This has been an active time for FDA alerts that have widespread applications for consumers, including those in community-based provider settings. One critical alert is the announcement regarding tainted skin sanitizer products. The Clarcon Biological Chemistry Laboratory’s products were those recalled. This lab recalled a long list of products in conjunction with the FDA and CMS alert. This alert also recommended disposal of these products, as these products were found to have high levels of disease-causing bacteria. Products include:
- Citrushield Lotion
- Dermasentials DermaBarrier
- Dermassentials by Clarcon Antimicrobial Hand Sanitizer
- Iron Fist Barrier Hand Treatment
- Skin Shield Restaurant
- Skin Shield Industrial
- Skin Shield Beauty Salon Lotion
- Total Skin Care Beauty
- Total Skin Care Work
Health care professionals and consumers are asked to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
Other FDA Alerts:
Levemir Insulin (Novo Nordisk) – The company and FDA together released an alert relative to stolen vials of Levemir being sold in the US market. The specific concerns related to these stolen vials were in the storage and integrity of the products. The specific lots that were stolen include the following: XZF0036, XZF0037, and XZF0038. All consumers and health care providers are asked to check insulin vials and to not use any with the above lot numbers. It is suggested that the Novo Nordisk Customer Care Center be contacted at 1-800-727-6500 regarding what to do with vials from these lots or if there are other questions relative to this product. For the complete MedWatch 2009 Safety Summary of this announcement, go to: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm.
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers – A Class I recall was issued for these specific devices. They have been found to fail in performing as necessary to pace the heart. Malfunctioning pacemakers have the potential to give the patient a return of symptoms associated with abnormal heart rate, including fainting or lightheadedness. If device malfunctioning is more severe, it is possible in rare cases, to result in serious injury or even death. The majority of pacemakers affected by this recall were implanted in patients five years ago or longer. To determine if a pacemaker is part of this recall, contact Medtronic at 1-800-505-4636. For access to the MedWatch Safety Summary, go to:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm165711.htm
Any other concerns relative to the type of pacemaker that has been implanted can also be followed up with the patient’s direct service provider.
Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) – The FDA reported receiving over 130 reports of loss of sense of smell associated with the use of these three Zicam products, both with first-time use and multiple usage. It was reported that the loss of smell could potentially be of long duration or permanent. An alert to discontinue the use of these over-the-counter [OTC] cold remedies was disseminated. For access to the MedWatch Safety Summary go to:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166996.htm
Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review - An extensive list of products was included in this release that addresses findings from a data and findings from a study. This release indicated that there was a possible association between the use of stimulant medications and sudden death in healthy children. The study further recommended that families discuss concerns with health professionals prescribing the medications. However, the release also advised that should cardiovascular symptoms (such as chest pain, shortness of breath or fainting) occur during stimulant medication treatment, the individual should be seen immediately by a doctor. For more information on this MedWatch 2009 Safety Summary, go to http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166667.htm.
Other Safety Information Releases:
Additional FDA patient safety information released in late May and June, including topics such as acetaminophen toxicity and overdose and recall information of Digoxin and Propafenone Tablets is available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=87
References: http://www.fda.gov |
