New drug approved for Alzheimer's, warnings issued on CT scans, local anesthetics


Warnings, label changes, recalls

A reminder about the increased risk of neural tube defects and other major birth defects in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. The FDA will be working with the manufacturers of these products to address labeling changes.

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A labeling change to diclofenac sodium topical gel's (Voltaren Gel 1%) warning about the potential for elevation in liver function tests. Cases of drug-induced hepatotoxicity and hepatic problems including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure have been reported. Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac.

A warning about the potential association between fosamprenavir calcium (Lexiva) and myocardial infarction and dyslipidemia in HIV-infected adults. The drug label now notes that increases in cholesterol have occurred with treatment, and triglyceride and cholesterol testing should be performed prior to initiating and at periodic intervals during therapy.

A recall of a lot of combination package Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels because labeling was reversed so that the label for the green Night product appears under some of the blue Day product and vice versa.

A recall of eleven lots of clevidipine butyrate (Cleviprex) injectable emulsion, due to the potential presence of inert stainless steel particles which could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.

Approvals

Agriflu, a new injectable vaccine against influenza virus subtypes A and B for people ages 18 years and older. The vaccine was approved using the FDA's accelerated approval pathway based on demonstrations that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Ecallantide (Kalbitor), a liquid injected under the skin to treat fluid buildup resulting from hereditary angioedema (HAE). Approved for patients age 16 and up, the drug should only be administered by a health care professional with appropriate support to manage anaphylaxis, a possible side effect. Other side effects include headache, nausea, diarrhea, swelling in the nose and throat, fever and skin irritations.

The first generic versions of donepezil hydrochloride orally disintegrating tablets for the treatment of dementia related to Alzheimer's disease. Although other generic versions of the drug are already available, the orally disintegrating tablets dissolve on the tongue, which may make it easier for older or disabled patients to take the medication.

Miscellaneous

After an additional 50 patients were found to have been exposed to excess radiation during CT perfusion scans, the FDA is recommending that facilities assess whether patients who underwent CT perfusion scans received excess radiation, review their radiation dosing protocols, implement quality control procedures, and check the CT scanner display panel before performing a study.

A notice that Powerheart and CardioVive automated external defibrillators may have defective components which may cause them to not deliver electric shocks and are not detected by the devices' self-test. The G3 Series devices were manufactured between August 2003 and August 2009. Users should contact the company to arrange for repair or replacement.

A reminder not to use local anesthetics as continuous intra-articular postoperative infusions after 35 reports of chondrolysis in patients given continuous intra-articular infusions with elastomeric infusion devices to control post-surgical pain. Joint pain, stiffness and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty.

A public health notification of six deaths and 77 injuries associated with Negative Pressure Wound Therapy (NPWT) systems. Patients should be selected for NPWT carefully and monitored frequently with particular vigilance for potentially life-threatening complications such as bleeding.

A review of preliminary data from a recent study suggesting that patients using sibutramine (Meridia) have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than those using a placebo. The analysis of these data is ongoing and the agency is making no conclusions about the preliminary findings at this time. Current sibutramine labeling advises avoiding use in patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.