Reglan Side Effects May Result In Tardive Dyskinesia Lawsuits
Reglan Side Effects Cause Tardive Dyskinesia. Are you among the Reglan users who have experienced involuntary and repetitive movements of the body? Chronic use of Reglan has been associated with a movement disorder called tardive dyskinesia, which can continue to affect Reglan users even after the drug is discontinued. In early 2009, … [Read more...] about Reglan Side Effects May Result In Tardive Dyskinesia Lawsuits
Lidocaine Mandates New Boxed Warning Treat Teething Pain
FDA Boxed Warning Over Lidocaine. Prescription 2 percent Lidocaine Viscous, has long been used to numb infants’ and children’s gums during teething, and has recently been the focus of a stringent U.S. Food and Drug Administration (FDA) warning. The agency has also issued communications concerning over-the-counter (OTC) brands of … [Read more...] about Lidocaine Mandates New Boxed Warning Treat Teething Pain
FDA Medication Labeling Changes
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 … [Read more...] about FDA Medication Labeling Changes
Lawmakers Call on FDA to Add Boxed Warning for Immediate-Release Opioids
Immediate-release (IR) opioids should carry a boxed warning on their labels, a group of nearly two dozen legislators said in a letter to the U.S. Food and Drug Administration (FDA). According to Regulatory Affairs Professionals Society (RAPS), the lawmakers want the label to reflect "the serious risks of abuse" associated with the … [Read more...] about Lawmakers Call on FDA to Add Boxed Warning for Immediate-Release Opioids
Boxed Warning for Dexferrum Modified due to Anaphylactic-Type Reactions
Dexferrum May Cause Anaphylactic-Type Reactions. The Boxed Warning for Dexferrum (iron dextran injection, UPS) has been updated to emphasize the warning about anaphylactic-type reactions that have occurred following parenteral administration. According to the Food & Drug Administration (FDA), some of these reactions … [Read more...] about Boxed Warning for Dexferrum Modified due to Anaphylactic-Type Reactions
FDA Orders Xolair Warnings
FDA Ordered Genentech Inc. To Add Warnings For Xolair. The U.S. Food and Drug Administration ordered Genentech Inc. to add a boxed warning to its asthmatic drug marketed as Xolair. The FDA said the boxed warning should emphasize Xolair (omalizumab) might cause anaphylaxis, including trouble breathing, chest tightness, dizziness, … [Read more...] about FDA Orders Xolair Warnings
