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FDA Medication Labeling Changes

Melanie H. Muhlstock
  • Avvo
  • FDA Medication Labeling Changes

    Numerous drugs have been approved for use, but that does not necessarily mean that the medical community is aware of all medication side effects. In fact, changes are frequently made to a drug's warning label to reflect the most recent knowledge. For instance, the U.S. Food and Drug Administration (FDA) may mandate revision to a drug's label to include a "Boxed Warning," the most serious type of warning, which warns about risks of serious or life-threatening side effects. Labeling changes may be prompted by various sources of information, including large clinical trials or new studies that reveal links to a side effect.

    Personal injury lawsuits filed over drug injuries often allege that manufacturers failed to warn about the risk of a side effect. In these cases, it is usually alleged that manufacturers knew or should have known that their drug increases the risk of a side effect or injury. Patients and healthcare professionals should be informed of all known risks when choosing a treatment option.

    Parker Waichman LLP is pursuing lawsuits, on behalf of individuals who have suffered injury due to treatment with defective medications, as well as medications that are not appropriately labeled.

    FDA Medication Labeling Changes

    Labeling Changes

    The FDA releases labeling updates on a monthly basis. Healthcare professionals should be aware of these changes so that they may ensure the most optimum treatment for their patients.

    March 2016 FDA Labeling Updates

    In March 2016, the FDA announced the following labeling changes:

    • Adcetris (brentuximab vedotin) for Injection
    • Angiomax (bivalirudin) Lyophilized Powder for Injection
    • Droxia (hydroxyurea) and Hydrea (hydroxyurea) Capsules
    • Faslodex (fulvestrant) Solution for Injection
    • Furosemide Tablets, Injection and Lasix (furosemide) Tablets
    • Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) Fixed-dose Combination Tablet
    • Herceptin (trastuzumab) Intravenous Infusion
    • Implanon (etonogestrel) Implant
    • Invega (paliperidone) Extended-Release Tablets
    • Invega Sustenna (paliperidone palmitate) Extended-release Injectable Suspension
    • Invega Trinza (paliperidone palmitate) Extended-release Injectable Suspension
    • Invokamet (canagliflozin and metformin hydrochloride) Tablets
    • Invokana (canagliflozin) Tablets
    • Jakafi (ruxolitinib phosphate) Tablet
    • Juxtapid (lomitapide) Capsules
    • Klonopin (clonazepam) Tablets
    • Nexplanon (etonogestrel) Implants
    • Oxytrol for Women (oxybutynin) Transdermal System
    • PLASMA-LYTE 56 and 5% Dextrose Injection
    • Prezcobix (darunavir and cobicistat) Tablet
    • Renagel (sevelamer hydrochloride) Tablets
    • Renvela (sevelamer carbonate) Powder for Oral Suspension
    • Risperdal (risperidone) Tablets, Oral Solution and Risperdal M-TAB (risperidone) Orally Disintegrating Tablets
    • Risperdal Consta (risperidone) Long Acting Injection
    • Sustiva (efavirenz) Capsules and Tablets
    • Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
    • Tudorza Pressair (aclidinium bromide inhalation powder)
    • Xgeva (denosumab, AMG 162; Human Monoclonal Antibody to RANK Ligand)
    • Zarxio (filgrastim-sndz)

    Parker | Waichman Logo Legal Help for Victims of Drug Injuries
    If you or someone you know suffered from a drug side effect, you may have valuable legal rights. For more information, fill out our online form or speak with an experienced personal injury attorney today by calling 1-800-YOURLAWYER (1-800-968-7529).


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