Boston Scientific recalls device after pieces broke off in patients – Boston Business Journal

The Marlborough-based medical device giant said the recall is voluntary, but that the Food and Drug Administration has classified it as Class 1, the most serious type.

Source: Boston Scientific recalls device after pieces broke off in patients – Boston Business Journal

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FDA Alert: Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions about Dose Confusion and Medication Errors

To my pharmacist and doctor friends – you might want to to take a look at this article. The FDA studied 7 cases and found that confusion was resulting because the strength of individual ingredients displayed on Zerbaxa’s vial labels and carton labeling was different. Some of the cases studied showed that this was resulting in a 50% over-administration of the drug. 

FDA Alert: Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication – FDA Cautions about Dose Confusion and Medication Errors.

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

Hysterectomy Device Tied to Spreading Cancer Recalled by Johnson & Johnson

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Image Credit: Wall Street Journal

J&J just announced that it is voluntarily pulling its power morcellators globally. J&J’s decision comes in the wake of the FDA’s April 2014 warning to doctors that this device may spread, and consequently accelerate, the growth of undetected cancer cells in women. The FDA found that as many as 1 in 350 woman who undergo this procedure may have cancer that this machine could spread outside the uterus.

Power morcellators are robots that are used to preform minimally invasive robotic hysterectomies. The American Medical Association estimates that as many as 20,000 woman have these types of procedures preformed on an annual basis.

Our firm is currently reviewing cases where woman have had robotic hysterectomies and experienced injuries or the spread of cancer.

Bloomberg News published a good article on this: http://www.bloomberg.com/news/2014-07-31/j-j-withdraws-hysterectomy-device-tied-to-cancer-spread.html

Spray Sunscreen May be Unsafe for Children

 

SunscreenConsumer Reports recently recommended not spraying sunscreen on children.  Past tests of sunscreen by Consumer reports found that some contain titanium dioxide and zinc oxide which could have nanoparticles — particles known for causing developmental issues in animals. The fear is that children are more susceptible to inhaling the fumes from spray sunscreens. The FDA began investigating this issue back in 2011 and has yet to reveal its findings.

For now, Consumer Reports recommends the following if you use spray sunscreens:

Don’t use sprays on children, unless you have no other product available. In that case, spray the sunscreen onto your hands and rub it on. As with all sunscreens, be especially careful on the face, taking care to avoid the eyes and mouth.

Adults can still use sprays—but don’t spray your face! Instead, spray on your hands and rub it on, making sure to avoid your eyes and mouth. And try to avoid inhaling it.

• Make sure you apply enough. Our tests have found that sprays can work well when used properly—but it is harder to make sure that you apply enough, especially when it’s windy. We recommend spraying as much as can be evenly applied, and then repeating, just to be safe. On windy days, you might want to spray the sunscreen on your hands and rub it on—or just choose one of our recommended lotions instead.

You can find the Consumer Reports article here: http://www.consumerreports.org/cro/news/2011/07/don-t-spray-sunscreens-on-kids-at-least-for-now/index.htm

The American Academy of Dermatology also recommends never spraying sunscreen around your or your child’s face or mouth and to be mindful of the wind direction to avoid inhalation.

You can find the AAD’s recommendation on sunscreens here: http://www.aad.org/media-resources/stats-and-facts/prevention-and-care/sunscreens

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

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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

Diet Drug Suprenza Fails to Disclose Adverse Reactions

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On June 6, 2014, the FDA dropped its hammer on both the maker (Akrimax Pharmaceuticals) and the marketing company (Citius Pharmaceuticals) of the diet drug Suprenza.  The website for Suprenza apparently completely failed to list ANY of the contraindications or adverse reactions.  The FDA’s letter states that the website “fails to disclose any of the other warnings and precautions associated with the drug. By omitting serious and frequently occurring risks associated with Suprenza, the webpage misleadingly suggests that Suprenza is safer than has been demonstrated.”

The FDA letter further admonishes the website for implying that people taking Suprenza will become “lean.”  The FDA states that it  “is not aware of substantial evidence or substantial clinical experience to support this implication…”  The FDA stated that such implication is misleading absent substantial proof, which apparently doesn’t exist for this drug.

This information was first reported by the Wall Street Journal, and can be found here: http://blogs.wsj.com/pharmalot/2014/06/16/a-diet-drug-website-is-lean-on-important-information-fda-says/.

You can read a complete copy of the FDA’s letter here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM400708.pdf

If you are considering taking Suprenza – Ask yourself why a manufacture would fail to disclose any of the known contraindications and adverse reactions and why it would attempt to mislead you. Then ask yourself is this really something I want to put in my body.

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

 

3 Million Adverse Drug Reactions Now Searchable Via FDA Website

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The FDA announced yesterday the launch of “openFDA” website.  This website will allow you to search over 3 million reported adverse drug side effects dating back to 2004.

Here is how the FDA envisions it being a very usual tool for you:

According to FDA’s Chief Health Informatics Officer, Dr. Taha Kass-Hout, “Using this data, a mobile developer could create a search app for a smart phone, for example, a consumer could then use to determine whether anyone else has experienced the same adverse event they did after taking a certain drug.”  Dr. Kass-Hout further stated, “OpenFDA will make our publicly available data accessible in a structured, computer-readable format.” It provides a “search-based” Application Programming Interface – the set of requirements that govern how one software application can talk to another – that makes it possible to find both structured and unstructured content online.

This is an incredibly important first step in making it easy for consumers to both report adverse side effects and to check to see if anyone else has experienced similar reactions. It also allow the FDA and drug manufacturers to monitor patient side effects and issue more accurate drug warnings or decide whether or not a safety recall is warranted.  This database could essentially create a social media outlet for patients to anonymously report side effects – informing other users  of previously unreported reactions.

Previously, only adverse side effects reported to the FDA or the manufacturer (assuming the manufacturer actually passed this information on to the FDA) were made public.  And, even then, a consumer would have to search the FDA website for reported side-effects to find this information – a task that is cumbersome at best.

You can find the openFDA website here: http://open.fda.gov/index.html