Murilo Freitas – Page 22

Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication – FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

Murilo Freitas - 05:00, 21 de January de 2025238

The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on treatment, after the fi

http://www.fda.gov/safety/medical-product-safety-information/copaxone-glatopa-glatiramer-acetate-drug-safety-communication-fda-adds-boxed-warning-about-rare

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FDA Roundup: January 17, 2025

Murilo Freitas - 21:03, 16 de January de 2025264

FDA Roundup: January 17, 2025
http://www.fda.gov/news-events/press-announcements/fda-roundup-january-17-2025

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Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Murilo Freitas - 20:00, 16 de January de 2025343

Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-issues-nationwide-recall-smartdrive-speed-control-dial-due-motor-being

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FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review

Murilo Freitas - 16:05, 15 de January de 2025242

FDA Authorizes Marketing of 20 ZYN Nicotine Pouch Products after Extensive Scientific Review
http://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review

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Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA

Murilo Freitas - 05:00, 15 de January de 2025193

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

http://www.fda.gov/medical-devices/medical-device-recalls/early-alert-infusion-pump-software-issue-fresenius-kabi-usa

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Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure

Murilo Freitas - 05:00, 15 de January de 2025258

Newly manufactured Giraffe Omnibed and Incubator Carestations for neonates may put off higher than expected formaldehyde levels for the first week of use.

http://www.fda.gov/medical-devices/medical-device-recalls/neonatal-incubator-correction-ge-healthcare-updates-use-instructions-ge-healthcare-giraffe-omnibed

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