vancomycin – risk of hemolytic anemia and Hepatobiliary disorders

leflunomide - risk of pulmonary nodule

Bisoprolol– risk of severe hypoglycaemia when used concurrently with sulfonylureas

Ibrutinib – risk of uveitis

EDA performs label update to include the following:
Fertility, Pregnancy and lactation

EDA performs label update to include the following:
Special warning and precaution for use

Undesirable Effects
Nervous System Disorder:
Idiopathic intracranial hypertension :Unknown

Undesirable effects
Eye Disorder: keratitis with frequency unknown

Roxadustat- Thrombocytopenia & increased blood copper levels

Sertraline – Risk of Multiple acyl-coenzyme A dehydrogenase deficiency (MADD)-like disorder

Oxcarbazepine – Risk of infants being small for gestational age (SGA)

Hydrocortisone (Systemic formulation) – Risk of Thyrotoxic Periodic Paralysis (TPP)

Meropenem –Risk of Drug-induced liver injury (DILI)

Abrocitinib– Risk of Neutropenia

Upadacitinib - Risk of Hypoglycemia

Olaparib – risk of drug-induced liver injury (DILI)

Baricitinib - Risks of Hypoglycemia

Carbamazepine - risks of Microcephaly, Small for gestational age (SGA), Neurodevelopmental disorders (Autism spectrum disorder, Intellectual disability,
ADHD) in Neonates

Nirmatrelvir/Ritonavir -new contraindication: co-administration with enzalutamide

Sugammadex -risk of serious Hypersensitivity Reaction

Tirzepatide-potential risk of pulmonary aspiration during general anesthesia or deep sedation 

Tacrolimus - risks of skin cancers and Kaposi's sarcoma

Oxaliplatin- risks of Splenomegaly &Microangiopathic haemolytic anaemia associated
with haemolytic uraemic syndrome

Vardenafil –Risks of Stevens-Johnson syndrome SJS ,toxic epidermal necrolysis
(TEN) and Central serous chorioretinopathy

Metformin-risks of aggravation of Mitochondrial Encephalopathy with Lactic Acidosis,
and Stroke-like episodes (MELAS) syndrome & Maternal inherited diabetes and deafness
(MIDD) in patients with mitochondrial diseases

Azathioprine –Risks of Non-cirrhotic portal hypertension, porto-sinusoidal
vascular disease and hepatic Damage

Propofol –Risks of hepatitis and acute hepatic failure

Lidocaine– New warning about risk of Kounis Syndrome

Atomoxetine-new warning about threatening behavior and thoughts of harming others

Semaglutide-Risks of Pulmonary Aspiration, intestinal obstruction & dysesthesia

Esketamine nasal spray – Risks of Bradycardia and Seizure

Teriflunomide – Risk of herpes virus infections

EDA performs label update to include the following:

Special warnings and precautions for use :Liver injury

Undesirable Effects:
Hepatobiliary Disorders
Rare: Liver injury

Conten

Valproate and increased risk of neurodevelopmental disorders (NDDs) in children
born to men treated with valproate in the 3 months prior to conception

Thiocolchicoside and restrictions associated with the risk of genotoxicity

Avanafil – Risk of Visual defects including central serous chorioretinopathy (CSCR)

Medroxyprogesterone – Risk of meningioma

Leflunomide – warning about impaired wound healing after surgery

Garcinia – Risk of liver injury

Pseudoephedrine – risk of abuse to be added as a new warning

Quetiapine – Concomitant administration of quetiapine and other serotonergic medications, such as MAO inhibitors, selective serotonin reuptake inhibitors, serotoninnorepinephrine reuptake inhibitors, or tricyclic antidepressants, may cause serotonin
syndrome, a potentially fatal condition

Upadacitinib – Risk of vertigo and dizziness

Menquadfi
EDA performs label update to include the following:

Dosage and administration

Ibuprofen – Risk of Kounis Syndrome

Promethazine—Contraindiction in children under 6 years of age due to the risk of
psychiatric and central nervous system side effects .

Pseudoephedrine – new contraindications and risk of PRES and RCVS

EDA performs label update to include the following:
Indications/Uses:
 discontinued.
Pregnancy, lactation:
Undesirable effects:
Undesirable effects from the post-marketing phase
General Administration for Pharmaceutical Vigilance
Infections and infestations
Mabthera is indicated for:
References:

Osimertinib – Risk of Hyperpigmentation

Dacarbazine – Extension of the period of contraception for women of childbearing
potential due to the genotoxic potential of dacarbazine

Sunitinib – Risk of Hyperammonaemic encephalopathy

Nirmatrelvir & Ritonavir – Contraindications with Medicinal products that are highly
dependent on CYP3A for clearance leadin to serious and/or life-threatening reactions

Azacitidine– Risk of Cutaneous vasculitis

Hydroxychloroquine Sulfate– Risk of drug-induced phospholipidosis, hepatotoxicity,
hepatitis B virus reactivation and aggravation of myasthenia gravis

Citalopram/Escitalopram– Risk of QT prolongation

Ashwagandha – Risk of liver injury and GIT irritation

Imovax Polio
EDA performs label update to include the following:

This vaccine is indicated for the prevention of poliomyelitis in infants, children
and adults, for primary vaccination (series of first vaccinations) and as a boost
er.
IMOVAX POLIO must be used according to effective official recommendations

Gabapentin– Risk of SCARs and toxic epidermal necrolysis

Terlipressin– Avoidance in patients with advanced renal dysfunction& Risk of
Respiratory failure and dyspnoea

Voriconazole– Interaction of Voriconazole with Flucloxacillin

Benzyl alcohol containing products —Risk of gasping syndrome in young children
& Allergic reaction and mild local irritation.

Remicade
Page 1
EDA performs label update to include the following:
2. What you need to know before you use Remicade
Warnings and precautions

4. Possible side effects
Uncommon: may affect up to 1 in 100 people
Weight gain (for most patients, the weight gain was small).

Rosuvastatin—Drug-Drug interaction of Rosuvastatin with Ticagrelor

IDACIO

EDA performs label update to include the following:
1. What Idacio is and what it is used for
2. How to use Idacio

Fluconazole—Risk of miscarriage and congenital malformations when using fluconazole during pregnancy also includes the use of lower doses.

Safet

y Alerts -Fluconazole

Conten

Alendronate - Risk of low-energy fractures observed in bones other than the femur

Darzalex
Page 1
EDA performs label update to include the following:
4. Possible side effects
Background:

Rybelsus
Page 1
EDA performs label update to include the following:
2. What you need to know before you take Rybelsus®
4. Possible side effects
Background:

Mesalazine - risk of discolouration of urine after contact with sodium hypochlorite
(bleach) & drug reaction with eosinophilia and systemic symptoms (DRESS)

Statins - risk of Myasthenia Gravis

Fentanyl transdermal Patches - risks of Accidental use and Ingestion

Safety Alerts -Fentanyl

Ibuprofen/Paracetamol - risks of kounis syndrome &fixed drug eruption

Ibuprofen-paracetamol - Safety Alerts 

Synflorix
EDA performs label update to include the following:
Posology and method of administration

Safety Alerts -Synflorix

Glucagen
Page 1
EDA performs label update to include the following:
2. What you need to know before you use GlucaGen®.
4. Possible side effects
Background:

Safety Alerts -Glucagen

Methyl Prednisolone- risk of Tumour lysis syndrome & hypothalamic pituitary-adrenal axis suppression

Methyl Prednisolone- Safety Alerts

Tofacitinib sodium succinate –Risk of Hypoglycemia & Retinal venous thrombosis

Tofacitinib  -Safety Alerts

Hydrocortisone sodium succinate –Risk of Tumor Lysis Syndrome

hydrocortisone -Safety Alerts 

Rivastigmine and risk of QT prolongation and torsade de pointes

Rivastigmine-Safety Alert

A new warning about Risk of Toxic Epidermal Necrolysis (TEN) for
Gabapentinoids

Gabapentin-Safety Alert

A new warning about Vancomycin and Risk of risk of Kounis syndrome

Vancomycin-Safety Alert

Clopidogrel—risk of hemorrhage with aspirin

Clopidogrel Safety Alerts 

Bupropion and the risk of unmasking of Brugada Syndrome

Bupropion-Safety alert

Betamethasone-Dexamethasone –risk of Pheochromocytoma

betametnasone Safety Alerts 

Clopidogrel has been shown to increase rosuvastatin exposure in patients

clopidogrel -safety alert

Conten

Risk of neural tube defects reported in infants born to women exposed to dolutegravir at the time of conception

dolutegravir safety alert

A new warning about Suicidal risk of Metronidazole

METONIDAZOLE -Safety Alerts

Hydroxycobalamin -risk of Interference with platetelet count, aluminuim toxicity,
lab tests

Hydroxycobalamin Safety Alert

Leflunomide relationship between leflunomide and skin ulcer

Leflunomide-Safety Alerts

Carbamazepine risk of Interaction with brivaracetam, warnings and recommendations on use during pregnancy and in women of childbearing potential and addition of hyperammonemia to undesirable effects

carbamazepine safety alert

Brinzolamide risks of Stevens-Johnson syndrome (SJS) and toxic epidermal

Brinzolamide -Safety Alerts

A new warning about the nephrotoxic potential of clindamycin capsules and
injections

clindamycin-Safety Alerts 

Association of Oxcarbazepine with neurodevelopmental disorders, congenital

 OXCARBAZEPINE-Safety Alerts 

Ketamine risk of Biliary duct dilatation

Ketamine safety alert

Linagliptin acid-risk of Hypoglycemia

linagliptin Safety Alerts 

Isavuconazole and risk of Anaphylactic reaction

Isavuconazole- Safety Alerts

PPIs risks of hypomagnesemia and severe cutaneous adverse drug reactions

PPIs- safety alert

Ribavirin risk of Embryo-Fetal Toxicity

Ribavirin-safety alert

Donepezil-QTc interval extension and Torsade de Pointes

Donepezil Safety Alerts 

A new warning about Thyroid Dysfunction of Iopromide in Pediatric Patients 0
to 3 Years of Age

 Iopromide -Safety Alerts 

A new warning about temozolomide concerning duration of contraception
following the end of treatment with a genotoxic drug.

 temozolomide-Safety Alerts 

Hydrocortisone in systemic route and risk of hypertrophic cardiomyopathy and
neonatal hypoglycemia

Hydrocortisone-Safety Alert

Icreased risk of Cardiovascular Events & Cardiovascular Mortality when
Hydroxychloroquine or Chloroquine used with Macrolide antibiotic

AZ Safety Alerts 

Omeprazole Risk of risk of nephrotoxicity

Omeprazole Safety Alerts

Upadacitinib and risk of diverticulitis

Upadacitinib-Safety Alert

Sacubitril/ Valsartan risks of psychiatric disorders as hallucinations , sleep and paranoia

Sacubitril/ Valsartan-Safety alert

Pregabalin and risks of Steven Johnson Syndrome and Toxic Epidermal Necrolysis

Pregabalin-Safety Alerts

Pirfenidone Risks of Stevens-Johnson syndrome (SJS) and toxic epidermal
necrolysis (TEN)

Pirfenidone-safety Alerts

Dexamethasone in systemic route and risk of hypertrophic cardiomyopathy and neonatal hypoglycemia

Dexamethasone-Safety Alerts

Ivermectin 3 mg and 6 mg Scored tablets: Risk of Disturbance of consciousness

Ivermectin Safety Alert

Tenofovir Alafenamide: Risk of Renal impairment including renal failure, proximal

tenofovir Safety Alerts

Voriconazole – Risk of drug-drug interaction with Lurasidone since it may result
in significant increase in Lurasidone exposure

Voriconazole Safety Alerts -

Obeticholic acid-risks of hepatic decompensation and liver failure

obeticholic acid Safety Alerts 

Methotrexate - Risk of Progressive Multifocal Leukoencephalopathy (PML)

Methotrexate Safety Alerts

Ondansetron and risk of myocardial ischemia

Ondansetron- Safety Alerts

Sulfamethoxazole-Trimethoprim-Hypersensitivity and Other Serious or Fatal Reactions

Trimethoprim Safety Alerts _

Venlafaxine and risk of serious discontinuation symptoms

Venlafaxine- Safety Alerts

Ethosuximide and risk of immune thrombocytopenia

Ethosuximide- Safety Alerts

NSAID and the risk of oligohydramnios in the second trimester

NSAID-Safety Alerts

Duloxetine may cause symptoms of sexual dysfunction

Duloxetine-Safety Alerts

Pentosan – pigmentary maculopathy (changes in the retina of the eye) risk of pigmentary maculopathy (changes in the retina of the eye), especially after long-term
use

Pentosan Safety Alerts

Restriction to use Chloramphenicol in paediatric population less than 2 years since it
contains boron and may impair fertility in the future

 chloramphenicol-Safety Alerts

Hydroxychloroquine Risk of Sweet’s Syndrome and Severe Cutaneous Adverse
Reactions (SCARS)

Hydroxychloroquine Safety Alert