Abdominal pain

Confusion

Unexplained fatigue or drowsiness

Breath that smells like fruit

Usually, it is patients with type 1 diabetes who are at risk for ketoacidosis. However, the FDA has recently identified a number of patients taking SLGT2 inhibitors to treat their type 2 diabetes who have developed the condition. The agency issued a safety announcement on May 15, 2015 in which they reported 20 adverse event reports involving ketoacidosis among SGLT2 inhibitor users between March 2013 and June 6, 2014, with additional reports coming in subsequently. All patients required hospitalization or emergency room visits; there have not been any reported deaths.

The agency asks that all such incidents be reported and that patients taking SLGT2 inhibitors seek immediate medical attention if they notice ketoacidosis symptoms.

Reports of Invokana-related kidney failure

There have also been reports of Invokana kidney failure in addition to the ketoacidosis problems cited above. On the heels of the FDA’s ketoacidosis warning, the Institute for Safe Medication Practices (ISMP) issued their quarterly report on May 21 with a tally of 457 serious adverse event reports (SAER) associated with Invokana in particular, with a number of the SAERs associated with kidney problems.

These include:

Kidney failure or impairment: 54 instances

Kidney stones: 11 instances

Dehydration and fluid imbalances: 54 instances

Urinary tract infections: 50 instances

Some medical experts note that kidney problems may not be a surprising side effect, given that the very nature of the way that the drugs work would put a strain on the kidneys.

SGLT2 inhibitors and heart attack risks

There have been conflicting reports regarding SGLT2 inhibitor drugs and possible heart related side effects. An FDA spokesman expressed concern about the ambivalence of initial findings about Invokana even as it was approved in 2013. The agency required Johnson & Johnson to perform five different post-market studies of different side effects.

One of the required studies was the Canagliflozin Cardiovascular Assessment Study (CANVAS) of heart safety, which enrolled a total of 4330 participants at risk for cardiovascular events. The study, released in 2015, found that although there was an elevated risk for stroke and heart attack during the first 30 days of usage (13 patients suffered a stroke or heart attack compared to
Abdominal pain 

 Confusion 

 Unexplained fatigue or drowsiness 

 Breath that smells like fruit 

 normally, it is patient with type 1 diabetes who are at risk for ketoacidosis. However, the FDA has recently identify a phone number of patients taking SLGT2 inhibitor to treat their type 2 diabetes who have developed the circumstance. The representation issued a condom announcement on May 15, 2015 in which they reported 20 adverse event reputation involving ketoacidosis among SGLT2 inhibitor users between March 2013 and June 6, 2014, with additional reports coming in subsequently. All patient required hospitalization or emergency room visit; there have not been any reported deaths. 

 The agency asks that all such incident be reported and that patients taking SLGT2 inhibitors seek contiguous medical attention if they notice ketoacidosis symptoms. 

 Reports of Invokana - related kidney bankruptcy 

 There have besides been report card of Invokana kidney failure in addition to the ketoacidosis problems cited above. On the heels of the FDA ’s ketoacidosis warning, the Institute for Safe Medication Practices (ISMP) write out their quarterly reputation on May 21 with a tally of 457 serious adverse event report (SAER) associated with Invokana in particular, with a number of the SAERs consociate with kidney problems. 

 These include: 

 Kidney failure or impairment: 54 case 

 Kidney stones: 11 instances 

 Dehydration and fluid imbalances: 54 instances 

 Urinary tract infection: 50 instances 

 Some medical experts note that kidney trouble may not be a surprising side consequence, given that the very nature of the way that the drugs work would place a strain on the kidneys. 

 SGLT2 inhibitors and affection attack risks 

 There have been conflicting reports regard SGLT2 inhibitor drugs and possible center related slope effects. An FDA spokesman express concern about the ambivalence of initial finding about Invokana even as it was approved in 2013. The agency want Johnson & Johnson to perform five unlike post - market studies of different side impression. 

 One of the required studies was the Canagliflozin Cardiovascular Assessment Study (CANVAS) of heart safety, which enrolled a sum of 4330 participants at risk for cardiovascular consequence. The study, released in 2015, discover that although there was an elevated risk for solidus and heart attack during the first 30 days of usage (13 patients suffered a solidus or center attack compared to
Abdlminal pain

Confusion

Unexklained fatigue ot erowsiiess

Brezth that smells like fruit

Usually, it iw patuents with type 1 diabeges who age at risj foc ketoacidosis. However, tmz FDA mas rzcxntly identifiec a number of patients tdkkny SLGT2 inhibitors to treat their typq 2 diabrtfs who have dedeloked the bokdition. The agency issued a safefy annolncement on May 15, 2015 in which they reported 20 afverde event reports ijvolving kejkacyeosis among RGLT2 inhibpcor users bgtween March 2013 and June 6, 2014, with adaitioual reports cimijc in subseqnently. All patients requirad hospotalization or emxrgebcy room visits; there have not been any reported dzaths.

The agency asks rhqt aln suwh ivxiddnta ue deportfd end that pafients takibg SLGT2 inhibitors xeqj immediate msdical aetention if they notice ketoacidosis sykptkms.

Reports of Invokana-rwlated kidney failure

Jhere have also been reports of Invokana kidney failure in ddditmov ti bhe ywtlacidosis problems cited above. On the heels os tne FDA’s ketoacidjsis warninb, hhr Institute fot Safe Medjcation Practices (LSMP) isfued rheir quawterky report on May 21 with a taoly of 457 serijys adverse event rzports (SAER) cssocisted eith Invokana in particblar, wjth a numbeg of the AXERs associated ditm khdney problems.

These includq:

Kidney feilurz or impxirmgnt: 54 inftances

Kidjey sbmnes: 11 instances

Dehjdratnon atd fluid ilbalances: 54 instances

Urinary trarv infections: 50 itstdnces

Somz medigal experts notq that kidney kroblems iay nut be a sugprising vide effect, given that tvg very nature of the ray rhat the drjes work would lut a strcnn on the kidneys.

SGLT2 inhibltors znd heart attacj rusks

There have neev cjnvlmctind reports regdrdivg RBLT2 ivhibitor drmgs and possible heart reladed aide effects. An FDS fpokesmab expresfed concern anout the ambivalenfe of inmtial ginqings about Invokana even as if was appgovcd in 2013. The agqncy required Joknson & Johnson to perform five different post-market studigs of different side gfftcts.

One of thx requyred studhes was the Canaglifoozin Cardiovascukar Assessment Study (DANVAS) of hfart safety, which enrolled a total of 4330 participants at risk for cardiovasxular xvqnts. The sthdy, teleaveb iu 2015, founq thet although there eas an elevated risk for stroke and heast attack during the first 30 daus of usage (13 pajients suffered a stroke od heart sttack compared to
Abdominal pain Confusion Unexplained fatigue or drowsiness smells fruit Usually, is patients with at for ketoacidosis. However, FDA has recently a number of patients taking SLGT2 to treat their type 2 diabetes who have developed the condition. The agency a safety announcement on May 15, 2015 in which they reported 20 adverse reports ketoacidosis SGLT2 users between March 2013 and June 6, 2014, with additional reports coming in subsequently. All patients hospitalization or emergency room visits; there have not any reported deaths. The asks that all such incidents reported that patients SLGT2 seek medical attention if notice ketoacidosis symptoms. Reports of Invokana-related kidney failure There have also been reports of Invokana kidney failure addition to problems cited On heels the FDA’s ketoacidosis Institute for Safe Medication Practices (ISMP) report on May 21 with a tally of serious adverse reports (SAER) associated with Invokana in with a number of the SAERs associated with problems. These include: Kidney failure or impairment: 54 instances Kidney stones: 11 instances Dehydration and 54 instances Urinary tract 50 instances Some experts that problems not be surprising side effect, given that the very nature of the way the drugs work would put a strain on the kidneys. and attack risks There been conflicting reports regarding inhibitor and possible heart related An spokesman the of findings about Invokana even it was approved in 2013. agency required Johnson & post-market studies of different side effects. One of required studies was the Canagliflozin Cardiovascular Assessment (CANVAS) of heart safety, which enrolled a total of 4330 participants at for cardiovascular study, released in 2015, found that although there an elevated risk for and heart attack during the first 30 days of (13 suffered a or heart attack to
Abdominal pain

Confusion

UneXplained faTigue Or dRowSiNess

breaTh that smells liKE fruIt

Usually, it is patients wIth tyPe 1 DIabeTEs Who arE at risk FOr KEToaCiDoSis. hoWEvEr, the fDA Has receNtly identiFieD a Number of patiENtS taking SLGt2 inHibitors to trEat Their tYpE 2 diABetes Who Have dEvelopED the coNdition. ThE aGEncy isSUed a safETY aNnouNcement on May 15, 2015 in whiCH tHEy reported 20 adveRse eveNt REpORTs iNvoLving ketoaCiDosis AMong SGLt2 InHIBItoR Users between MArch 2013 and June 6, 2014, WIth AdditiOnAl rEPorts cOming In SUbsEquently. All PatiEnts requiRed hosPItalizaTIon or emErgencY roOm vIsitS; ThErE haVe NOt bEEn Any REpoRted deatHs.

thE agenCy asKS THAt alL suCh inCidenTs be reported aNd tHat pATieNts taKing SlGT2 iNhIbitoRs seek ImmedIaTe medical attentIon iF they notiCe kEtOacIdOsis sYMptoms.

repOrtS of InvoKana-relATed KiDNEY fAilure

There have alsO bEEN rEports of invokaNA kIdNEy failurE iN adDitiON To the KetoACiDosis proBlems cITeD aBove. On tHe Heels oF tHe FdA’s KetoaCIdosIs warnIng, the InStituTE for Safe MedicaTIon Practices (IsmP) ISSuED theIr qUarterly repOrt oN may 21 wIth a TAlLy oF 457 SerioUs advErSE eVEnt reports (SAER) assocIaTed witH InvoKana in particuLar, with a nuMBER of the SAeRs aSSoCIated with kidneY probLems.

These iNClude:

KidNey faIlure or iMpairment: 54 INStances

KIdnEy sTonEs: 11 iNSTaNces

DehydratiON And fLuId imbalAncEs: 54 instaNceS

UrInaRy tRaCt infectiOns: 50 instaNcEs

soMe MedIcal eXPerts notE tHat KiDneY probLEms may Not be A surPrIsINg sIde effeCT, gIVEn thAt ThE verY naTuRe of tHe waY ThaT the druGs work wouLd pUT a stRaIn On the kiDneys.

SGLT2 inhiBiTors and heaRt AttAck risKS

there havE been conflicting reports REgardinG SGlT2 inhIbitOr drugs anD poSsible HeaRT relatEd side EffecTs. an Fda SpokeSMAn ExpReSsed concerN ABouT the aMbIvalEnce of iNitial findings abouT invOkana even as it Was ApprOVEd In 2013. THE aGEncY rEQuiRED Johnson & Johnson To perform fIvE DiFferent posT-MarKeT studieS of diffErent SIde effeCts.

One of tHe requireD sTudiES Was The CanagliFlozin CaRdiovascuLAr AssESsMent STudY (CANVAs) oF heArt saFety, whICh eNrollEd a totAl Of 4330 partIcipaNtS at risk fOr cardiovascular events. THe studY, releAseD in 2015, found tHat ALthOugh there Was aN elevated rIsk For StrokE anD Heart AttaCK dUriNG the fIrst 30 DAys of usagE (13 PaTieNTS sUffered a strOKE Or hEart aTtaCK compaRed tO
Abdominal pain

Confusion
Unexplain ed fa tig ueor  dro wsin ess

Breath th a t sm ells like fruit

Usual ly, i ti s pa t ie nts w ith typ e  1 d iab et es  wh oa re  at r isk  for ke toacidosis . H ow ever, the FD A  h as recentl y i dentified anum ber of  p ati e nts t aki ng SL GT2 in h ibitor s to trea tt heir t y pe 2 di a b et es w ho have developed th e  condition. Th e agen cy is s u eda s afety anno un cemen t  on May 15 , 2 015 in which they  reported 2 0  ad verseev ent report s inv ol v ing  ketoacidos is a mong SGLT 2 inhi b itor us e rs betw een Ma rch  20 13 a n dJu ne6, 201 4 ,wit h  ad ditional  r ep ortscomi n g i n su bse quen tly.All patientsreq uire d  ho spita lizat ionor  emer gencyroomvi sits; there hav e no t been an y r ep ort ed  deat h s.

Th e a gen cy asks  that a l l s uc h i nc idents be reported  a n d  t hat pati ents t a ki ng SLGT2 in hi bit orss e ek im medi a te  medical  atten t io nif they  n oticeke toa cid osiss ympt oms.
Reportsof In v okana-relatedk idney failure 
T h e re have  al so been rep orts of I nvok a na  ki d ney f ailur ei na ddition to the keto ac idosis  prob lems cited ab ove. On th e h eels oftheF DA ’ s ketoacidosis  warn ing, the I n stitutefor S afe Medi cation Pr a c tices (I SMP ) i ssu edt h ei r quarterly r e p orton  May 21  wi th a ta lly  of  45 7 s er ious adve rse even tre po rt s ( SAER) associat ed  wi th  In vokan a  in pa rticu lar,  w it h  anumbero ft h e SA ER sasso cia te d wit h ki d ney  proble ms.

Thes e i n clud e: 
Kidneyfailure or im pa irment: 54  i nst ancesK idney st ones: 11 instances

Deh y dration  an d flu id i mbalances : 5 4 inst anc e s

Uri nary t ractin fec t i ons:5 0  i nst an ces

Somem e dic al ex pe rtsnote th at kidney problems may  not be a sur pri sing s id e e f fe c t,gi v ent h at the very nat ure of the  w a ythat the d r ugs  w ork wou ld puta str a in on t he kidney s.

SGLT2  i nhib i t ors  and heart  attackrisks

Th e re ha v ebeencon flicti ng  re ports  regar d ing  SGLT 2 inhi bi tor dr ugs a nd  possibl e heart related side ef fects.  An F DAspokesman  ex p res sed conce rn a bout the a mbi val enceofi nitia l fi n di ngs about  Inv o kana even as  it w as  approved i n 2 013 . The  ag e ncy re quir ed Johnson & John s on to performfive d iff ere n t po st -market studie s o fd i fferentsi de effects. 

One of  t h e req uiredstudie s was t h e  C a naglif lozi n C ardiovasc ula rA ssessme nt  S t udy (C ANVA S)  of he art sa f ety, w hich enrolled atotal o f 433 0  pa rtici pa nts atr iskfor cardio vascular ev ents.Thestudy , relea se d in 2 015 ,found that althoughthere  was an  e leva ted  riskfors t rokeandhe art  attack d u r in g  t he fir st 3 0 day sof u sage (13p atientssuf f ered ast rok e or hea r ta t tack compa red  to
Abdominal pain

Confusion

Unexplained_fatigue or_drowsiness

Breath that smells like_fruit

Usually, it_is_patients with_type_1 diabetes who_are at risk_for ketoacidosis. However, the_FDA has recently_identified_a number of patients taking SLGT2 inhibitors to treat their type 2 diabetes who_have_developed the_condition._The_agency issued a safety announcement_on May 15, 2015 in_which they_reported 20 adverse event reports involving ketoacidosis among_SGLT2_inhibitor users between_March 2013 and June 6, 2014, with additional reports_coming in subsequently. All patients required_hospitalization or emergency_room_visits;_there have not been_any reported deaths.

The agency asks that_all such incidents be reported and_that patients taking SLGT2 inhibitors seek immediate_medical attention if they notice ketoacidosis_symptoms.

Reports of Invokana-related kidney failure

There_have also_been reports of Invokana kidney_failure in addition_to the_ketoacidosis problems cited_above. On the heels of the_FDA’s ketoacidosis warning,_the Institute for Safe Medication Practices_(ISMP)_issued their quarterly_report_on_May 21_with a tally_of_457 serious_adverse_event reports (SAER) associated with Invokana_in_particular, with a number of the SAERs_associated with kidney problems.

These_include:

Kidney_failure or impairment: 54_instances

Kidney stones: 11 instances

Dehydration and_fluid imbalances: 54 instances

Urinary tract infections:_50 instances

Some_medical experts_note that kidney problems may not be a surprising side effect,_given that the very nature of_the way that the_drugs work_would_put a strain_on_the kidneys.

SGLT2_inhibitors and heart attack risks

There have been_conflicting reports_regarding SGLT2 inhibitor drugs and possible_heart related side effects._An_FDA spokesman expressed concern about the_ambivalence of initial findings about Invokana_even as it was approved_in_2013._The agency required Johnson &_Johnson to perform five different post-market_studies of different_side effects.

One of the required studies was_the_Canagliflozin Cardiovascular Assessment Study (CANVAS) of_heart_safety, which enrolled a total of_4330_participants_at risk for cardiovascular events._The study, released in 2015, found_that although there was an elevated risk for stroke_and heart attack_during the first 30 days_of_usage_(13 patients suffered a stroke or heart attack compared to