On July 31, 2020 the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) issued this Drug Safety Update, “Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection“, which began as follows: Before initiating systemic vascular endothelial growth factor (VEGF) pathway inhibitors, carefully consider the risk of aneurysm …
• A Clinical Evaluation Report (CER) for Medical Device is a document that contains the conclusions of the clinical evaluation performed on the medical device based on all relevant clinical data available.• before obtaining CE marking in the European Union, the medical device manufacturers must prove that their devices meet …
New rules are coming into effect for over-the-counter laxatives for adolescents, as well as the size of packs of stimulant laxatives that can be sold to adults. Over-the-counter laxatives for adolescents aged 12 to 17 years can now only be supplied under the supervision of a pharmacist, following the results …
Nitrosamine impurities have now been found in two tuberculosis drugs, prompting the US Food and Drug administration (FDA) to clarify how it will handle elevated levels of the potential carcinogen in life-saving antibiotics. FDA recently became aware of nitrosamine impurities in certain samples of rifampin and rifapentine. These are antibacterial …
Hydrochlorothiazide (HCTZ) is associated with an increased risk of nonmelanoma skin cancer, and patients who take the drug should limit sun exposure and undergo regular skin cancer screening, according to updates to the medication’s label. The skin cancer risk is small, however, and patients should continue taking HCTZ, a commonly used …
The planned discontinuation of first-line bipolar disorder treatment Priadel has caused concern that some patients could relapse and face hospitalisation. The manufacturer of first-line bipolar disorder treatment Priadel is discontinuing production of the medicine, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced — causing concerns that patients could relapse and face hospital admission. A supply disruption alert (SDA) issued by …
Russia will begin a phase 3 trial of its Sputnik V COVID-19 vaccine on 40,000 volunteers this week, Russia’s state news agency Tass announced Friday. The controversial vaccine developed at Moscow’s Gamaleya Institute was approved for use in Russia on Aug. 11 although it had yet to enter a late-stage …
The new coronavirus SARS-CoV-2 is spreading rapidly worldwide. To date, there are no proven effective therapies for this virus. Knowledge about SARS-CoV-2 virology is rapidly increasingand a large number of potential drug targets are being investigated. Currently, infection management is mainly supportive and common drugs prescribed for infection control include …
Cosmetics are regulated in the European Union by Regulation (EC) No 1223/2009. The main objectives of this regulation are to create a set of rules that all cosmetics comply with and to ensure a high level of protection for human health. One of the requirements of the regulation is that …
All NHS hospitals in England have been told to destroy a powerful medicine after health care staff in England mistakenly used it because its packaging looks the same as another drug. A national safety alert was issued following several incidents, including the deaths of two babies at hospitals in England, in which patients …
