Risks of diclofenac sodium, fosamprenavir calcium detailed


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 work with the manufacturers of these products to address labeling changes.

Art 1

A labeling change to diclofenac sodium topical gel (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 that could theoretically reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.

A warning that clopidogrel (Plavix) and omeprazole (Prilosec/Prilosec OTC) should not be used together based on new manufacturer data showing that when the drugs are taken together, the effectiveness of clopidogrel is reduced. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction. Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine.

A voluntary recall of three lots of Vicks Sinex Nasal Spray because the bacteria Burkholderia cepacia were found in a small amount of product. There have been no reports of illness.

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 older, 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 that 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.