Drug Safety Communication: Zoledronic Acid [Reclast] Associated with New Contraindication and Updated Warning on Kidney Impairment

September 2, 2011

September 01, 2011 – Risk factors for developing renal failure include underlying moderate to severe renal impairment, use of kidney-damaging (nephrotoxic) or diuretic medications at the same time as Zoledronic Acid [Reclast], or severe dehydration occurring before or after Zoledronic Acid [Reclast] is given. The risk of developing renal failure in patients with underlying renal impairment also increases with age.

The American Food and Drug Administration (FDA) has now notified healthcare professionals and patients of an update to the drug label for Zoledronic Acid [Reclast] regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis or having a fatal outcome following Zoledronic Acid [Reclast] use have been reported to FDA. The revised label states that Zoledronic Acid [Reclast] is contraindicated in patients with creatinine clearance less than 35 mL/min or in patients with evidence of acute renal impairment. The label also recommends that healthcare professionals screen patients prior to administering Zoledronic Acid [Reclast] in order to identify at-risk patients.

The Zoledronic Acid [Reclast] Medication Guide for patients is being updated to contain information about the risk of severe kidney problems. In addition, the manufacturer of Zoledronic Acid [Reclast] will issue a Dear Healthcare Provider letter to inform healthcare professionals about this risk.

These labeling changes are being made to the Zoledronic Acid [Reclast] label only, although Zoledronic Acid, also sold as  [Zometa], is approved for treatment of cancer-related indications. Renal toxicity is already addressed in the Warnings and Precautions section of the [Zometa] label. Dose reductions for [Zometa] are provided for patients with renal impairment.

Recommendation:

Zoledronic Acid [Reclast] is contraindicated in patients with creatinine clearance less than 35 mL/min, or in patients with evidence of acute renal impairment. Healthcare professionals should screen patients prior to administering Zoledronic Acid [Reclast] in order to identify at-risk patients. Healthcare professionals should also monitor renal function in patients who are receiving Zoledronic Acid [Reclast].

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at www.fda.gov/MedWatch/report.htm. Alternatively, download the form or call +1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to +1-800-FDA-0178.

Read here the MedWatch safety alert, including links to the Drug Safety Communication, including a Data Summary, and prescribing information.


Drug Safety Communication: Asenapine Maleate [Saphris] Associated with Serious Allergic Reactions

September 2, 2011

September 01, 2011 – Asenapine Maleate [Saphris] is used to treat symptoms of schizophrenia and bipolar disorder. The American Food and Drug Administration (FDA) has notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Asenapine Maleate [Saphris]. The Contraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Information sections have been revised to include information about type I hypersensitivity reactions which may include anaphylaxis, angioedema, low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash. In several cases, these reactions occurred after the first dose.

Healthcare professionals should be aware of the risk of hypersensitivity reactions with Asenapine Maleate [Saphris] and counsel patients who are receiving the drug about how to recognize the signs and symptoms of a serious allergic reaction. Asenapine Maleate [Saphris] should not be used in patients with a known hypersensitivity to the drug.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program as follows: Complete and submit the report online at www.fda.gov/MedWatch/report.htm. Alternatively, download form or call +1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to +1-800-FDA-0178. Read here the MedWatch safety alert, including links to the Drug Safety Communication with Data Summary,  and prescribing information.


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