancies. 958 women in the study took paroxetine in the first three months of their pregnancy.
Together these new studies suggest that:
About 4 in 100 babies whose mothers take paroxetine in early pregnancy will be born with a birth defect. This compares with 3 in 100 babies born to women who didn’t take paroxetine.
About 2 in 100 babies whose mothers take paroxetine in early pregnancy will be born with a heart defect. This compares with 1 in 100 babies born to women who didn’t take paroxetine.
http://en.wikipedia.org/wiki/Paroxetine#Pregnancy
Pregnancy
The American College of Obstetricians and Gynecologists recommends that for pregnant women and women planning to become pregnant, „treatment with all SSRIs or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine use among pregnant women or women planning to become pregnant be avoided, if possible.”[15] According to the prescribing information[24] „epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). In general, septal defects range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve spontaneously. If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus. Unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant. For women who intend to become pregnant or are in their first trimester of pregnancy, paroxetine should only be initiated after consideration of the other available treatment options.” These conclusions are supported by multiple systematic reviews and meta-analyses that found that, on average, the use of paroxetine during pregnancy is associated with about 1.5–1.7-fold increase in congenital birth defects, in particular, heart defects.[25][26][27][28][29] A recent non-systematic review, reporting to have received support from GSK, came to a different conclusion: „the teratogenic potential of paroxetine that has been reported in some studies remains unproven”.[30] Other reviews vary on whether the teratogenic risks outweigh the risk of disease relapse if the drug is discontinued: some advocate discontinuation,[25] while others suggest caution;[27] even where the overview of antidepressants generally is favorable, paroxetine is singled out for specific risks.[28] Paroxetine use during pregnancy increases the risk of spontaneous abortion.[31][32]
A large 2010 study — using the Swedish Medical Birth Register (MBR) from 1 July 1995 up to 2007 identified women who reported the use of antidepressants in early pregnancy or were prescribed antidepressants during pregnancy by antenatal care — found a specific association between Paxil use and infant cardiovascular defects.[33] A strong association between Paxil and hypospadias was also concluded in this study, though the researchers concluded that it is not clear if these effects were due to drug use or underlying pathology.[33]
Abrupt discontinuation of psychotropic drugs during pregnancy can also lead to serious adverse effects.[34]
Counseling is effective in reassuring women to adhere to therapy,[34] but neonatal paroxetine withdrawal symptoms described above have been documented from mothers taking Paxil during pregnancy.[35]
http://www.cfp.ca/content/56/8/767.full
In the fall of 2005, GlaxoSmithKline published a study on its website, with findings that indicated infants exposed to paroxetine might be at higher risk of congenital malformations, in particular cardiovascular defects.4 This study was based on outcomes of 815 infants, and the reported incidence of cardiovascular malformations (unspecified in terms of severity) was 2% compared with 1% in the comparison group. Data were later re-analyzed and adjusted to 1.5% in the exposed group.5
The U.S. Food and Drug Administration (FDA) recently announced that early research studies with the drug Paxil (paroxetine) suggest that taking the drug during the first three months of pregnancy may increase a woman’s risk of having a baby with birth defects, particularly heart defects.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2661986/?report=classic
CONCLUSION
This study suggests a possible association between cardiovascular anomalies and first-trimester exposure to fluoxetine.
They review also found evidence of health risks for pregnant women taking antidepressants including an increase in miscarriage and two potentially dangerous conditions, pregnancy-induced hypertension and preeclampsia, especially if use extends beyond the first trimester.
Premature birth was the „most pressing” obstetrical complication in more than 30 studies researchers reviewed. Urato said, „This is a significant finding because we know that babies born before 37 weeks are at risk for many short and long-term health problems.”
There was also a „strong signal” of birth abnormalities, most notably between the antidepressant Paxil and heart defects in newborns. In 2005, the FDA asked GlaxoSmithKline to change Paxil’s risk factor to demonstrate risk to the fetus, and the Mayo Clinic says the drug is „generally discouraged” during pregnancy.
http://www.babble.com/kid/i-took-paxil-while-pregnant/
I’m not a doctor. But I can say that my son does not have a heart condition or any side effects regarding my Paxil use during pregnancy. I had a normal, healthy pregnancy. And if I were to get pregnant again, it would (Dear God!) be planned. This means I would talk to my OB-GYN, GP, and Ped BEFORE I conceived. If they wanted me to taper off and be meds-free while pregnant, I would agree. I would cross my fingers, but I would agree.
http://www.mothertobaby.org/paroxetine-paxil-and-pregnancy-p150188
Can taking paroxetine during my pregnancy cause birth defects?
Several studies have suggested that exposure to paroxetine may be associated with an increased risk for heart defects. In the general population, the background risk for heart defects is one percent. These studies showed that paroxetine use during the first trimester of pregnancy may increase this risk to two percent. One of the heart defects seen most often involves the wall dividing the right and left sides of the heart. This type of defect can range from very mild (no treatment needed) to more significant, which may require surgery. It has been suggested that because infants exposed to paroxetine are followed more closely at birth, mild heart defects that might otherwise not be discovered are found. There have also been recent studies that have not supported the association between paroxetine and heart defects. Currently the information is uncertain, but if the risk exists it is likely to be small. Women who take paroxetine during the first trimester can consider asking their doctor for a fetal echocardiogram (ultrasound of the baby’s heart) at 20 weeks of pregnancy.
http://www.washingtonpost.com/wp-dyn/content/article/2005/12/08/AR2005120802118.html
The Food and Drug Administration warned pregnant women and their doctors away from the antidepressant Paxil yesterday because of an increased risk of heart defects in newborns.
http://www.aafp.org/afp/2012/0415/p747.html
Two studies have found an association between first trimester paroxetine use and congenital malformations, notably cardiac malformations. The first study, completed in 2005, showed “a trend towards a 1.5-fold increased risk for cardiovascular malformations for paroxetine compared to other antidepressants. This study also showed a statistically significant increased overall risk of major congenital malformations (inclusive of the cardiovascular defects) in infants exposed to paroxetine compared to other antidepressants.”1
In the second study, an analysis of data from the Swedish Medical Birth Register revealed an association between use of paroxetine and cardiovascular congenital defects, most notably ventricular and atrial septal defects.2 On the basis of these two studies and at the FDA’s request, GlaxoSmithKline downgraded their rating of paroxetine safety in pregnancy to category D.3
CONTEXT: Although a large number of women of reproductive age use new selective serotonin reuptake inhibitors (SSRIs) and half of all pregnancies are unplanned, no data exist on the safety of these agents for the human fetus. OBJECTIVE: To assess fetal safety and risk of fluvoxamine, paroxetine, and sertraline. DESIGN: A prospective, multicenter, controlled cohort study. SETTING: Nine Teratology Information Service centers in the United States and Canada. PATIENTS: All women who were counseled during pregnancy following exposure to a new SSRI and followed up by the participating centers. Controls were randomly selected from women counseled after exposure to nonteratogenic agents. MAIN OUTCOME MEASURES: Rates of major congenital malformations. RESULTS: A total of 267 women exposed to an SSRI and 267 controls were studied. Exposure to SSRIs was not associated with either increased risk for major malformations (9/222 live births [4.1%] vs 9/235 live births [3.8%] in the controls, relative risk, 1.06, 95% confidence interval, 0.43-2.62) or higher rates of miscarriage, stillbirth, or prematurity. Mean (SD) birth weights among SSRI users (3439 [505] g) were similar to the controls (3445 [610] g) as were the gestational ages (39.4 [1.7] weeks vs 39.4 [1.9] weeks). CONCLUSION: The new SSRIs, fluvoxamine, paroxetine, and sertraline, do not appear to increase the teratogenic risk when used in their recommended doses.
http://www.babymed.com/medications/paxil-paroxetine-during-pregnancy-and-breastfeeding
Effects on Pregnancy:
Paxil has been placed in pregnancy category D by the Food and Drug Administration. There is evidence that the drug causes birth defects when taken during pregnancy. Possible birth defects associated with Paxil include heart and lung disorders. You must contact your doctor immediately upon finding out you’re pregnant. It may be suggested for women in their childbearing years use one or more birth control methods to prevent pregnancy while on Paxil.
Some studies suggest the birth defects associated with Paxil could be serotonin syndrome or drug discontinuation syndrome. For this reason, if you are thinking about becoming pregnant talk with your physician beforehand so your medication can be changed.
http://www.anxiety-disorder-depression-help.com/paxil.html
Paxil poses a health risk to your unborn child.
Why?
A teratogen interferes with the normal development of a fetus. And, causes birth defects. As a result, one or more abnormalities could grow in your unborn baby. It’s suspected Paxil is a teratogen.
http://www.attorneyone.com/paxil/paxil-birth-defect-lawsuit/
New Study Links Paxil during Pregnancy to Adverse Events for Babies
A new study, published on May 2nd, 2012 in the online edition of the American Journal of Obstetrics & Gynecology, revealed that, during pregnancy, second trimester antidepressant use is associated with preterm birth, and third trimester SSRI use (including Paxil) is associated with infant convulsions. Paxil (paroxetine), produced by GlaxoSmithKline and approved in 1992 by the FDA, is an antidepressant drug belonging to a group called selective serotonin reuptake inhibitors (SSRIs). In January 2012, the British Medical Journal published a study revealing that selective SSRIs, including Paxil, are linked to pulmonary hypertension in newborns (PPHN) of mothers who took the drug during pregnancy. Now, AttorneyOne.com, a recognized authority on law, can provide helpful, proven advice and simple solutions including how to get in contact with legal counsel so anyone can easily and inexpensively deal with cases of Paxil severe adverse events
SSRIs and birth defect risk
Eight prospective or case-control studies of SSRIs in >5,400 pregnant women have been published since 1993 (Table).3-10 Five included paroxetine.6-10 The studies ranged from small to large, and none showed a significant increase in major malformations with any SSRI. Even in a study of >2,500 women, no single malformation was overrepresented.8
In addition, a recent meta-analysis11 of 7 prospective comparative cohort studies involving 1,774 pregnant women showed no increased risk of major birth defects from exposure to any of the 8 antidepressants studied, including 4 SSRIs used during the first trimester. The review identified no specific malformation or cluster of malformations associated with first-trimester antidepressant use.