Archive for the ‘FDA Medication Watch (MedWatch)’ Category


FDA Mediation Watch: Valproate Anti-Seizure Products: Drug Safety Communication – Contraindicated for Pregnant Women for Prevention of Migraine Headaches

Based on a recent study, there is evidence that these medications can cause decreased IQ scores in children whose mothers took them while pregnant. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Cardinal Health: Class 1 Recall – Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit

Plastic packaging may become lodged in the filter potentially causing an obstruction in airflow, which may result in low blood oxygen (hypoxia), suffocation and death. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Medtronic: Class 1 Recall – Medtronic Deep Brain Stimulation Lead Kit and Activa Dystonia HDE Kit

Use of lead cap may cause lead damage. Lead replacement may be required or optimal therapy may not be provided. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Maquet SERVO-i Ventilator Battery Module: Class 1 Recall – Battery Run Time Shorter Than Expected

May result in unexpected ventilator shut downs, which can result in serious adverse health consequences, including death. MedWatch Safety Alert RSS Feed

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FDA Mediation Watch: Lightning Rod Capsules: Recall – Undeclared Drug Ingredient

Testing revealed the product contains an analogue of sildenafil, which may interact with nitrates found in prescription drugs such as nitroglycerin, and lower blood pressure to dangerous levels. MedWatch Safety Alert RSS Feed

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