Specialty pharmaceutical company CMP Pharma, Inc. announced that its Potassium Phosphates Injection, the first ever FDA Approved Potassium Phosphates Injection, was approved on September 19, 2019. “This will provide Health Care Providers, for the first time, an FDA approved potassium phosphates injection. The availability of this product will help alleviate supply …
Beovu injections are used to treat wet age-related macular degeneration, a condition which can eventually lead to blindness and affects around 20 million people worldwide. Novartis received approval from the FDA for Beovu in October and the go-ahead in Europe earlier this month. Recently American Society of Retinal Specialists (ASRS) …
Disproportionality methods are largely used to identify statistical associations between products and events in their respective databases of safety reports. They should be distinguished from ‘potential signals’ that can originate from individual case analysis and formal epidemiological studies. Proportional Reporting Ratio (PRR): The PRR is a simple way to get …
Children of mothers who took macrolide antibiotics during early pregnancy have shown an increased risk of major birth defects, particularly heart defects, than children of mothers who took penicillin, in a study published in The BMJ. Macrolide antibiotics (including erythromycin, clarithromycin, and azithromycin) are used to treat common bacterial infections and …
The US Food and Drug Administration (FDA) has approved a new treatment for chronic idiopathic constipation (CIC). The approval allows Braintree Laboratories to move forward with lactitol (Pizensy), an osmotic laxative indicated for the treatment of CIC in adults for a recommended dosage of 20 grams orally daily. The FDA suggests reducing …
Modafinil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy, with or without cataplexy. Based on post-marketing reports from the US Nuvigil and Provigil Pregnancy Registry and other spontaneous sources, use of modafinil during pregnancy is suspected to cause congenital malformations (including congenital heart defects, hypospadias, …
Cyproterone is an anti-androgen that, in the form of its acetate (cyproterone acetate), also has progestational properties. It is used in the treatment of hypersexuality in males, as a palliative in prostatic carcinoma, and, in combination with estrogen, for the therapy of severe acne and hirsutism in females. Following a …
A safety signal raised for Levonorgestrel-Releasing Intrauterine Device. There are 602 reports for the MedDRA preferred term ‘panic attack’ associated with LNG-IUDs in VigiBase. Sixty-two percent of the cases were considered as serious. Levonorgestrel is a hormonal contraceptive progestin drug used in gynaecology for different indications. It can be used …
Side effects revealed during post-marketing experience are not listed on Atrolak XL prolonged-release tablet patient information leaflets, announces the MHRA. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced a Class 4 medicines defect information alert. According to the regulatory body, the Patient Information Leaflet (PIL) for Atrolak XL prolonged-release …
A recent analysis of antibiotic treatments suggests that prothrombin time (PT) prolongation and coagulation disorders may be more likely to occur with cefoperazone-sulbactam compared with treatment using cefoperazone-tazobactam or ceftazidime. The results of the analysis were published in Expert Opinion on Drug Safety. This retrospective cohort study was based on data obtained from …
