Ostrzeżenia FDA dotyczące leków

OSTRZEŻENIA FDA DOTYCZĄCE LEKÓW

FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine

Audience: Patient, Pharmacy, Health Care Professional August 27, 2025 -- FDA Removes Risk Evaluation and Mitigation Strategies (REMS) Program for the Antipsychotic Drug Clozapine Neutropenia Risk Remains, but REMS No Longer Necessary and REMS May...

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Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

Audience: Consumer, Pharmacy, Health Care Professional August 27, 2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The...

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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)

Audience: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics August 22, 2025 -- Today the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics...

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B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter

Audience: Pharmacy, Health Care Professional BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL...

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DermaRite Industries Issues Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination

Audience: Consumer August 8, 2025 -- DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia. Risk Statement: Burkholderia Cepacia Complex...

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FDA Approves Required Labeling Changes for Increased Risk of Hematologic Malignancy Following Treatment with Skysona (elivaldogene autotemcel)

Audience: Health Professional August 7, 2025 -- In November 2024, FDA issued a safety communication, “FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel),” to provide information on...

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FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks

Audience: Consumer, Pharmacy, Health Care Professional July 31, 2025 -- The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their...

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FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers

Audience: Consumer July 29, 2025 -- The U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as...

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FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies

Audience: Health Care Professional As of July 18, 2025, the Food and Drug Administration (FDA) has received three reports of fatal acute liver failure following treatment of patients with Sarepta AAVrh74 gene therapies that appear to have been...

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FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

Audience: Industry July 15, 2025 -- The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the...

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