Warning about contrast agents, review underway on Stalevo

Drug recalls, warnings, approvals.

Recalls, warnings

A worldwide recall of the Integra NeuroBalloon Catheter after complaints regarding the inflation or deflation of the catheter during pre-implant testing or the procedure.

Photo by Comstock
Photo by Comstock.

A voluntary market withdrawal of all lots of octagam [Immune Globulin Intravenous (human)] 5% Liquid Preparation as a result of an increased number of reported thromboembolic events, some of which were serious.

A class I recall of certain Huber needles that produce cores when inserted into ports. Coring may lead to infection, damage or death of tissue, swelling, or other serious adverse health consequences, occurring as a result of the core travelling through blood vessels into the patient's lungs.

A warning added to the label of tigecycline (Tygacil) about an increased mortality risk associated with the use of this drug compared to that of other antibiotics. The increased risk was seen most clearly in patients treated for hospital-acquired pneumonia, especially ventilator-associated pneumonia, but was also seen in patients with complicated skin and skin structure infections, complicated intra-abdominal infections and diabetic foot infections.

A recall of AngioSculpt EX Percutaneous Transluminal Coronary Angioplasty catheters because they may become separated during use and fragments of the catheter may become lodged in coronary arteries, potentially resulting in serious injuries, including death.

A new warning on gadolinium-based contrast agents (GBCAs) about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis, if the drug is administered to certain patients with kidney disease. Three of the GBCAs (Magnevist, Omniscan, and Optimark) will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration.

A class I recall of Hospira Symbiq One-Channel and Two-Channel Infusers due to potential for the device to fail to detect air in line at the end of an infusion, which may result in the delivery of air to the patient.

A nationwide recall of certain lots of BagEasy Manual Resuscitation Devices, which have been found to have a potential for disconnection at the retention ring of the patient port manifold.


Pegloticase (Krystexxa) to treat gout in adults who do not respond to or who cannot tolerate conventional therapy. Clinical trials demonstrated that the drug lowered uric acid levels and reduced deposits of uric acid crystals in joints and soft tissue, but one out of every four patients in the clinical trials experienced a severe allergic reaction. Clinicians should dispense a corticosteroid and an antihistamine to their patients beforehand in order to minimize the risk of such a reaction.

A new indication for three cardiac resynchronization therapy defibrillators (CRT-Ds) used to treat heart failure patients. The defibrillators are now approved to treat left bundle branch block in patients who have either mild heart failure or heart failure with no apparent symptoms.


The FDA is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) for Parkinson's disease may be at an increased risk for cardiovascular events compared to those taking carbidopa/levodopa (sold as the combination product Sinemet). A recent trial reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. While the review is ongoing, the FDA recommends that health care professionals regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease.