On January 5, 2010, The FDA issued a MedWatch safety and information report including information about a Class 1 recall of the Trailblazer Support Catheter device.

The recalled catheter is a medical device used to help with the delivery of solutions in the veins or arteries for the treatment of patients.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Specifically, this device may crack near the radiopaque marker band which may result in serious patient injury, including insufficient oxygen supply to the tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery, and/or death.

Ev3 Endovascular, Inc., has sent a letter to all of its consumers summarizing the problem with the device and requesting the product be returned to their company.

Model Numbers recalled include: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, SC-035-150.

Labels: Class 1 recall, FDA, MedWatch

The FDA announced today a warning concerning loss of smell associated with the use of the over the counter cold remedy, Zicam. The FDA has received reports of over 130 cases of ansomia, or loss of smell, associated with the use of Zicam. Zicam is an intranasal product that contains zinc. The agency urged consumers to quit using the product and to throw away any Zicam that they may already have at home. Zicam is marketed as an over the counter cold remedy that can shorten the length and severity of the common cold.

The effected products are:
• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21) (this has already been discontinued)

The products are sold in retail stores and pharmacies without a prescription. Zicam Kids Size has already been discontinued, but the FDA is concerned that some people may still have the product in their homes. The FDA has special concerns about the use of zinc in children. The anosmia that can be experienced by consumers can either be temporary or permanent.

The FDA sent a warning letter to Matrixx Initiatives, the manufacturer of Zicam, stating that they can no longer sell their product without FDA approval and that their warnings regarding the loss of the sense of smell are adequate. “Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” said Deborah M. Autor, director of the FDA’s Center for Drug Evaluation and Research Office of Compliance.

Anyone who has used this product and experiences a loss of the sense of smell should report the incident to their doctor right away. Any problems should also be reported to MedWatch. Consumers can report problems to MedWatch either online through the FDA’s website, or they can call at 1-800-FDA-1088.

For more information, see the FDA Consumer Update:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm166931.htm

The FDA News Release:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167065.htm

The FDA Safety Information
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm

The FDA Public Health Advisory:
http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm166059.htm

Labels: anosmia, Common cold, FDA, MedWatch, zicam

On April 16, 2009, the Drug Safety Oversight Board briefly discussed orlistat and the potential risk of hepatotoxicity.

Orlistat is the active ingredient in anti-obesity drugs such as the prescription drug Xenical and the over-the-counter drug Alli.

Xenical is manufactured by Roche, which is headquartered in Nutley, N.J. Alli is manufactured GlaxoSmithKline, which is headquartered in England.

Sue Sutter of Scrip News in her May 21, 2009 article "US FDA examining reports of liver damage with orlistat" gives more details on the relationship between Orlistat and hepatotoxicity.

"Orlistat was discussed in the context of both non-prescription and prescription versions and the potential risk of hepatotoxicity based on several post marketing reports," the FDA told Scrip.

The agency said it was still reviewing the case reports to determine the extent of orlistat's contribution, if any, to the development of liver damage. The FDA declined to provide the number of post marketing reports it has received and said any action would depend upon results of its ongoing analysis....

Roche said more than 35 million patients have been exposed to orlistat therapy, and obesity is a high risk factor for hepatic injury. "The available information – post marketing spontaneous reports, clinical trial data and published literature as well as epidemiology data for drug-induced liver disease – does not suggest that orlistat is causally related to hepatic events."

Currently in Xenical’s package insert there are only rare reports of hepatic, or liver, injury.

The FDA has investigated Orlistat over concerns of rectal bleeding. See: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008

Any adverse reactions, such as hepatitis, liver injury or liver failure experienced with the use of Xenical or Alli should be reported to the FDA’s MedWatch Program

by phone at 1-800-FDA-1088,
by fax at 1-800-FDA-0178,
by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787,
or on the MedWatch website at www.fda.gov/medwatch.

Labels: Alli, FDA, hepatic, Hepatotoxicity, Liver, MedWatch, Orlistat, Xenical

Respironics, the manufacturer of the SmartMonitor 2 Infant Apnea Monitor, announced that it has voluntarily recalled 4,992 infant apnea monitors. The device continuously monitors infant respiration and heart rate in the hospital or in the infant's home or in the hospital. The monitor was designed to detect, and sound an alarm for, periods of temporary interruption of breathing (central apnea) or low heart rates. The FDA announced that the Class 1 recall is necessary to protect consumers from serious injury.

Class 1 is the most serious degree of recall, involving a reasonable probability that use of affected products will cause serious injury or death.

This recall applies to SmartMonitor 2 models 4002 and 4003 -- caregivers and/or parents using a SmartMonitor 2 Infant Apnea Monitor for their infant should contact their homecare provider immediately to determine if their device is affected. However, they should continue using the apnea monitor until it is replaced, unless directed otherwise by a physician.

Any adverse reactions experienced with the use of this device should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Labels: Adverse Events, Class 1 recall, devices, FDA, MedWatch, SmartMonitor