Reglan For Reflux has been BLACK BOXED BY THE FDA

Reglan Lawsuits Lawsuits for Reglan-induced damages are becoming so numerous that a Reglan class action lawsuit is being initiated. The reflux/heartburn drug's potential side effects — which include the tardive dyskinesia now highlighted in a "Black Box Warning" on the product's label — have harmed a significant number of people, and victims have filed a motion with the federal Judicial Panel on Multidistrict Litigation to consolidate their Reglan lawsuits.
At least 15 different lawsuits for Reglan drug damages have been filed, in more than 10 jurisdictions across the U.S. A typical Reglan lawsuit is that of Shirlean and Elmer Meade in West Virginia. Shirlean was prescribed a generic version of Reglan (metoclopramide) for her reflux, and she developed tardive dyskinesia. She reported that because of this drug she is now unable to control her:

facial expressions
tongue
mouth
jaw
Reglan Lawsuit Information
Reglan plaintiffs asked in early April 2009 that their lawsuits be combined in the U.S. District of Nevada, where the presiding judge is already familiar with the Reglan issues. He has been handling Reglan lawsuits for more than a year. Thus, the Las Vegas-based federal district court of Judge James C. Mahan may become the central location for lawsuits involving Reglan injuries.
The defective drug attorneys and law firms who are defending Reglan patients who have been injured note that by transferring the Reglan lawsuit to one forum will not only save time, but will also help eliminate conflicting rulings and schedules.

Reglan Lawsuit Settlement
It is hoped that the various lawsuits for Reglan will bring about one or more full and fair Reglan settlement. The many metoclopramide side effects that have been documented by the FDA may result in a recall of Reglan and other versions of this drug (e.g., Maxolon, Degan, Maxeran, Primperan, and Pylomid).

Talk to a Reglan Lawyer
The FDA has already issued a severe-worded advisory regarding potential side effects of Reglan syrup, injections and tablets. A Reglan recall may be next. In the meantime, if you feel that you may have a Reglan lawsuit and are in need of experienced legal support, please contact our Reglan lawyer today.

FDA Alert: Reglan gets Black Box warning
Reglan, generically known as metoclopramide, is a drug commonly prescribed to treat gastrointestinal disorders such as gastroesophageal reflux disease (GERD), persistent heartburn, nausea, vomiting, and a feeling of stomach fullness. Reglan increases pressure at the point where the esophagus connects to the stomach and helps the stomach deliver food into the intestines to complete the digestive process.
In addition to being prescribed to adults for heartburn and reflux, Reglan has also been prescribed by doctors for use in babies, often to treat GERD. While many medical practitioners assured parents of Reglan’s safety and lack of side effects, we now know this is not the case.

Is Your Child Showing Signs of Tardive Dyskinesia?
Evidence shows that extended use of Reglan can cause the serious neurological syndrome, tardive dyskinesia. Tardive means “delayed” and dyskinesia means “abnormal movement.” Tardive Dyskinesia can mimic disorders such as Parkinson's Disease, Tourette's Syndrome, Huntington's Chorea, tics, cerebral palsy, stroke and hyperactivity. Tardive Dyskinesia is often irreversible, may become permanent, and greatly reduces the quality of life of your child.

Symptoms of tardive dyskinesia include:
Involuntary movements - tongue and facial movement specifically
Making faces through grimacing, lip movement and puckering, and sticking out the tongue
In some cases the arms and legs may also suffer, thereby making walking, running or even moving around the home difficult
Tarvdive dyskinesia is difficult to diagnose in your baby since they are learning to use their arms, legs, and make faces without reason, but be sure to watch the babies face and tongue for involuntary movements. Your baby will appear more agitated than normal and these movements should appear different from others. If your baby is showing these signs, contact your pediatrician immediately to discuss Reglan use and if an alternative may be available.

Free Reglan Side Effects Case Evaluation
If you, or your baby, have been taking Reglan and have experienced signs of tardive dyskinesia, contact us to learn your legal rights. All calls and cases reviews are free of charge. Cases are accepted only after a careful review of the facts, medical records and diagnosis. These cases are handled on a contingency fee basis. Client pays no attorneys fees or expenses unless the case is settled out of court or a judgment is obtained in court.

Swaddling website

Miracle Blanket set up the following website and it is really a good site.

www.SwaddlingTruth.com is in response to some bad information and rumors that have been swirling about the country regarding swaddling. These messages are being created by people who have an unjustified dislike of swaddling or a hidden agenda and it’s obvious that they clearly have NOT read the research on the subject. The bad information is being disseminated via “education” and through mislabeled products. It’s confusing and disingenuous at best, and it’s potentially harmful at worst.

Sleep Positioner Dangers FDA Warning

CPSC and FDA News Release
For Immediate Release: Sept. 29, 2010
Media Inquiries: CPSC: (301) 504-7908; FDA: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: CPSC: (800) 638-2772; FDA: (888) INFO-FDA

Deaths prompt CPSC, FDA warning on infant sleep positioners

WASHINGTON, D.C. – The U.S. Consumer Product Safety Commission (CPSC) and the U.S. Food and Drug Administration (FDA) today warned consumers to stop using infant sleep positioners. Over the past 13 years, CPSC and the FDA have received 12 reports of infants between the ages of 1 month and 4 four months who died when they suffocated in sleep positioners or became trapped and suffocated between a sleep positioner and the side of a crib or bassinet.

Most of the infants suffocated after rolling from a side to stomach position. In addition to the reported deaths, CPSC has received dozens of reports of infants who were placed on their backs or sides in sleep positioners, only to be found later in potentially hazardous positions within or next to the sleep positioners.

“The deaths and dangerous situations resulting from the use of infant sleep positioners are a serious concern to CPSC,” said CPSC Chairman Inez Tenenbaum. “We urge parents and caregivers to take our warning seriously and stop using these sleep positioners, so that children can have a safer sleep.”

The two main types of infant sleep positioners are flat mats with side bolsters or inclined (wedge) mats with side bolsters.


FLAT MAT INCLINED/WEDGE

Both types of sleep positioners typically claim to help keep infants on their backs and reduce the risk of Sudden Infant Death Syndrome (SIDS). The FDA has never cleared an infant sleep positioner to prevent or reduce the risk of SIDS. In addition, CPSC and the FDA are unaware of any scientific studies demonstrating that infant positioners prevent SIDS or are proven to prevent suffocation or other life-threatening harm.

“To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS,” said Dr. Joshua Sharfstein, FDA Principal Deputy Commissioner and a pediatrician. “We want to make sure parents, health care professionals, and childcare providers understand the potential risk of suffocation and stop using infant sleep positioners.”

Sleep positioners also typically claim to do one or all of the following: aid in food digestion to ease colic or the symptoms of gastroesophageal reflux disease (GERD); and prevent flat head syndrome (plagiocephaly). In light of the new safety data, FDA believes any benefit from using these devices to ease GERD or prevent plagiocephaly is outweighed by the risk of suffocation.

CPSC and the FDA are warning parents and child care providers to:

STOP using sleep positioners. Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary.
NEVER put pillows, infant sleep positioners, comforters, or quilts under a baby or in a crib.
ALWAYS place an infant on his or her back at night and during nap time. To reduce the risk of SIDS, the American Academy of Pediatrics recommends placing infants to sleep on their backs and not their sides.

The American Academy of Pediatrics does not support the use of any sleep positioner to prevent SIDS.

Manufacturers of infant sleep positioners with medical claims that have not been reviewed by the FDA should stop marketing those products until they submit, and the FDA clears, appropriate premarket review submissions, including necessary safety and effectiveness data.

FDA has informed manufacturers of cleared devices of the agency's serious concern and has requested that they submit clinical data showing the benefits of their products outweigh the risk of suffocation or other serious harm.

Prompt reporting of adverse events can help the FDA and CPSC identify and better understand the risks associated with infant sleep positioners. If you have had a problem with an infant sleep positioner, the agencies encourage you to file a report through FDA’s MedWatch program, at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.

CPSC is interested in receiving incident or injury reports related to these products. Please visit https://www.cpsc.gov/cgibin/incident.aspx to file a report.

For more information:

CPSC: Consumer BlogFDA: Infant Sleep Positioners Pose Suffocation Risk (Consumer article)FDA: Infant Positioner Initial CommunicationFDA: Letter to Manufacturers Concerning Medical Claims About Infant Sleep PositionersFDA: Letter to Manufacturers of 510(k)-cleared Infant PositionersNIH: Back to Sleep CampaignNIH: Preventing Sudden Infant Death Syndrome and Suffocation
AAP: Policy Statement on SIDS


HAZARD



About CPSC
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of the thousands of types of consumer products under the agency’s jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $800 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard. CPSC’s work to ensure the safety of consumer products—such as toys, cribs, power tools, cigarette lighters, and household chemicals—contributed to a significant decline in the rate of deaths and injuries associated with consumer products over the past 30 years.

To report a dangerous product or a product-related injury, call CPSC’s Hotline at (800) 638-2772, teletypewriter at 800-638-8270, or visit www.cpsc.gov/talk.html. Consumers can obtain this press release and recall information at www.cpsc.gov. To join a free email subscription list, go to www.cpsc.gov/cpsclist.aspx.

Miscarriages for the HINI Vaccine

Warning All Pregnant Women: Miscarriages From H1N1 Vaccine As High As 3,587 Cases
September 21, 2010 by Alex
Filed under Eugenics & Depopulation, Featured, Health & Environment, U.S. News
2 Comments
Prevent Disease.com

A shocking report from the National Coalition of Organized Women (NCOW) presented data from two different sources demonstrating that the 2009/10 H1N1 vaccines contributed to an estimated 1,588 miscarriages and stillbirths. A corrected estimate may be as high as 3,587 cases. NCOW also highlights the fact that the CDC failed to inform their vaccine providers of the incoming data of the reports of suspected H1N1 vaccine related fetal demise. NCOW collected the data from pregnant women (aged 17 to 45) that occurred after they were administered a 2009 A-H1N1 flu vaccine.The raw data is available on the ProgressiveConvergence.com website

Using the Vaccine Adverse Event Reporting System (VAERS), including updates through July 11, 2010 as a second ascertainment source, capture-recapture statistical methods were used to estimate the true number of miscarriages and stillbirths following A-H1N1 flu vaccination in the U.S.

Typically , even so-called “complete” studies conducted by the CDC have been shown to miss from 10% to 90% of the actual cases because of under-reporting.

The statistical method employed is an expeditious and cost effective method of attempting to ascertain a complete count of all cases when two or more ascertainment sources (VAERS and NCOW survey) have failed to collect all the existing cases.

Overall, this approach show that approximately 15% of the occurences of a miscarriage or stillbirth were actually reported.

Read Entire Article

Different approach to sleep training

The Bliss of Baby Sleeping--All Night Long

by Tera of "Thriving Momma

"The first year with my babies was a litany of sleep-deprived nights, up every two hours to feed. Though I had a co-sleeper next to my bed, baby ended up by my side, my nursing breast accessible whenever baby whimpered. In the morning I’d wake up, pajama draped around my neck but baby snuggled close. I barely remember that first year. Sleep deprivation stymied my sentences and short-term memory. With my third child I vowed not to repeat this saga again.

The other night I lay my 2-month-old baby down on her mattress. She was awake and protested slightly. But she looked at herself in the mirror–a montessori-style sleeping arrangement set-up for the infant. After several minutes she drifted off to sleep. She stayed asleep for 5 hours. My heart danced with joy.

How did I manage this shift? Whether it’s sleeping habits, colic, bedwetting, or sibling rivalry, using the Law of Attraction can help shift the challenging behavior.

1. Set the intention. Journal what you would like to create. I like to write a letter to my angels. Write it in present tense as if it has already happened. Express gratitude. For example, “I am so happy and grateful my baby goes to sleep peacefully on her own and sleeps through the night. etc.”

2. Use energy work such as Emotional Freedom Technique EFT or Calyco Healing to find the emotional block and clear it. EFT is a free technique that uses tapping on acupressure points while repeating a release statement, followed by repeating the affirmation of what you want to create. For example, when I first attempted to put my baby on her crib mattress, she cried. While she cried, I comforted her and tapped lightly between the eyebrows, on her sternum, underneath her armpit, and on the crown of her head. I could see her distress lessen.

3. Use muscle-testing to pinpoint the root cause of the challenge. One method is to make an “O” with your thumb and finger on one hand. Use your other finger to try to break the O. Practice by testing the difference when you say Yes versus No. For example, the second night when my baby cried, I thought she was still resistant to sleeping on her mattress. Muscle-testing revealed that she was fine with her mattress, but was not comfortable with sleeping apart from me. We were able to clear that through Calyco Healing.

If you are not comfortable with EFT or Calyco Healing, you can always seek help from an energy work practitioner. Calyco Healing has been an amazing tool I use with my own clients because it can release emotional blocks about multiple issues in one session.

Know that when we face a challenge, this is simply the in-between space before overcoming the struggle. Keep on moving forward and the storm will pass. Remembering this will help shift the vibration faster in your favor.

Now, my breastmilk-fed baby sleeps until the morning.

Happy Parenting!

Kangaroo Care Saves Baby

Categories: News

This week, an Australian couple, Kate and David Ogg, said that a "kangaroo cuddle" saved the life of one of their twins. Doctors told the couple that baby boy Jamie, who was delivered prematurely at 27 weeks and weighed 2.2 pounds, would not live.

Hospital staff tried to resuscitate the child for 20 minutes before giving the parents the heartbreaking news that Jamie had died, meaning only one of their babies would make it, French news agency AFP reported.

But Kate placed the baby on her chest and used the kangaroo method, which involves skin-to-skin contact between mother and child. She remained in that position for two hours and soon the infant's gasps became more regular and, after a while, he opened his eyes. When the Oggs sent their doctor a message that Jamie was showing signs of life, he dismissed the movements as reflexes.

Kangaroo care is a method that's often used on premature babies where the infant has skin-to-skin contact with his or her mother, just like a marsupial. It's thought that this type of closeness can help regulate the preemie's heartbeat and body temperature, giving the baby a better chance of survival.

In typical kangaroo care, the baby wears only a diaper and is secured to the mother's chest in a head-up position with a piece of cloth (example top left). The cloth wraps around under the baby's bottom to create a tight bundle -- like a kangaroo pouch.

Dr. Mitchell Goldstein, who practices neonatal-perinatal medicine and pediatrics in West Covina, Calif., tells AOL Health that it is possible that this baby was saved by kangaroo care. "This story is intriguing. I'm not saying that in all cases kangaroo care will resuscitate every preterm baby, but there are certain cues moms provide for babies -- it's something that's a testimony to the maternal instinct bond," he says.

"In the NICU, we're applying chest compression and respiration that are much more vigorous. Medications and fluids were probably given, and then when these things did not make a difference, they gave up. Would I advocate using kangaroo care before vigorous resuscitation? No. But after trying it, yes," says Goldstein.

But kangaroo care isn't for all preemies. If a baby is so small that his skin hasn't had a chance to fully developed, the skin could stick to the mother's body, causing more harm than good, Goldstein says.

Kangaroo care widely is used in developing countries where hospital crowding is common and there is a shortage of caregivers. If there aren't enough incubators available, skin-to-skin contact can regulate the baby's temperature. The method also allows for easy access for breast feeding and bonding opportunities between parent and baby (dads can do it, too).

Other benefits of kangaroo care include less stress for the parent and baby and lower hospital costs. But for the Oggs, the proof that kangaroo care works comes from the fact that their son Jamie is now very much alive and thriving. Now 5 months old, he and his twin sister have been taken to the United States on a media tour with their parents.

"Studies have shown that in third world countries kangaroo care improves survival rates by 90 percent," says Goldstein. "Moms are nature's incubators -- and not only to warm a baby. If a baby's temperature gets too high the mom will cool down. Kangaroo care also improves breast feeding. It can have a tremendous benefit for all babies, whether or not they are in distress or preterm."

Breast Milk Storage discussed

This is a quote from a mother who was not identified:

I have to say that for the better part of the 8+ years I have been pumping and breast feeding my four kids, I have never left it out this long, but the most definitive research performed says you can leave fresh breast milk at room temperature for 10 HOURS!
Breast milk has anti-bacterial qualities which inhibit bacterial growth in the milk, even at room temperature. In fact, the bigger issue is not from the milk itself, but rather from other contaminants that affect the milk collection process, such as germs on mom’s hands and skin, the bottle, cap, etc.

Here are a couple of really interesting references for the 10 hour figure. There was a landmark study done in 1987 by researchers named Barger and Bull that compared milk in clean but not sterile containers left for 10 hours at room temperature and 10 hours in the refrigerator. The study found no statistically different bacteria levels! Just amazing! Here are some articles in order of preference.....

http://www.llli.org/FAQ/milkstorage.html
http://members.tripod.com/~bmsg/storageconcerns.htm

http://www.llli.org/NB/NBJulAug98p109.html
http://parenting.ivillage.com/baby/bbreastfeed/0,,3x9q,00.html
I myself, never left milk out longer than probably four hours or so. There were a few times when at work I realized I forgot the ice packs and it stayed warm the whole day. There were no ill effects on junior! All of this may have had more to do with my germ paranoia than actual science.
When my youngest was in the NICU and I was hospitalized after his birth I was pumping. I couldn’t get out of bed to deliver his milk to the NICU, and the poor nurses were often too busy to cart it down there for me. So I often worried about it "spoiling". Once when the neonatologist visited me to discuss my son I asked him about the milk at room temperature. I didn’t believe him at the time, but he said expressed breast milk was fine for up to 12 hours, and in fact has been used over the course of history in medicine to treat the wounds of patients who were injured in emergency situations when no other form of treatment was available. Again, just AMAZING!
Enjoy your breastfeeding experience and good luck with the pumping. What a wonderful gift for your baby!!