From the category archives:

MedWatch

Epidural Corticosteroid Injection: Drug Safety Communication – Risk of Rare But Serious Neurologic Problems

April 23, 2014

Injection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original [...]

Read More Details →

Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall – Visible Particulates

April 22, 2014

Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

Read More Details →

Thinogenics Products by Nature’s Universe: Recall – Undeclared Drug Ingredient

April 18, 2014

Use of undeclared sibutramine can lead to increased risk of seizures, heart attacks, arrhythmia and stroke. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

Read More Details →

Propofol Injectable Emulsion, USP by Hospira: Recall – Visible Particulates

April 18, 2014

Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View [...]

Read More Details →

S.W.A.G: Public Notification – Undeclared Drug Ingredient

April 18, 2014

Contains undeclared Sildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full [...]

Read More Details →

Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication – Use Discouraged Due to Increased Risk in Women With Uterine Fibroids

April 17, 2014

If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to [...]

Read More Details →

ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall – Software Defect May Cause System to Stop Working

April 16, 2014

Defect may cause serious adverse health consequences, including hypoxemia and death. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

Read More Details →

Infinity: Public Notification – Undeclared Drug Ingredient

April 11, 2014

Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will [...]

Read More Details →

Lite Fit USA: Public Notification – Undeclared Drug Ingredient

April 11, 2014

Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will [...]

Read More Details →

March 2014

April 11, 2014

Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014. This is a summary of an alert issued by MedWatch: The FDA Safety Information and Adverse Event Reporting Program. The link below will take you to the original notice. View Full Details Of The Original MedWatch Notice Here.

Read More Details →