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Safety Alerts

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2024
2023
2022
2021
2020
2019
2018
2017
2016
2015
2014

14Oct

[Updated] 17-Hydroxyprogesterone Caproate (17-OHPC): Cancellation of Product Registration and Product Recall

10Oct

Paracetamol and Fixed Drug Eruption (FDE): Upward Trend of Reports Involving Paediatric Patients

01Oct

Fluconazole: Updates on the Known Risk of Spontaneous Abortion During Pregnancy and Congenital Malformations in Children Exposed to Fluconazole in Utero

30Sep

Pseudoephedrine: Risk of Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS)

02Sep

Safety Signal Alert: Mefenamic Acid-Associated Generalised Bullous Fixed Drug Eruption (GBFDE)

26Aug

Progestogens (Cyproterone Acetate, Medroxyprogesterone Acetate, Chlormadinone): Risk of Meningioma

12Aug

Azacitidine (Injectable Formulation): Risk of Cutaneous Vasculitis

22Jul

17-Hydroxyprogesterone Caproate (17-OHPC): Potential Cancer Risk in Offspring Exposed in Utero and Limited Efficacy Data

15Jul

Hydroxychloroquine: Risk of Sweet’s Syndrome (Acute Febrile Neutrophilic Dermatosis)

28Jun

Anti-Clusters of Differentiation 20 (CD20) Antibodies (Rituximab, Obinutuzumab, Ofatumumab, Ocrelizumab): Risk of Pyoderma Gangrenosum

29May

Amoxicillin: Risk of Aseptic Meningitis

28May

Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors (Dapagliflozin, Empagliflozin, Canagliflozin): Interaction with Lithium (for Therapeutic Use) Leading to Decreased Serum Lithium Concentration

06May

[Updated] Olmesartan: Risk of Autoimmune Hepatitis

30Apr

Proton Pump Inhibitors: Risk of Erectile Dysfunction

29Apr

Levetiracetam and Clobazam: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

18Apr

Hydrochlorothiazide: Risk of Acute Respiratory Distress Syndrome (ARDS)

17Apr

Ciprofloxacin, Moxifloxacin, Levofloxacin and Ofloxacin (Fluoroquinolones) for Systemic Use (Oral and Injection): Risk of Suicidal Behaviours

12Mar

Domperidone: Risk of Psychiatric Withdrawal Events When Used Off-Label for Lactation Stimulation

04Mar

[Updated] Metformin: Risk of Vitamin B12 Deficiency

19Feb

Statins (Atorvastatin, Rosuvastatin, Simvastatin): Interaction with Ticagrelor Leading to Increased Risk of Rhabdomyolysis

22Jan

Imatinib: Risk of Thrombotic Microangiopathy

19Jan

Rivastigmine: Risks of QT Prolongation and Torsade de Pointes

01Dec

Clomiphene: Risk of Serious Visual Disturbances Potentially Leading to Blindness

30Nov

Ibrutinib (IMBRUVICA®): Package Insert Updates to Dose Modifications for Adverse Reactions and to Special Warnings and Precautions for Use

29Nov

[Updated] Loperamide: Risk of Acute Pancreatitis

29Nov

[Updated] Topiramate: Neurodevelopmental Disorders in Children Exposed to Topiramate during Pregnancy

13Oct

Isotretinoin: Risk of Psychiatric Disorders and Sexual Dysfunction

05Sep

Cephalosporins: Risk of Seizures

23Aug

Valaciclovir: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

07Aug

[Updated] Clindamycin (Systemic): Risk of Acute Kidney Injury

02Aug

Third-Generation Aromatase Inhibitors (Anastrozole; Exemestane; Letrozole): Risk of Tendon Disorders

18Jul

Statins: Risk of Inducing or Aggravating Myasthenia Gravis

13Jun

Terlipressin (Glypressin®): Serious or Fatal Respiratory Failure and Sepsis/Septic Shock in Patients with Type 1 Hepatorenal Syndrome (Type 1 HRS)

03May

Griseofulvin: Risk of Severe Cutaneous Adverse Reactions (SCARs)

02May

Comirnaty Vaccine: Risk of Heavy Menstrual Bleeding

19Apr

Azacitidine: Risk of Differentiation Syndrome

11Apr

Off-Label Use of Diclofenac Suppositories to Treat Fever in Children: Potential Risk of Acute Necrotising Encephalopathy of Childhood (ANEC)

23Mar

[Updated] Pholcodine: Risk of Anaphylaxis to Neuromuscular Blocking Agents (NMBAs)

16Jan

Donepezil: Risk of QT Prolongation and Torsade de Pointes

20Dec

Pneumococcal Polysaccharide Vaccine (23-Valent): Extensive Swelling of Vaccinated Limb

09Dec

Sorafenib: Risk of Thrombotic Microangiopathy (TMA)

06Dec

Hydroxychloroquine and Chloroquine: Risk of Hepatic Impairment

02Nov

Methadone: Risk of Hypoglycaemia

01Nov

Piperacillin: Risk of Haemophagocytic Lymphohistiocytosis (HLH)

27Oct

Iodinated Contrast Media: Risk of Hypothyroidism (Particularly in Newborns and Young Children)

20Oct

Safety Updates on COVID-19 Vaccines: Risk of Tinnitus

19Oct

Labetalol: Risk of Nipple Pain and Raynaud's Phenomenon of the Nipple

17Oct

Sertraline: Risk of Microscopic Colitis

05Oct

Nirmatrelvir/ Ritonavir (PAXLOVID): Risk of Anaphylaxis and Hypersensitivity Reactions

29Sep

Brolucizumab (Pagenax®): Risk of Intraocular Inflammation, Including Retinal Vasculitis and/or Retinal Vascular Occlusion (Updated Recommendations to Minimise the Known Risks)

28Sep

Alectinib (Alecensa®): Risk of Haemolytic Anaemia (New Warning and Precaution and Dose Modification Guidance)

27Sep

Metformin: Risk of Vitamin B12 Deficiency

19Jul

Corticosteroids (Systemic): Risk of Pheochromocytoma Crisis

19Jul

Chloroquine and Hydroxychloroquine: Risk of Psychiatric Disorders

18Jul

Azathioprine: Risk of Erythema Nodosum

23Jun

Loperamide: Risk of Acute Pancreatitis

20Jun

Empagliflozin: Risk of Tubulointerstitial Nephritis

16Jun

Olmesartan: Risk of Autoimmune Hepatitis

13Jun

Mavenclad® (Cladribine): Risk of Serious Liver Injury and New Recommendations About Liver Function Monitoring

17May

Safety Updates on COVID-19 Vaccines: Risk of Vaccine-Induced Immune Thrombotic Thrombocytopenia (VITT) / Thrombosis with Thrombocytopenia Syndrome (TTS)

06May

Warfarin: Risk of Anticoagulant-Related Nephropathy (ARN)

05May

Hydrochlorothiazide, Chlorthalidone, Indapamide and Acetazolamide: Risk of Choroidal Effusion, Acute Myopia & Acute Angle-Closure Glaucoma

06Apr

Betamethasone (Systemic): Risk of Pheochromocytoma Crisis

21Mar

Tenofovir Alafenamide: Risk of Renal Adverse Effects

03Jan

Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]

31Dec

Janus Kinase (JAK) Inhibitors in Rheumatoid Arthritis Patients: Risk of Major Adverse Cardiovascular Events (MACE) and Malignancies [Excluding Non-Melanoma Skin Cancer (NMSC)]

31Dec

Clindamycin: Risk of Acute Renal Failure

30Dec

Sulfamethoxazole & Trimethoprim (Co-Trimoxazole): Risk of Acute Respiratory Distress Syndrome (ARDS)

14Dec

Decitabine: Risk of Differentiation Syndrome

29Nov

Anastrozole: Risk of Depression

12Oct

Bortezomib: Risk of Guillain-Barré Syndrome and Demyelinating Polyneuropathy

07Oct

Non-Vitamin K Antagonist Oral Anticoagulants (NOACs): Risk of Abnormal Uterine Bleeding

09Sep

Sacubitril/Valsartan: Risk of Psychiatric Events

29Jul

Mycophenolate Mofetil (MMF) and Myocophenolic Acid (MPA): Risk of De Novo Purine Synthesis Inhibitors-Associated Acute Inflammatory Syndrome

08Jul

Oseltamivir: Risk of Haemorrhages

22Apr

Antidepressants (citalopram; desvenlafaxine; escitalopram; fluoxetine; fluvoxamine; paroxetine; sertraline; venlafaxine; vortioxetine): Risk of Postpartum Haemorrhage (PPH)

22Apr

Tecentriq® (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)

20Apr

Vascular endothelial growth factor (VEGF) inhibitors for systemic use (except application on eyes): Risk of artery dissections and aneurysms

20Apr

Mirtazapine: Risks of (i) Amnesia and (ii) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)

20Apr

Ceftriaxone: Risk of encephalopathy

17Feb

Safety Updates on COVID-19 Vaccine (Comirnaty®)

29Jan

Mesalazine and sulfasalazine: Nephrolithiasis

29Jan

Efavirenz (including combination products): Risk of late onset neurotoxicity

29Jan

Oseltamivir: Thrombocytopenia

29Jan

Clozapine: Risk of serious bowel complications caused by constipation

29Jan

Abiraterone: Risk of hypoglycaemia due to drug interaction

20Jan

Ondansetron: Information updates on risk of birth defects

20Jan

Alemtuzumab (Lemtrada®): Revised indication, additional contraindications and risk minimisation measures

20Jan

Tumour Necrosis Factor alpha (TNFα): Kaposi’s Sarcoma

14Dec

Esmya (ulipristal acetate 5 mg): Withdrawal of product registration

08Sep

Gilenya® (fingolimod): New contraindication in pregnant women and in women of childbearing potential who are not using effective contraception

27Aug

Parenteral nutrition containing amino acids and/or lipids: Risk of toxic degradations of ingredients when exposed to light, which may lead to adverse outcomes in paediatric patients less than 2 years of age

25Aug

Propofol: Risk of priapism

14Aug

Plaquenil® (hydroxycholoroquine): Risk of QT prolongation and other drug-drug interactions in the context of COVID-19 management

06Aug

Topiramate: Risk of uveitis

06Aug

Insulin: Risk of cutaneous amyloidosis

23Jun

Reminder on the risk of oculogyric crisis with metoclopramide use

04Jun

Domperidone: Restriction of use in paediatric patients less than 12 years of age

28May

Proton pump inhibitors: Risk of microscopic colitis

28May

Gabapentin: Risk of dysphagia

12May

Rocuronium: Kounis syndrome

12May

Nintedanib: Ischaemic colitis

07Apr

Guselkumab: Risk of anaphylaxis

06Apr

Esmya (ulipristal acetate 5 mg): Product recall due to potential risk of liver injury

06Apr

Intravenous iron-containing products: Kounis syndrome

06Apr

Nivolumab: Reports of cytomegalovirus (CMV) infection or reactivation

06Apr

Kyprolis® (carfilzomib): (i) Risk of progressive multifocal leukoencephalopathy (PML); (ii) Risk of hepatitis B virus (HBV) reactivation

06Apr

Esbriet® (pirfenidone): Drug-induced liver injury (DILI)

26Feb

Sulfasalazine: Interference with dihydronicotinamide-adenine dinucleotide/ dihydronicotinamide-adenine dinucleotide phosphate (NADH/NADPH) reaction assays

26Feb

Ondansetron: Birth defects

26Feb

Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors: Risk of severe lung inflammation

21Jan

New safety measure for sodium valproate: (i) Risk of congenital malformation in neonates and neurodevelopmental problems in children exposed to sodium valproate during pregnancy; (ii) Additional educational material for healthcare professionals and patients/caretakers

26Nov

Retinoids: Updated measures for pregnancy prevention during retinoids use

26Nov

FEBURIC® (febuxostat): Increased risk of cardiovascular death and all-cause mortality in patients treated with febuxostat in the CARES study

30Oct

Smecta® (dioctahedral smectite): Not recommended for use in children aged below 2 years and pregnant or breastfeeding women

03Sep

Clopidogrel: Interaction with boosted antiviral Human Immunodeficiency Virus (HIV) therapy leading to insufficient inhibition of platelet aggregation

03Sep

LEMTRADA® (alemtuzumab): (i) Risk of autoimmune hepatitis (ii) Other serious reactions temporally associated with alemtuzumab infusion (iii) Haemophagocytic lymphohistiocytosis

26Aug

Diclofenac (systemic use): (i) Risk of anastomotic leakage and (ii) Risk of Kounis syndrome

26Aug

Actemra® (tocilizumab): New important identified risk of hepatotoxicity

20Jun

Imovane® (zopiclone): New restriction of the indication and additional warnings on abuse and dependence

20Jun

TECENTRIQ® (atezolizumab): A new important identified risk – immune-related myositis

20Jun

Posaconazole: Pseudohyperaldosteronism

12Jun

Deferiprone: Risk of neurological disorders in children

12Jun

DARZALEX (daratumumab): New identified risk of Hepatitis B Virus reactivation

12Jun

Benlysta® (belimumab): Increased risk of serious psychiatric events

09Apr

Carbimazole and methimazole (thiamazole): (i) Risk of birth defects and neonatal disorders in case of exposure during pregnancy; (ii) Risk of pancreatitis

04Apr

Oral retinoids: Risk of neuropsychiatric symptoms

04Apr

Tapentadol: Risk of seizures and reports of serotonin syndrome when co-administered with other drugs

15Mar

Xylometazoline: Increased risk of serious ventricular arrhythmia in patients with long QT syndrome

15Mar

Direct-Acting Antivirals (DAAVs) : Risk of hypoglycaemia in patients with diabetes

31Jan

Ceftriaxone: Disturbed consciousness, convulsions or involuntary movements

31Jan

Beta-Lactam antibiotics: Severe Cutaneous Adverse Reactions (SCARs)

31Jan

Lamotrigine: Risk of hemophagocytic lymphohistiocytosis (HLH)

31Jan

Acetazolamide: A new contraindication during pregnancy

31Jan

Fluoroquinolones: Risk of aortic aneurysm and dissection

31Jan

Epilim® (Sodium Valproate): Important new restrictions on use

26Oct

Succinylated gelatin (modified fluid gelatin): Possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (Alpha-gal)

26Oct

Tivicay® (dolutegravir): Reports of neural tube defects

26Oct

Xgeva® (denosumab): Risk of new primary malignancy

26Oct

Eltrombopag: Risk of interference with bilirubin and creatinine test results

26Oct

Tecentriq® (atezolizumab): Risk of nephritis

26Oct

Esmya® (ulipristal acetate): New contraindication, restricted indication and liver function monitoring requirement

10Oct

Varenicline tartrate: Loss of consciousness

10Oct

Montelukast sodium: Update on neuropsychiatric adverse reactions – obsessive-compulsive symptoms

10Oct

Isoniazid: Risk of pancreatitis

10Oct

Saccharomyces boulardii: Risk of fungaemia

10Oct

Azithromycin, clarithromycin, erythromycin and roxithromycin: Risk of Severe Cutaneous Adverse Reactions (SCAR)

10Oct

Apixaban: Drug interaction between apixaban and Selective Serotonin Reuptake Inhibitors (SNRI) and/or Serotonin and Noradrenaline Reuptake Inhibitors (SNRI) leading to increased risk of bleeding

28Aug

Iodinated Contrast Media: Risk of Severe Cutaneous Adverse Reactions (SCAR)

30Jul

Stilnox® 10 mg film-coated tablet (zolpidem): Restriction of indication

30Jul

Domperidone and clarithromycin: Drug interaction leading to increased risk of QT interval prolongation

30Jul

Noradrenaline: Stress cardiomyopathy

25Jun

Acetazolamide: Risk of Severe Cutaneous Adverse Reactions (SCARs)

25Jun

Carbocisteine and acetylcysteine: Anaphylactic/anaphylactoid reactions and Severe Cutaneous Adverse Reactions (SCARs)

25Jun

Efavirenz: Risk of QTc interval prolongation

16Jun

Drug interaction of oral contraceptives containing ethinylestradiol with the direct-acting antiviral combinations of paritaprevir, ritonavir and ombitasvir with or without dasabuvir

15Jun

Mesalazine: Risk of photosensitivity reactions

13Jun

Methotrexate: Pulmonary alveolar haemorrhage

12Jun

Pemetrexed: Risk of nephrogenic diabetes insipidus and renal tubular necrosis

11Jun

Amoxicillin-containing products: Risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and strengthening the risk of Severe Cutaneous Adverse Reactions (SCARs)

10Jun

Propofol and sodium valproate: Risk of increased propofol blood level when co-administered with valproate

24Apr

Esmya® 5 mg tablets (ulipristal acetate): Women taking Esmya® for uterine fibroids to have regular liver tests while safety review is ongoing; do not initiate treatment in new patients or those who have completed a previous treatment course

23Mar

Doxycycline: Risk of Jarisch-Herxheimer reaction

23Mar

Gadolinium-based Contrast Agents: Suspension/restriction of use following evidence of gadolinium deposits in the brain after magnetic resonance imaging (MRI) body scans

23Mar

Intravenous (IV) fluids containing electrolytes and/or carbohydrates: Risk of hyponatraemia

23Mar

Levetiracetam and methotrexate: Risk of drug-drug interaction

22Feb

Ofev® (nintedanib): Information on severe liver injury and the need for regular monitoring of liver function associated with the use in patients with idiopathic pulmonary fibrosis (IPF)

29Dec

Xofigo® (radium-223 dichloride): Important Safety Information Update Regarding Increased Incidence of Deaths and Fractures in a Randomized Clinical Trial with Xofigo® used in Combination with Abiraterone Acetate and Prednisolone/ Prednisone

06Oct

Ribomustin® (bendamustine): Increased Mortality Observed When Used in Non-approved Combination Treatments or Outside the Approved Indications; Monitor for Opportunistic Infections and Hepatitis B Reactivation

06Oct

Xgeva® (denosumab): Risk of Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation

03Jul

Keytruda® (pembrolizumab): Risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

03Jul

Zelboraf® (vemurafenib): Important Drug Warning – Risk of Dupuytren’s Contracture and Plantar Fascial Fibromatosis

05Jun

Domide® (thalidomide): New important advice regarding viral reactivation and pulmonary hypertension

05Jun

Revlimid® (lenalidomide): New important advice regarding viral reactivation

11Apr

Madonna® (levonorgestrel): Levonorgestrel-containing emergency hormonal contraception ─ New advice on interactions with hepatic enzyme inducers and contraceptive efficacy

11Apr

Escapelle® & Postinor-2® (levonorgestrel): Levonorgestrel-containing emergency hormonal contraception ─ New advice for users of hepatic-enzyme inducers

28Feb

Pomalyst® (pomalidomide): New important advice- Hepatitis B Virus status to be established before initiating treatment with pomalidomide

30Dec

Zaltrap® (aflibercept): Information on the risk of osteonecrosis of the jaw

24Nov

Implanon NXT® (etonogestrel): Implants have been found rarely in the vasculature and lung. An update on possible risks and complications regarding insertion, localisation, removal and migration

24Nov

Invokana® (canagliflozin): Advice on the risk of lower limb amputation (primarily of the toe) during treatment with canagliflozin-containing medicines

24Aug

Tarceva® (erlotinib): First-line maintenance indication now restricted to treatment of patients whose tumours harbour an EGFR-activating mutation

03Aug

Adempas® (Riociguat): New Contraindication for Patients with Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP)

08Jun

Locabiotal® Solution (fusafungine): Withdrawal of registration following European Medicines Agency’s benefit-risk assessment

08Jun

Glivec® (imatinib) & Tasigna® (nilotinib): Risk of Hepatitis B reactivation

08Jun

Xalkori® (crizotinib): Inclusion of a new warning regarding cardiac failure

08Jun

Viekirax® (ombitasvir/ paritaprevir/ ritonavir) with or without Exviera® (dasabuvir): Not recommended in Child-Pugh B Patients

08Jun

Xgeva® 120mg & Prolia® 60mg (denosumab): Clinically Significant Cases of Hypercalcaemia after Cessation of Treatment with Denosumab in Paediatric Patients

31Dec

Cellcept® (mycophenolate mofetil): Teratogenic risk – important new pregnancy prevention advice for women and men

04Sep

Forxiga® (dapagliflozin): Risk of Diabetic Ketoacidosis During Treatment With Sodium Glucose Co-transporter 2 (SGLT2)Inhibitor - Dapagliflozin

04Sep

Motilium® (domperidone): New recommendations to minimise cardiac risks

23Mar

Xgeva®120mg Solution for Injection (denosumab): Updated recommendations to minimise the risk of severe symptomatic hypocalcaemia (SSH) and osteonecrosis of the jaw (ONJ)

12Feb

Artrodar®50mg (diacerein): New restrictions of use to limit the risk of severe diarrhoea and effects on the liver

31Dec

Reminyl® (galantamine hydrobromide): New Warning: Serious skin reactions (Stevens Johnson Syndrome [SJS] and acute generalised exanthematous pustulosis [AGEP])

21Oct

Revatio® (sildenafil citrate): Safety Information regarding Revatio® tablets for the treatment of pulmonary arterial hypertension (PAH)

21Oct

Topamax® (topiramate): Updated Warnings and Precautions on Visual Field Defects

27Aug

Protaxos® (strontium ranelate): New restricted indication and contraindications for use

27Aug

Neupogen® (filgrastim) & Neulastim® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only)

19Aug

Gran® (filgrastim) & Peglasta® (pegfilgrastim): Risk of capillary leak syndrome in patients with cancer (filgastrim & pegfilgastrim) and in healthy donors (filgastrim only)

15Jul

Vectibix® (panitumumab): Rare cases of Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) have been reported in patients treated with Vectibix®

15Jul

Mencevax ACWY™ (meningococcal vaccine): New antibody persistence data

15Jul

Ritalin and Ritalin LA® (methylphenidate hydrochloride): New warning on priapism in patients treated for Attention Deficit Hyperactivity Disorder (ADHD)

17Jun

Risperidone and Paliperidone: Risk of Intraoperative Floppy Iris Syndrome (IFIS) in Patients Undergoing Cataract Surgery

30May

Dilatrend® (carvedilol): Warning on Severe Adverse Cutaneous Reactions

20May

Combination Products containing Cyproterone Acetate 2mg and Ethinylestradiol 0.035mg: Restriction of Indication and Measures to Reduce Risk of Thromboembolism

30Apr

Tykerb® (Lapatinib): Comparative data have shown that lapatinib based regimens are less effective than trastuzumab based regimens for metastatic breast cancer in certain settings

30Apr

Concerta® (Methylphenidate hydrochloride): New warning on priapism in patients treated for Attention Deficit Hyperactivity Disorder (ADHD)

30Apr

Zofran® (Ondansetron): Dose-dependent QT interval prolongation – updated information on posology for intravenous (IV) use in the prevention of Chemotherapy-Induced Nausea And Vomiting (CINV)

30Apr

Erbitux® (Cetuximab): Importance of establishing wild type RAS status (exons 2,3,4 of KRAS and NRAS) before treatment in metastatic colorectal cancer (mCRC)

30Apr

Ultracet® Tablet (tramadol and paracetamol): Association with Serious Skin Reactions–Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

30Apr

Frisium® (clobazam): Update to include serious skin reactions in package insert for Malaysia

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