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

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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

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

5 Things You Probably Didn’t Know (But Should Know) About Your Homeowner’s Insurance

1. Coverage for Tort Claims – Many policies automatically include coverage for you or a family member who resides in the same household for tort claims filed against you.  Make sure to check your policy if you find yourself in this unfortunate position.

2. “Replacement Value” isn’t Paid Until You Replace the Item – Most polices won’t pay you “replacement value” until you actually replace the item.  What they pay you is the “actual value” (“fair market value” minus depreciation).  Then, and only then, if you replace the item, they will pay you the remainder.  Here is an example of why this is unfair:

Assume your house burns down and everything in it is destroyed (“complete loss”).  The insurance adjuster comes out and determines the “actual case value” of everything in the house.  The adjuster determines that your refrigerator’s “actual cash value” (factoring in depreciation for age, condition, etc.) is $200, but the cost to replace it (“replacement value”) is $800.   He then hands you a check for $200 and tells you that you need to come up with the remaining $600 and go buy the refrigerator before he will write you another check for the same $600.  He then proceeds to go through all your destroyed possessions and do the same thing.  By the time he’s done, he’s written you a check for $25,000 for $150,000 worth of destroyed items leaving you to figure out a way to pay the rest before he kicks in the rest.

Keep in mind that you are paying a higher premium for a “replacement cost” policy.  So why do insurance companies do this? Because they know most people won’t replace the item because they can’t afford to.  Why can’t they afford to?  Because the insurance company won’t pay them the “replacement cost” up front, leaving you holding the bag.

And no, I’m not making this stuff up.

3. Don’t Trust Your Adjuster’s “Depreciation” Analysis – This is where insurance companies really hammer you.  Whenever you have a loss, adjusters come in an depreciate everything in your house, including your actual house (structure).  They use their own internal depreciation schedules to come up with these values (see #3 above). DO NOT TRUST THEIR DEPRECIATION DETERMINATION. Challenge the adjuster on these schedules.  Demand to see the depreciation schedule he/she used FOR EACH ITEM HE/SHE DEPRECIATED.  And, don’t let the adjuster tell you that he’s not allowed to send you the schedules – because thats crap.  You are entitled to see the schedule and know exactly how much each item is being depreciated.

We recently represented a couple from Florida who had a vacation home here in Georgia. Their Georgia home burned down and was a complete loss.  The adjuster initially tried to tell me that their home and possessions were worth only $60,000 factoring in depreciation.  After jumping through six months of hoops, the insurance company finally relented and paid $140,000 for the loss.  If they will do it to me, they will do it to you.

4. In the Event of a Loss, Read your Policy Closely – I can’t stress this one enough.  The first thing you need to do after a loss is get a copy your policy and go over it with a fine tooth comb. One of the main ways insurance companies avoid paying you for your loss is by claiming you “failed to cooperate” or failed to provide the required notice.  I would highly recommend immediately taking your policy to a lawyer who handles these types of cases for review.  This is not a time to figure it out on your own.

Almost every policy requires that you provide written notice of the loss within a certain time period (typically 30 days) after the loss.  This notice is normally required to be sent on a specific form, sent to a specific address, and itemizing the items destroyed to include estimated values. Don’t send it on the right form – claim denied.  Don’t provided all the required information – claim denied.  Send it a day late – claim denied. Remember, insurance companies don’t make money paying claims.  Give them a reason, and they will deny your claim.

Once you provided the required written notice, then be prepared for the dog and pony show. You may be required to: itemize everything in your home, provide the date every item was purchased, provide the amount paid for every item, provide the condition of every item, give a recorded statement the adjuster or their lawyer, tell them whether or not you have ever had a claim on any other policy, give them financial information (bank statements, credit card statements, etc.), as well as a host of other information.  God forbid the adjuster “suspects” foul play, as the list of hoops you will have to jump through will grow exponentially.  And, if you don’t do everything they require, claim denied for “failure to cooperate.”

5. Insurance Companies Routinely Increase the Value of Your Home, Increasing Your Premiums – Keep an eye on this.  Because home value fluctuate, and because your premium is largely based on the value of your home, monitor the value the insurance company places on your home. Make sure it coincides with the actual value of your home based upon the market.  It it doesn’t, let the insurance company know and demand a correction.

Let me know if you have any questions about your policy. I’m happy to review it free of charge and point out the important areas you need to be mindful of.  While most polices have similar standard language, all policies will differ to some degree. Similarly, not all insurance companies are created equally. Some are especially more problematic than others.

Nathan T. Williams

 

 

 

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

574 People Sick in 27 States from Chicken

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The CDC just reported that 574 people in 27 states have reported salmonella relating to chicken from Foster Farms (http://www.fosterfarms.com/).  One of these has been linked to a man in Georgia.  Thirty-seven (37) percent have been reportedly hospitalized and 13% have developed blood infections.  No deaths have been reported thus far.

Whats strange about this incident is the fact that the original outbreak was reported over a year ago – March 1, 2013 – and that many of the people interviewed said that they had gotten sick from newly purchased chicken – not chicken that had been previously purchased and frozen.

You can read a good article on this at http://www.foodsafetynews.com/2014/05/cdc-50-new-cases-of-salmonella-linked-to-foster-farms/#.U4Xf4pRdWzu.  Food Safety News is an excellent site to monitor similar incidents.

Please let us know if you believe you have suffered an illness relating to Foster Farms.

TheWilliamsLitigationGroup.com

Some Doctors Ignoring FDA Advice to Stop Using Power Morcellators

FDA Warning

The Wall Street Journal (5/22, A1, Levitz, Kamp, Subscription Publication, 5.51M) reported that the FDA has discouraged Doctors from using power morcellators to remove uterus and uterine fibroids.  The agency had warned against using the procedure because of concerns it could accidentally spread cancer to other parts of the body.

A morcellator is a surgical instrument used for division (“morcellation“) and removal of large masses of tissues during laparoscopic surgery

This comes in the wake of Johnson & Johnson suspending worldwide sales its power morcellators on April 30, 2014.

If you have to to undergo laparoscopic surgery for removal of uterus and uterine fibroids, make sure you confirm with your doctor that he/she is not planning on using a power morcellator.

Nathan T. Williams

TheWilliamsLitigationGroup.Com