DRUG AND THERAPY BULLETINhpspc.in/pdf/drug_therapy_25_jun_2019.pdf · 2019-06-25 · Pharma News...

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DRUG AND THERAPY BULLETIN HIMACHAL PRADESH STATE PHARMACY COUNCIL DRUG INFORMATION CENTER LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101 Toll Free: 18001210443|Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected] Toll Free: 18001210443 Issue 21|Volume 3|Jun 2019 Contents Drug Updates Pharma News Press Cutting

Transcript of DRUG AND THERAPY BULLETINhpspc.in/pdf/drug_therapy_25_jun_2019.pdf · 2019-06-25 · Pharma News...

DRUG AND THERAPYBULLETIN

HIMACHALPRADESHSTATEPHARMACYCOUNCIL

DRUGINFORMATIONCENTER

LAUREATE INSTITUTE OF PHARMACY, KATHOG, DISTT. KANGRA, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Toll Free: 18001210443

Issue 21|Volume 3|Jun 2019

ContentsDrug Updates

Pharma News

Press Cutting

DRUG AND THERAPY BULLETIN

Content

EDITORIAL

AdvisoryBoard

Dr. Navneet Marwah, Mr. Sanjeev Pandit, Dr. Manoj Kumar, Dr. Ranjit Singh, Prof. CPS Verma,

Dr. Poonam Sandhu, Dr. Rajender Guleria,Mr. Arvind Kumar,Mr. Bihari Lal Gupta,Mr, Hemant Sharma,

Mr.RakeshChandel,Mr.PraveenUpadhya,Mr.KamashwarChauhan,Mr.LokeshKumar,Mr.VishalKumar,

Mr.Y.S.Chandel,Mr.BirbalSharma,Mr.ManojKumar,Mr.YogeshVerma,Mr.SurenderNadda,Dr.Parshuram

Patron

Mr.GopalKrishanSharmaandDr.RanSingh

Editor-in-Chief

Dr.KamleshNaikandDr.M.S.Ashawat

Co-Editors

Dr.VinayPanditandMr.AnkushSharma

DrugUpdates

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

VraylarforBipolarDepression . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

PiqrayforPIK3CA-MutatedBreastCancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

JakafinowforGVHD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Zolgensma:1stInfantSMAGeneTherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

MidazolamNasalSprayApproved. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Fragmin:1stPedanticoagulant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

GattexforPediatricSBS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

VenclextaPlusGazyvaforCLL/SLL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Xeominfor1stlinetreatmentofBlepharospasm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

EyleaforDiabeticRetinopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

FirstBiomarker-DrivenHCCTherapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1

Content (Continued)

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

RuzurgiforPediatricsLEMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Vyndaqel,VyndamaxforATTR-CM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

KadcylaNowforEBC. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

QternmetXRforType2Diabetes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

TibsovoforNewlyDiagnosedAML . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

FirstFDAapprovedDengueVaccine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

MavyretforPediatricUse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

KalydeconowforYoungerInfants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

BenlystaforPediatricSLE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

HealthNews

VitaminDmayhelpcancerpatientslivelonger:research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Thyroid,irondeficiency,stresscanleadtohairfall:Doctors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Herbalmedicinesaidnewbornsdigestivesystem:Expert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

E-cigaretteuse,flavoringsmayincreaseheartdiseaserisk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Licoriceteacauseshypertensiveemergencyinpatient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Aspirin'safe'forbrainstrokepatients:Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Unsaltedtomatojuicecanlowerbloodpressureandcholesterollevelinadults. . . . . . . . . . . . . . . . . . 9

Antibioticusecanincreasenervedamagerisk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Scientistsdiscovernovelgenesresponsibleforregulatingmusclecells . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Researchersdiscoverplacentalstemcellsthatcanregenerateheartafterheartattack . . . . . . . . . . 11

One-offinjectionmaydrasticallyreduceheartattackrisk. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Arsenicindrinkingwaterdamagesheartsofyoungadults,studysays . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Whysleepinglessthan7hoursmayharmyourhealth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14–15PressCutting

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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

VraylarforBipolarDepression

On May 28, 2019, the US FDA expanded the

Òindication for Vraylar (R) (cariprazine) oral

tablets to treat depressive episodes associated

withbipolarIdisorderinadultpatients.Approval

for this indication is based on 3 trials in which

cariprazine demonstrated an increase over

placebo from basel ine to week 6 on the

MontgomeryAsbergDepressionRatingScaletotal

score.Withthisapproval,theboxedwarningwas

updated to include awarning regarding suicidal

thoughtsandbehaviors.

The prescribing information can be found at:

https://www.allergan.com/assets/pdf/vraylar_pi.

Piqray for PIK3CA- Mutated Breast

Cancer

ÒOnMay24,2019, theUSFDAapprovedPiqray

(alpelisib) oral tablets indicated in combination

withfulvestranttotreatpostmenopausalwomen,

and men, with hormone receptor (HR)-positive,

human epidermal growth factor receptor 2

(HER2)-negative, PIK3CA-mutated, advanced or

metastatic breast cancer as detected by an FDA-

approvedtestfollowingprogressiononorafteran

endocrine-basedregimen.Piqray,whichisthefirst

drug to treatHR+/HER2-advancedbreastcancer

patientswithaPIK3CAmutation,incombination

with fulvestrant significantly prolonged median

progression-free survival compared with

fulvestrantaloneintheSOLAR-1clinicaltrial

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/212526s000lbl.pdf.

JakafinowforGVHD

On May 24, 2019, the US FDA approved a new

ÒindicationforJakafi (ruxolitinibphosphate)oral

tablets for the treatment of steroid-refractory

acute graft-versus-host disease (GVHD) in adult

and pediatric patients 12 years of age or older.

Jakafi, whichwas granted breakthrough therapy

andorphandrugdesignationsforthisindication,

wasapprovedbasedonoverallresponseratedata

fromtheREACH1trial.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs

/label/2019/202192s017lbl.pdf.

Zolgensma: 1st Infant SMA Gene

Therapy

On May 24, 2019, the US FDA approved

ÒZolgensma (onasemnogeneabeparvovec-xioi)IV

suspension indicated to treat pediatric patients

youngerthan2yearsofagewithspinalmuscular

atrophy (SMA) with bi-allelic mutations in the

survivalmotorneuron1(SMN1)gene.Zolgensma,

an adeno-associated virus vector-based gene

therapy that targets the cause o f SMA,

demonstrated significant improvement in ability

to reach developmental motor milestones (eg,

headcontrolandtheabilitytositwithoutsupport)

compared with the natural history of infantile-

onsetSMAinanongoingclinicaltrial.

Drug Updates

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Prescribing information can be found at:

https://www.avexis.com/content/pdf/prescribing_

information.pdf.

MidazolamNasalSprayApproved

ÒOnMay20,2019,theUSFDAapprovedNayzilam

(midazolam) nasal spray indicated for the acute

treatmentof intermittent, stereotypicepisodesof

frequentseizureactivity(ie,seizureclusters,acute

repetitiveseizures)thataredistinctfromapatient's

usualseizurepatterninpatientswithepilepsy12

yearsofageorolder.Nayzilam,the firstandonly

nasal formulation for treating cluster seizures,

demonstrated effectiveness in a clinical trial in

whichasignificantlyhigherpercentageofpatients

treatedwithnasalmidazolamachievedtheprimary

efficacyendpoint(ie,terminationofseizureswithin

10minutesafter the initialblindeddoseof study

drugand theabsenceof a recurrenceof seizures

within6hoursoftheinitialblindeddoseofstudy

drug)comparedwiththosetreatedwithplacebo.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/211321s000lbl.pdf.

Fragmin:1stPedanticoagulant

OnMay16,2019,theUSFDAexpandedtheuseof

ÒFragmin (dalteparin sodium) subQ injection to

includepediatricpatients1monthofageorolder

for the treatment of symptomatic VTE. Fragmin,

thefirstanticoagulantforpediatricusetogainFDA

approval, was granted priority review for this

expandedindicationandcarriesaboxedwarning

forspinalandepiduralhematomas.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/020287s072lbl.pdf.

GattexforPediatricSBS

OnMay16,2019,theUSFDAexpandedtheuseof

ÒGattex (teduglutide) subQ injection to include

pediatric patients 1 year of age and older with

shortbowelsyndrome(SBS)whoaredependent

on parenteral support (PS). Gattex, which was

or ig inal ly approved in adults with SBS ,

demonstratedefficacyinapediatricclinicaltrialin

whichteduglutidereducedthevolumeofdailyPS

requiredandtimespentadministeringPS.

Prescribing information can be found at:

https://www.shirecontent.com/PI/PDFS/Gattex_U

SA_ENG.pdf.

VenclextaPlusGazyvaforCLL/SLL

On May 15, 2019, the US FDA approved a new

ÒindicationforVenclexta (venetoclax)oraltablets

incombinationwithGazyva(R)(obinutuzumab)IV

injection for previously untreated patients with

chronic lymphocytic leukemia (CLL) or small

lymphocytic lymphoma (SLL). Venclexta and

Gazyva combination therapy,whichwas granted

breakthrough therapy designation for this

indication, demonstrated superior progression-

free survival compared with chlorambucil plus

obinutuzumabinaclinicaltrial.

Prescribing information can be found at:

http://www.rxabbvie.com/pdf/venclexta.pdf.

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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

4

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

Xeominfor1stlinetreatmentof

Blepharospasm

On May 13, 2019, the US FDA approved an

Òexpanded indication for Xeomin (incobotu-

linumtoxinA) IM injection for the first-line

treatment of blepharospasm in adult patients.

Xeomin,whichwasapprovedforblepharospasmin

adult patientswhowerepreviously treatedwith

Botox(R)(onabotulinumtoxinA)IMinjection,was

approvedforthisexpandedindicationbasedona

clinical trial in which patients treated with

incobotul inumtoxinA showed signif icant

improvement comparedwith those treatedwith

placebo.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/125360s074lbl.pdf.

EyleaforDiabeticRetinopathy

On May 13, 2019, the US FDA expanded an

Òindication for Eylea (aflibercept) intravitreal

injection to include all stages of diabetic

retinopathy.Previouslyapprovedforpatientswith

diabeticretinopathywithmacularedemaonly,this

indication allows all patients suffering from the

diseasetohaveareductioninriskofgoingblind.

Approvalfortheexpandedindicationwasbasedon

the PANORAMA trial that demonstrated a

reduction in risk of developing proliferative

diabetic eye disease by 85% to 88% after being

treatedwith16-weekor8-weekdosingregimens,

respectively.

Prescribing information can be found at:

https://www.regeneron.com/sites/default/files/

EYLEA_FPI.pdf.

FirstBiomarker-DrivenHCCTherapy

On May 13, 2019, the US FDA approved a new

Òindication for Cyramza (ramucirumab) IV

injection as a single agent for the treatment of

patientswithhepatocellularcarcinoma(HCC)who

have an a lpha fetoprotein (AFP) of 400

nanograms/mLorgreaterandhavebeentreated

with sorafenib. Cyramza, which is already

approved for gastric, non-small cell lung, and

colorectalcancer,wasapprovedforthisindication

basedon significantly prolongedoverall survival

and progression-free survival compared with

placeboinaclinicaltrial.Additionally,theFDAhas

removed the boxed warning from the Cyramza

prescribinginformation.

Prescribing information can be found at:

http://uspl.lilly.com/cyramza/cyramza.html.

RuzurgiforPediatricsLEMS

ÒOnMay6,2019, theUSFDAapprovedRuzurgi

(amifampridine) oral tablets indicated to treat

Lambert-Eaton myasthenic syndrome (LEMS) in

pediatricpatients6yearstoyoungerthan17years

ofage.Ruzurgi,whichisthefirstFDAapprovalofa

treatment specifically for pediatric patientswith

LEMS,wasapprovedbasedonadequateandwell-

controlledstudiesofthedruginadultswithLEMS.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

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DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

label/2019/209321s000lbl.pdf.

Vyndaqel,VyndamaxforATTR-CM

ÒOnMay3,2019,theUSFDAapprovedVyndaqel

(tafamidis meglumine) oral capsules and

Vyndamax(TM)(tafamidis)oralcapsulesindicated

for the treatment of the cardiomyopathy ofwild

type or hereditary transthyretin-mediated

amyloidosis (ATTR-CM) in adults to reduce

cardiovascular mortality and cardiovascular-

relatedhospitalization. Vyndaqel andVyndamax,

which are the first FDA-approved therapies for

ATTR-CM,havethesameactivemoiety,tafamidis,

buttheyarenotsubstitutableonamg-to-mgbasis

andtheirrecommendeddosesdiffer.

Prescribing information can be found at:

http://labeling.pfizer.com/ShowLabeling.aspx?id=

11685.

KadcylaNowforEBC

On May 3, 2019, the US FDA approved a new

Òindication for Kadcyla (ado-trastuzumab

emtansine)IVinjectionfortheadjuvanttreatment

ofpatientswithHER2-positiveearlybreastcancer

(EBC) who have residual invasive disease after

neoadjuvant taxane and trastuzumab-based

treatment.Kadcyla,whichisalreadyapprovedfor

metastatic breast cancer, was approved for this

indication based on a significantly reduced

invasivedisease-freesurvivalratecomparedwith

trastuzumabintheKatherineTrial.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/125427s105lbl.pdf.

QternmetXRforType2Diabetes

ÒOnMay3,2019,theUSFDAapprovedQternmet

XR (dapagliflozin/metformin hydrochloride/

saxagliptin)oraltabletsasanadjuncttreatmentto

diet and exercise to improve glycemic control in

adultswithtype2diabetes.ApprovalforQternmet

XRcomesafter2trialsdemonstratedanincreasein

t h e numbe r o f p a t i e n t s a c h i ev i n g t h e

recommendedHbA1ctreatmentgoal.QternmetXR

carriesablackboxwarningforlacticacidosis.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/210874s000lbl.pdf.

TibsovoforNewlyDiagnosedAML

On May 2, 2019, the US FDA approved a new

Òindication forTibsovo (ivosidenib) oral tablets

for the treatment of newly-diagnosed acute

myeloid leukemia (AML) with a susceptible

isocitrate dehydrogenase-1 (IDH1) mutation as

detectedbyanFDA-approvedtestinadultpatients

who are 75 years of age or older or who have

comorbidities that preclude use of intensive

induction.Tibsovo,which isalreadyapproved to

treat adult patients with relapsed or refractory

AMLandanIDH1mutation,wasgrantedpriority

review and accepted under the FDA's Real-Time

OncologyReviewpilotprogrammakingitthefirst

and only therapy to gain FDA approval for this

indication.

Prescribing information can be found at:

6

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/211192s001lbl.pdf.

FirstFDAapprovedDengueVaccine

ÒOnMay1,2019,theUSFDAapprovedDengvaxia

(denguetetravalentvaccine,live)subQinjectionto

prevent dengue disease caused by dengue virus

serotypes 1, 2, 3, and 4 in pediatric patients 9

through16yearsofagewithlaboratory-confirmed

previous dengue infection and living in endemic

areas.Dengvaxia, the firstFDA-approveddengue

disease vaccine, demonstrated efficacy in

preventingdenguediseaseinclinicaltrials.

Prescribing information can be found at: https://

vaccineshoppe.com/assets/pdf/DengvaxiaPI.pdf.

MavyretforPediatricUse

OnApril30,2019,theUSFDAexpandedtheuseof

ÒMavyret (glecaprevir/pibrentasvir)oral tablets

to include pediatric patients 12 years of age or

olderwithchronichepatitisCvirusgenotype(GT)

1,2,3,4,5or6infectionwithoutcirrhosisorwith

compensatedcirrhosis.Mavyret,whichisalready

approvedinadultpatients,demonstratedefficacy

in clinical trialswhere 100%of patients treated

with glecaprevir/pibrentasvir had no virus

detected in theblood12weeksaftercompleting

therapy.

Prescribing information can be found at:

https://www.rxabbvie.com/pdf/mavyret_pi.pdf.

KalydeconowforYoungerInfants

OnApril30,2019,theUSFDAexpandedtheuseof

ÒKalydeco (ivacaftor) oral granules to include

pediatricpatients6monthsof ageorolderwith

cystic fibrosis (CF) who have 1 mutation in the

conductance regulator (CFTR) gene that is

responsivetoivacaftorbasedonclinicaland/orin

vitro assay data. Kalydeco, which was already

approvedintheUStotreatpediatricpatients12

monthsofageorolder,isthefirstCFTRmodulator

togainapproval ineligible infantsasyoungas6

monthsofage.

Prescribing information can be found at:

https://www.accessdata.fda.gov/drugsatfda_docs/

label/2019/203188s029,207925s008lbl.pdf.

BenlystaforPediatricSLE

OnApril26,2019,theUSFDAexpandedtheuseof

ÒBenlysta (belimumab) IV injection to include

pediatric patients 5 years or olderwith systemic

lupuserythematosus(SLE).Benlysta,thefirstdrug

to gain FDA approval for pediatric patients with

SLE, demonstrated efficacy in a clinical trial in

whichasignificantlygreaterproportionofpediatric

patients treated with intravenous belimumab

achievedthecompositeprimaryendpointofanSLE

response index (SRI-4) compared with those

treatedwithplaceboplusstandardtherapy.

Prescribing information can be found at:

www.gsksource.com/pharma/content/dam/Glaxo

SmithKline/US/en/Prescribing_Information/Benly

sta/pdf/BENLYSTA-PI-MG-IFU.PDF.

Ref:www.micromedexsolutions.com

7

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

VitaminDmayhelpcancerpatientslive

longer:research

VitaminDsupplements,iftakenforatleastthree

years, could add years to the lives of cancer

patients,astudyhasfound.Theresearchersfrom

MichiganStateUniversityintheUSsuggestthatthe

vitamincarriessignificantbenefitsotherthanjust

contributingtohealthybones.

"VitaminDhadasignificanteffectonloweringthe

risk of death among those with cancer, but

unfortunatelyitdidn'tshowanyproofthatitcould

protect against getting cancer," saidTarekHaykal,

from Michigan State University. The researchers

lookedatdata related todiseaseprevention from

morethan79,000patientsinmultiplestudiesthat

randomly compared the use of vitamin D to a

placebooveratleastathree-yearperiod.

Ref:www.health.economictimes.indiatimes.com

Thyroid,irondeficiency,stresscanlead

tohairfall:Doctors

Hair loss or alopecia is still considered a beauty-

relatedproblemandpeopleprefertousecosmetic

solutions and alternative treatments provided by

corporate clinics. However, alopecia needs to be

treated medically by dermatologists as reasons

behind it could defer— from iron deficiency to

psychologicalstress.DrPradeepSethifromAIIMS,

NewDelhi,saidpeopleshouldvisitadermatologist

instead of going to corporate hair fall clinics and

searchingforonlinehairtransplantoptions.“These

clinics and websites call themselves as trained

practitionersoftrichology.Thisisjustabranchof

dermatology concerned with hair and scalp.

Dermatologistsbestunderstandthereasonsbehind

hairlossandtreatthemaccordingly,”hesaid.

Endocrinologist Parimal Tayade said diabetes,

thyroiddiseaseandandrogenexcesscouldbethe

reasons behind hair fall. “Sudden and excessive

hairlosscouldbeearlysignsofdiabetesorthyroid.

It's always good to check blood sugar before

startingtreatmenttostophairfall,”DrTayadesaid.

Psychiatrist Vikas Bhute said life has become

stressfulwhichisoneoftheleadingreasonsbehind

hairfall.

DietitianMeghnaKumre shared some important

diet-relatedtipstoavoidhairfall.“Irondeficiency

couldbethereasonbehindhairfall.Peopleprefer

toeatspinachwhenitcomestoirondeficiency.But,

wall nuts, cashews, rajma and black-eyed pea

(chawli beans) are richer sources of iron than

spinach,”shesaid.

Hairfallcontrol

¨Irondeficiencycouldbethemajorreason.

¨Improveironabsorptioncapacityofbodytodeal

withit.

Pharma News

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

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8

whileseveralof liquidsweremoderatelytoxicto

the endothelial cells, the cinnamon andmenthol

flavored e-liquids significantly decreased the

viabilityofthecellsincultureevenintheabsence

ofnicotine.

Exposure to the e-liquids also increased the

relative levels of reactive oxygen species-

molecules that can cause DNA damage- and the

level of molecules associated with programmed

celldeath.

Ref:wwwmed.stanford.edu

Licoriceteacauseshypertensive

emergencyinpatient

Licorice tea, apopularherbal tea, isnotwithout

healthrisks,asacasestudyofamanadmittedto

hospital for a high-blood pressure emergency

demonstrates in CMAJ (Canadian Medical

Associationjournal)

Productscontaininglicoricerootextractcanraise

blood pressure causes water retention and

decreasepotassiumlevelsifconsumedinexcess.

Ref:medicalxpress.com

Aspirin‘safe’forbrainstrokepatients:

Study

Peoplewhohavesufferedbrainhaemorrhagecan

take commonmedicines such as aspirinwithout

raising their risk of another stroke, suggest

researchers.AspirinandClopidogrel,alsoknown

antiplatelet medicines are often prescribed to

olderpeoplebecausetheycanlowerriskofheart

attackandstrokecausedbyabloodclot.

Although doctors wary of recommending

antiplateletmedicinesforstrokepatients,fearing

theriskofanotherbrainbleeding,thisnewstudy

called"Restart",publishedinTheLancetjournal,

has found thatbrainhaemorrhage survivors can

"safely"continuetotakeantiplateletmedicinesto

reducetheirriskoffutureheartattacksorstrokes.

Ref:www.health.economictimes.indiatimes.com

Unsaltedtomatojuicecanlowerblood

pressureandcholesterollevelinadults

Unsalted tomato juiceworkswonders for adults

who are at risk of cardiovascular disease.

Researchers have found that drinking unsalted

tomato juice can lower blood pressure and

9

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

¨Gardengreenswith lemonjuice increases iron

absorption.

¨Amixture of poppy and sesame seeds can be

usedindailydiet.

¨Early thyroid could be the reason behind the

problem.

¨Thisdoesn'tneedmeditationassimpledietary

changeswilldo.

¨Intake of carbohydrates and proteins in daily

dietshouldbemaintained.

¨Usingdietarysupplementsorfollowingin-trend

dietpatternsshouldbeavoided.

¨Diarrhoeaandaciditycouldalsobethereasons.

¨Over-consumption of tea, coffee should be

avoided.

Ref:www.health.economictimes.indiatimes.com

Herbalmedicinesaidnewborns

digestivesystem:Expert

Medicines with natural ingredients like Dill Oil,

Guduchi and Amalaki help regularise bowel

movementsandcontroldigestivedisturbancesin

babies,anexperthassaid.

"Theinitialthreeyearsoflifearethemostcrucial

for a baby's growth and development, and the

digestivesystemplaysanimportantrole.Healthy

digestionsupportshealthygrowthinbabiesandis

vital for their overall well-being," said Rajesh

Kumawat, Head, Medical Services and Clinical

Development, theHimalaya Drug Company. To

relievethebaby'sdigestivediscomfort,theparents

mustensurethatthebabyisfedinsmallquantities

atfrequentintervalsandincludeenoughliquids,he

said.Thiswillhelptodigestthefood.

Ref:health.economictimes.indiatimes.com

E-cigaretteuse,flavoringsmay

increaseheartdiseaserisk

Researchers found that when grown in a

laboratory, endothelial cells exposed to the e-

liquidsortobloodcollectedfrome-cigaretteusers

shortly after vaping are less viable and exhibit

significantly increased levels of molecules

implicatedinDNAdamageandcelldeath.Thecells

arealsolessabletoformnewvasculartubesandto

migrate and participate in wound healing. The

severityofthedamage,aspectsofwhichoccureven

in theabsenceofnicotine,variesamongpopular

flavors, the researchers said. Cinnamon and

mentholwerefoundtobeparticularlyharmful.

The researchers investigated the effect of six

different popular e-liquid flavors- fruit tobacco,

sweet tobacco, with caramel and vanilla, sweet

butter scotch, cinnamon and menthol- with

nicotinelevelsof0,6and18mg/mlonendothelial

cellsderivedfromhumaniPScells.Theyfoundthat

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

10

cholesterol level in adults who are at risk of

cardiovasculardisease,accordingtoastudy.

For the study, published in the journal of Food

ScienceandNutrition,researchersfromtheTokyo

MedicalandDentalUniversityinJapanexamined

nearly500residents-184malesand297females.

Itwasfoundthatbloodpressurein94participants

withuntreatedpre-hypertensionorhypertension

dropped significantly. Tomato juicemayhelp in

boostinghearthealthbycuttingdowntheriskof

heart-related ailments. High LDL (or bad)

cholesterol levels in 125 participants decreased

fromanaverageof155to149.9mg/dL,saidthe

study. According to researchers, these beneficial

effectsweresimilaramongmenandwomenand

alsofordifferentagegroups.

Ref:www.economictimes.indiatimes.com

Antibioticusecanincreasenerve

damagerisk

ResearchfromtheUniversityofDundeehasshown

that a commonly used class of antibiotics may

increaseapatient'sriskofsufferingaseriousand

potentially permanent form of nerve damage by

almost50percent.Peripheralneuropathyhaslong

been recognised as a potential side effect of

fluoroquinolone antibioticsbut itwasnot known

howstrongthisassociationwasandhowitcould

beaffectedbythelengthoftreatment,orbyageand

gender.Researchers ledbyDr.DanielMorales,of

the University's School of Medicine, looked at a

databaseof1.3millionadultsissuedoneormore

prescriptions of fluoroquinolone or amoxicillin-

clavulanate antibiotics with no diagnosis of

peripheralneuropathyattheoutsetoftreatment.

They found that current use of systemic fluoro-

quinoloneantibioticsappearedtoincreasetherisk

ofperipheralneuropathyby47percent,causingan

additional2.4casesper10,000patientsperyearof

treatment.Apersonprescribedwithamoxicillin-

clavulanate was not significantly more likely to

experienceperipheralneuropathy.

Theriskwashigherformenandrosewithageand

with the length of fluoroquinolone treatment. A

peripheral neuropathy diagnosis remained more

likelytobediagnosedforuptosixmonthsafterthe

fluoroquinolone prescription. "The safety of

fluoroquinolone antibiotics has received a lot of

attention regarding theirpotential to cause long-

termsideeffectsinsomepeople,"hesaid."Oneof

theseisperipheralneuropathywherenerves,most

commonly affecting the lower limbs, can be

affected, leading to numbness, pain, or problems

with balance. "Fluoroquinolones are effective

antibiotics but health care professionals should

recognise that peripheral neuropathymay rarely

occurfollowingfluoroquinolonetherapy.Antibiotic

stewardshipiscriticallyimportanttoensurethese

valuablemedicinesareusedappropriately.

Ref:www.medicalxpress.com

Scientistsdiscovernovelgenes

responsibleforregulatingmusclecells

YorkUniversityscientistshaveuncoveredaunique

setofgenesthatplayaroleinmusclecellulargene

11

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

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expressionanddifferentiationwhichcouldleadto

newtherapeutic targets toprevent thespreadof

musclecancer.

Theresearchersanalyzedgenenetworksinmuscle

cells and found that the Smad7 and β-catenin

proteins work cooperatively inside the body to

regulate muscle cell differentiation, growth and

repair. When these regulatory proteins work in

harmony,theycontrolthepathwayfornormalgene

expression, resulting in normal skeletal muscle

cells.

Ref:www.medicalxpress.com

Researchersdiscoverplacentalstem

cellsthatcanregenerateheartafter

heartattack

Researchers at the Icahn School of Medicine at

Mount Sinai have demonstrated that stem cells

derivedfromtheplacentaknownasCdx2cellscan

regeneratehealthyheartcellsafterheartattacksin

animalmodels.Thefindings,publishedintheMay

20issueofProceedingsoftheNationalAcademyof

Sciences(PNAS),mayrepresentanoveltreatment

forregeneratingtheheartandotherorgans.

"Cdx2cellshavehistoricallybeenthoughttoonly

generate the placenta in early embryonic

development,butneverbeforewereshowntohave

theabilitytoregenerateotherorgans,whichiswhy

thisissoexciting.

These findings may also pave the way to

regenerative therapy of other organs besides the

heart," saidprincipal investigatorHinaChaudhry,

MD, Director of Cardiovascular Regenerative

MedicineattheIcahnSchoolofMedicineatMount

Sinai. "They almost seem like a super-charged

populationofstemcells,inthattheycantargetthe

site of an injury and travel directly to the injury

throughthecirculatorysystemandareabletoavoid

rejectionbythehostimmunesystem."Thisteamof

MountSinairesearchershadpreviouslydiscovered

thatamixedpopulationofmouseplacental stem

cellscanhelptheheartsofpregnant femalemice

recoverafteraninjurythatcouldotherwiseleadto

heart failure. In that study, they showed that the

placentalstemcellsmigratedtothemother'sheart

anddirectlytothesiteoftheheartinjury.Thestem

cellsthenprogrammedthemselvesasbeatingheart

cellstohelptherepairprocess.

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

The new study was aimed at determining what

typeofstemcellsmadetheheartcellsregenerate.

TheinvestigatorsstartedbylookingatCdx2cells,

themostprevalentstemcelltypeinthepreviously

identified mixed population, and found them to

comprise thehighestpercentage (40percent)of

thoseassistingtheheartfromtheplacenta.

Researchers noted two other properties of the

Cdx2cells:theyhavealltheproteinsofembryonic

stemcells,whichareknowntogenerateallorgans

of the body, but also additional proteins, giving

themtheabilitytotraveldirectlytotheinjurysite,

which is somethingembryonicstemcells cannot

do, and they appear to avoid the host immune

response.Theimmunesystemdidnotrejectthese

cells when administered from the placenta to

anotheranimal.

Ref:www.medicalxpress.com

One-offinjectionmaydrastically

reduceheartattackrisk

Doctors in the US have announced plans for a

radicalgenetherapythataimstodrasticallyreduce

theriskofheartattack,theworld'sleadingcauseof

death, with a one-off injection. The researchers

hopetotrialthetherapywithinthenextthreeyears

inpeoplewithararegeneticdisorderthatmakes

thempronetoheartattacksintheir30sand40s.If

the treatment proves safe and effective in the

patients,doctorswillseekapprovaltoofferthejab

toawiderpopulation.

“Thetherapywillberelevant,wethink,toanyadult

atriskofaheartattack,”saidSekarKathiresan,a

cardiologist and geneticist at Harvard Medical

Schoolwhowillleadtheeffort.“Wewantthisnot

onlyforpeoplewhohaveheartattacksatayoung

agebecauseofageneticdisorder,but forgarden

varietyheartattacksaswell.”

HeartdiseaseistheNo1killerinmanycountries.

Theestimated18milliondeathsareattributedto

theconditioneveryyear,thevastmajorityofwhich,

about 85%, are caused by heart attacks and

strokes.

Peoplewhoareatriskofaheartattackaretypically

putonarangeofmedicines,suchasbloodthinners,

cholesterol-lowering statins, and pills for high

bloodpressure.Mostmustbetakendaily forthe

rest of the person's life, butmany drift off their

medicationovertime.

Ref:www.theguardian.com

Arsenicindrinkingwaterdamages

heartsofyoungadults,studysays

"Thehigherthearseniccontentindrinkingwater,

thegreaterthedamagetotheheart,"saidPichler,

who is amedical specialist atHospitalHietzing/

12

13

DRUG INFORMATION CENTER HIMACHAL PRADESH STATE PHARMACY COUNCIL

Laureate Institute of Pharmacy, Kathog, Distt Kangra, HP - 177101

Toll Free : 18001210443 |Phone: 9218428042/9459220253|E-mail: [email protected]/[email protected]

HeartCenterClinicFloridsdorfinVienna,Austria.

Long-termexposuretoinorganicarsenic,ahuman

poison thatoccursnaturally in theEarth's crust,

hasbeenlinkedtovariouscancers,kidneydamage,

hypertension,cardiovasculardiseaseanddiabetes.

Organicarsenic,suchaswhat'sfoundinseafood,is

notknowntobetoxictohumans.Thougharsenic

canbefoundintheairandsoil,theWorldHealth

Organization says the greatest threat to public

healthgloballycomesfromgroundwater,whichis

contaminated as it flows through rocks and

mineralscontainingarsenic.

Ref:www.edition.cnn.com

Whysleepinglessthan7hoursmay

harmyourhealth

The research , pub l i shed in the journa l

Experimental Physiology, shows that sleep

deprivation can increase the level of three

physiologicalregulators(microRNAs)intheblood,

which influence gene expression and play a key

roleinmaintainingvascularhealth.MicroRNAsare

smallmoleculesthatsuppressgeneexpressionof

certain proteins in cells. The exact function of

circulating microRNAs in the cardiovascular

systemandtheirimpactoncardiovascularhealthis

receivingalotofscientificattention,anddrugsare

currentlyindevelopmentforavarietyofdiseases,

including cancer, to correct impaired microRNA

signatures. For the study, which is the first to

explore the impact of insufficient sleep on

circulatingmicroRNAsignatures,researcherstook

bloodsamplesfrom24healthymenandwomen,

age 44 to 62, who had filled out questionnaires

abouttheirsleephabits.

Halfsleptsevento8.5hoursnightlywhiletheother

halfslept5 to6.8hoursnightly.They foundthat

peoplewithinsufficientsleephad40to60percent

lowercirculatinglevelsofmiR-125A,miR-126,and

miR-146athanthosewhosleptenough.

“However,itisplausiblethatpeopleneedatleast

sevenhoursofsleeppernighttomaintainlevelsof

important physiological regulators, such as

microRNAs,”hesaid.

Ref:www.business-standard.com

MOUsignedbetweenMinistryof

AYUSHandCouncilofScientificand

IndustrialResearch

A Memorandum of Understanding (MOU) was

signed between the Ministry of AYUSH and

Council of Scientific and Industrial Research

(CSIR),NewDelhi.TheMoUwassignedbyVaidya

RajeshKotecha,Secretary,MinistryofAYUSHand

Dr.ShekharC.Mande,DirectorGeneral,CSIRand

Secretary,DSIRinthepresenceofseniorofficials

from both the organizations. Speaking on the

occasion,Secretarystatedinduecognitionofthe

growing interest of traditional medicines

worldwide, there isaneedofmultiprongedand

innovativeapproachesfortheacceptanceofthis

science. He said that the combination of

traditionalhealthcareandmodernbasicscience

hasahugepossibilitytodoinnovativeandpath-

breaking researches which can be used for the

explanation of various basic concepts. DG, CSIR

apprec i a ted the ongo ing p ro j e c t s and

programmesbetweenthe twoorganizations.He

stated that enhancing the collaboration through

joint R&D efforts ranging from fundamental

science to validation and thereafter product

development,willsignificantlyhelpinthegrowth

of the Indian contributions to this important

sector,notonlynationallybut internationallyas

well.

Ref:www.pharmatutor.org

14

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Press Cutting

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