Drug Safety Alert from Malaysian Health Authority: Kounis syndrome associated with Rocuronium use

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released a new drug safety alert for rocuronium. Rocuronium is an amino steroid non-depolarizing neuromuscular blocker or muscle relaxant which is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation, provide skeletal muscle relaxation during surgery and facilitating mechanical ventilation in

TGA’s Safety Advisory on Vitamin B6

Therapeutic Goods Administration (TGA) has released a safety advisory on usage of Vitamin B6 (pyridoxine) containing medicinal products for an expected safety concern-Peripheral neuropathy. Vitamin B6 is an essential nutrient widely distributed in various foods in different forms. It is commonly present in multivitamin and mineral preparations, vitamin B complexes, and in combination with magnesium for

Update on COVID-19 Treatment: A triple combination antiviral therapy shows favourable results in a Phase-2 randomised clinical trial.

In an open label, randomised, phase 2 clinical trial, triple combination of interferon beta-1b (an injectable interferon), lopinavir–ritonavir (oral protease inhibitor) and ribavirin (oral nucleoside analogue) were shown safe and superior to monotherapy with lopinavir‑ritonavir. This triple combination shown efficacy in shortening virus shedding, alleviating symptoms, and facilitating discharge of COVID-19 patients with mild to

Drug Safety Updates from Health Canada-June 2020

Drug Safety Alerts from Health Canada

Health Canada has released two new drug safety alerts to raise awareness to health care professionals and public about the two safety concerns which recently made safety labelling changes for the respective product monographs. –Health Product Info Watch – April 2020. Below are the two safety concerns discussed in brief. Interstitial lung disease risk associated

Highlights of Remdesivir (A potential treatment for COVID-19?)

Remdesivir (GS-5734) is being developed by Gilead Sciences, an American biopharmaceutical company based in California with a primary therapeutic focus in antiviral medicines. Remdesivir is an antiviral drug (broad spectrum) under clinical trial investigation for the treatment of COVID-19 (coronavirus disease). Remdesivir gained public attention due to publication of some of its clinical study results

EMA

Drug Safety Alerts from European medicines agency (EMA)-April 2020

EMA has released some drug safety updates in its recent Issue 133 April 2020. The safety topics discussed below based on their therapeutic areas. Meningioma risk associated with cyproterone use: Cyproterone is an antiandrogen (blocks the action of androgens, a type of sex hormone found in both men and women) and progestin medication (blocking the

USFDA’s Drug Safety Communication: Caution on COVID-19 medication

Food and Drug Administration (FDA) in the United States announced a serious safety concern on the use of hydroxychloroquine or chloroquine for the treatment of 2019 Coronavirus Disease (COVID-19) due to abnormal heart rhythms like QT prolongation and ventricular tachycardia. Currently, there are no medicines proven effective for the treatment of COVID-19. On 28‑Mar‑2020, FDA released

EMA (PRAC) Recommends new testing procedure before treatment with fluorouracil, capecitabine, tegafur and flucytosine

European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) recommended a test for identification of the “lack or inadequate presence of an enzyme, dihydropyrimidine dehydrogenase (DPD)” in the body before receiving treatment with fluorouracil (by injection or infusion) and the its prodrugs which included capecitabine and tegafur (these drugs are converted to fluorouracil in the body)

Ingenol mebutate is having negative benefit to risk ratio: PRAC concludes

In a new release from European Medicines Agency (EMA), Pharmacovigilance Risk Assessment Committee (PRAC) stated that ingenol mebutate may increase the risk of skin cancer and concluded that risks for ingenol mebutate medicine are greater than its benefits. On 09-May-2019, PRAC initiated the procedure of review for assessing the benefit risk profile for ingenol mebutate

Drug Safety Alerts from Malaysian Health Authority

The Malaysian Health Authority-National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia released the following new drug safety alerts. Drug Safety Alert 1: Risk of anaphylaxis associated with Guselkumab use Drug Safety Alert 2: Kounis syndrome associated with Intravenous iron-containing products Drug Safety Alert 3: Reports of cytomegalovirus (CMV) infection or reactivation with Nivolumab use

error: Content is protected !!