EMA had released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Summary points: The latest safety data for this vaccine are …
Elmiron (pentosan polysulfate sodium / “PPS”) was approved by the FDA in 1996 for the treatment of interstitial cystitis (“IC”), also known as “bladder pain syndrome” or “painful bladder syndrome” and it is the only drug approved to treat pain associated with IC. In recent years, there have been reports …
Trivalent chromium is an essential trace element that is considered safe when ingested in normal quantities. Trivalent chromium compounds are used by patients to enhance weight loss, increase lean body mass, and/or improve glycemic control. Information regarding the toxicity of chromium picolinate is limited. As per few articles, chromium supplements …
The phase 1 results for Covaxin are now in the Lancet. Covaxin is the inactivated vaccine by Bharat Biotech, India. Covaxin – BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). The study was conducted at 11 …
As vaccines to combat COVID-19 are now being administered around the world, healthcare practitioners should be aware that error reporting for therapeutic products under an Emergency Use Authorization (EUA) is mandatory. For errors related to COVID-19 vaccines that are available under EUA, reports must be sent to the country specific …
Dimethyl fumarate (Tecfidera) is authorised to treat adults with relapsing-remitting multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. A recent European review of safety data identified 11 cases of PML with lymphopenia associated with Tecfidera treatment, including 3 cases in patients with mild lymphopenia …
The Spontaneous/voluntary adverse drug reaction reporting structure is the voluntary and the most common way through which the regulatory bodies collect ADR information for medicines once they are on the market. Who should report? Healthcare Professionals are the preferred source of information in pharmacovigilance, for example physicians, family practitioners, medical specialists, and dentists. …
Covishield vaccine has been given restricted use license for emergency situation. It does not have a marketing authorization, however, this approval for the restricted use in emergency situation grants permission for the vaccine to be used for active immunization of individuals aged 18 years and older for the prevention ofcoronavirus …
Metamizole (also known as dipyrone) is a potent analgesic, antipyretic and nonsteroidal anti‐inflammatory drug (NSAID) used in the treatment of pain, fever, and spasms. This medicine was introduced into the market nearly 100 years ago. Due to serious adverse drug reactions like agranulocytosis, this medicine was withdrawn in many countries. …
As of 31 December 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) have published new guidance on the qualified person responsible for pharmacovigilance (QPPV) and the pharmacovigilance system master files (PSMF) for existing marketing authorisation holders (MAH) in the United Kingdom (UK) in light of Brexit. QPPV: Regardless of …
