Month: March 2020
-
Safety alert: Levothyroxine – Potential adverse reactions when switching brands
The Health Products Regulatory Authority (HPRA) Ireland, has announced that SmPC and PL for levothyroxine preparations (Eltroxin®, Levothyroxine Teva®, Oroxine® and other generic products) will be updated to include advice for patients switching brands or formulation due to the increased risk of adverse drug reactions following a potential imbalance of thyroid hormones. This follows recommendations…
-
Safety alert: Olmesartan medoxomil – Risk of interstitial pneumonia
The Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) Japan, have announced that the package inserts for olmesartan medoxomil containing products (Olmetec® and Rezaltas®) should be revised to include interstitial pneumonia as an adverse drug reaction. Olmesartan is indicated to treat hypertension. A total of seven cases of…
-
Ibuprofen – Risk of renal toxicity
New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has informed health-care professionals of the risk of impaired renal function associated with the use of ibuprofen. Ibuprofen is widely used for the temporary relief of pain or inflammation and is available over the counter and with a prescription. The Centre for Adverse Reactions Monitoring (CARM) has received…
-
Signal Alert: Oral contraceptive and night sweats, vulvovaginal dryness and dry eye
Desogestrel is a oral contraceptive, marketed in some countries as a single ingredient, whereas it is only used in fixed-dose combination products together with ethinylestradiol in other parts of the world. Desogestrel achieves its contraceptive effect primarily by the inhibition of ovulation. Other effects include increased viscosity of the cervical mucus and decreased oestradiol levels,…
-
Counterfeit antimalarials in West and Central Africa
WHO releases medical product alert on Monday regarding falsified Quinine Sulphate 300mg presented in below six different combinations of batch numbers, expiry and manufacturing dates. The fraudulent use of the outdated WHO Essential Drugs Programme logo may create a false sense of product quality. “Recently received results of analysed samples show they do not contain any of…
-
Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review
Novartis announced that the US Food and Drug Administration (FDA) accepted and granted Priority Review to capmatinib’s (INC280) New Drug Application (NDA). Capmatinib is a MET inhibitor being evaluated as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC). If…
-
Changes in Safety Testing for new Type 2 Diabetes Drugs – FDA
In a draft guidance issued on 09 March, the US Food and Drug administration (FDA) proposed a new, broader approach to conducting safety evaluations for new drugs to treat type 2 diabetes that looks beyond assessing cardiovascular (CV) risk. Background After a meta-analysis published in the New England Journal of Medicine in 2007 raised concerns that the widely-used diabetes drug Avandia…
-
Fiasp – ultrafast acting insulin aspart injection – New approved paediatric indication
Fiasp (manufactured by Novo Nordisk) is a new ultrafast-acting insulin drug that allows for safe and effective control of blood glucose rising rapidly after meals. Diabetes patients often have difficulty controlling post-meal blood glucose, barring them from reaching HbA1c target goals. The additions of vitamin B3 (niacinamide) and L-arginine amino acid to existing fast-acting insulin…
-
Safety Alert: Serious Breathing Problems with Gabapentin and Pregabalin
Gabapentinoids are FDA-approved to treat a variety of conditions including partial seizures and nerve pain from spinal cord injury, shingles, and diabetes. Other approved uses include fibromyalgia and restless legs syndrome. Gabapentin was first approved in 1993 and pregabalin was first approved in 2004. They inhibit the alpha 2-delta subunit of voltage- gated calcium channel.…
-
43. Reporting Odds Ratio (ROR)
The Reporting Odds Ratio (ROR) the odds of a certain event occurring with your medicinal product, compared to the odds of the same event occurring with all other medicinal products in the database. A signal is considered when the lower limit of the 95% confidence interval (CI) of the ROR is greater than one. The…