Label Changes for:
Reclast (zoledronic acid) Injection
June 2008
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008
| The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. |
| Sections Modified | Summary of Changes to Contraindications and Warnings |
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CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
PATIENT COUNSELING INFORMATION
PATIENT PACKAGE INSERT
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CONTRAINDICATIONS Hypersensitivity to zoledronic acid or any components of Reclast Hypersensitivity reactions including rare cases of urticaria, angioedema, and anaphylactic reaction/shock have been reported... WARNINGS AND PRECAUTIONS Hypocalcemia and Mineral Metabolism ...Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended... All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels... Renal Impairment ...Monitor serum creatinine before each Reclast dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; consider interim monitoring of serum creatinine in at-risk patients. Musculoskeletal Pain In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. The time to onset of symptoms varied from one day to several months after starting the drug. Consider withholding future Reclast treatment if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate... Patients with Asthma ...Use Reclast with caution in aspirin-sensitive patients. |
