Global Drug Safety Updates from National Health Authorities

Global Drug Safety Updates from National Health Authorities

Recent Drug Safety Updates which included Signals, Product label updates, DHPC letters, etc.,

Read More

Building Blocks [ICSR] in Drug Safety

Building Blocks [ICSR] in Drug Safety

Know the Basic fundamentals in Individual Case Safety Report (ICSR) - Case Processing in a Drug Safety Database

Read More

PBRER Writing

PBRER Writing

Theoretical Guidance for writing a Periodic Benefit-Risk Evaluation Report (PBRER) - Know the fundamentals of presenting safety information in each section/subsections in PBRER

Read More

DSUR writing

DSUR writing

Theoretical Guidance for writing a Development Update Safety Report [DSUR] - Know the fundamentals of presenting safety information in each section/subsections in DSUR

Read More

Propylhexedrine: Potential risk of drug misuse, abuse and serious health consequences

United States Food & Drug administration (USFDA) released a drug safety communication to bring more awareness on potential drug misuse and abuse of propylhexedrine associated with serious complications like abnormal heart rhythm, high blood pressure, and paranoia. It is marketed under the brand name Benzedrex. Propylhexedrine is a nasal decongestant available in the retail pharmacy

DHPC – Zolgensma (onasemnogene abeparvovec): risk for thrombotic microangiopathy

European Medicine Agency (EMA) released a direct healthcare professional communication (DHPC) pertaining to the risk of thrombotic microangiopathy (TMA) associated with Zolgensma gene therapy to bring increased awareness of TMA for patients receiving onasemnogene abeparvovec. Zolgensma (onasemnogene abeparvovec) is a gene therapy medication used in the treatment of spinal muscular atrophy indicated for children of

Boxed Warnings for Pregabalin and Gabapentin

Pregabalin is an anticonvulsant and anxiolytic medication used in the treatment of epileptic seizures, neuropathic pain, restless leg syndrome, fibromyalgia, and generalized anxiety disorder. Gabapentin is an anticonvulsant medication used in the treatment of partial seizures and neuropathic pain. Both Pregabalin and gabapentin which are referred as “gabapentinoids” acts on voltage dependent calcium channels in

Severe cutaneous adverse reactions (SCARs) associated with atezolizumab use: DHPC for an identified risk

A direct healthcare professional communication (DHPC) released by Swissmedic, Switzerland health authority pertaining to a safety concern – severe cutaneous adverse reaction (SCAR) associated with Tecentriq® (atezolizumab) use. Atezolizumab is an anticancer medicine available with the brand name – Tecentriq®. It is a monoclonal antibody used in the treatment of urothelial carcinoma, non-small cell lung

Metamizole induced liver injury: Direct health care professional communication (DHPC)

European Medicines Agency (EMA) released a direct health care professional letter (DHPC) pertaining to the risk of drug-induced liver injury (DILI) by metamizole. We encourage all health care professionals to be aware of this new safety alert and to disseminate this significant information to the relevant stakeholders for a better patient safety. Metamizole (also known

Ototoxicity associated with aminoglycoside class of medicines – MHRA drug safety update

Aminoglycosides are potent, broad-spectrum class antibiotics which act by inhibition of bacterial protein synthesis. These are traditional antibacterial medications for gram-negative bacterial infections. Antibacterial medicines coming under this class of ‘aminoglycosides’ are gentamicin, amikacin, tobramycin, and neomycin. Medicines and Healthcare products Regulatory Agency (MHRA) – United Kingdom regulatory health authority released a drug safety update

An increased risk of postpartum haemorrhage associated with SSRI/SNRI antidepressant medicines

Selective serotonin reuptake inhibitors (SSRI) and serotonin and norepinephrine reuptake inhibitors (SNRI) are antidepressant class of medications used in the treatment of depression. They act by increasing the levels of serotonin and norepinephrine in the brain for therapeutic effect. United Kingdom health authority – Medicines and Healthcare products Regulatory Agency (MHRA) released a drug safety

An unfavourable benefit-risk profile for Ulipristal acetate 5 mg: A drug withdrawal story

Ulipristal acetate is a selective progesterone receptor modulator which acts by preventing the effects of the female progesterone hormone. This medicine is available in two brand names in market for the below two different therapeutic uses. Esmya® tablets comprising 5 mg ulipristal acetate and therapeutically indicated for Uterine fibroids. It is used for the treatment

Restricted use of oral antihistamines for sedation in children: MedSafe Update

Antihistamines are class of medications which are commonly used in getting relief from allergic symptoms. The most common therapeutic/adverse effect produced by antihistaminergic drugs is drowsiness (sleepiness). These sedating antihistaminic drugs are available as over the counter (OTC) medicine category and can be used for a range of conditions in both adults and children. MedSafe,

TRISENOX (arsenic trioxide) and potential medication errors: DHPC from Teva Pharmaceuticals

Arsenic trioxide is a chemotherapeutic medication used in the treatment of newly diagnosed low-to-intermediate risk acute promyelocytic leukaemia (APL) and relapsed/refractory APL characterized by the presence of leukaemia/retinoic-acid-receptor-alpha (PML/RAR-alpha) gene. The initial approved formulation available in market for arsenic trioxide is 1 mg/ml single-use 10 ml of glass ampoule (This formulation comprises 10 mg of

error: Content is protected !!