Warning about contrast agents, reviews under way on Stalevo

Recalls, warnings, approvals and other regulatory news.

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.


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 warning added to the label of tigecycline (Tygacil) reminding health care professionals of 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 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.


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 to minimize the risk of such a reaction.

Pediatric use of pralidoxime chloride (Protopam Chloride), a drug used to treat poisoning by organophosphate pesticides and chemicals (e.g., nerve agents).

A new indication for three cardiac resynchronization therapy defibrillators used to treat heart failure patients. The defibrillators are now approved to treat left bundle-branch block in patients who have 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.

The FDA is also reviewing data on whether diabetes drug pioglitazone (Actos) is associated with an increased risk of bladder cancer. The drug manufacturer, Takeda, has submitted data from an ongoing, 10-year epidemiological study to the FDA. Overall, there was no statistically significant association between Actos exposure and bladder cancer risk. However, further analyses found an increased risk of bladder cancer among patients with the longest exposure to the drug, as well as in those exposed to the highest cumulative dose. At this time, the FDA has not concluded that Actos increases the risk of bladder cancer, but the review is ongoing.