Think Twice Before Giving Your Child Probiotic Medicine!! Infant Death Linked to Probiotic ABC Dophilus Powder

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The FDA issued a warning to parents and medical personnel that the probiotic ABC Dophilus Powder has been linked to the death of an infant. The FDA warning states, in part, that:

“A premature infant administered a dietary supplement, ABC Dophilus® Powder (Solgar®), as part of in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the moldRhizopus oryzae and died.”

The FDA further cautions parents and medical personnel about the use of dietary supplements containing live bacteria or yeast in infants and adults that have a compromised immune system. Parents should be aware that the FDA does not monitor these types of drugs in the same manner as most pharmaceuticals. The FDA also does not ensure that these types of drugs do what the manufacturer claims.

I know that my wife and I frequently gave our children probiotic medicines when they were infants. I also know that I would have never done this had I known the risks associated.

Want to read the FDA’s warning letter? Click on this link:

http://www.fda.gov/downloads/BiologicsBloodVaccines/SafetyAvailability/UCM426233.pdf

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Some Weight Loss Drugs Contain “Hidden Drugs” that Can Lead to Death, FDA Warns

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FDA has identified an emerging trend where over-the-counter products, frequently represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for weight loss.

Cleveland.com [http://www.cleveland.com/healthfit/index.ssf/2014/07/fda_warns_of_prescription_drug.html] reported that the FDA has warned consumers NOT to use the following weight loss supplements due to them containing a dangerous drug known to cause heart attacks and strokes:

1. Mix Fruit Slimming sold on Amazon

2. Lingzhi Cleansed Slim Tea sold on Amazon

3. Trim Fast

4. 24 ince

5. Sliming (sic) Diet by Pretty White sold on ebay

6. Lipo

FDA’s List of additional products just for 2014 with “hidden drugs:”

You can watch the FDA’s video on “Tainted Weight Loss Products” here: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm.

 

FDA to Parents – DON’T Use Lidocaine Viscous on Infants to Treat Teething Pain

FDA Warning

The FDA just notified health professionals and caregivers of infants that prescription oral viscous lidocaine (2% solution) should not be used to treat infants and children with teething pain.  The FDA will now require a “Boxed Warning” to the drug labeling that will highlight this warning.

This year the FDA reviewed 22 case reports of serious adverse reactions in infants and children. The adverse reactions noted were seizures, severe brain damage, heart problems, and even death. The age range for the reviews was 5 months to 3.5 years old.

The FDA further advised that viscous lidocaine should NOT be prescribed by doctors, and warned parents that even over-the-counter topical medications should not be used due to potential harmful side effects.

You can find the FDA’s Drug Safety Communication Notice here: http://www.fda.gov/Drugs/DrugSafety/ucm402240.htm

You can find the FDA’s Consumer Update Notice here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm385817.htm

Drug Recalled due to “the Presence of Visible Particulate Matter” – Soliris® (eculizumab) Concentrated Solution

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June 2, 2014 – Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level. This recall has been initiated due to the presence of visible proteinaceous particles detected in a single lot during periodic stability testing for Soliris. This lot was distributed only in the U.S.

The recalled lots pose a potential safety risk to patients in two general areas: immune reaction and blood clots. Particulates could cause blockage of flow of blood in vessels, which could be life-threatening.

The single affected Soliris lot is #10007A. Although these lots currently remain in specification, Alexion is including the following remaining lots, which were produced with the same process component during vial filling, within the scope of the U.S. recall: 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.

Soliris is primarily used in treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two ultra-rare and life-threatening disorders.  If you or a loved one is being treated for either condition, make sure your doctor is aware of this recall.

You can find the FDA Recall Notice here: http://www.fda.gov/Safety/Recalls/ucm399527.htm

 

Death Suspected in Recalled Lots of NaturaLyte Liquid Bicarbonate Concentrate

Recall Fresenius

 

Fresenius Medical Care North America issued a recall for certain lots of NaturaLyte Liquid Bicarbonate Concentrate, 6.4 liters.  NaturaLyte is drug used in hemodialysis machines.  Laboratory test identified a Gram Negative bacteria (Halomonas).  The FDA issued recall notices on May 21 and May 28th of this year.  The FDA has received one report of death and two reports of injuries suspected to be related to the infected drug.  The FDA further stated that the affected product could cause serious adverse health consequences, including sepsis, bacteremia, and death.

You can find the FDA recall notices here:

http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm399124.htm

http://www.fda.gov/Safety/Recalls/ucm398488.htm

Nathan T. Williams

TheWilliamsLitigationGroup.com