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Thursday 7 April 2011

FEDERAL DRUG AGENCY - WARNING NON-STIMULANT ADHD DRUG = Atomoxetine has increased Suicide risk! (2006)

Red is natures colour warning - danger!
The FDA  approved Atomoxetine, a new non-stimulant drug in 2005 to treat ADHD in adults and children over age 6. This was not the first non-stimulant medication for ADHD though. Antidepressants, including Wellbutrin (bupropion hydrochloride) and tricyclics, like Desipramine and Imipramine, have long been considered second line medications, and are sometimes used when two or more stimulants don't work, are contraindicated, or cause too many side effects. Antidepressants are usually not considered to be as effective as stimulants though. And these medicines aren't FDA approved to treat ADHD, so Strattera's(Atomoxetine) claim of being 'the first non-controlled medication that's FDA-approved to treat ADHD' is technically true.

The introduction of Atomoxetine

was going to be welcome news for most parents. Although widely known to be safe and effective, stimulants like Adderall and Ritalin, have long had a bad reputation and many parents are anti-Ritalin and hesitant to put their kids on a stimulant. So if it isn't a stimulant, how does Atomoxetine work? It is thought to be 'a potent inhibitor of the presynaptic norepinephrine transporter,' which causes more norepinehrine to be available to increase attention and control hyperactivity and impulsivity. Like the stimulants, it is not yet known exactly how Strattera works though.

Although a new medicine, six research studies have already been done that show that Atomoxetine is safe and effective.

One of these studies, Atomoxetine and methylphenidate treatment in children with ADHD: a prospective, randomized, open-label trial, compared Strattera and Ritalin. These children with ADHD, 228 in all, received either Atomoxetine or Ritalin for 10 weeks, and those who took Atomoxetine were found to have 'symptom reduction' and 'tolerability' that were 'comparable to that observed with' Ritalin.

Atomoxetine Suicide Warning
Adrian Wade committed suicide 2006 after taking Atomoxetine for 115 days.

The drug's manufacturer  has admitted  that their drug  prescribed to treat ADHD and hyperactivity causes more children to have suicidal thoughts. This is after the FDA requested that they provide the data that they apparently had not disclosed showing the link between suicide and this ADHD drug. After reviewing this information the FDA seems to have requested that it carry a warning on it’s label.

THE WASHINGTON POST — The Food and Drug Administration warned doctors recently about reports of suicidal thinking in some children and adolescents who are taking Atomoxetine, a drug used to treat attention deficit hyperactivity disorder in children.

  The drug'smanufacturer announced that a black-box warning will be added to the drug’s label in the United States. Such a warning is the most serious that can be added to a medication’s label, and similar warnings will be added to the drug’s labels in other countries. The company said a study showed instances of suicidal thinking were rare.

In a statement, the FDA said it “is advising health care providers and caregivers that children and adolescents being treated with Atomoxetine should be closely monitored for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of therapy or when the dose is changed.”

From studies in the U.S. that were provided the FDA results from Atomoxetine clinical trials of 1,357 patients that found five youths taking the medication reported having suicidal thoughts, while none of 851 patients taking a placebo reported having any. One young person taking Atomoxetine attempted suicide, but survived, company and FDA officials said.

There was no evidence of increased suicidal thoughts in adults taking Atomoxetine, which also goes by the generic name atomoxetine.

“The actual risk is very low,” said Dr. Thomas Laughren, head of the FDA’s psychiatric drug unit. Despite the warning, he said, “FDA still views Strattera as an effective drug.”

At the FDA’s request, a guide will be published for doctors and pharmacists to give to people who are prescribed Atomoxetine.

Based on the information that was provided to the FDA on  the statistics are very concerning. If you take the total number of children being treated for ADHD and hyperactivity with drugs like these (over 5 million kids) you get some alarming numbers. Assuming that similar drugs have the same side effects there are  thousands of kids experiencing suicidal thoughts from these drugs. Statistically using the same figures that were  provided in their press release you get these numbers:

  Thousands of children will have been having suicidal thoughts as a direct side effects of these medications. The most horrific number is the nearly 4,000 children who have been likely to act on these thoughts and attempted suicide.What are the figures for deaths as a result?

Drugs often lift the childs energy level before their mood is enhanced so they then have the energy to carry out their black thoughts.

The facts are there to be seen in the press and pharmaceutical company reports that have often been based on 'selected / or cherry picked'studies. The drug treatments can sometimes cause suicide and psychosis as direct side effects. The amount of potential damage inflicted on society for these children is huge. It’s time that the psychiatry profession and the drug companies re-evaluate this risk of damage and reduce the  harm to our children in this way in the future.

Shareholders - the question of ethical investments. 

 The manufacturer said it is working with the FDA to finalize the product label. It also is working with regulators outside the United States.

ADHD affects 3 to 7 percent of school-age children and manifests itself in inappropriate levels of attention, concentration, activity, distractibility and impulsivity.

This makes prescribing expensive drugs an ever expanding "market opportunity" for sale of these drugs with consequent increases in share values.Is this ethically acceptable? 

Companies with ethical investment portfolios like the Co-Op would review buying these shares.

Some of the manufacturer's own warnings published-2011.

WARNINGS AND PRECAUTIONS-----------------------
• Suicidal Ideation – Monitor for suicidality, clinical worsening, and
unusual changes in behaviour.
• Severe Liver Injury – Should be discontinued and not restarted in
patients with jaundice or laboratory evidence of liver injury.
• Serious Cardiovascular Events – Sudden death, stroke and myocardial infarction have been reported in association with atomoxetine treatment.
Patients should have a careful history and physical exam to assess for presence of cardiovascular disease. Atomoxetine generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or
other serious cardiac problems that may place them at increased vulnerability to its noradrenergic effects. Consideration should be given
to not using Atomoxetine in adults with clinically significant cardiac abnormalities.
• Bipolar Disorder – Screen patients to avoid possible induction of a mixed/manic episode.
• Aggressive behaviour or hostility should be monitored.
• Possible allergic reactions, including anaphylactic reactions,
angioneurotic edema, urticaria, and rash.
• Growth – Height and weight should be monitored in pediatric patients.

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