Indications added for Gardasil, breast implants questioned
Recalls, warnings, and approvals.
Recalls and warnings
A recall of all lots of sterile and non-sterile alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad Group and sold under the names Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, and Conzellin due to concerns about potential contamination with Bacillus cereus.
The recall prompted the FDA to remind clinicians that non-sterile pads are not intended to prep patients prior to procedures requiring strict sterility measures (such as catheter insertion or surgery) and should not be used in hospitals or on patients with depressed immune systems.
A class I recall of CombiSet True Flow Series hemodialysis blood tubing set with priming set and transducer protectors for use with the blood volume monitor, due to the risk of kinking of the arterial line, which can cause the destruction of red blood cells and may result in serious injury and/or death.
A labeling change on rosiglitazone medications (Avandia, Avandamet, Avandaryl) describing the drug's cardiovascular risks and noting that the drug should only be used in patients already being treated with these medicines or those whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their health care professional, do not wish to use pioglitazone-containing medicines.
A recall of certain lots of American Regent potassium phosphates injection and sodium thiosulfate injection because some vials exhibit translucent visible particles consistent with glass delamination. Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.
A class I recall of the Merit Prelude short sheath catheter introducer because the tip may detach during use, causing arterial injury, hemorrhaging, or other serious events, and/or introducer tip material may enter into the bloodstream, causing thrombosis.
Approvals
An additional indication of the human papillomavirus vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to HPV types 6, 11, 16, and 18 in people ages 9 through 26 years. The vaccine was studied in a randomized, controlled trial of men who self-identified as having sex with men in which it was shown to be 78% effective in the prevention of HPV 16- and 18-related anal intraepithelial neoplasia.
The first mobile radiology application for viewing medical images on the iPhone and iPad. The application allows physicians to view images and make medical diagnoses based on computed tomography, magnetic resonance imaging, and nuclear medicine technology, such as positron emission tomography. It is not intended to replace full workstations and is indicated for use only when there is no access to a workstation.
Miscellaneous
An FDA review has found a possible association between saline and silicone gel-filled breast implants and anaplastic large-cell lymphoma (ALCL).
Data reviewed by the FDA suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. In total, the agency is aware of about 60 cases of ALCL in women with breast implants worldwide.
Most cases reviewed by the FDA were diagnosed when patients sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (peri-implant seroma), hardening of breast area around the implant (capsular contracture), or masses surrounding the breast implant.
