FDA Mandate 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) […]
FDA Mandate 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.
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.
In March 2016, the FDA announced the following labeling changes:
The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).