Do you use caffeine to treat your attention deficit disorder? Or do you avoid caffeine at night to protect your mission-critical sleep? In either case, you probably ought know how much you’re taking and when. Problem is, if you’re drinking decaf coffee, you can’t always be sure.

Excerpt from A Wake-Up Call for Coffee Drinkers, New York Times, October 25, 2007:

Coffee sleuths from Consumer Reports recently tested cups of decaf ordered at Dunkin’ Donuts, Starbucks, Seattle’s Best Coffee, 7-Eleven, McDonald’s and Burger King. They visited six locations of each chain, evaluating 36 cups of decaf in all.

A regular cup of coffee has from 85 to 100 milligrams of caffeine. Most of the 10- to 12-ounce decafs tested had less than five milligrams, the magazine reports in its November issue. But one decaf from Dunkin’ Donuts contained 32 milligrams of caffeine — about the same amount in 12 ounces of Coca-Cola Classic. A cup of Seattle’s Best was found to contain 29 milligrams of caffeine, while a tall Starbucks decaf packed 21 milligrams. Results varied at each chain, but the magazine found that the decaf at McDonald’s consistently had the lowest levels of caffeine.

Coffee beans image courtesy of iband clip art for all.

Excerpt from Caffeine: “Herbal” Treatment of ADD/ADHD, by Monroe Gross, MD

Over 60% of ADD/ADHD people who entered my medical practice came to me using substantial amounts of caffeine to fight daytime tiredness and inadequate mental focus. This tells us, of course, that many ADD/ADHD people benefit from caffeine but it also says that many give up caffeine because it offers less than adequate treatment of their ADD/ADHD brain chemistry.

Caffeine is a potent stimulant. It does reduce daytime tiredness and improves mental focus in many with and without ADD/ADHD. It may not be as powerful as the amphetamines and methylphenidate (Ritalin), but it sure can be helpful for many with ADD/ADHD when it comes to functioning at work, in school, and in society.

…For completeness, let’s keep in mind some of the major drawbacks of caffeine for treating ADD/ADHD. First of all, caffeine is a short-acting stimulant with effectiveness usually for only three to four hours after each dose. Mental focus is improved but usually not to the degree it is with the amphetamines and methylphenidate. At doses that improve mental function, many ADD/ADHD people experience irritability, feel shaky, and are emotionally edgy. Also, when the stimulatory effect wears off, sedentary (i.e., those sitting and reading) individuals usually suffer from a mental “crash” characterized by listlessness, enervation, lack of motivation, feeling cranky, and being explosive. Finally, long-term users of caffeine who suddenly stop ingesting caffeine often suffer for one to three days with severe headache.

– Dr. Monroe Gross, MD, is founder of the ADD Medical Treatment Center of Santa Clara Valley.

The FDA requires pharma manufacturers to include “New Drug Application” (NDA) data in some of their packaging inserts.  Here is an excerpt of the side effects data for Strattera:

Commonly observed adverse events in acute adult placebo-controlled trials — Commonly
observed adverse events associated with the use of STRATTERA (incidence of 2% or greater) and not observed at an equivalent incidence among placebo-treated patients (STRATTERA incidence greater than placebo) are listed in Table 2. The most commonly observed adverse events in patients treated with STRATTERA (incidence of 5% or greater and at least twice the incidence in placebo patients) were: constipation, dry mouth, nausea, appetite decreased, dizziness, insomnia, decreased libido, ejaculatory problems, impotence, urinary hesitation and/or urinary retention and/or difficulty in micturition, and dysmenorrhea.

Source: Strattera NDA 21-411 (p. 16)  The NDA also includes other conditions that prompted subjects to drop out of the test.

Modafinil (marketed as Provigil): Serious Skin ReactionsFDA has been monitoring cases of serious skin reactions, including erythema multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), in its postmarketing reviews of adverse event reports associated with the use of modafinil. The product labeling for modafinil has been recently updated to include a bolded warning for serious rash, including SJS. Based on postmarketing data for modafinil, a recently approved drug with a similar chemical structure, armodafinil, includes a similar bolded warning in the product labeling. Healthcare professionals and patients should be watchful for skin reactions associated with the use of modafinil and armodafinil and report cases to FDA’s MedWatch.

From FDA Drug Safety Newsletter, Fall 2007.

Modafinil (sold as Provigil, which is targeted for prevention of certain sleep disorders) is often provided as an off-label prescription for the treatment of attention deficit disorder. In 2006, the FDA denied the Cephalon company’s request to approve modfinil (to be sold under the brand name Sparlon) as an ADHD treatment for children and adolescents. In denying the request, the FDA cited particular concern for the potential of SJS. Full article on Sparlon here at Marketwatch.

“Working memory is a mysterious kind of inward eye that allows us to maintain brain-based models of our surroundings…

“Drugs like guanfacine [occasionally used to treat ADHD] work by stopping production of cyclic AMP, thus allowing the cortical network to remain connected and critical working-memory functions to proceed unchecked.

“[Yale University neurobiologist] Arnsten next plans to investigate whether conditions like ADHD, schizophrenia, and age-related cognitive decline might be touched off by the opening of too many HCN channels, leading to mental lapses.”

– from Gatekeepers of the Mind, in Yale Alumni Magazine, July/August 2007

According to the National Institute of Health, guanfacine (sold under the brand name Tenex® by ESP Pharma) is primarily used for high blood pressure, with some use for migraine headaches and drug withdrawal symptoms.

A Yahoo! Health article on ADD/ADHD states:

“[Other]  medications are sometimes tried if symptoms persist after initial treatment with one of the above medications. These medications are usually not used in younger children.

• Antihypertensives, such as Catapres and Tenex, which may be used to treat aggression and impulsivity not controlled by ADHD medications.”

New medicine on the market — from the makers of Adderall XR. Their press release, below:

FDA Approval of VYVANSE™ as a Novel Treatment for ADHD

23 Feb 2007 - Basingstoke, U.K., Philadelphia, PA and Radford, VA – FEBRUARY 23, 2007 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and its collaborative partner New River Pharmaceuticals Inc. (NASDAQ: NRPH) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d-amphetamine is covalently linked to l-lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d-amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication’s unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Additional information about VYVANSE and other Shire treatments for ADHD is available at www.ShireADHDTreatments.com.

ADHD Drug Makers to Warn of Side Effects

The Associated Press

Wednesday, February 21, 2007; 7:01 PM

WASHINGTON — Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death.

The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems.

Draft versions of the guides posted on the FDA Web site include discussion of reports of increased blood pressure and heart rate in ADHD patients, as well as cases of sudden death in some who have heart problems and heart defects. In adult patients, the reported problems also include stroke and heart attack.

The alerts also cover psychiatric problems, such as hearing voices, unfounded suspicions and manic behavior, of which there is a slightly increased risk in patients who take the drugs, the FDA said. The guides also tell patients and their parents of precautions they can take to guard against the risks.

Wednesday’s announcement came roughly a year after two panels of FDA advisers recommended that the drugs include such patient medication guides. The announcement covers 15 drugs, including extended-release, patch and chewable versions of some of them.

Ritalin is manufactured by Novartis Pharmaceuticals Corp. and in generic form by other companies; Adderall is made by Shire Pharmaceuticals Inc.; Strattera by Eli Lilly & Co.

ADHD affects an estimated 3 percent to seven percent of school-age children and four percent of adults, the FDA said.

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On the Net:
Food and Drug Administration ADHD drug information: http://www.fda.gov/cder/drug/infopage/ADHD/default.htm

Here’s a new item I hadn’t heard about until today: Focus ADDult for Adult ADD, a herbal remedy from Native Remedies. According to the manufacturer’s site (NativeRemedies.com), the active ingredients are:

- Centella asiatica (main ingredient)
- Rosmarinus officinalis (Rosemary), and
- Panax Ginseng

Has anyone tried it?

Here are the product claims from the Amazon listing:

Focus ADDult for Adult ADD, Improve Concentration, 50ml, $27.90

Focus ADDult, a 100% natural and proven herbal remedy, is formulated to treat and relieve symptoms of Adult and Teen ADD without side effects and dangers of prescription drugs. With Focus ADDult concentration, focus and memory will improve and improvement should increase over time and with continued use. Youll notice you can think more clearly and in more focused way. Students and scholars should notice increased concentration span and ability to study effectively for longer time periods.

Being 100% natural, with no artificial preservatives, Focus ADDult for adults and teens, is non-addictive and has NO SIDE EFFECTS. It has become the formula of choice by thousands of satisfied customers around the world for treating Adult and Teen ADD.

Adults and teens who suffer from ADD have had to resort to prescription psycho-stimulant drugs with the dangers of addiction and side effects. A safe and natural alternative for adults and teens with ADD, Focus ADDult uses a specially selected therapeutic blend of herbs from around the world, specifically to address symptoms of Adult ADD. Be aware that lifestyle factors like diet, health and fitness levels will all play a part in concentration and overall cognitive functioning.

Obvious disclaimer: This ADDexecutive article does not constitute an endorsement of this product. The ADDexecutive would, however, love to know if anyone has tried it or knows more. Your comments are welcome, below.

Photo credit: Amazon.com. Click pic to enlarge.

Medication Management for Adults with AD/HD – 16 pages, published March 2004 by The National Resource Center for AD/HD (a program of CHADD).

Why didn’t my doctors give me this paper on our very first meeting?

It would have answered half the questions I tried to get answered
during our too-brief sessions, and a lot of questions I never got to
ask like, “has anyone taken a good look at how these meds will affect
my cardiovascular health?” and “can you tell me again why Adderall
might be better for me than Prozac (or vice versa)?”

I like how this piece is both readable and technically
comprehensive.  Among the contents: comparisons of different meds,
dosing considerations and effects, side effects, and cautions on
addiction risk.

Excerpt:

“This information and resource sheet will:

• provide a basic understanding of how stimulants can be used safely and effectively to treat AD/HD in adults.
• discuss nonstimulant medications for AD/HD in adults, including
  those approved by the Food and Drug Administration for the treatment of
  AD/HD in adults
• discuss the effect of coexisting psychiatric disorders on the medical treatment of adults with AD/HD.”

Note: If you find other references like this one (or better in any way), please leave a comment to let us know.