FDA

An alert from the Institute for Safe Medication Practices warns about potentially fatal errors that can occur with concentrated oral opiate solutions.

FDA is reminding healthcare professionals that patients who take amiodarone along with drugs that contain simvastatin have an increased risk of rhabdomyolysis, a type of muscle injury that can lead to kidney failure and death. Amiodarone is an antiarrhythmic drug and simvastatin (found in Zocor, Vytorin and Simcor) is used to lower cholesterol.

FDA is alerting healthcare professionals that certain patients are more likely to experience serious and potentially fatal hypersensitivity reactions when treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen and is part of the combination products Epzicom and Trizivir.

FDA is requiring that "conventional" antipsychotic drugs carry a boxed warning stating that these drugs increase the risk of death when they are used to treat dementia-related psychosis in elderly patients. This category includes such drugs as Haldol (haloperidol) and Prolixin (fluphenazine). A similar warning was added to "atypical" antipsychotic drugs in 2005.

As the flu season approaches, FDA is urging healthcare facilities to ensure that influenza vaccination programs are available for their personnel. Vaccinating healthcare workers will decrease the likelihood that they will contract influenza, and also decrease the chance that they will infect others.

In October 2007, FDA warned healthcare professionals about reports of acute pancreatitis in patients taking the antidiabetic drug Byetta (exenatide). Since then, FDA has received reports of six cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta. Two were fatal.

FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence.

FDA has received nearly 200 reports of injection site reactions, including cellulitis, induration, hematoma, abscess, sterile abscess and necrosis. Some patients needed surgical intervention. The risk may be increased if the drug is injected subcutaneously or accidentally into fatty tissue.

Practitioners using Vivitrol should use only the specially designed needle that comes with the drug, and take care not to inject the material intravenously, subcutaneously, or into fatty tissue. The special needle may not be long enough to reach muscle tissue in patients with significant gluteal fat. Healthcare providers should consider alternative treatment in these cases.

The manufacturers of Humira (adalimumab), Cimzia (certolizumab pegol), Enbrel (etanercept), and Remicade (infliximab) must strengthen warnings about the risk of developing opportunistic fungal infections from these drugs. These infections have been fatal in some patients.

Humira, Cimzia, Enbrel, and Remicade are tumor necrosis factor alpha blockers (TNF blocker) which suppress the immune system. These drugs are approved to treat one or more of several diseases, including juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis.

The labeling for these drugs already includes warnings about the risk of serious infections, including fungal infections. But based on reports reviewed by FDA, cases of histoplasmosis and other invasive fungal infections have not been recognized consistently, and that has delayed antifungal treatment and led to death in some patients.

The Institute for Safe Medication Practices (ISMP) is warning again about the possibility of potentially fatal glucose monitoring errors in patients receiving products that contain other sugars. These include oral xylose, parenterals that contain maltose or galactose, and peritoneal dialysis solutions that contain icodextrin. This issue was also reported in an earlier edition of FDA Patient Safety News.

The problem is that some point-of-care glucose meters use a type of test strip that cannot distinguish between glucose and other sugars. So in these cases, the meter's reading of the test strip will reflect both the patient's actual blood glucose and the other sugar the patient has received. This falsely elevated reading can lead to aggressive insulin treatment, which can result in hypoglycemic shock and death.

FDA is alerting healthcare professionals about reports of life-threatening complications from the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion.

Although FDA has approved two rhBMP products for very specific medical conditions, the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and FDA has not approved it for this use.

Over the past four years, FDA has received about 40 reports of complications associated with using rhBMP in the cervical spine. They involved swelling of neck and throat tissue, which resulted in compression of the airway or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking.

Most of the complications occurred between 2 and 14 days following surgery. When airway complications occurred, emergency medical intervention was frequently necessary.