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.,

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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

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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

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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

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Risk of Leaking heart valves with Fluoroquinolone class of antibiotics: Drug Safety Alert Health Canada

Safety update: Potential Risk of leaking heart valves (heart valve regurgitation) associated with the use of antibiotics belonging to the Fluoroquinolone class which included ciprofloxacin-, levofloxacin-, moxifloxacin- and norfloxacin-containing medicinal products which are administered by injection or by mouth (systemic) and by breathing in (inhaled). Fluoroquinolones broader spectrum antibiotics which are used in the treatment

Risk of microscopic colitis with sertraline: TGA Drug Safety Alert

Safety update: Potential risk of microscopic colitis associated with the use of sertraline. Sertraline is antidepressant medication marketed under the brand name Zoloft and multiple generic brands. It acts as a selective serotonin re-uptake inhibitor (SSRI) with the below therapeutic indications: Treatment of obsessive compulsive disorder (OCD) in children and adolescents (aged 6 years and

Risk of venous thromboembolism with Dienogest: TGA Drug Safety Alert

Safety update: Risk of venous thromboembolism with Dienogest: Product label update Dienogest is an oral a progestogen used for contraception in the two below combinations- Valette (dienogest/ethinylestradiol) is indicated for oral contraception and treatment of mild-moderate acne in women wanting contraception Qlaira (dienogest/estradiol valerate) is indicated for oral contraception and treatment of heavy or prolonged

Risk of serious liver injury with the use of Ocaliva (obeticholic acid) in patients with advanced cirrhosis: USFDA Boxed warning

USFDA issued a drug safety communication for the restricted use (new contraindication) of Ocaliva (obeticholic acid) in patients with advanced cirrhosis due to the risk of serious liver failure (sometimes requiring liver transplant). Ocaliva is a prescription medicine which is used in the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid. It

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

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