The Therapeutic Goods Administration (TGA), in conjunction with state health authorities, is investigating a report of the presence of dangerous levels of lead and other heavy metals in the Ayurvedic medicine Manasamitram Pills. If high levels of lead are present in these products, taking them could result in lead poisoning. …
From their meeting in September, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. September’s meeting saw seven medicines recommended for approval including three new medicines, one orphan medicine, one biosimilar, one generic and one hybrid medicine. A conditional marketing authorisation was …
Regulatory agencies have made it clear that quality is integral to drug safety, and pharmacovigilance (PV) quality management systems constitute the foundation of PV operations. The International Conference on Harmonisation (ICH), European Medicines Agency (EMA) and US Food and Drug Administration (US FDA) have laid out their expectations with respect …
Benzodiazepines are class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder. The current prescribing information for benzodiazepines does not provide adequate warnings about these serious risks and harms associated with these medicines so they may be prescribed and used inappropriately. This increases these …
The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the classification of suspected adverse reactions as well as aggregated data analysis and case assessment in the frame of the day-to-day pharmacovigilance activities of stakeholders in …
Health agencies, in particular the US Food and Drug Administration (FDA) and European Medicine Agency (EMA) have detailed requirements on how to set up a quality system in pharmacovigilance to ensure the Quality. What a Quality System is, its purpose, and what it typically includes? The pharmacovigilance quality management system …
The US FDA has released a safety alert regarding the use of atezolizumab alongside paclitaxel in light of data indicating a potential survival detriment from the IMpassion131 study of the combination in treatment-naïve triple-negative breast cancer (TNBC). The PD-L1 inhibitor given in combination with nab-paclitaxel is currently approved for metastatic TNBC patients …
Elmiron (pentosan polysulfate sodium / “PPS”) was approved by the FDA in 1996, is prescribed for treatment of interstitial cystitis, also known as “bladder pain syndrome” or “painful bladder syndrome”. However, in the past few years, there are case reports of Elmiron causing eye problems such as retinal pigmentary changes …
Baricitinib is a Janus kinase (JAK) inhibitor used for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. A European review has assessed cases of diverticulitis associated with baricitinib reported in clinical …
Increased risk of vertebral fractures was observed after stopping or delaying ongoing treatment with Denosumab. Denosumab 60mg (Prolia) is indicated for the treatment of osteoporosis and bone loss. The Commission on Human Medicines’ Pharmacovigilance Expert Advisory Group has considered EU and worldwide safety data, together with data submitted by the …
