Category: Drug safety alert
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Safety advisory – alternative product filling shortage may cause airway irritation if administered via inhalation
Therapeutic Goods Administration (TGA, Australian department of health) advising consumers and health professionals that Gentamicin 40 mg/ml Injection (Hospira UK Limited) may cause constriction or irritation to the airways if used as an inhalation to treat certain infections in the lungs, due to the presence of the preservatives, sodium metabisulfite, methyl hydroxybenzoate and propyl hydroxybenzoate.…
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Paediatric labeling updates for doxycycline, clindamycin and caffeine citrate
Drug labels for doxycycline, clindamycin and caffeine citrate now include better information for healthcare providers on recommended usage and dosage in pediatric populations. The data that informed these label changes came from research funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. Doxycycline is…
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Recall alert: Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules (Dr. Reddy’s Laboratories)
Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced on Thursday, that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking…
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Self medication can lead to Drug poisonings from chloroquine (potential Corona Virus treatment)
AVOID SELF MEDICATION Currently social media groups spreading information regarding the dosage for Corona Virus treatment in the US (Hydroxy Chloroquine + Azithromycin) and stating to have this treatment at home. The World Health Organization recommended that people suffering from COVID-19-like symptoms should avoid self-medicating. As Hydroxychloroquine is prescription only medication (POM) and dose for…
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Safety alert: Baricitinib: risk of venous thromboembolism
MHRA issued alert to discontinue baricitinib treatment permanently if clinical features of deep vein thrombosis or pulmonary embolism occur. Prescribers are reminded to use caution if using baricitinib in patients with risk factors for deep vein thrombosis or pulmonary embolism in addition to rheumatoid arthritis. Baricitinib (Olumiant) is indicated for the treatment of moderate to…
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Suspension of ulipristal acetate for uterine fibroids
European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended, as a precautionary measure, that women should stop taking 5mg ulipristal acetate (Esmya and generic medicines) for uterine fibroids while a safety review started this month is ongoing. No new patients should start treatment with these medicines, says the EMA. The start of the review…
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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…
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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…
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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,…
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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…