Clonidine Overdose risk: Medicine Safety Update from TGA

Health Authority of Australia – Therapeutic Goods and Administration (TGA), released a new safety update for the safe use of clonidine by disseminating information of potential overdose instances in children. Clonidine is an anti hypertensive medication (used for lowering blood pressure) which acts centrally as alpha-agonist agent. This medicine is also approved for use in

Increased risk of heart rhythm problems with lamotrigine: Drug safety alert from USFDA

Lamotrigine is an anticonvulsant medicine been in the market for more than 25 years with the brand name Lamictal and also available in generics. It is used in the treatment of epileptic seizures and also as maintenance treatment for delaying the occurrence of mood episodes such as depression, mania, or hypomania in patients with the

Benefit-Risk Assessment for medicinal products – Part 1 (General Introduction)

It can also be called as benefit-risk ratio, benefit-risk analysis, or benefit-risk balance. Ideally the concept is same which involves weighing the positive – therapeutic effect of a medicine (benefit) against the negative – undesirable side effects of a medicine (risks). Benefit-Risk (BR) analysis is crucial for all the medicinal products in any stage of

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

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