Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
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During packaging and labeling, tablets from one product type may have carried over into packaging of another product.
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Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.
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Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.
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Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).
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Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.
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The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.
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Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.
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Possibility of an adverse reaction or unknown drug-drug interaction.
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New Boxed Warning and Contraindication highlighting these risks added to product labeling.
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