Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.
The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy.
Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.
If you’ve ever had a credit card with Home Depot, be sure to check your credit report.
ISSUE: Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its appetite controldietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Bloomberg news just reported that Johnson & Johnson’s first trial concerning its “Pinnacle” hip replacements will begin today. There are a total of approximately 6,000 cases alleging that the Pinnacle hip replacements were defectively designed causing metal debris to be absorb into patient’s blood stream.
We are currently handling both these cases and other similar cases involving J&J’s “ASR” hip replacements. Please let us know if you have received either hip implant, as you may be unknowingly suffering from metal poisoning. If you or a loved one has received a hip replacement between the years of 2005 – 2013, I would strongly advise you to contact your doctor to determine the exact make and model of the implant. Let us know if you need help finding this out. All initial consultations are free.
Johnson & Johnson JNJ, which set aside $2.5 billion last year to resolve claims that 8,000 of its artificial hips were defective, faces a new round of lawsuits over another line of hip implants blamed for poisoning patients.J&J’s DePuy unit is starting its first trial of allegations that the metal-on-metal version of the Pinnacle hip was defectively designed and caused metal debris to leech into patients’ bloodstreams. The cobalt-and-chromium material caused an infection that forced Kathleen Herlihy-Paoli to have her artificial hips surgically removed, she said in court filings.
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
Consumer 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
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
FDA’s List of additional products just for 2014 with “hidden drugs:”
- 07/08/2014 Public Notification: Mix Fruit Slimming Contains Hidden Drug Ingredients
- 07/08/2014 Public Notification: Lingzhi Cleansed Slim Tea Contains Hidden Drug Ingredient
- 07/08/2014 Public Notification: 24 Ince Contains Hidden Drug Ingredient
- 07/08/2014 Public Notification: Lipo 8 Burn Slim Capsules Contain Hidden Drug Ingredient
- 07/08/2014 Public Notification: Sliming (sic) Diet By Pretty White Contains Hidden Drug Ingredient
- 07/08/2014 Public Notification: Trim-Fast Slimming Softgel Contains Hidden Drug Ingredient
- 06/17/2014 Public Notification: Sport Burner Contains Hidden Drug Ingredient
- 06/17/2014 Public Notification: Toxin Discharged Tea Contains Hidden Drug Ingredient
- 06/17/2014 Public Notification: Sliming Diet Contains Hidden Drug Ingredient
- 06/10/2014 Public Notification: La Jiao Shou Shen Contains Hidden Drug Ingredient
- 06/05/2014 Public Notification: B-Perfect Contains Hidden Drug Ingredient
- 05/16/2014 Public Notification: Asset Bold Contains Hidden Drug Ingredient
- 05/12/2014 Public Notification: Asset Bee Pollen Contains Hidden Drug Ingredient
- 05/05/2014 Public Notification: Natural Body Solution Contains Hidden Drug Ingredient
- 05/05/2014 Public Notification: Slim Trim U Contains Hidden Drug Ingredient
- 04/10/2014 Public Notification: Lite Fit USA Contains Hidden Drug Ingredient
- 04/10/2014 Public Notification: Infinity Contains Hidden Drug Ingredient
- 04/02/2014 Public Notification: New You Contains Hidden Drug Ingredients
- 03/19/2014 Public Notification: Vitaccino Coffee Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Citrus Fit Gold Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Tonic Life BP Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Hot Detox Contains Hidden Drug Ingredient
- 01/28/2014 Public Notification: Thinogenics Contains Hidden Drug Ingredient
- 01/21/2014 Public Notification: Dream Body Slimming Capsule Contains Hidden Drug Ingredient
- 01/21/2014 Public Notification: Magic Slim Contains Hidden Drug Ingredient
You can watch the FDA’s video on “Tainted Weight Loss Products” here: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm.
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
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.