דיווח על תופעות לוואי בתרופות

רשות
משרד הבריאות
תאריך התשובה
2020-09-25
מסמכים
2 מסמכים

הבקשה

בפנייה התבקש המידע הבא –1. האם דווחו למשרד הבריאות תופעות לוואי של התרופה Propecia להתקרחות?2. האם אפשר לקבל ריכוז דיווחים על תופעות לוואי של תרופות בכלל?כמה דיווחים התקבלו בעשור האחרון במשרד הבריאות עם פירוט התרופות והתופעות?מצ"ב המענה שניתן ביום 26.8.20

מסמך 1 מתוך 2

פתיחת הקובץ באתר הממשלה (pdf, 493 KB)

ו' באלול ,התש"פ

26/08/2020

סימוכין347951720:

מס' פניה633610:

שולמית בלנק

לכבוד

********

שלום רב,

הנדון :בקשה לפי חוק חופש המידע – דיווח על תופעות לוואי בתרופות

בפנייתך ביקשת לקבל את המידע הבא –

.1האם דווחו למשרד הבריאות תופעות לוואי של התרופה Propeciaלהתקרחות?

.2האם אפשר לקבל ריכוז דיווחים על תופעות לוואי של תרופות בכלל?

כמה דיווחים התקבלו בעשור האחרון במשרד הבריאות עם פירוט התרופות והתופעות? השאלה היא הן לפי טופס זה

והן בדרכים אחרות.

לאחר בירור מול הגורמים המקצועיים במשרד להלן תשובתנו –

.1רצ"ב טבלה בה מרוכזים הדיווחים על התרופה PROPECIAשהתקבלו מאז הקמת המאגר הממוחשב שהוקם

בספטמבר ,2014יום כניסת התיקון לתקנות הרוקחים (תכשירים) ,התשמ"ו – ,1986לתוקפו .הושמטו

מהטבלה שמות הגורמים המדווחים מטעמי פגיעה בפרטיות.

.2מאז ספטמבר 2014ועד היום נאגרו במערכת 66,533דיווחים .דיווחים שהתקבלו לפני ספטמבר 2014אינם

ממוחשבים ויש לספור אותם ידנית ,דבר המהווה הקצאת משאבים בלתי סבירה.

ביחס להערתך בדבר טופס הדיווח שהורד מהאתר – רצ"ב קישור לפורטל דיווח החדש-

https://www.gov.il/he/service/adverse_effects_reportsטופס הדיווח הישן פעל במקביל לפורטל החדש זמן ממושך,

ודיווחים נמסרו בשני האפיקים ,ולאחרונה הטופס הישן הוסר.

תודה על פנייתך.

בכבוד רב

שולמית בלנק ,עו"ד

ממונה על העמדת המידע לציבור

אגף השירות

תחום חופש המידע

ת.ד 1176.ירושלים 91010

call.habriut@moh.health.gov.il

טל *5400 :פקס02-5655971 :

Service Division

Freedom of information

P.O.B 1176 Jerusalem 91010

call.habriut@moh.health.gov.il

Tel: *5400 Fax: 02-5655971

מסמך 2 מתוך 2

פתיחת הקובץ באתר הממשלה (xlsx, 47 KB)

PROPECIA

שם המוצרמספר פניהמספר סימוכיןסוג גורם מדווחגורם מדווחתאריך דיווחתאריך קליטהתאור ארוע
PROPECIA19765IL-009507513-1611ISR000132חברה מסחרית***30/10/201617/11/2016This spontaneous report was received from a Foundation concerning a 21 year old male patient with post finasteride syndrome. The patient's pertinent medical history was not reported. On an unspecified date in April 2013, the patient started therapy with finasteride (PROPECIA) tablets, per oral route. (Strength, dose, frequency, lot #, expiration date and indication were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced Post-Finestaride Syndrome (PFS) (detail of adverse event was unknown). Therapy with finasteride (PROPECIA) was discontinue
PROPECIA+3:510436IL-009507513-1512ISR006627חברה מסחרית***09/12/201520/12/2015Information was received via a report (local reference #ISR/15/0517) regarding a case concerning a 31 year old male patient, who used finasteride (PROPECIA) (dates of therapy, dosage and frequency not provided) for alopecia. It was reported that a dermatologist prescribed finasteride (PROPECIA) to the patient without informing him of the damage the drug will cause. The patient argued that following his use of finasteride (PROPECIA), his sexual desire and fertility were damaged (onset not provided). The patient claimed that when he was 24 years old, he suffered from alopecia and a dermatologist
PROPECIA61634IL-009507513-2002ISR005530חברה מסחרית***13/02/202025/02/2020This spontaneous prospective pregnancy report was received from a physician via company representative, referring to a female patient of unknown age. On an unknown date, the female patient was exposed therapy with finasteride (PROPECIA) 1 mg, through male partner via unknown route (exposure via body fluid) (dose, frequency, indication, lot number and expiry date were not reported). According to physician the male partner uses finasteride (PROPECIA) on and off like one pill every other day. On an unknown date, the patient became pregnant (maternal exposure during pregnancy). The last menstrual
PROPECIA61633IL-009507513-2002ISR008318חברה מסחרית***13/02/202025/02/2020This spontaneous report was received from a physician via company representative, referring to a male patient of unknown age. On an unknown date, the patient started therapy with finasteride (PROPECIA) 1 mg, (dose, frequency, indication, lot number and expiry date were not reported). According to physician, the patient uses finasteride (PROPECIA) on and off like one pill every other day (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown. This is one of two reports received from the same reporter.
PROPECIA48422IL-009507513-1901ISR004432חברה מסחרית***09/01/201921/01/2019This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. The patient's concurrent conditions and concomitant medications were not reported. The patient's medical history included problems with fertility. On approximately 10-JAN-2017, the patient's first sperm analysis did not show any findings. On an unknown date in July 2017, the patient started therapy with finasteride (PROPECIA) 1mg tablet (dose, frequency, indication, lot# and expiration date were not reported). On an unknown date in 2018, the patient could not conceive. On an unknown date in Janu
PROPECIA43544IL-009507513-1808ISR004471חברה מסחרית***01/11/201811/11/2018Information has been received from a male patient of unknown age referring to himself. Information about historical condition and concomitant medication was not provided. The patient's concurrent condition included hair loss.The patient previously took finasteride (other company) and another generic of another company but they did not have an effect. On an unknown date in 2016 (reported as 2 years ago), the patient started therapy with finasteride (PROPECIA) (white tablet, dose, frequency and lot # were unknown) orally for an unknown indication and the effect was good. On approximately 16-JUL-
PROPECIA42007IL-009507513-1807ISR010710חברה מסחרית***22/07/201830/07/2018This spontaneous report was received from a consumer via company representative, refers to a 35 year old male patient. The patient's medical history and concomitant medications were not reported. On an unknown date, several years ago, patient used finasteride(PROPECIA)(dosing details, route and lot# were unknown) for alopecia. On an unknown date, the consumer reported that her husband and she were having fertility problems because according to the test patient has a low sperm percentage ( sperm concentration decreased and infertility). Therapy with finasteride(PROPECIA) was discontinued. The o
PROPECIA41362IL-009507513-1806ISR002638חברה מסחרית***06/06/201809/07/2018This spontaneous report has been received from an approximately 30 year male referring to himself. There was no concomitant therapy included for the entire therapy duration. Information about concurrent condition and medical history was not provided. On an unspecified date in 2013 (also reported as at the age of 23-24, by the recommendation of dermatologist after it has been identified via saliva test that the patient carried the gene for baldness), the patient started therapy with finasteride(PROPECIA) orally for alopecia for the duration of five years. During the first three years, the patie
PROPECIA41263IL-009507513-1806ISR001783חברה מסחרית***03/06/201805/07/2018This spontaneous report was received from a consumer via a company representative who read the information on a web article, and refers to a 42 year old male patient. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On an unknown date, the patient started therapy with finasteride (PROPECIA), tabolets, orally (strength, indication, dose, frequency, lot number and expiration date were not provided). Since an unknown date, it was reported that the patient had many cases of performance anxiety (anxiety). F
PROPECIA38650IL-009507513-1804ISR005362חברה מסחרית***09/04/201823/04/2018This spontaneous report was received from a male patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date in approximately 2008 (reported as "for over 10 years"), the patient started therapy with finasteride (PROPECIA) oral tablet, 1 mg (frequency, lot number, expiration date and indication were not reported). On an unknown date, the patient had high values of unspecified liver tests, which suggested hepatic lipidosis. The dermatologist suggested the patient to discontinue the therapy with
PROPECIA35552IL-009507513-1801ISR014443חברה מסחרית***30/01/201826/02/2018This spontaneous report was received from a physician (dermatology) refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in 2011 (also reported as 7 years), the patient started therapy with finasteride(PROPECIA) (strength, dose, frequency, lot number, expiry date and indication were not reported). On an unknown date, the patient experienced decreased efficacy (drug ineffective). Therapy with finasteride(PROPECIA) was unknown and the outcome of drug ineffective was unknown. Causality asses
PROPECIA33328IL-009507513-1711ISR010282חברה מסחרית***21/11/201714/12/2017Information has been received from a physician concerning to a male patient (age not reported). Medical history, concomitant medications nor concurrent conditions were reported. In 2010 (reported as "for 7 years"), the patietn was placed on therapy with finasteride (PROPECIA), oral tablet (dose, duration, indication, lot number and expiration date not reported). On an unknown date (reported as "recently") the finasteride (PROPECIA) effect decreased. Action taken regarding therapy with finasteride (PROPECIA) was not reported. The relationship between drug effect decreased and finasteride (PROPE
PROPECIA32411IL-009507513-1711ISR005803חברה מסחרית***13/11/201719/11/2017This spontaneous report as received from a consumer refers to his friend, a male patient of unknown age. The patient’s medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient started therapy with finasteride(PROPECIA)(lot, expiry date, dose, frequency, route of administration and indication were not reported). On an unknown date the patient experienced a 30% injury in sexual dysfunction. The action taken was reported as unknown. The outcome of sexual dysfunction was reported as not recovered. The reporter considered sexual dysfunctio
PROPECIA26872IL-009507513-1705ISR004285חברה מסחרית***07/05/201708/06/2017Information has been received from 35 year old male patient via a company representative referring to himself. The patient's concurrent condition, concomitant therapies and medical history were not provided. On an unknown date, the patient started therapy with finasteride(PROPECIA)1 mg(dose, frequency, route and indication were unknown). Recently (in 2017), the patient experienced libido decreased and sexual activity injury. Therapy with finasteride(PROPECIA) was continued. The outcome of the event was unknown. Causality was not provided. Additional information has been requested.
PROPECIA22903IL-009507513-1701ISR010081חברה מסחרית***19/01/201719/02/2017This spontaneous report was received a male patient of unknown age referring to himself. No information regarding the patient's medical history and concurrent conditions was provided. No concomitant medications were involved. In approximately October 2016 (reported as "approximately 3,5 months ago") the patient started therapy with finasteride (PROPECIA) 1 mg oral tablet (dose, frequency, lot number, expiration date and indication were not reported). The patient stated, that ever since he started using finasteride (PROPECIA), he had been experiencing heartburns every morning that lasted for se
PROPECIA20630IL-009507513-1611ISR014340חברה מסחרית***28/11/201614/12/2016Information has been received from a pharmacist who received a question from a physician who asked her whether finasteride (PROPECIA) caused anemia referring to a male patient of unknown age. The patient's medical history and concomitant medication were unknown. In 2011, the patient started therapy with finasteride (PROPECIA) (dose and frequency unknown) orally for unknown indication. Since 2014, the patient has a mild decrease in hemoglobin. In addition, it was noted that the patient became a vegan. Action taken with finasteride (PROPECIA) and the outcome of the event were unknown. In view of
PROPECIA10443IL-009507513-1512ISR008038חברה מסחרית***09/12/201520/12/2015Information was received from a report regarding a case concerning the wife (age unknown) of a male patient (local reference #ISR/15/0517). The patient's husband started therapy with finasteride (PROPECIA) for alopecia (dates of therapy, dosage and frequency not provided) and used finasteride (PROPECIA) for four and a half years. During this period, the husband and wife tried to get pregnant, but failed. Testing showed that the husband's concentration of sperm in his semen was low (see MARRS#1512ISR006627). A physician ordered her husband to discontinue finasteride (PROPECIA) (date of disconti
PROPECIA8500IL-009507513-1510ISR000615חברה מסחרית***13/11/201719/11/2017Information has been received from a 32 year old male patient (also a physician) referring to himself. Concurrent condition and medical history were not reported. On an unknown date in 2009 the patient started therapy with finasteride (PROPECIA) tablet (dose, frequency and indication were unknown, orally). Concomitant therapies were not reported. On an unknown date, the patient experienced slowly decreased Libido, until it disappeared completely. After this period, and after consulting with an urologist, the patient stopped using finasteride (PROPECIA) on an unknown date in 2015 and used minox
PROPECIA6270IL-009507513-1506ISR013511חברה מסחרית***23/06/201509/07/2015This spontaneous report as received from a consumer via Company Representative refers to a male patient of unknown age. There were no concomitant medications, concurrent conditions and medical history reported. In approximately 2009 (reported as six years ago), the patient started therapy with finasteride(PROPECIA) default to oral (strength, dose, frequency, lot number, expiration date and indication were not reported). In approximately April 2015 (reported as in the last three months), the patient started again hair loss, and there is no improvement, or at least stable condition of the hair.
PROPECIA15102IL-009507513-1605ISR012877חברה מסחרית***24/05/201602/06/2016This spontaneous report as received from a consumer via a company representative and refers to a currently 27 to 28 year old male patient. Information on patient's concurrent conditions, medical history and concomitant medication were not provided. On an unknown date in 2016 (reported as few weeks before the time of this report), the patient started therapy with finasteride (PROPECIA) for some unspecified period of time (formulation, strength, dosage, lot number and expiration date was not provided) for hair growth. On an unknown date in 2016, after sometime, the patient was diagnosed with tes
PROPECIA14603IL-009507513-1605ISR004875חברה מסחרית***22/05/201629/05/2016This spontaneous report as received from a consumer (2 friends of company representative) via company representative refers to a 49 year old male patient. The patient's pertinent medical conditions, allergies or drug reactions were not reported. Approximately in August 2015 (reported as 9 months ago), the patient started therapy with finasteride (PROPECIA) (strength, dose, frequency, lot number and therapy route were not reported) for the treatment of alopecia. Approximately in 2015 (reported as one week after started therapy with finasteride (PROPECIA)), the patient experienced adverse event
PROPECIA10437IL-009507513-1512ISR006517חברה מסחרית***17/12/201520/12/2015Initial information has been received on 09 DEC 2015 from a report which רefers to a male patient . Following the use of finasteride (PROPECIA) his sexual desire and his fertility were damaged. The patient, a man aged 34, claims that when he was 29 years old a dermatologist suggested to him that he take finasteride(PROPECIA) (indication not reported). He used the drug for six months. According to the patient, at a certain point he began to feel sexual dysfunction and immediately stopped using the drug. Two years later, he began to suffer from urinary tract problems and genital pain. A physicia
PROPECIA5396IL-009507513-1506ISR001278חברה מסחרית***27/05/201508/06/2015This spontaneous report as received from a consumer via call center pharmacist refers to a male baby of unknown age. In November 2013 the patient’s father started therapy with finasteride (PROPECIA) (oral tablet; dose, frequency and indication unknown). On an unknown date the patient’s mother got pregnant (fetal exposure during pregnancy / fetal exposure via father) (MARRS case no. 1410ISR000858). Approximately in May 2015 (reported as: in recent days) the mother gave birth to the patient. The patient was born with a birth defect, a fistula in the buttocks (anal fistula). The baby had another
PROPECIA513358284ציבור רחב***29/05/201529/05/2015ערפול, ראייה היקפית ולילית חלשה מאוד, זיכרון סנסורי חלש, ליבידו נמוך, חוסר באורגזמה, בעיות שינה, חרדה, דיכאון. שם מלא: *** (משום מה, שדות השם בטופס מוגבלים לשני תווים)
PROPECIA17376IL-009507513-1608ISR006158חברה מסחרית***09/08/201621/08/2016Information was received from a 34 years old male patient via the Agency (Israel Ministry Of Health) referring to herself. The patient's medical history, concurrent condition and concomitant therapy were not reported. In approximately September 2011(reported as 5 years ago), the patient was placed on therapy with finasteride (PROPECIA) (dose, strength and frequency unknown) orally for unspecified indication. On unspecified dates, the patient experienced all the events that are listed on the "Post-Finasteride Foundation" as follows: Sexual Symptoms: Libido: decreased or complete loss of sex dri
PROPECIA15549IL-009507513-1606ISR004539חברה מסחרית***08/06/201619/06/2016This spontaneous report as received from a a 33 year old male patient via a company representative refers to himself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In approximately 2014 (reported as about 2 years ago), the patient started therapy with finasteride (PROPECIA) (strength, dose, frequency, indication, lot # and expiration date were not reported) for a period of two months. During this time, he felt a decrease in sexual function (date unspecified, approximately 2014). After relating the functional problems with
PROPECIA13483IL-009507513-1604ISR000793חברה מסחרית***05/06/201406/04/2016This spontaneous report was received from a male patient of unknown age via a call center nurse, reporting on himself. Information regarding patient's medical history, concurrent condition and concomitant therapy were unspecified. On an unknown date, the patient received a prescription for finasteride (PROPECIA) (dosing details and indication were unspecified) and initiated his therapy with it. The patient thought that he developed a decrease in libido since an unspecified date and discontinued his therapy after two or three days from the day he started taking the drug. He stated that the adve
PROPECIA13300IL-009507513-1603ISR011966חברה מסחרית***17/04/201624/04/2016Initial spontaneous information has been received on 22MAR2016 concerning a male who used finasteride (PROPECIA) (dose, duration and indication not reported.) The article concerns a 32 year-old male, high tech employee. The patient reported',"it is hard to get an erection, loss of libido, ejaculation disorders, orgasm disorders, decreased quantity of semen and pain in the testicles - those side effects observed with some users and continued after use."The patient turned to a dermatologist who recommended him to use finasteride (PROPECIA) and warned him about the decline in the number of sperm,
PROPECIA8385IL-009507513-1509ISR005566חברה מסחרית***10/09/201501/10/2015This spontaneous report as received from a 32 year old male patient with hair loss reporting on himself. There was no information about patient's concomitant medications and medical history reported. In 2007, the patient started therapy with finasteride (PROPECIA) orally, (dose, frequency, lot#, expiry date were not reported) for hair loss. The patient stated that in the first months of therapy there was no change in the hair and then hair loss was arrested and everything worked out. In April 2015, the hair loss started again. Hair loss was not great as it had been prior to therapy with finast
PROPECIA8052IL-009507513-1509ISR005562חברה מסחרית***07/10/201513/10/2015This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. On an unknown date, the patient started therapy with finasteride (PROPECIA) 1 mg oral tablet (dose, frequency, lot#, expiry date and indication were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced haematospermia reported as "blood during ejaculation of semen". The action taken with finasteride (PROPECIA) was not reported. The outcome of the event was n
PROPECIA8048IL-009507513-1509ISR004417חברה מסחרית***06/09/201516/09/2015This spontaneous report as received from a male patient of unknown age, refers to himself. There were no concomitant medications, concurrent conditions and medical history reported. Since approximately 2005 (date estimated based on "for about 10 years"), the patient started therapy with finasteride(PROPECIA) orally (dose, frequency, lot number, expiration date and indication were not reported). According to the reporter, he checked his liver functions every time he used finasteride(PROPECIA) in order to see if everything was normal and noticed that when he took the drug his liver function valu
PROPECIA8046IL-009507513-1107ISR00046חברה מסחרית***31/08/201516/09/2015Information has been received from a physician in an advisory call center who received the information from a 40 year old male who on approximately 13-JUL-2007 was placed on therapy with finasteride, 1 mg tablet for the treatment of hair loss (total daily dose and duration not reported). Therapy helped the patient. The patient experienced an insult to his sexual desire. Sexual function was normal. There were no other adverse events. Therapy with finasteride was discontinued. Subsequently, the patient recovered from insult to sexual desire. On 13-JUL-2011 the patient consulted with the advisory
PROPECIA8045IL-009507513-1304ISR013530חברה מסחרית***31/08/201516/09/2015Information has been received from a nurse in patient supporting program who received the information from a usually healthy 40 year old male who on 23-JUL-2011 was placed on therapy with finasteride(PROPECIA) 1 mg tablet orally for the treatment of hair loss. No concomitant therapy included. Two months from therapy onset, on 23-SEP-2011, the patient experienced libido decreased and felt that he did not have a lot of sperm. The patient continued therapy with finasteride(PROPECIA) for additional seven months and then discontinued therapy with finasteride(PROPECIA), in approximately April 2012.
PROPECIA7940IL-009507513-1509ISR004228חברה מסחרית***02/09/201510/09/2015Information was receved on 02SEP15 from a lawyer via a television program about drugs and their adverse events. The lawyer stated that close to 100 people reached him having experienced fertility injury following therapy with finasteride (PROPECIA). No other information was reported. Additional information is not expected.
PROPECIA7624IL-009507513-1508ISR006941חברה מסחרית***16/08/201526/08/2015This spontaneous report as received from a male patient of unknown age via call center pharmacist refers to himself. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately 2006, the patient started therapy with finasteride(PROPECIA), oral tablet, (dose, frequency, lot number, expiration date and indication were not reported). The patient reported that he had recently begun to swim and saw hair loss after the pool, when taking off his cap (on an unspecified date). Therapy with finasteride(PROPECIA) was continued at
PROPECIA6926IL-009507513-1507ISR011051חברה מסחרית***21/07/201503/08/2015This spontaneous report as received from a consumer via company representative refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medicines were not reported In approximately 2014 (reported as taken for about a year) the patient started therapy with finasteride (PROPECIA) 1 mg, orally (dose, frequency and indication were not reported). On an unknown date, after taking finasteride (PROPECIA) for about a year patient said that he felt that the dropout stopped, but there was no hair growth. The patient also noted that he had heard there w
PROPECIA6359IL-009507513-1507ISR005034חברה מסחרית***04/06/201513/07/2015This spontaneous report as received from a consumer refers to a patient of unknown demographics. Medical history and concurrent conditions were unknown. On an unknown date, the patient started therapy with finasteride(PROPECIA) (dosing details, lot number, indication unknown). Concomitant therapies were unknown. Reporter stated that he entered online talkbacks he read on people and he saw someone in the talkbacks for whom the libido had not returned even six months after cessation of treatment. Action taken on finasteride(PROPECIA) was reported as withdrawn. The case is also related to 1506ISR
PROPECIA6358IL-009507513-1506ISR004102חברה מסחרית***04/06/201513/07/2015This spontaneous report as received from a consumer refers to unspecified patients of unknown demographics. Medical history and concurrent conditions were unknown. On unspecified dates, the patients started therapy with finasteride(PROPECIA) (dosing details, lot number, indication unknown). Concomitant mediications were unknown. Reporter stated that he entered online talkbacks he read on people for whom the libido did not return (loss of libido). The outcome of the event and action taken on finasteride(PROPECIA) were unknown. The case is also related to 1506ISR003864, 1506ISR003836, 1506ISR004
PROPECIA6355IL-009507513-1507ISR004298חברה מסחרית***19/02/201213/07/2015This spontaneous report as received from a 24 year old healthy male patient reporting on himself. On 19-APR-2011 (reported as for 8 months), the patient started therapy with finasteride (PROPECIA) oral tablet, (1 mg, once a day), (lot # and expiration date were not provided) for an unknown indication. Concomitant therapies included methylphenidate hydrochloride (RITALIN). On approximately 19-APR-2011 (possibly since the onset of therapy), the patient experienced red sores and itching at the occipital area (erythema, pruritus and pain). At the time of the report, therapy with finasteride (PROPE
PROPECIA6133IL-009507513-1506ISR003864חברה מסחרית***04/06/201506/07/2015This spontaneous report as received from a consumer refers to a 27 year old male patient with allergy to olive trees (reported as "once a year"), who was reporting on himself. It was reported that the patient was generally healthy (no information regarding his medical history or concurrent conditions was provided). On an unknown date in 2014 (reported as 9 and a half months ago), the patient started therapy with finasteride(PROPECIA) 1 mg oral tablet, dose, frequency, indication, lot# and expiry date unspecified. There were no co-suspect or concomitant therapies. Before starting the treatment
PROPECIA5726IL-009507513-1506ISR009689חברה מסחרית***18/06/201516/07/2015Information has been received from a male consumer (age unknown) via a company representative, referring to himself. Concurrent conditions and medical history were not reported. In approximately 2013 (reported as the patient was taking finasteride(PROPECIA) for two years), the patient started therapy with finasteride(PROPECIA) (strength, dose and lot # not reported), orally, for an unknown indication. Concomitant therapies were unknown. On an unknown date the patient experienced nodules in the knee. The patient asked whether nodules in the knee were related to the use of finasteride(PROPECIA).
PROPECIA5720IL-009507513-1506ISR004469חברה מסחרית***04/06/201521/06/2015This spontaneous report was received from a generally healthy 27 year old male patient regarding himself. The patient reported he was allergic to olive trees once a year. On an unknown date, the patient started therapy with finasteride (PROPECIA) orally for an unspecified indication. No concomitant medications were reported. The patient stated that he was using finasteride for 9 and a half months. On 04-JUN-2015, the patient visited his family doctor for a routine blood test and told the doctor that he experienced sexual side effects (onset date not specified). The doctor told the patient she
PROPECIA5052IL-009507513-1505ISR009804חברה מסחרית***20/05/201527/05/2015This spontaneous report was received from a male consumer of unknown age, reporting on himself. Medical history and concurrent conditions were not reported. On an unknown date the patient started therapy with finasteride(PROPECIA) tablet, oral, (strength, dosage, frequency and indication were not reported). Concomitant therapy was not reported. On an unspecified date in May 2015, (reported as in the last two weeks) the patient could not get the finasteride(PROPECIA), so he did not take it for two weeks. He was referred to a pharmacy. Additional information is not expected because the patient d
PROPECIA4986IL-009507513-1505ISR008592חברה מסחרית***17/06/201506/07/2015Information has been received from a male consumer via call center pharmacist referring to himself of unknown age. Current conditions and medical history was not reported. In approximately October 2013, reported as "for a year", the patient started therapy with finasteride (PROPECIA) oral tablet, orally (lot#, expiration date, dose, strength, frequency and indication were not reported). Secondary suspects and concomitant therapy were not reported. The patient reported that during the last week (in May 2015) he did not take finasteride (PROPECIA) on a regular basis. He took it 2 times a week (I
PROPECIA4909IL-009507513-1410ISR000858חברה מסחרית***27/05/201508/06/2015This spontaneous prospective pregnancy report was received from a consumer via a call center nurse referring to his wife, female patient of unknown age . Current conditions and medical history was not reported. In approximately October 2013, reported as "for a year", the patient's husband started therapy with finasteride (PROPECIA) oral tablet, (lot#, expiration date, dose, strength, frequency and indication were not reported). Concomitant therapy was not reported. On an unknown date, the patient became pregnant (Transmission of drug via semen). An ultrasound was performed showing gestational
PROPECIA4122IL-009507513-1504ISR014652חברה מסחרית***21/04/201526/04/2015This spontaneous report as received from a dermatologist via a call center pharmacist refers to a 30 year old healthy male patient. Current conditions and medical history were not reported. On an unknown date (also reported as for many years, between 5-8 years), the patient started therapy with finasteride (PROPECIA) (strength 1 mg) tablet, orally (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. It was also reported that apparently, the patient was not taking other drugs, and if he did, it was not something substantial. On 12-JAN-2015
PROPECIA2305IL-009507513-1502ISR000285חברה מסחרית***29/03/201531/03/2015This spontaneous report as received from a male patient of unknown age via call center nurse referring to himself. The patient's concurrent conditions and medical history were not reported. In approximately May 2014 (reported as about 8 months ago), the patient started therapy with finasteride(PROPECIA) film-coated tablet, oral (dose, frequency and indication were not provided). No information about concomitant therapy was reported. It was reported that the patient was satisfied with the treatment. There was a stop in hair loss, but not yet growth. On 29-DEC-2014, a month ago, the patient bega
PROPECIA2289IL-009507513-1501ISR006481חברה מסחרית***18/01/201505/02/2015This spontaneous report was received from a consumer refers on behalf of himself as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, for several years (2-3 years) the patient started therapy with finasteride(PROPECIA) (dose, frequency, route, lot # were not reported) for an unknown indication. Concomitant therapy was not reported. The patient was satisfied with the treatment. Last month on an unknown date approximately in December 2014, the patient also began to use Laser hair growth system and he began to see hair loss. The pharmacist explained the
PROPECIA2265IL-009507513-1501ISR001255חברה מסחרית***04/01/201505/02/2015This spontaneous report as received from a male patient of unknown age refers to himself. On an unknown date the patient started therapy with finasteride(PROPECIA) (therapy route defauted to oral, dose, units, frequency, lot number and indication were not reported). On 22-AUG-2014 the patient experienced sexual function side effects. Therapy with finasteride(PROPECIA) was discontinued in September 2014 (reported as 4 months ago). The outcome of had sexual function side effects was reported as recovered on 01-SEP-2014 (reported as after 10 days). The reporter considered had sexual function side
PROPECIA2080IL-009507513-1412ISR004083חברה מסחרית***14/12/201405/02/2015This spontaneous report as received from a male patient of unknown age refers to himself. On an unknown date in August 2014 (reported as "for fourth months"), the patient started therapy with finasteride(PROPECIA) tablet (strength, dose, frequency, indication were not reported), route default as oral. The patient complained of no improvement at all (unknown date in 2014). Action taken with finasteride(PROPECIA) was not reported. The outcome of the event was not reported. The relatedness between the event and finasteride (PROPECIA) was not reported. Follow up information has been received on 14
PROPECIA1957IL-009507513-1401ISR013820חברה מסחרית***04/12/201428/01/2015This spontaneous report was received from a nurse refers to a 38 year old male patient. On 31-DEC-2013 the patient started therapy with finasteride (PROPECIA) (dosing regimen unspecified) for an unknown indication. No concomitant therapy was reported. On 22-JAN-2014, the patient experienced shortness of breath and lack of sleep. Therapy with finasteride (PROPECIA) was discontinued on 24-JAN-2014 upon patients’s own discretion. The outcome of shortness of breath and lack of sleep is unknown. The patient felt that shortness of breath and lack of sleep were related to therapy with finasteride (PR
PROPECIA1956IL-009507513-1409ISR011030חברה מסחרית***04/12/201428/01/2015This spontaneous report as received from a 29 year old male patient refers to himself. It was reported that the patient was healthy. On an unknown date in 2006 (reported as "since the age of 21"), the patient started therapy with finasteride(PROPECIA) tablets, oral (dose, frequency and indication were not reported). The patient did not take additional medication except finasteride(PROPECIA). On an unknown date (also reported as in February), the patient underwent arthroscopy knee surgery and everything was fine. The patient reported that finasteride(PROPECIA) had worked fine so far, but approx
PROAVENIR63528Portal_39633חברה מסחרית***10/05/202010/05/2020erectile dysfunction (impotence) On 27.04.2020 *** received a report from a patient who reported that he was treated with ProAvenir and experienced uncomfortable adverse event. On the same day, *** contacted the patient to receive more information about the case. According to the 48 years old patient, he switched from a generic brand (Propecia) that he used for almost 10 years to ProAvenir and used the drug for 5 days. After the fifth day he experienced absolute erectile dysfunction and remembered that it happened to him in the past when he tried to switch to ProAvenir. The patient stopped usi
PROAVENIR48215111815חברה מסחרית***10/01/201914/01/2019Rash (PT MedDRA 10037844) On 13.11.2018 *** received a report from Maccabi Pharm VIA SLE (Distributor) about a patient who reported that he was treated with ProAvenir (Batch number: X06753; Exp. Date: 02/2020) and the drug caused him a rash. On 15.11.2018 *** contacted the pharmacist at Maccabi Pharm in order to receive more information about the case. According to the pharmacist, the 58 years old patient bought the drug on 03-Oct-2018 and returned it to Maccabi Pharm on 16-Oct-2018 after using 11 pills, because it caused him a rash on his chest and on his arms. The rash abated after stopping
PROAVENIR2327884391חברה מסחרית***27/02/201719/03/2017Loss of libido (PT MedDRA 10024870) Asthenia (PT MedDRA 10003549) Spontaneous case report that was received on 03-Jan-2017 from Israel: A male patient (age unknown) that after consulting with his pharmacist switched from a generic brand that he used for long time to ProAvenir experienced problems with sexual function. The problems with sexual function lasted 3 weeks and he stopped using the drug. Follow-up information received on 23-Jan-2017 following a conversation with the patient: The patient took 1 tablet daily of Pro-Avenir (for unknown duration). Before, he used Propecia for 4-5 years.Th
PROAVENIR3213394687חברה מסחרית***12/11/201712/11/2017(Product taste abnormal (PT MedDRA 10069227 On 26-Oct-2017, *** received a complaint from an employee of Maccabi pharm on behalf of a patient that reported of bitter taste of the tablet. The batch number and expiry date were not reported. No more information is available.
finasteride18962IL-009507513-1610ISR002016חברה מסחרית***30/09/201613/10/2016This spontaneous report has been received from a 25 year old male patient referring to himself. Information about concurrent condition, medical history or concomitant therapies was not reported. On an unknown date the patient started therapy with finasteride (manufacturer unknown) (dose, frequency and lot# not reported) for unknown indication. In approximately 2007 the patient experienced Post-Finasteride Syndrome (PFS) (detail of adverse event was unknown). It was reported that the event was almost for 9 years, and the patient still couldn't stand on his legs. The patient couldn't continue hi
finasterid teva43611107150אחר***13/09/201813/09/2018התאשפז עם באבי בטן, בחילות, מאובחן בדלקת לבלב חריפה. מומלץ להפסיק Finasterid
FINASTERIDE TEVA 1 MG50377IL-TEVAIL-2019-IL-1024529חברה מסחרית***26/02/201924/04/201926-Feb-2019, Spontaneous, Patient/Consumer Not Serious report (Local #ISR110320190322416). This case was reported from a consumer (patient's mother) who reported about a 18-Years-old Male treated with FINASTERIDE TEVA 1 MG (FINASTERIDE, Teva product, Unknown route, for a month and a week) for BALDING. While on the suspect product, the patient experienced SEVERE RASH ON 50-60% OF THE BODY; HOT, RED, BOTHERSOME RASH, RASH IS EXTREMELY PAINFUL, RASH IS INFLAMED( All Not Serious , since 11-Feb-2019, until 03-Mar-2019). Also, the following was noticed: VERY ITCHY RASH, SKIN MARKS, ALLERGIC REACTION
FINASTERIDE TEVA ® 1 MG2122581754חברה מסחרית***01/01/201701/01/201730-Nov-2016, Spontaneous, Patient/Consumer Not Serious report (Local#ISR061220160207550).A Consumer/other non health professional reported the case of a 48-Years-old Malepatient who received FINASTERIDE TEVA 1 MG (FINASTERIDE, Teva product).The patient took FINASTERIDE TEVA 1 MG for TO PREVENT ALOPECIA (FINASTERIDE,Film-coated tablet, Oral, from -Jan-2016, until -Jun-2016, 1Milligram per day).While on the suspect product(s), the patient experienced SCALP ITCHING(NotSerious , since -Mar-2016, until --2016); HAIR LOSS(Not Serious , since-Mar-2016, until --2016); ALOPECIA WORSENING(Not Serious ,
FINASTERIDE TEVA45162IL-TEVAIL-2018-IL-970396חברה מסחרית***13/11/201828/11/201822-Oct-2018, Spontaneous, Patient/Consumer Not Serious report (Local #ISR291020180305950). A Consumer reported, via email, the case of a Male patient who received FINASTERIDE TEVA (FINASTERIDE, Tablet, Unknown route of administration, a Teva product) batch: T26880A, expiry date: 10-08-2020. While on the suspect product, the patient experienced HAIR LOSS (Not Serious). The patient reported this: I would like to draw your attention to the fact that a few months ago I chose to return using FINASTERIDE Teva tablets, since the price is reduced in compare to the original company - PROPECIA, and they
FINASTERIDE TEVA39447IL-TEVAIL-2018-IL-891483חברה מסחרית***15/05/201823/05/201802-May-2018, Spontaneous Not Serious report (Local #ISR090520180280369). A Pharmacist reported the case of a 30-Years-old Male patient who received FINASTERIDE TEVA (FINASTERIDE, a Teva product). The patient took FINASTERIDE TEVA (FINASTERIDE, Tablet, Unknown, FINASTERIDE TEVA 1 MG 30 TAB) batch: A541525. While on the suspect product(s), the patient experienced NAUSEA(Not Serious ) . Case as received: FINASTERIDE TEVA 1 MG 30 TAB Caused female patient nausea. Batch: A541525 16/19 On 03-May-2018 a conversation was made with the pharmacist and the following was added: The patient is a male and n
Finasteride (Teva)37982IL-TEVAIL-2018-IL-867520חברה מסחרית***27/02/201829/03/201827-Feb-2018, Spontaneous, Patient/Consumer Not Serious report (Local #ISR050320180271035). (Report duplicates - Merck) A Consumer/other non health professional reported the case of a 27-Years-old Male patient who received Finasteride (Teva) (FINASTERIDE, Teva product). The patient took Finasteride (Teva) for PREVENTION OF HAIR LOSS (FINASTERIDE, Start Date: about 2 years ago, End Date: after a month). While on the suspect product(s), the patient experienced PAIN IN THE GENITAL AREA(Not Serious ) . The following complaint was sent to the LSO on the 27-Feb-18 by MERCK. no contact details were pr
finasteride21656IT-009507513-1701ITA005075חברה מסחרית***02/01/201724/01/2017Literature Report: Cauci S, et al. Androgen Receptor (AR) Gene (CAG)n and (GGN)n Length Polymorphisms and Symptoms in Young Males With Long-Lasting Adverse Effects After Finasteride Use Against Androgenic Alopecia. Sex Med 2016; e1-e11 Information has been received from a published literature article titled as stated above. Long-term adverse symptoms of men who used oral finasteride against androgenic alopecia have been recently described as post-finasteride syndrome (PFS). To detetmine whethet (CAG)n-ts4045402 and (GGN)n-ts3138869 polymotphisms in the andtogen receptor (AR) gene are implicate
FINASTERIDE TEVA ® 1 MG1622374371חברה מסחרית***12/07/201612/07/2016A Consumer/other non health professional reported the case of a 27-Years-old Male patient who received FINASTERIDE TEVA 1 MG (FINASTERIDE, Teva's product). The patient took FINASTERIDE TEVA 1 MG for HAIR LOSS (FINASTERIDE, Film-coated tablet, Oral, from -Dec-2015, until -Jun-2016, 1Milligram per day). While on the suspect product(s), the patient experienced BRANDED FINASTERIDE WAS SUBSTITUTED WITH TEVA FINASTERIDE(Not Serious , since -Dec-2015); SEVERE HEADACHES(Not Serious , since -Jan-2016); DAILY MIGRAINES(Not Serious , since -Mar-2016); HAIR LOSS DURING SHAMPOOING/MULTIPLE HAIR FOLLICLES O
finasteride10992IL-009507513-1512ISR011446חברה מסחרית***20/12/201507/01/2016This spontaneous report as received from a male patient of unknown age, reporting on himself. Information regarding patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patient started therapy with finasteride (Manufacturer unknown) (dose, frequency, lot # and indication was not provided). The patient reported that he stopped using finasteride (Manufacturer unknown), and returned using it again. Overall, he used finasteride (Manufacturer unknown) for the third time and he noticed a decrease in efficacy. He experienced that it did no
finasteride10733IL-009507513-1512ISR009906חברה מסחרית***15/12/201530/12/2015This spontaneous report was received from a pharmacist via company representative referring to a 40 year old homosexual male patient. Concurrent conditions included psoriasis,mild heart rhythm disorder, not treated but monitored wolff-parkinson-white syndrome (WPW). Vegan diet. The patient decided to have a child through surrogacy and in vitro ferrtilization. On an unknown date (reported as for more than 15 years) the patient started therapy with finasteride (PROPECIA) (oral tablet; dose, frecuency and indication unknown). The patient was not taking other medication. On an unknown date the pat