Umbralisib and potential increased risk of death [under USFDA investigation]: Need for consistent evaluation of benefits & risks

USFDA released a drug safety communication for the updated significant safety information of the cancer medicine – umbralisib to disseminate awareness for optimal, safe & effective usage of this product in patients suffering from cancer of the lymph nodes and respective healthcare professionals involved in treating this patients. Ukoniq (umbralisib) is a cancer medicine used

Additional Risk Minimization measures [updated recommendations] for Safe & Effective usage of Venetoclax (Venclyxto▼)

Venetoclax is anti-cancer medication used in the treatment of chronic lymphocytic leukemia. This medicine is under additional monitoring with special focus on its safety profile consistency from post-marketing exposure. Tumor lysis syndrome (TLS) is phenomena of release of cellular contents from tumor cells into the blood stream such as uric acid, potassium leading to the

DHPC from Novartis: Updated recommendations to minimize the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion

Drug Safety Communication pertaining to the safe & effective use of Beovu® (brolucizumab) released from Novartis via a direct healthcare professional communication (DHPC) letter for the implementation of updated recommendations based on the recent safety evidence from MERLIN Study (Interventional clinical trial being conducted for the comparison of Safety and Efficacy of Brolucizumab to Aflibercept

Risk of Respiratory depression with Pregabalin: Drug Safety Alert from Europe Medicines Agency

Safety Alert: Serious risk of respiratory depression associated with the use of pregabalin even without concomitant use of opioid medications or other CNS depressants. Health Authority: Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) Pregabalin-containing medicinal products are marketed under various brand names for the treatment of following conditions: Generalized anxiety disorder

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

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

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

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