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

Drug Safety Alert, Global Safety Alerts, Health Canada, Medicinal Product Updates, Safety Communications, ,

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…

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Risk of acute pulmonary oedema with Nifedipine use during pregnancy

Drug Safety Alert, Global Safety Alerts, Medicinal Product Updates, TGA-Australia, Voluntary ADR reporting, ,

Safety update: Risk of acute pulmonary oedema with Nifedipine when used for the treatment of preterm labor in pregnancy: Product label update from Therapeutic Goods & Administration (TGA) – Health authority of Australia. The ‘Fertility, pregnancy and lactation’ section of the nifedipine PI (section 4.6) has been updated to include the following information: ‘Acute pulmonary…

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Risk of microscopic colitis with sertraline: TGA Drug Safety Alert

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, TGA-Australia, Voluntary ADR reporting, ,

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…

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Risk of venous thromboembolism with Dienogest: TGA Drug Safety Alert

Drug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, TGA-Australia, Voluntary ADR reporting, ,

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…

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

Pharmacovigilance

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…

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Clonidine Overdose risk: Medicine Safety Update from TGA

Drug Safety Updates, Global Safety Alerts, Medication Errors, Medicinal Product Updates, Pharmacovigilance, TGA-Australia, Voluntary ADR reporting, ,

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…

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

Drug Safety Alert, Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of America, Voluntary ADR reporting, ,

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…

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

Pharmacovigilance

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…

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

Drug Safety Updates, Global Safety Alerts, Medicinal Product Updates, Safety Communications, US-FDA, USFDA-United States of America, , ,

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…

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

EMA-European Medicines Agency, Global Safety Alerts, Risk Minimization Measures, Safety Communications, , ,

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…

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