Gov't Advisers Reject Strong ADHD Warnings

[Dover]

Gov't Advisers Reject Strong ADHD Warnings

By ANDREW BRIDGES, Associated Press Writer
Fri Mar 24, 1:17 AM ET



WASHINGTON - Federal health advisers said Wednesday that Ritalin and other drugs for attention deficit hyperactivity disorder should not carry strong "black-box" warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration pediatric advisory committee recommended that the drug labels include warning language written so people can understand it. "I wouldn't use the word 'tougher,' said panel chair Dr. Robert Nelson, of the Children's Hospital of Philadelphia. "'Clearer.'"

By rejecting the black-box warnings in a consensus decision, the advisory panel broke with another committee that voted just last month to include them on some ADHD drugs.

The FDA was poised Wednesday to follow the more recent recommendations.

"I think we are likely to follow them, yes," said Dr. Robert Temple, director of the FDA's office of medical policy, following the meeting.

Any updated language may not appear on labels until pharmaceutical companies begin using a recently adopted format, something that could take several years. And the FDA may yet require black-box warnings on stimulants to treat ADHD that would alert adults to increased risk of heart attacks, strokes and other similar problems, Temple said...cont'd

http://news.yahoo.com/s/ap/adhd_drugs;_ylt=AgIiIJv4tsSBkdEgxlLamYys0NUE;_ylu=X3oDMTA2Z2szazkxBHNlYwN0bQ--

[rodeodance]

1. yet, this FDA has sat on the morning after pill for years! and now 'poised

for this drug (which has proven to have severe problems).


.....The FDA was poised Wednesday to follow the more recent recommendations.

[bloom]

2. I suppose the "Gov't advisors" are people from Lilly, Novartis

and whoever is making these drugs.


For more about the psychological affects see:

Ritalin may cause "hallucinations of insects, snakes or worms". NYT

http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=222x6001

[Celebration]

3. Evaluating Health Warnings Ritalin Abuse

http://www.sfgate.com/cgi-bin/article.cgi?file=/chronicle/archive/2006/03/24/EDGU9GJG091.DTL

Until two weeks ago, my concerns about prescription-stimulant abuse were based only on rumor and anecdote. Now, the first hard data come from a study funded, not surprisingly by Eli Lilly, the maker of Strattera, the only nonstimulant approved for the treatment of ADHD (but also vetted by the officials at the Drug Enforcement Administration). The study, published in the journal Drug and Alcohol Dependence, uses a government survey of 54,000 people from 2002 and projects that, nationwide, 21 million individuals have misused a prescription stimulant at least once. Some 3 million have abused only prescription stimulants, and 75,000 young people between the ages of 12 and 25 meet psychiatric criteria for addiction and drug abuse. Since 2002, rates of prescription stimulants to adults have continued to rise, suggesting that this number of 75,000 may be higher today.

With the suggested black-box warning, the committee clearly wanted to get the nation's attention, not only about the cardiovascular risks of the prescription stimulants, which include other well-known drugs such as Adderall and Concerta, but also to alert everyone to their potential overuse in children. The panel kept referring to a study where 1-in-10 11-year-old boys around the country take Ritalin or its equivalent.

The possibility of dying from Ritalin is extremely small for a child without a pre-existing heart condition (on the order of 0.0002 percent). However, 75,000 prescription-stimulant addicts dwarf the number of children who died taking the drug. It also represents a real, not an hypothetical, risk such as that for heart attack and stroke, which so worried the FDA cardiovascular committee.

Of those who casually misused Ritalin, according to this survey, 1 in 10 went on to develop tolerance and addiction to the drug. If one recalls the graffiti on the walls of San Francisco's Haight-Ashbury in the 1960s that read "Speed Kills," the concerns about a 10 percent-addiction rate are indeed chilling.

[bloom]

5. The Lilly angle is interesting

I googled news on Ritalin and this came up:

Sen Grassley also pointed out that in September of 2005, the FDA had issued an alert to healthcare professionals regarding the use of Strattera, after reviewing data showing an increase in suicidal thoughts in 12 separate studies, and directed Eli Lilly, to “revise the labeling…to include a boxed warning and additional warning statements regarding an increased risk of suicidal thinking in children and adolescents.”

As an added pressure, Sen Grassley asked for a complete list of names of participating panel members and a complete list of conflict disclosures for both the February 9-10 2006, advisory committee and the March 22, 2006, Pediatric Advisory Committee....

The report could not have considered the increase in emergency room visits associated to Ritalin abuse alone over the past decade. According to the Drug Abuse Warning Network, while there were 271 Ritalin-related emergency room visits in 1990, there were 1,478 Ritalin-related visits in 2001....

The drugs contain the exact same amphetamine that was THE main ingredient in the once popular "B-12" injections given weekly to wealthy patients in doctor's offices all over the country until they were banned.

So here we are in 2006, with pharma making a killing by selling dangerous drugs that have been outlawed time and time again. What kind of profits are we looking at? As of September 2005, Walgreen's prices for a 30 day supply for the lowest dosage of the top selling drugs were:

• Methylphenidate (generic Ritalin) $15.69

• Ritalin (brand name): $27.79

• Amphetamine/dextroamphetamine (generic Adderall): $47.09

• Adderall (brand name): $94.49

• Concerta: $103.99

• Strattera: $123.99

According to Dr Mosholder, since March 2002, prescriptions written for adults rose by 90%, to about 1 million a month as of June 2005, and to about 2 million a month for children.

http://www.bestsyndication.com/Articles/2006/p/pringle_evelyn/031906_adhd_pharma.htm

[bloom]

4. "Health Canada to boost warnings on ADHD drugs"

"Health Canada plans to add tougher warnings to the stimulants in April that caution people with a family history of heart problems, patients taking another stimulant and those who engage in strenuous physical activity."

http://www.cbc.ca/story/science/national/2006/03/22/adhd-warnings060322.html