Diabetes Drug Invokana and Amputation Risk

The U.S. Food and Drug Administration (FDA) informed manufacturing giant Johnson & Johnson in May, 2017 that they must put new warning labels on diabetes drug, Invokana (generic, canagliflozin), and its variations, Invokamet and Invokamet XR.  The new warning is to alert the consumer to the clinical study findings that taking the diabetes drug can put them at double the risk of amputation of the leg and/or foot.   The clinical studies,  CANVAS and CANVAS-R were studies done by Johnson & Johnson that the manufacturer was counting on to show that Invokana was safe.  The opposite was true and the drug had already had a past reputation for its side effects of diabetic ketoacidosis, bone fractures, heart attacks, strokes, in addition to the increased risk of amputations.  For consumers taking Invokana, the FDA warns to look out for pain/tenderness, sores, ulcers, or infections in the leg and feet that are new since taking the drug.  These conditions bring a much more significant chance of partial or total amputation and must be monitored carefully. 

If you or a loved one has been negatively impacted by Invokana, Invokamet, or Invokamet XR (or the generic form, canagliflozin), or other medical device, drug, or products, consult your medical provider and do not hesitate to contact  Inserra Kelley Sewell, Personal Injury Attorneys, to discuss your possible claim and entitlement to compensation for your damages.   

To learn more, visit: When it Comes to Invokana Diabetic Drug Lawsuits, We’re Fighting for Nebraskan’s Rights 

There Could be Lead in Your Baby’s Food

A report recently conducted by the  Environmental Defense Fund, a not for profit, nonpartisan advocacy group, shows that twenty percent of baby food samples taken in their studies were positive for lead that is higher than the incidence of lead being in regular food.  A vegetable and beef baby food was found to be the highest in lead, but it is unfortunate that the study did not name names for the brands of baby food.  The study showed that fruit juices, root vegetables, and cookies were the baby foods containing lead most often. Unfortunately, the U.S. Food and Drug Administration (FDA) and other government agencies are very slow in responding to science that shows no amounts of lead are safe in baby food, so lead positive baby foods currently meet current government standards.   While the FDA is said to be working with baby food manufacturers to see what might work to limit the amount of lead found in foods frequently given to children, the U.S. Centers for Disease Control and Prevention stated way back in 2012 that there are no safe levels of lead for children.  The food manufacturers are working to play this down and point fingers to lead being “naturally” in soil and water all over the world.  Researchers counter this argument by stating that lead in soil is often not “naturally” occurring and instead from pesticides, leaded gasoline, industrial sources, and processing in food handling equipment. The Environmental Defense Fund is aware that perhaps lead cannot be limited altogether, but they are working to push food manufacturers to test more during processing and voluntarily set a 1 ppb of lead in baby food limit.

Why should consumers be concerned about lead in their child’s food?  Research has found that children with higher lead in their blood are more likely to suffer from lower IQ’s that are associated with difficulties in school and learning, as well as cognitive and speech problems.  While the fight continues with advocacy groups trying to get the government to tighten food/lead standards, and push the food manufacturers themselves, parents must ask themselves what to do about their own baby’s diet.  Fortunately, in this age of health consciousness many parents have gone to making their own baby food out of organic ingredients to better now what is going into their baby’s nutrition.  All parents must weigh out the pros and cons of using manufactured baby foods, versus homemade foods and make decisions for what will be safest for their family.        

Inserra Kelley Sewell, Personal Injury Attorneys, strives to keep its readership aware of potential dangers to themselves and their loved ones in a world full of product dangers and recalls.  If you or one of your loved one has been ill-impacted by a product do not hesitate to contact the firm to inquire as to whether you might have a claim.

Mibelas Nationwide Birth Control Recall

Lupin Pharmaceuticals, Inc. has voluntarily recalled some of its birth control pills, called Mibelas 24 Fe (Lot L600518, Expiration Date 05/18).  A packaging error occurred, in at least one market reported complaint, in which the blister pack the pills are housed in was rotated 180 degrees so that the weekly tablet schedule was reversed and the wrong pills were taken at the wrong time.  The first four days taken by the consumer were the placebos rather than the active pills.  The result of such a mistake in manufacturing can be pregnancy.   In addition to causing an unwanted pregnancy by such an error, the stakes could go even higher if an individual should become pregnant when pregnancy is contraindicated and even life threatening. 

Customers with possible lot number of L600518 birth control pills, in a wallet of 28 tablets or carton of 3 wallets, are supposed to receive a recall letter.  If in doubt, check the lot number on prescribed Mibelas pills to be safe.  If you do find you have the affected lot, contact your personal doctor and take the pack back to your pharmacy immediately.  The U.S. Food and Drug Administration (FDA) has a MedWatch program to which adverse events from such a product can be reported.  The online version can be obtained at www.fda.gov/medwatch/report.htm, and the version to be downloaded can be obtained at www.fda.gov/MedWatch/getforms.htm.   

If you or a loved one has already been adversely affected by Lupin’s Mibelas, or any medical device, drug, or other product, consult your medical provider immediately, and do not hesitate to contact Inserra Kelley Sewell, Personal Injury Attorneys, to discuss your possible claim and entitlement to compensation for your damages.     

Fidget Spinner Choking Hazards

2017 has netted a new, perhaps somewhat controversial, product fad in the fidget spinner.  This toy was at first looked to by parents as a possible aid to kids with attention deficit hyperactivity disorder or autism spectrum disorders.  The popularity then spread like wildfire to the mainstream masses, perhaps looked to by harried parents to occupy their kids for a little while.  The fidget spinner, in addition to not being as loved by teachers in the classroom as parents might think, now is found to be a choking hazard.  A firefighter’s young daughter reportedly came close to choking on a metal piece that came flying off the spinner and into her mouth.  The firefighter, schooled in rescues, reported performing five minutes’ worth of back blows to get the metal piece out of his own little one’s esophagus.  The metal piece, unfortunately, then went into the girl’s stomach so she had to be hospitalized.  This young girl’s story turned out okay in the end, but this girl is not the only story and the fidget spinners pose future risks for other users.  A girl in Texas also had a part from her fidget spinner lodge in her throat and after the mother could not get it to dislodge by Heimlich maneuver, surgeons had to remove it endoscopically.   

If you or a loved one has already been injured by a fidget spinner, or another product, do not hesitate to contact Inserra | Kelley | Sewell  for compassionate expertise concerning whether there may be a claim to compensation.