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Drug Alerts


Drug Alerts

The preliminary analysis of SUSARs 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

Sunitinib & Pazopanib

 

Cardiac Dysfunction

7

Ambroxol

 

Anaphylactic Reactions, SJS/ TEN, Scars including Erythema Multiforme

8

Rabies Vaccine

 

Erythema Multiforme/ Stevens–Johnson syndrome

9

Sodium Valproate

 

Slurred Speech

10

Meropenem

 

Ludwig Angina (Cellulitis)

11.

Ticagrelor

 

Monoparesis

12.

Roflumilast

Reduce the risk of Chronic Obstructive Pulmonary Diseases exacerbations.

Gynecomastia

13.

Clozapine

Management of Schizophrenic patients.

Neutropenia

14.

Disulfiram

Alcohol-Abuse Deterrent

Erythroderma

15.

Peginterferon alpha-2a

Chronic active Hepatitis B & C

Vasculitis

16.

Piperacillin & Tazobacam

In the treatment of lower RTI/UTI/intra-abdominal infections, skin and skin structure infections, bacterial septicaemia polymicrobic infection

Vision abnormal

17.

Mometasone Furoate, Topical

Steroid responsive dermatitis , eczema, or atopic dermatitis

Hypertrichosis/Hirsutism, Skin depigmentation

18.

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).

 

MI

19.

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

20.

 

Doxorubicin

Soft tissue and bone sarcomas, acute leukaemia, 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 leukaemia, thyroid carcinoma, neuroblastoma.

Photosensitivity Reaction

21.

Crizotinib

Locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that is Anaplastic Lymphoma Kinase (ALK) – positive.

Pneumonitis, Hepatic Encephalopathy

22.

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

23

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).

24

Artemether & Lumefantrine

For treatment of uncomplicated falciparum malaria, mixed infections of falciparum and Chloroquine resistant vivax malaria.

Stevens- Johnson syndrome/Toxic epidermal necrolysis

25

Cefixime

Otitis media, respiratory tract infections, uncomplicated UTIs, effective against infections caused by Enterobacteriaceae, H.influenza species.

Acute generalised exanthematous pustulosis (AGEP)

26

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

27

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.

 

28

 

Lacosamide

As an adjunctive treatment of partial onset seizures in patients > 17 years of age.

 

 

Red Man Syndrome

29

 

Dimethyl fumarate

 

For Relapsing remitting multiple sclerosis.

 

Osteonecrosis

30

Sodium citrate/Diphenhydramine hydrochloride/Ammonium chloride

 

For Symptomatic treatment of cough.

 

 

Myocardial Infraction

31

Cabergoline

For the treatment of hyperprolactinemia and inhibition of lactation

Steven Johnson Syndrome

32

Amlodipine

Angina, hypertension, Coronary artery disease

Alopecia

33

Nitrofurantoin

Urinary tract infections; cystitis

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

34

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)

35

Cefixime

Otitis media, respiratory tract infections, uncomplicated UTIs, effective against infections caused by Enterobaceriaceae, H.influenza species.

Anal Ulcer

36

Atenolol

Angina and myocardial infarction; arrhythmias; hypertension; migraine prophylaxis

Dermatitis Lichenoid

37

Olanzapine

Schizophrenia and other psychotic disorders, mania/mixed episode, psychomotor agitation and violent behaviour

Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

38

Meropenem

Nosocomial infections like septicaemia, febrile neutropenia, intraabdominal and pelvic infection etc., caused by cephalosporin’s resistant bacteria, meningitis cystic fibrosis

Hypokalaemia

39

Montelukast

Prophylaxis of mild to moderate asthma

Tinnitus

40

Cefepime

Cefepime has an extended spectrum of activity against Gram-positive and Gram-negative bacteria, with greater activity against both types of organism than third-generation agents.

CEFEPIME INDUCED DERMATITIS LICHENOID