Spine Safety Notice: Acetaminophen

Information for Healthcare Professionals:
Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication

Source: FDA MedWatch

Audience: Pharmacy, Pain Management

Spine Safety Notice: Remicade for IV Injection

Tags

Spine Safety Warning

Information for Healthcare Professionals: remicade (infliximab) for intravenous (iv) injection: warnings and adverse reactions – labeling changes

WARNINGS

Hypersensitivity

• In rheumatoid arthritis, Crohn’s disease and psoriasis clinical trials, re-administration of Remicade after a period of no treatment resulted in a higher incidence of infusion reactions relative to regular maintenance treatment. In general, the benefitrisk of re-administration of Remicade after a period of no-treatment, especially as a reinduction regimen given at weeks 0, 2 and 6, should be carefully considered. In the case where Remicade maintenance therapy for psoriasis is interrupted, Remicade should be reinitiated as a single dose followed by maintenance therapy.

Spine Safety Notice: Fentanyl Transdermal System

Information for Healthcare Professionals:
Fentanyl Transdermal System:
Recall – Potential for Active Ingredient to Release Faster Than Specified

AUDIENCE: Pharmacist, Anesthesia

ISSUE: The FDA notified health care professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation  and apnea.

Spine Safety Notice: Excelsior Medical 5 mL Fill in 6 cc Prefilled Saline Flush Syringes

Information for Healthcare Professionals:
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall – Potential Loss of Sterility

AUDIENCE: Risk Manager

ISSUE: Routine internal testing conducted on this product found that some of these syringes may leak and lose sterility. This recall pertains only to syringes with the following product code numbers: E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, and S5. Exposure to syringes with a sterility issue could result in systemic infection, which may lead to serious injury and/or death.

Spine Safety Notice: Bisphosphonates (Osteoporosis Drugs)

Information for Health care Professionals:
Bisphosphonates (Osteoporosis Drugs):
Label Change – Atypical Fractures Update

AUDIENCE: Patient, Family Practice, Geriatric

ISSUE: The FDA is updating the public regarding information previously communicated describing the risk of atypical fractures of the thigh, known as subtrochanteric and diaphyseal femur fractures, in patients who take bisphosphonates for osteoporosis. This information will be added to the Warnings and Precautions section of the labels approved to treat osteoporosis, including Fosamax, Fosamax Plus D, Actonel, Actonel with Calcium, Boniva, Atelvia and Reclast (and their generic products). A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.

Spine Safety Notice: Epogen & Procrit (Epoetin alfa)

Information for Health care Professionals:
Epogen and Procrit (epoetin alfa):
Recall – Particulate Matter in Vials

AUDIENCE: Risk Manager, Oncology, Nephrology

ISSUE: Amgen and the FDA notified health care professionals that certain lots of Epogen and Procrit (Epoetin alfa) vials are being recalled as a precaution, because the vials may contain extremely thin glass flakes (lamellae) that are barely visible. The potential serious adverse events resulting from the use of a sterile injectable product with particulates by the intravenous route include embolic, thrombotic and other vascular events (eg, phlebitis), and by the subcutaneous route include foreign body granuloma, local injection site reactions, and increased immunogenicity.

Spine Safety Notice: Heparin Sodium in Dextrose Injection and in Sodium Chloride Injection

Information for Health Care Professionals: Drug Safety Labeling Changes – Heparin Sodium in Dextrose Injection and in Sodium Chloride Injection

According to MedWatch, FDA notified health care professionals that the WARNINGS text for Heparin Sodium in Dextrose injection and in Sodium Chloride injection has been updated. The following sentences have been added to the labeling:

Spine Safety Warning: Gadolinium-Based Contrast Agents

Information for Health Care Professionals:  Gadolinium-Based Contrast Agents: Class Labeling Change – Risk of Nephrogenic Systemic Fibrosis

AUDIENCE: Radiology, Nephrology, Dermatology

ISSUE: The FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction. NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease.