Drug Safety Alerts from PvPI-IPC
Drug Safety Alerts issued by Pharmacovigilance Programme of India (PvPI), Indian Pharmacopoeia Commission (IPC), Ministry of Health and Family Welfare, Government of India till April 2017.
The preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database reveals that the following drugs are associated with the risks as given below.
|
S.No
|
Suspected Drugs
|
Indication
|
Adverse Reactions
|
|
|
1
|
Phenytoin
|
Generalized tonic-clonic seizures; partial
seizures; status epilepticus
|
Angioedema
|
|
|
2
|
Phenytoin
|
Generalized tonic-clonic seizures; partial
seizures; status epilepticus
|
Osteoporosis
|
|
|
3
|
Nicorandil
|
Angina Pectoris, Vasodialator
|
Risk of ulcer complication
|
|
|
4
|
Olanzapine
|
Schizophrenia, acute mania episodes in
bipolar disorder
|
Hyponatraemia
|
|
|
5
|
Crizotinib
|
Locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)
|
Risk of cardiac failure
|
|
|
6
|
Roflumilast
|
Reduce the risk of Chronic Obstructive Pulmonary Diseases exacerbations
|
Gynecomastia
|
|
|
7
|
Clozapine
|
Management of Schizophrenic patients
|
Neutropenia
|
|
|
8
|
Disulfiram
|
Alcohol-Abuse Deterrent
|
Erythroderma
|
|
|
9
|
Peginterferon alpha-2a
|
Chronic active Hepatitis B & C
|
Vasculitis
|
|
|
10
|
Piperacillin & Tazobacam
|
In the treatment of lower RTI/UTI/intra abdominal infections, skin and skin structure infections, bacterial septicaemia polymicrobic infection
|
Vision abnormal
|
|
|
11
|
Mometasone Furoate, Topical
|
Steroid responsive dermatitis , eczema, or atopic dermatitis
|
Hypertrichosis/Hirsutism, Skin depigmentation
|
|
|
12
|
Ranibizumab
|
Neovascular Age-Related Macular Degeneration (AMD), Visual impairment due to Diabetic Macular Edema (DME), visual impairment due to Choroidal Neovascularization (CNV) secondary to Pathologic Myopia (PM).
|
Myocardial Infarction
|
|
|
13
|
Amphotericin B
|
Life threatening fungal infections including histoplasmosis, coccidioidomycosis, paracoccidioidomycosis, blastomycosis, aspergillosis, cryptaococcosis, mucormycosis, sporotrichosis and candidiasis; visceral and mucocutaneous leishmaniasis unresponsive to pentavalent antimony compounds; severe meningitis. perioral candidiasis.
|
Bone Marrow Depression
|
|
|
14
|
Doxorubicin
|
Soft tissue and bone sarcomas, acute leukemia, malignant lymphoma, Hodgkin’s diseases, breast carcinoma, small cell carcinoma of lungs, AIDS-related Kaposi’s sarcoma, multiple myeloma. Gastrointestinal tract carcinoma, bladder cancer, ovarian carcinoma, acute myeloblastic leukemia, thyroid carcinoma, neuroblastoma.
|
Photosensitivity Reaction
|
|
|
15
|
Crizotinib
|
Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that is Anaplastic Lymphoma Kinase (ALK) – positive.
|
Pneumonitis, Hepatic Encephalopathy
|
|
|
16
|
Febuxostat
|
For treatment of chronic hyperuricemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).
|
Allergic vasculitis
|
|
|
17
|
Oxcarbamazepine
|
Monotherapy or adjunctive therapy in the treatment of partial seizure, secondary generalized seizure, substitution for Carbamazepine can be made abruptly with an Oxcarbamazepine – to – Carbamazepine ratio of 300:200.
|
Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH).
|
|
|
18
|
Artemether & Lumefantrine
|
For treatment of uncomplicated falciparum malaria, mixed infections of falciparum and Chloroquine resistant vivax malaria.
|
Stevens- Johnson syndrome/Toxic epidermal necrolysis
|
|
|
19
|
Cefixime
|
Otitis media, respiratory tract infections, uncomplicated UTIs, effective against infections caused by Enterobacteriaceae, H.influenza species.
|
Acute generalised exanthematous pustulosis (AGEP)
|
|
|
20
|
Hepatitis B immune globulin (human)
|
Active immunisation against Hepatitis B virus (HBV) infection in subjects considered at risk of exposure to HBV-positive material.
|
Encephalopathy
|
|
|
21
|
Cefotaxime
|
Infections due to sensitive gram-positive and gram-negative bacteria such as bacteraemia, cellulitis, Intra-abdominal infections, gonorrhoea, bone or joint infections, skin and skin structure infections, urinary tract infections, septicaemias, surgical prophylaxis, endometritis, life threatening resistant/hospital acquired infections, infections in immune-compromised patients, Haemophilus epiglottitis and meningitis.
|
Anaphylactic Shock.
|
|
|
22
|
Lacosamide
|
As an adjunctive treatment of partial onset seizures in patients > 17 years of age.
|
Red Man Syndrome
|
|
|
23
|
Dimethyl fumarate
|
For Relapsing remitting multiple sclerosis.
|
Osteonecrosis
|
|
|
24
|
Sodium citrate/Diphenhydramine hydrochloride/Ammonium chloride
|
For Symptomatic treatment of cough.
|
Myocardial Infraction
|
|
|
25
|
Cabergoline
|
For the treatment of hyperprolactinemia and inhibition of lactation
|
Steven Johnson Syndrome
|
|
|
26
|
Amlodipine
|
Angina, hypertension, Coronary artery disease
|
Alopecia
|
|
|
27
|
Nitrofurantoin
|
Urinary tract infections; cystitis
|
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
|
|
|
28
|
Cefoperazone Sulbactam
|
For treatment of RTI, UTI (lower & upper), Septicemia, Meningitis, Skin & Soft tissue infection, Endometritis, Other infection of genital tract, Intra abdominal infection bone & joint infection
|
Acute Generalised Exanthematous Pustulosis (AGEP)
|
|
|
29
|
Cefixime
|
Otitis media, respiratory tract infections, uncomplicated UTIs, effective against infections caused by Enterobaceriaceae, H.influenza species.
|
Anal Ulcer
|
|
|
30
|
Atenolol
|
Angina and myocardial infarction; arrhythmias; hypertension; migraine prophylaxis
|
Dermatitis Lichenoid
|
|
|
31
|
Olanzapine
|
Schizophrenia and other psychotic disorders, mania/mixed episode, psychomotor agitation and violent behaviour
|
Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
|
|
|
32
|
Meropenem
|
Nosocomial infections like septicaemia, febrile neutropenia, intraabdominal and pelvic infection etc., caused by cephalosporin’s resistant bacteria, meningitis cystic fibrosis
|
Hypokalaemia
|
|
|
33
|
Montelukast
|
Prophylaxis of mild to moderate asthma
|
Tinnitus
|
|
|
34
|
Cefepime
|
For serious CRTI, uncomplicated and complicated UTI, Uncomplicated skin & skin structure, infection acute exacerbation of chronic bronchitis & intraabdominal infection
|
Dermatitis Lichenoid
|
|
|
35
|
Losartan
|
Congestive heart failure, hypertension (myocardial infarction along with stroke including reduction of stroke risk in hypertension) with left ventricular hypertrophy, diabetic nephropathy in type II diabetes
|
Burning Micturation
|
|
|
36
|
Amisulpride
|
For acute and chronic schizophrenic disorders, in which positive symptoms and or negative symptoms are prominent, including patients characterised by predominant negative symptoms.
|
Tinnitus
|
|
|
37
|
Carbamazepine
|
Partial seizures with or without secondary generalisation, trigeminal neuralgia, bipolar disorder
|
Bruxism
|
|
|
38
|
Clomipramine
|
Obsessive-compulsive disorder; panic disorder
|
Melasma
|
|
|
39
|
Glimepiride
|
Type 2 diabetes mellitus
|
Lichenoid Drug Eruption
|
|
|
40
|
Metoprolol
|
Supraventricular arrhythmia, angina pectoris, hypertension, myocardial infarction; migraine prophylaxis; hyperthyroidism, heart failure
|
Lichenoid Drug Eruption
|
|
|
41
|
Levamisole
|
For the treatment of roundworm and hookworm infestations
|
Skin Exfoliation
|
|
|
42
|
Deferasirox
|
Treatment of chronic iron overload in patients with non-transfusion dependent thalassemia (NTDT) syndromes
|
Osteoporosis
|
|
|
43
|
Ambroxol
|
All forms of tracheobronchitis, emphysema with bronchitis pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm asthma
|
Lacrimation
|
|
|
44
|
Lurasidone
|
Treatment of Patients with Schizophrenia
|
Thrombocytopenia
|
|
|
45
|
Etoricoxib
|
Short term use in acute painful condition
|
Skin Hyperpigmentation
|
|
|
46
|
Dexamethasone
|
Adjunct in the emergency treatment of anaphylaxis; short term supression of inflammationin allergic disorders; adrenocortical insufficiency, ocular inflammation, autoimmune disorders, rhematic disorder, cerebral oedema, unresponsive shock, bacterial meningitis along with antibiotics
|
Hiccups
|
|
|
47
|
Cabergoline
|
For the treatment of Parkinson’s disease, hyperprolactinemia and inhibition of lactation.
|
Skin Hyperpigmentation
|
|
|
48
|
Sodium Valproate
|
Generalised tonic-clonic seizures; partial seizures; atonic seizures; absence seizures; myoclonic seizures; acute mania; migraine
|
Psoriasis
|
|
|
49
|
Amoxycillin
|
Urinary tract infections, upper respiratory tract infections, bronchitis; pneumonia; otitis media; dental abscess; osteomyelitis; Lyme disease in children; endocarditis prophylaxis; postsplenectomy prophylaxsis; gynaecological infections; gonorrhoea; Helicobacter pylori eradication
|
Eye Irritation
|
|
Health care professionals, Patients/Consumers are advised to closely monitor the possibility of the above adverse events associated with the use of above drugs. If such events are encountered please report to the NCC-PvPI either by filling of Suspected Adverse Drug Reactions Reporting Form/ Medicines Side Effect Reporting Form for Consumer (http://www.ipc.gov.in) or by PvPI Helpline No. 1800-180-3024.
Or contact your nearby Adverse Drug Reaction Monitoring Centre (ADRMC List available on http://ipc.nic.in/showfile.asp?lid=514&EncHid=)
Reference:
http://ipc.nic.in/index2.asp?slid=541&sublinkid=449&lang=1&EncHid=