Health ministers agree on new policy to prevent and control noncommunicable diseases in children, adolescents, and young people

Cristina Mitchell

26 Sep 2023

These drug samples which are declared not of standard quality include Misoprostol Tablets I.P. 200 mcg manufactured by Synokem Pharmaceuticals, Cefotaxime for Injection IP 500 mg manufactured by Maan Pharmaceuticals, Telmisartan, and Chlorthalidone Tablets manufactured by Pure & Cure Healthcare, Paracetamol 120 mg plus Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT) manufactured by Fourrts (India) Laboratories and others.

Apart from this, the list further includes popular diabetes drug combination Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR M2 FORTE) manufactured by Mankind Pharma and AMTAS PRP (Amlodipine and Perindopril Tablets) manufactured by Intas Pharmaceuticals.

This came after analysis and tests conducted by the CDSCO Drugs Control Department on 1166 samples. Out of these, 1118 samples were found to be of standard quality while 48 of them were declared as Not of Standard Quality (NSQ).

A few of the reasons why the drug samples tested failed were the failure of the assay, failure of the dissolution test, failure of the disintegration test, failure of the sterility test, etc.

The samples collected were tested in five laboratories, namely CDL Kolkata, CDTL Chennai, CDTL Mumbai, RDTL Chandigarh, and RDTL Guwahati.

List of Drugs, Medical Devices, and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of AUGUST – 2023

List of Drugs, Medical Devices and Cosmetics declared as Not of Standard Quality/Spurious/Adulterated/Misbranded for the Month of

AUGUST – 2023

Total number of samples tested

1166

Total number of samples declared as of Standard Quality

1118

Total number of samples declared as Not of Standard Quality

48

Total number of samples declared as Spurious

00

Total number of samples declared as Misbranded

00

S.No

Name of Drugs/medical device/cosmetics

Batch No.

Date of Manufa cture

Date of Expiry

Manufactured By

Reason for failure

Drawn By

From

1

MOL-PCB Syrup (Paracetamol, Bromhexine Hydrobromide Chlorpheniramine Maleate, Phenylephrine

Hydrochloride, Menthol Syrup) – 60 ml

L22541

03/2023

02/202

5

Aan Pharma Private Limited, 816/1, Pramukh Ind. Estate, Rakanpur 382 721, Ta. Kalol Dist. Gandhinagar (Guj.) India

pH, Assay of Bromhexine Hydrobromide and Phenylephrine Hydrochloride

CDSCO,

Ahmedaba d

CDL

Kolkata

2

Nifedipine Sustain Release Tablets I.P. 20 mg

T230307

03/2023

02/202

5

Medisky Pharmaceuticals Pvt. Ltd., Plot No. 260, GIDC, Talod – 383 215, Sabarkantha, Gujarat

Dissolution

CDSCO,

Ahmedaba d

CDL

Kolkata

3

DICLOGLOBE 50

(Diclofenac Sodium Tablets

I.P. 50 mg)

GT23026

01/2023

12/202

5

Globela Pharma Pvt. Ltd., 357, 358, G.I.D.C. Sachin,

Surat- 394 230, Gujarat, India

Disintegration

CDSCO,

Ahmedaba d

CDL

Kolkata

4

Trimax Expectorant (Terbutaline Sulphate with BromhexineHCl& Guaiphenesin),

23009

01/2023

10/202

4

Norris Medicines Limited, Plot No. 901/3-5, G.I.D.C. Estate,

Ankleshwar – 393 002 (Gujarat).

Assay of Bromhexine Hydrochloride &Menthol.This sample is found to contain 0.118% w/v of Ethylene Glycol and this sample does

not give positive test for Diethylene Glycol

CDSCO,

Ahmedaba d

CDL

Kolkata

5

Frusemide Injection IP (2ml)

AI22236

08/2022

07/202

4

Alves Healthcare Private Limited, NangalUperla, Swarghat Road, Nalagarh, Dist. Solan, Himachal Pradesh - 174101

pH

CDSCO,

Ahmedaba d

CDL

Kolkata

6

Refined Glycerin CP Grade

21100637

10/2021

09/202

5

Adani Wilmar, Pitampura, New Delhi – 110 034

Assay of Glycerin.Thi sample is found to contain 0.025% w/w of Ethylene Glycol and does not give positive result for

Diethylene Glycol

CDSCO,

Ahmedaba d

CDL

Kolkata

7

Sterile Noradrenaline Concentrate IP (2mg /1ml)

INABB23 01

04/2023

03/202

5

Samarth Life Sciences Pvt. Ltd., Unit II: Plot No.2, Industrial Area, Lodhimajra, Baddi, H.P. 173205, India

Description & Particulate Matter

CDSCO,

Ahmedaba d

CDL

Kolkata

8

CyproheptadineHCl with Tricholine Citrate Syrup (Sylpro Plus Syrup)

33002

05/2023

04/202

5

Norris Medicines Limited, Plot No. 801/P, 901/4-5, G.I.D.C.

Estate, Ankleshwar – 393 002 (Gujarat).

Assay of TricholineCitrate.This sample is found to contain Diethylene Glycol 0.243%w/v and Ethylene Glycol

0.171%w/v

CDSCO,

Ahmedaba d

CDL

Kolkata

9

Sibolone (Tibolone Tablets IP)

PLSB230 1

02/2023

09/202

5

Phaarmasia Ltd., Unit – II, Plot No. 145, Phase V, IDA, Jeedimetla (V), Qutubullapur (M), MedchalMalkajgiri (Dist.) 500 055

Dissolution

CDSCO,

Hyderabad

CDL

Kolkata

10

Methylprednisolone Sodium Succinate for Injection USP 40mg

22MS03

11/2022

10/202

4

SAI Parenterals Limited, D1 & D4, Survey No.280, Phase- V, IDA, Jeedimetla, Hyderabad- 500055, Telangana, India.

Uniformity of Dosage Units, Loss on Drying & Assay of Methylprednisolone Sodium Succinate

CDSCO,

Hyderabad

CDL

Kolkata

11

Misoprostol Tablets I.P. 200 mcg

22S1GTA

026

01/2022

12/202

3

Synokem Pharmaceuticals Ltd., Plot No.35-36, Sector- 6A, I.I.E (SIDCUL), Ranipur

(BHEL), Haridwar- 249403, Uttarakhand.

Assay

CDSCO

Bangalore

CDL

Kolkata

12

Cefotaxime for Injection IP 500 mg

CD22002

03/2022

02/202

4

Maan Pharmaceuticals Ltd., Plot-1, G.I.D.C., Phase II,

Modhera Road, Mehsana – 384 002, Gujarat, India

Particulate Matter & Clarity of Solution

CDSCO

Bangalore

CDL

Kolkata

13

Bacillus Clausii Spores Suspension (EbaniproSuspension)

AFL2258 8

08/2022

07/202

4

Aarmed Formulation Pvt. Ltd., Survey No. 431/2, Plot No.1, Steel Town, Moraiya, Tal. Sanand, Distt.

Ahmedabad (Gujarat)

Purity & Specified Pathogen (Pseudomonas aeruginosa)

Drug Control Departmen t Jammu & Kashmir

CDL

Kolkata

14

(Absorbable Surgical Suture

U.S.P (synthetic) 70 cm), (Monofilament Poliglecaprone 25) (STERGIC)

TV22212 7

09/2022

08/202

5

Sugii Surgical India Pvt. Ltd., No.3, Old No. 49/51, 8th Main, Peenya 2nd Stage, Bengaluru – 560058

Diameter

CDSCO

Bangalore

CDL

Kolkata

15

Erythromycin Stearate Tablets IP 250 mg

AT23118

04/2023

03/202

5

Alves Healthcare Private Limited, Village: NangalUperla, Swarghat Road, Tehsil, Nalagarh, Distt. Solan - 174101 (H.P.), India

Dissolution

CDSCO,

South Zone Chennai

CDL

Kolkata

16

Selamer-400 Tablets (Sevelamer Carbonate Tablets 400 mg)

MT22612 4B

12/2022

11/202

4

Mascot Health Series Pvt. Ltd, Plot No.79, 80, Sec-6A, IIE, Sidcul, Haridwar – 249 403, Uttarakhand, India.

Description

CDSCO,

South Zone Chennai

CDL

Kolkata

17

Telmisartan and Chlorthalidone Tablets

PF8C006

09/2022

08/202

4

Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, I.I.E., SIDCUL,

Ranipur Haridwar – 249 403, Uttarakhand

Dissolution of Chlorthalidone

CDSCO

East Zone Kolkata

CDL

Kolkata

18

AMTAS PRP (Amlodipine and Perindopril Tablets)

K2200008 2

01/2022

12/202

4

Intas Pharmaceuticals Ltd., Bhageykhola, Rangpo, East Sikkim -737132, India.

Assay of Perindopril Erbumine

CDSCO

East Zone Kolkata

CDL

Kolkata

19

Esylate (Etamsylate Injection 250 mg)

I-2359

12/2021

11/202

3

Jackson Laboratories Pvt. Ltd., Majitha Road, Amritsar 143001 (India).

Description, Particulate Matter & Extractable Volume

CDSCO

East Zone Kolkata

CDL

Kolkata

20

Montelukast Sodium and Levocetirizine Hydrochloride Tablets IP (Montzer-C)

MTZ2200 3

12/2022

11/202

4

Tirupati Medicare Limited, Nahan Road, Paonta Sahib, Distt. Sirmour (H.P.) 173 205.

Dissolution of Montelukast

CDSCO

East Zone Kolkata

CDL

Kolkata

21

Nicomode-2 (Nicoumalone Tablets IP 2 mg)

T222932

02/2023

01/202

5

United Bioceuticals Pvt. Ltd., Plot No. 33C, Industrial Park IV, Begumpur, Haridwar - 249402, Uttarakhand

Related Substances

CDSCO

East Zone Kolkata

CDL

Kolkata

22

Erythromycin Stearate Tablets (Enthrocin-500)

ATG3A04 8

01/2023

12/202

4

Anrose Pharma, 147, Mauza Sansiwala, P.O. Barotiwala, Tehsil Kasauli, Distt. Solan (H.P.).

Dissolution

CDSCO

East Zone Kolkata

CDL

Kolkata

23

Cefoperazone & Sulbactam for injection

S3A099

01/2023

12/202

4

Arion Healthcare, GMP Certified Company Vill. Kishanpura, Baddi, Distt. Solan 174 101 (H.P).

Assay of Sulbactam

CDSCO

Hyderabad

CDL

Kolkata

24

Doxycycline and Lactic Acid Bacillus Capsules(DOXORIA-L)

SOC- 2062A

11/2022

10/202

4

Symbiosis Pharmaceuticals Pvt. Ltd., At C/o Ovation Remedies, Behind IITT Engg. College, Trilokpur Road, Kala Amb- 173030 (Sirmour), HP

Assay /Content of Gram positive rod shaped spore forming bacteria

CDSCO

East Zone Kolkata

CDL

Kolkata

25

Amoxycillin Capsules IP 500 MG (AMOXYCILLIN

500)

C-5076

Oct- 2022

Sep- 2024

Jackson Laboratories Pvt.Ltd., 22-24, Majitha Road, Bye Pass, Amritsar-143 001

TEST FOR DISSOLUTION

CDSCO

Subzone Bangalore

CDTL

Chennai

26

Ciprofloxacin Hydrochloride Tablets IP 500 mg

0700323

Feb- 2023

Jan- 2025

Karnataka Antibiotics & Pharmaceuticals Limited, Plot No.14, II Phase, Peenya, Bangalore-560058.

TEST FOR DISSOLUTION

CDSCO

South Zone Chennai

CDTL

Chennai

27

Ofloxacin & Metronidazole Benzoate Suspension (VIVFLOX-MZ Suspension) (For Paediatric USE ONLY)

PFS-1204

Nov- 2022

Oct- 2024

Proceed Formulations, 17, Ind. Area, Morthikri,

Ramgarh-Derabassi Road,, Derabassi – 140 201.

ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN

CDSCO

South Zone Chennai

CDTL

Chennai

28

Metronidazole & Ofloxacin Suspension (nor-metrogyl o Suspension)

XSWN22 006

April- 2022

Mar- 2024

Hema Laboratories Pvt. Ltd. Plot No.29, Pharma City, Selaqui Industrial Area,

Dehradun – 248 011 (State Uttarakhand)

ASSAY OF METRONIDAZOLE BENZOATE AND OFLOXACIN

CDSCO

South Zone Chennai

CDTL

Chennai

29

Ibuprofen and Paracetamol Dispersible Tablets (Ibucon Plus Kid)

C211143 003

March- 2023

Feb- 2026

Concept Pharmaceuticals Ltd., A-28/3, MIDC,

Chikalthana, Aurangabad – 431 006

Diameter & Uniformity of Dispersion

CDSCO

West Zone Mumbai

CDTL

Mumbai

30

Calamine, Zinc Oxide, Aloe vera & Light Liquid Paraffin (Calmin Lotion)

C-012

Apr- 2022

March- 2025

Gladios Products Pvt Ltd., 31, Virat Industiral Estate, Dhanot, Gandhinagar, Gujarat – 382721

Specific gravity

CDSCO

Zonal Office

Ahmedaba d

CDTL

Mumbai

31

Lorazepam Tablets I.P. 2 mg

LZMT100 6

Feb- 2023

Jan- 2025

Unicure India Ltd., C-21, 22 & 23, Sector-3, Noida- 201301, Distt. : Gautam Budh Nagar (U.P.)

Dissolution and Assay

CDSCO

West Zone Mumbai

CDTL

Mumbai

32

Calcium and Vitamin D3 Tablets I.P.

KTB2176 AL

Nov - 2022

Apr- 2024

Karnataka Antibiotics & Pharmaceuticals Limited., Plot No.37, Site No.34/4, NTTF Main Road, 2nd Phase, Peenya Industrial

Area, Bengluru- 560058. At: Plot No. 5-9, Survey No.38/2,

Uniformity of content for Vitamin D3

CDSCO

West Zone Mumbai

CDTL

Mumbai

Aliyali Palghar (W), Dist. Palghar- 401404 (M.S).

33

Levocetirizine and Amrboxol Syrup (C & C Syrup)

BL23015

Feb- 2023

Jan- 2025

Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408, Uttarakhand.

Assay of Ambroxol Hydrochloride

CDSCO

Ghaziabad

RDTL

Chandigarh

34

Povidone-Iodine Ointment USP 5% w/w

P1040

Aug- 2022

Jul- 2025

Babu Ram Om Prakash (BROP), Trilokpur Road, Ogli Village, Kala Amb,

Assay of Povidon Iodine calculated asAvailable Iodine

CDSCO

Ghaziabad

RDTL

Chandigarh

35

Cefpodoxime Proxetil for Oral Suspension IP

UCST- 2310

Mar- 2023

Feb- 2025

Ultra Drugs Pvt. Ltd., Manpura, Nalagarh, Distt.Solan-174101 (H.P.)

pH

CDSCO

Sub-Zone Jammu

RDTL

Chandigarh

36

Diclofenac Prolonged- Release Tablets IP 100 mg

CHT- 3037

Jan- 2023

Dec- 2024

Cotec Healthcare Pvt. Ltd., NH.No. 74, Roorkee- Dehradun Highway, Kishanpur, Roorkee-247667

(Uttarakhand)

Dissolution

CDSCO

Ghaziabad

RDTL

Chandigarh

37

Aspirin Gastro-resistant and Atorvastatin Capsules IP (75mg/10mg)

54CAT09

6

Sep- 2022

Aug- 2024

Swiss Garnier Life sciences, 21-23, Industrial Area, Mehatpur, Dist. Una, Himachal Pradesh- 174315.INDIA

Dissolution (buffer stage) of Aspirin and The Assay of Atrovastatin Calcium calculated as Atorvastatin

CDSCO

Ghaziabad

RDTL

Chandigarh

38

Mupirocin Ointment IP (MUPIJAI OINTMENT)

008

Sep- 2022

Aug- 2024

Baxil Pharma Pvt. Ltd., 10km, Nainital Highway, Shyampur, Haridwar 249408,

Assay of Mupirocin

Drug Control Departmen t Ghaziabad

RDTL

Chandigarh

39

The auto disable syringe (KOJAK SELINGE)

312053KJ M1

Mar- 2023

Feb- 2028

HINDUSTAN SYRINGES & MEDICAL DEVICES LTD., 174, 178/25, BALLABGARH, FARIDABAD, INDIA-121004

Design (Piston/Plunger Assembly) Fit of piston in barrel

CDSCO

Sub Zone Baddi

RDTL

Chandigarh

40

Rabeprazole Gastro- resistant Tablets IP (RABALKEM-20)

RBL2202 0RH

Oct- 2022

Sep- 2024

Ravian Life Science Pvt. Ltd., Plot No.34, Sector-8A, IIE, SIDCUL, Haridwar-249 403, Uttarakhand INDIA.

Dissolution

Drug Control Departmen t Assam

RDTL,

Guwahati

41

Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5ml syrup (COLD OUT)

SF001A0 1

Jan- 2022

Dec- 2024

Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103.

Tamil Nadu, INDIA.

Content of Ethylene Glycol 1.9%w/v & Diethylene Glycol 0.14%w/v

CDSCO,

South zone, Chennai

RDTL

Guwahati

42

Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)

SF001B0 1

Feb- 2022

Jan- 2025

Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103.

Tamil Nadu, INDIA.

Content of Ethylene Glycol 1.22%w/v

CDSCO,

South zone, Chennai

RDTL

Guwahati

43

Paracetamol 120 mg + Chlorpheniramine Maleate 2 mg/ 5 ml syrup (COLD OUT)

SF001A0 2

Jan- 2022

Dec- 2024

Fourrts (India) Laboratories Pvt. Ltd., Vandalur Road, Kelambakkam-603 103.

Tamil Nadu, INDIA.

Content of Ethylene Glycol 2.23%w/v& Diethylene Glycol 0.17%w/v

Drugs Inspector, CDSCO,

South

zone, Chennai

RDTL

Guwahati

44

CALCIUM ACETATE TABLETS USP 667 mg.,

(Lanum)

D222313

Jul-2022

Jun- 2025

STANDFORD LABORATORIES PRIVATE

LIMITED, 8, Industrial Area, Mehatpur, Dist. Una, H.P. - 174315

Assay

Drugs Inspector, Guwahati, Assam

RDTL

Guwahati

45

GENTAMYCIN INJECTION

I.P. (GENTAVIK 2ml.)

TGL0223 0318

Feb- 2023

Jan- 2025

T & G MEDICARE, Village- Kunjahal, P.O. Baddi, Distt. Solan (H.P.)

Sterillity and Bacterial Endotoxins Test

lnspector of Drugs, Arunachal Pradesh

RDTL

Guwahati

46

Pantoprazole Gastro Resistant Tablets I.P. (PAVE -40)

BBT2217 94

May - 2022

Apr- 2024

Biomax Biotechnics (P) Ltd., 261, HSIIDC, Industrial Estate, Alipur, Barwala- 134118 (Haryana)

Dissolution

Drugs Inspector, RAnchii,Jh arkhand

RDTL

Guwahati

47

Metformin Hydrochloride Prolonged Release and Glimepiride Tablets IP (GLIMESTAR® M2 FORTE)

P9IAV007

Nov- 2022

Oct 2024

MANKIND PHARMA LTD.

Doring Block, Bermiok Elaka, Dist. Namchi, Sikkim 737126

Disintegration and Dissoluton

Drugs Inspector, Mizoram

RDTL

Guwahati

48

COMPOUND SODIUM LACTATE INJECTION I.P.

03BF173

7

Aug- 2022

Jul- 2025

PASCHIM BANGA PHARMACEUTICAL, NH-31 TIN MILE HAT, SONAPUR HAT, P.S.-CHOPRA, DIST:

UTTAR DINAJPUR, PIN- 733214 (W.B.)

Bacterial Endoxtoxins Test

Drugs Inspector, AJZAWL,

Mizoram

RDTL

Guwahati

Also Read:Drug Alert: 51 Drug samples fail to qualify CDSCO test

Cuban Doctor Receives PAHO Award for Health Services Management and Leadership

Cristina Mitchell

26 Sep 2023

Jamaica has reported 565 cases of dengue. Although there are no confirmed dengue-related deaths in the country so far, six deaths are being investigated, health officials said.

Amid the outbreak of dengue fever currently sweeping Jamaica, health experts are warning about the dangers of the mosquito-borne illness.

Jamaica’s Ministry of Health & Wellness announced the outbreak on Saturday. As of Friday, the country had recorded 565 suspected, presumed and confirmed cases of dengue. 

A majority of the confirmed cases in the Caribbean nation have been in Kingston, Saint Andrew, Saint Catherine and Saint Thomas.

Six deaths are being investigated, but they have not been confirmed as dengue-related.

JAMAICA DECLARES DENGUE FEVER OUTBREAK WITH HUNDREDS OF CONFIRMED AND SUSPECTED CASES

Dengue fever is caused by one of four different types of dengue viruses, according to Mayo Clinic's website.

The fever is spread by mosquito bites and cannot be transmitted directly from person to person.

Women who become infected while pregnant may spread the dengue virus to the baby during childbirth, however.

In rare cases, dengue fever can be transmitted through organ transplant, blood transfusion or needle stick injury, per the CDC.

Dengue occurs primarily in tropical and subtropical regions. 

Although it is most concentrated in Latin America, Southeast Asia, the Western Pacific Islands and Africa, it has been emerging in parts of Europe and the southern U.S., according to Mayo Clinic.

Up to 400 million people worldwide get infected with dengue each year, according to the Centers for Disease Control and Prevention (CDC).

Approximately 100 million people experience illness from the infection, and 40,000 die from severe effects.

In mild cases, dengue fever causes flu-like symptoms (nausea, vomiting, body aches) and high fever, Mayo Clinic states.

About one in 20 people will develop a more severe form, called dengue hemorrhagic fever.

DENGUE FEVER CASES COULD REACH NEAR-RECORD HIGHS THIS YEAR: WHAT TO KNOW ABOUT THE TROPICAL INFECTIOUS DISEASE

Symptoms of severe dengue include belly pain, frequent vomiting, bleeding from the nose or gums, fatigue, irritability, restlessness, and blood in vomit or stool, per the CDC website.

In these cases, symptoms can include serious bleeding, a sudden drop in blood pressure and organ damage, which can sometimes be fatal.

"On occasions, the illness can progress to severe dengue, which can result in organ failure as well as bleeding (hemorrhage), and severe fluid depletion that can lead to shock and death," Dr. Jacquiline Bisasor McKenzie, chief medical officer of Jamaica’s Ministry of Health & Wellness, said in a statement on the Ministry of Health & Wellness website.

DENGUE VIRUS SPREADS ACROSS FLORIDA COUNTIES, HEALTH OFFICIALS SAY

"Persons experiencing fever, vomiting, severe abdominal pain, bleeding under the skin (petechial rash), feeling very weak or getting confused, are to seek immediate medical attention," she added.

Those who experience symptoms and have been in an area where dengue fever is common should see a health care provider right away, as severe effects can develop quickly, states the CDC.

Infected people should take acetaminophen for pain relief and fever control, drink hydrating fluids and rest, the agency said on its website.

A blood test is the only way to confirm dengue fever.

People who are infected with dengue fever develop long-term immunity to the type of virus that initially caused the infection, but they will still be susceptible to the other three types.

Those who have had dengue fever in the past are at a higher risk of contracting severe symptoms if they get it again, according to Mayo Clinic.

CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTER

In regions where dengue fever is prevalent, a vaccine called Dengvaxia is available to people between the ages of 9 and 45 who have previously been infected.

For people who have not previously had dengue fever, the vaccine has been shown to actually increase the risk of severe symptoms and hospitalization upon infection, Mayo Clinic states.

For those who cannot receive the vaccine, the best method of prevention is to protect against mosquito bites.

On its website, Mayo Clinic offers these recommendations for people who live in or travel to areas where dengue fever is common:

For more Health articles, visit www.foxnews.com/health. 

PAHO Director opens 60th Directing Council, reflects on progress towards five priority areas of work

Cristina Mitchell

25 Sep 2023

Brolucizumab is a low molecular weight humanized antibody
fragment as a vascular endothelial growth factor (VEGF) inhibitor. Registered
Phase III clinical trials HAWK and HARRIER showed brolucizumab was associated
with gains in visual acuity (VA) that were statistically noninferior to
aflibercept for treatment-naïve patients with active choroidal
neovascularization secondary to neovascular age related macular degeneration
(nvAMD). Brolucizumab received FDA approval on October 8th, 2019 for the
treatment of nvAMD in the US. The recommended dosage regimen is 6 mg/0.05 mL
via intravitreal injection (IVI) monthly for the first 3 doses, then once every
8–12 weeks.

With growing uncertainty concerning the safety and efficacy
of brolucizumab relative to other anti-VEGF agents, authors Nicholas J Saba and
Scott D Walter set out to retrospectively analyze practice’s initial
post-marketing experience with brolucizumab during the first 8 months following
FDA approval of the drug on October 7, 2019. Unlike the clinical trial
population which enrolled only treatment-naïve eyes with nvAMD, this study
population was mostly comprised of eyes switched from another anti VEGF therapy
(563/626 eyes, 89.9%). Typically, these patients were switched to brolucizumab
for persistent fluid, or with the hope of achieving a longer treatment
interval. As such, this was a nonrandom and highly selected population of NVAMD
patients. However, authors felt that this population was probably more
representative of the nvAMD patients currently being treated with brolucizumab
in the United States. Study research questions included whether switching to
brolucizumab was associated with changes in VA, improvement in anatomic
outcomes, or increases in treatment interval; and whether the observed
incidence of adverse events following IVI of brolucizumab was similar to the
SRC analysis of the HAWK and HARRIER trials.

Study evaluated the visual and anatomic efficacy of
brolucizumab, examined changes in treatment intervals after switching to
brolucizumab, and estimated the incidence of drug-related adverse events in the
real world. This was a retrospective consecutive case series of 626 eyes (543
patients) with nvAMD treated with 1438 brolucizumab injections at a single
retina practice between 10/1/2019 and 5/15/2020. Changes in visual acuity (VA);
anatomic outcomes assessed by optical coherence tomography (OCT) including
central subfield thickness (CST), macular volume (MV), presence of intraretinal
fluid (IRF), subretinal fluid (SRF), and serous pigment epithelial detachment
(sPED) on foveal line scans; treatment intervals before and after receiving
brolucizumab; and the incidence of brolucizumab-related adverse events.

The majority of eyes (N = 531, 89.7%) had received prior
anti-VEGF therapy with aflibercept, ranibizumab, and/or bevacizumab. VA
improved in treatment-naïve eyes (+3.7 letters, p = 0.04), and was maintained
in previously treated eyes. There were significant improvements in all anatomic
outcomes in both groups (p < 0.001). Study observed a 4.8% incidence of
intraocular inflammation (IOI) and a 0.6% incidence of retinal vasculitis. The
average treatment interval increased from 6.3 to 6.8 weeks (p = 0.001).

“Our real-world experience with brolucizumab largely
confirmed the key findings of the HAWK and HARRIER trials. Treatment naïve
patients showed significant improvements in vision and anatomy after initiating
treatment with brolucizumab. Previously treated eyes maintained VA after
switching to brolucizumab, supporting the claim of noninferiority to other
anti-VEGF agents. Our analysis found that brolucizumab was highly effective in
reducing fluid within all retinal compartments, even in previously treated
nvAMD eyes. We found that patients may achieve extended dosing intervals
shortly after switching to brolucizumab, especially those with prior treatment
intervals.”

Keywords: Beovu, brolucizumab, anti-VEGF, intraocular
inflammation, retinal vasculitis

Source: Nicholas J Saba, Scott D Walter; Clinical
Ophthalmology 2023:17 2791–2802

PAHO convenes ministers of Health of the Americas to discuss Health priorities for the Region 

Cristina Mitchell

25 Sep 2023

Although some industry players propose alternative labelling options, with our people’s health on the line, we need the label that is backed by sound, scientific research; and the Octagonal Warning Label (OWL) is 9 TIMES more effective at helping us quickly, correctly and easily identify products that are high in sugars, sodium and fats than other labeling system.

THE OCTAGONAL WARNING LABEL IS AT THE CENTRE OF A WIDER STRATEGY!

The Octagonal Warning Label enables other healthy food policies because it clearly and effectively identifies products that are high in sugars, sodium and fats and, therefore, harmful to health of our families and children.

This means it makes it easier to design, implement and enforce healthy policies like:

• Regulating the sale and marketing of these unhealthy food products in and around schools, and school settings like youth sporting events
• Regulating the marketing of these foods to children
• Taxing unhealthy food products and subsidising healthy foods

So, the Octagonal Warning Label is a crucial launchpad for these policies that can protect our children and families, and also make it easier and more affordable for citizens to make healthy food choices.

THIS VOTE AND THESE POLICIES ARE MORE IMPORTANT THAN EVER!

Modern diets lack fresh, minimally processed food and are inundated with ultra- processed food products high in sugar, fats and salt which lead to our region’s biggest killers: obesity, diabetes, hypertension, high blood pressure and even some cancers.

With these ultra-processed food products being made easily accessible, attractively marketed, cheap and convenient, it’s more important than ever to have clear facts about the food we buy and consume.

That clarity can go a long way toward helping us make healthier food choices and protect our families and children from the harmful results of unhealthy options.

It is a step toward rebuilding the health of our population one family, one meal, one choice at a time!

PEOPLE LIVING WITH DIET-RELATED DISEASES NEED CLEAR NUTRITIONAL FACTS!

Everyone should to be able to correctly and easily identify foods high in sugar, sodium and fats.

But, for people living with living with diabetes, hypertension, high blood pressure, obesity and even some cancers, clarity and honesty can actually help to control their conditions, and ultimately save their lives by helping them make better, healthier choices in the long-term!

IT’S JUST EASIER TO MAKE HEALTHY CHOICES WHEN THE FACTS ARE CLEAR!

Appealing and persuasive package designs, clever marketing and misleading claims on packaging, and confusing nutrition labels can often lead to unhealthy food products being mistaken as “good for us”. Consumers need help to combat these tactics.

This is why we need a label that provides clear facts that let us quickly, correctly and easily identify unhealthy food products.

CAMPAIGN AT A GLANCE

Launch Date: Monday | 25 SEPTEMBER, 2023

Locale: Regional/Caribbean

Type: Social Media Campaign

Purpose: To advocate and build support for the current final draft regional standard for labelling pre-packaged foods, which includes the octagonal front-of-package warning labelling system.

In October 2023, CARICOM countries voted on whether to approve the Octagonal Warning Labels or not. Thanks to everyone who signed the petition in support of the Octagonal Warning Label!

1470

People Signed (including Caribbean Academics, Researchers and Health Practitioners)

RELATED RESOURCES

The post Octagonal Warning Labels Help Consumers Act on Facts appeared first on Healthy Caribbean Coalition.