FDA U.S. FOOD & DRUG Administration update

 Adverse Event Reporting Program

Certain Homeopathic Teething Products: FDA Warning - Confirmed Elevated Levels of Belladonna

AUDIENCE: Consumer

ISSUE: FDA announced that its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not to use these products.

In light of these findings, the FDA contacted Standard Homeopathic Company in Los Angeles, the manufacturer of Hyland’s homeopathic teething products, regarding a recall of its homeopathic teething tablet products labeled as containing belladonna, in order to protect consumers from inconsistent levels of belladonna. At this time, the company has not agreed to conduct a recall.

BACKGROUND: Homeopathic teething products have not been evaluated or approved by the FDA for safety or effectiveness. The agency is unaware of any proven health benefit of the products, which are labeled to relieve teething symptoms in children. In September 2016, the FDA warned against the use of these products after receiving adverse event reports.

In November 2016, Raritan Pharmaceuticals (East Brunswick, New Jersey) recalled three belladonna-containing homeopathic products, two of which were marketed by CVS.

RECOMMENDATION: The FDA recommends that consumers stop using these products marketed by Hyland’s immediately, and dispose of any in their possession.

Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating, or agitation after using homeopathic teething products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the FDA news release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538687.htm

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Recall - Potential Inaccurate Test Results

AUDIENCE: Laboratory, Patient, Pathology

ISSUE: This is a continuation of bioMerieux's previous recall for NucliSENS easyMAG Magnetic Silica. The firm has identified additional affected product lots, and an additional product, the NucliSENS Magnetic Extraction Reagents, which have been determined to be in scope of the previous recall.

bioMerieux is recalling the NucliSENS reagents and accessory products due to a quality problem of the magnetic silica (MagSil) component. MagSil is used to extract and purify genetic material from patient samples.  Kits with the affected lots of the magnetic silica may not be able to fully extract nucleic acids from the sample and detect infection or provide proper diagnosis. The detection problem could lead to a risk of false negative results, invalid results, or under-quantification for clinical laboratory tests. This error may result in inappropriate treatment or delay in treatment. The use of the affected product may cause serious adverse health consequences, including death.

BACKGROUND: The NucliSENS easyMAG Magnetic Silica is used to extract nucleic acids (RNA or DNA) which contain genetic material from biological samples, such as blood, tissue, etc., which could then be used in various applications for molecular infectious disease assays, molecular oncology assays, and molecular genetics assays.

The NucliSENS Magnetic Extraction Reagents are accessory products that enable the automated extraction of RNA/DNA from biological samples. These products are intended for in vitro diagnostic use by health care professionals.

RECOMMENDATION: On November 23, 2016, bioMerieux sent Urgent Product Safety Correction Notices to affected customers. The notice asked customers to:

• Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product, including others to whom you may have transferred this product.
• Use systematically an extraction internal control which mimics the extracted target (with same nature/structure), and/or external controls as recommended in the instructions for use and in good laboratory practices to detect any extraction performance issue.
• In case of a detected issue, reduce the sample input volume to 200μl.
• Discuss any concern regarding previously reported results with your Laboratory Medical Director to determine the appropriate course of action.
• Contact your local customer service if you observe the issue.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the news release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538682.htm