New gadolinium contrast agent approved

Details on approval of a new gadolinium contrast agent, a recall of certain infusion agents, and more.


Recalls and warnings

A recall of several American Regent injectable products (bacteriostatic sodium chloride, concentrated sodium chloride, sodium thiosulfate, and potassium phosphates) because of visible particulates consistent with glass delamination, which could result in damage to blood vessels in the lung, localized swelling, and granuloma formation.

Photo by Comstock
Photo by Comstock.

A recall of certain lots of AccuProbe culture identification tests for Group B streptococcus, Mycobacterium tuberculosis and Mycobacterium avium because the kits may contain tube components that are partially empty or empty of solution. Possible false-negative results may occur.

A recall of Roche ACCU-CHEK FlexLink Plus infusion sets due to potential for under-delivery of insulin due to a cannula which may become kinked or bent.

A recall of one lot (FI0510058-A) of citalopram 10-mg tablets (100-count bottle) and finasteride 5-mg tablets (90-count bottle) due to the possibility that incorrect labels may have been placed on the bottles by a third-party manufacturer. Bottles labeled as citalopram may contain finasteride.

A recall of five lots of irinotecan hydrochloride injection, after customer reports of a particulate in one lot. The particulate was found to be a fungal microbial contaminant and lots produced before and after the affected one have been recalled as a precaution.

A recall of the Millar Mikro-Tip angiographic catheter, Model SPC-454D and SPC-454F, due to the finding of particulate debris within the catheter lumen, which potentially could result in embolization of foreign debris to tissues, vasculature, and organs, potentially causing myocardial infarction, stroke, limb ischemia, and/or death.

A recall of the Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD due to a software anomaly which leads to software Error Code 45, resulting in a shutdown of the pump.

A recall of compounded IV products from Meds IV Pharmacy due to an outbreak of Serratia marcescens bacteremia in Alabama hospitals, which CDC investigators have tied to total parental nutrition from this pharmacy.

Approvals

An expansion of approval for the Zostavax vaccine, for the prevention of shingles in individuals 50 to 59 years of age. The vaccine was already approved for use in individuals 60 years of age and older.

Gadobutrol (Gadavist), a new gadolinium-based contrast agent (GBCA), for use in patients undergoing MRI of the central nervous system. Gadobutrol is more concentrated than the other GBCAs and should be administered at half the volume.

Miscellaneous

The FDA is currently reviewing the safety of lenalidomide (Revlimid) after clinical trials conducted inside and outside the United States found that patients treated with the drug may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. At this time, the agency is not recommending delay, modification or restriction for patients being treated according to the FDA-approved indications.

The FDA is alerting health care professionals and the public about the association of methemoglobinemia, a serious and potentially fatal adverse effect, with benzocaine sprays, gels and liquids. Benzocaine gels and liquids are sold over-the-counter under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. The sprays are used during medical procedures to numb the mucous membranes of the mouth and throat and are marketed under different brand names such as Hurricaine, Cetacaine, Exactacain, and Topex. Methemoglobinemia is a rare, but serious condition in which the amount of oxygen carried through the bloodstream is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Patients who develop methemoglobinemia may experience signs and symptoms such as pale, gray or blue colored skin, lips, and nail beds; headache; lightheadedness; shortness of breath; fatigue; and rapid heart rate. In some cases, symptoms of methemoglobinemia may not always be evident or attributed to the condition. The signs and symptoms usually appear within minutes to hours of using benzocaine.