Pholcodine is an opioid medicine widely present in many over-the-counter cough syrups, for its antitussive activity. Pholcodine is in market since 1950s and the products containing pholcodine are approved for the following conditions: Treatment of dry cough (non-productive) in adults and children older than 6 years of age. Treatment of symptoms of cold and influenza…
Pentosan polysulfate sodium is a semi-synthetically produced heparin which has anticoagulant and fibrinolytic effect. It is used in the treatment of bladder pain and discomfort caused by cystitis (bladder inflammation or irritation). Product information (PI) of Pentosan polysulfate sodium (‘Section 4.4 Special Warnings and Precautions for Use’ and ‘Section 4.8 Adverse Effects’) are updated with…
Propylthiouracil and Carbimazole are the medications used in the treatment of hyperthyroidism. The product information (PI) documents which were previously having status of category “C” for use in pregnant women is being updated to category “D” Category C status: Based on the mechanism of action & pharmacological activity, suspicion of causing harmful effects to the…
Safety update: Product Information (PI) for minocycline is in the process of being updated to include information about agranulocytosis, a rare but potentially life-threatening adverse event. Minocycline is a tetracycline antibiotic that may be used to treat acne that is resistant to other antibiotics, as well as various other susceptible infections. Agranulocytosis is a serious…
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…
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…
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…
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…
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…
An unacceptable benefit-risk ratio identified for a topical medicine- ‘Bufexamac’ which had been in the Over the Counter (OTC) medicine market since decades. In Brief Risks (serous skin ADRs-allergic contact dermatitis leading to hospitalization) Outweighs anticipated benefits (No proven efficacy data, reports of lack of efficacy & Insufficient studies on efficacy) Bufexamac is a cyclo-oxygenase…