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Alarms are sounding over some prescription drugs for kids

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Warnings about the drugs are disturbing.  Parents and caretakers should exercise extreme caution when Tramadol, Paxil or Risperdal are recommended for their children.  The popular medications have serious side effects.  Some are exceedingly dangerous.  The U.S. Food and Drug Administration (FDA) recently announced an investigation of the painkiller Tramadol and its potentially fatal side effect in children.  A new study of the anti-depressant Paxil claims it is not safe for teenagers.  And claims are mounting that Risperdal; a widely used drug for autism, can permanently alter the physical development of young children.

New warnings about Tramadol

New research indicates it may not be safe for those under the age of 17.  The U.S. Food and Drug Administration (FDA) recently announced it has begun investigating its use among children.  The pain killer turns into a morphine-like drug once it’s administered.  It can slow down breathing to dangerous levels in some children.  Although it is not FDA approved for use after tonsillectomies and surgery to remove adenoids, it is not illegal for doctors to prescribe it, even though “the risk may be increased” in young patients who receive Tramadol after these procedures.

Some children are “ultra-metabolizers,” meaning their bodies quickly convert Tramadol into a morphine-like derivative, resulting in an overdose.  The FDA recently approved OxyContin for use in children who have pain after surgery, accidents or other medical conditions.  OxyContin, has guidelines for prescribing it for children, unlike Tramadol, which doctors have used “off-label “for kids even though that is not recommended.

New warnings about Paxil   

A new study of Paxil - which has been used to treat depression in teenagers - concludes that it is not “safe or effective” for teens.  The study used GlaxoSmithKline’s own files for its reanalysis of the research that the drug’s maker submitted to the FDA 14 years ago to get Paxil approved.  The new review concluded that Paxil’s side effects were “mislabeled” and that it had” no clear effectiveness.”

Prescriptions of Paxil for teens surged after it was approved in 2001, increasing “by 36 percent between 2002 and 2003.”  They slowed after the FDA ordered a black box warning for labels of the drug.  The warning was added because Paxil can cause severe suicidal and homicidal ideation.  In the original research that GSK presented to the FDA in 2001, it called those side effects” “emotional lability,” but provided no detail.  The term covered up attempted suicides and homicidal plots by teenagers.

In 2010, GlaxoSmithKline paid close to $1.14 billion to settle lawsuits charging that Paxil caused birth defects.  In 2012, GSK pled guilty to promoting Paxil and another of its drugs for unapproved uses and paid $3 billion in fines.  The company was also found guilty of paying kickbacks to doctors.

New warnings about Risperdal

Risperdal is an anti-psychotic drug that has been widely used to treat autism, schizophrenia and bi-polar disorder in children between the ages of 10 and 17.  It was the first drug of its kind approved by the FDA for treating kids who have violent tantrums, are inclined to self-injury and hotheaded aggression.  And it has been effective in controlling these behaviors.  But its side effects are being seriously questioned by some parents and some in the medical profession.

Risperdal has serious risks – very rapid weight gain and metabolic changes.  It increases prolactin.  The hormone makes the body “think it is pregnant,” according to one medical expert, who points to the development of “breasts” in some boys and breast milk in girls.  It can also cause tardive dyskinesia – rapid involuntary movements such as jerks and twitches that cannot be controlled.

Medical experts warn that Risperdal should only be prescribed in the most serious cases of anti-social and disruptive behavior, given its disturbing side effects.  Its maker, Johnson & Johnson, “has agreed to pay” more than $2.2 billion “to resolve claims that it improperly marketed Risperdal and two other drugs.”

Take action with Wayne Wright

The Wayne Wright law firm is dedicated to aiding children and families victimized by pharmaceutical companies selling bad drugs to unsuspecting victims.  Consultations are free and calls are welcomed.  For more than 30 years, the firm has been successfully representing those who have been hurt by unscrupulous drug companies that sacrifice health for profits.

 

 

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