Category: Drug safety alert
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Remdesivir Liver Toxicity – case study
Remdesivir, the only drug cleared to treat Covid-19, sped the recovery time of patients with the disease, but its benefit appeared much more limited in patients who needed mechanical ventilation as part of their treatment. Although the antiviral agent remdesivir has been shown to shorten recovery time in patients with COVID-19, it has also been…
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Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals are recalling products in the US markets
Indian drug firms like Lupin, Marksans Pharma, Aurobindo Pharma and Alembic Pharmaceuticals are recalling products in the US market, as per the latest enforcement report by the US Food and Drug Administration (USFDA). While Lupin and Marksans Pharma are recalling diabetes drug, Aurobindo and Alembic are recalling psychiatric medication in the US market. As per…
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Counterfeit Alprazolam 2mg and Kalma 2 tablets in Australia
In conjunction with NSW and QLD health, the Therapeutic Goods Administration (TGA) has investigated reports of counterfeit Alprazolam in community circulation. Testing of a number of products labelled ‘Alprazolam 2mg’ and ‘Kalma 2’ has found that: The Alprazolam 2mg product is an attempted counterfeit of a genuine product in the international marketplace. Whilst this is…
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Safety Signals from Vigibase
Tramadol and hyperacusis Tramadol and hyperacusis was identified as a potential signal in a screening of VigiBase, the WHO global database of individual case safety reports, focusing on patient reports. As of June 2019, there were 20 reports for the combination. Overall, they support an association between tramadol and hyperacusis with all cases reporting tramadol…
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Falsified and contaminated Defibrotide identified in Western Pacific, Europe and Eastern Mediterranean
WHO has released an alert relates to falsified DEFIBROTIDE 200MG VIALS OF 2.5ML (80MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION which is sold under the brand name Defitelio, identified in Australia, Latvia and Saudi Arabia. DEFIBROTIDE is used to treat hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by…
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Safety alert from TGA on Vitamin B6 (pyridoxine)
Therapeutic Goods Administration (TGA) has released safety advisory for Vitamin B6, also known as pyridoxine, which is commonly present in multivitamin and mineral preparations, vitamin B complexes, and in combination with magnesium. A known side effect of vitamin B6 is peripheral neuropathy, which has symptoms of tingling, burning or numbness, usually in the hands or…
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Recall of drug used to treat male pattern hair loss
As per FDA alert on Monday, MasterPharm, LLC. is voluntarily recalling 1 lot of drug used to treat male pattern hair loss, Finasteride Plus 1.25mg, capsules to the consumer level. The Finasteride Plus capsules have been found to contain undeclared minoxidil, an antihypertensive drug, at levels greater than those found in FDA approved products. The…
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FDA warning to sellers of Miracle Mineral Solution
The U.S. Food and Drug Administration has issued a warning letter to a seller that markets fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” for prevention and treatment of “Novel Coronavirus Disease 2019” (COVID-19). The FDA has previously warned consumers not to purchase or drink chlorine dioxide products sold online as medical treatments, as the agency…
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Falsified HIV rapid diagnostic test circulating in Guyana and Kenya
WHO was informed that at least 8,240 falsified rapid diagnostic tests to detect HIV-1/2 have been distributed in Guyana at end-user level. The product is Uni-Gold™ HIV and claims to be manufactured by Trinity Biotech plc. Subsequent reports revealed that the same falsified product is also circulating in Kenya. Uni-Gold™ HIV is a single-use rapid diagnostic…
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WHO update on falsified medical products, including in vitro diagnostics, that claim to prevent, detect, treat or cure COVID-19
The Coronavirus disease (COVID-19) pandemic (caused by the virus SARS-CoV-2) has increased demand for medicines, vaccines, diagnostics and reagents, all related to COVID-19, creating an opportunity for ill-intended persons to distribute falsified medical products. 1. FALSIFIED IN VITRO DIAGNOSTICS AND LABORATORY REAGENTS WHO has received multiple reports regarding falsified in vitro diagnostics (IVDs) and laboratory…