How do you want your Strattera be delivered? Choose here!

Clinical Psychiatry News - FDA warns manufacturers about ADHD drug claims

admin — Mon, 12 Jan 2009 05:10:18 +0000

The Food and Drug Administration has warned five manufacturers of drugs for attention-deficit/hyperactivity disorder against using what it terms “false or misleading” promotional materials that overstate the drugs’ efficacy and downplay risks.
The warnings, contained in letters sent in late September to the makers of Adder-all XR, Concerta, Focalin XR, Methylin, and Strattera, “cite issues we’ve been seeing across the promotion for this therapeutic area,” said FDA spokeswoman Sandra Walsh in an interview.

Related Results

StratteraStrattera dispensingStrattera now availableStrattera now availableApprovable letter for Strattera

Ms. Walsh said the letters to the five manufacturers, which were developed together, were part of the FDA’s “routine monitoring of drug ads and promotional materials” and did not signal forthcoming additional FDA enforcement action against the companies. Regulators “had some concerns with promotion of one product in that class,” Ms. Walsh said. ‘As a procedural process, we decided to look at all the drugs in that class.” She declined to name the drug that prompted the review.
In the letters, the FDA’s division of drug marketing, advertising, and communications cites promotional materials for Adder-all XR, Methylin, and Focalin XR that imply the drugs can reduce negative consequences potentially seen with ADHD, such as poor social-emotional development and job problems, and poor academic performance. Meanwhile, promotional materials for Strattera imply that the drug will reduce the likelihood of substance abuse disorders, car accidents, and injuries, along with “impulsive sexual behavior,” the FDA said. And promotional materials for Concerta imply that the drug has a positive effect on adolescents’ ability to pursue interests outside of school, it said.
All these assertions are unsupported by the evidence and therefore are misleading, the FDA said.
In addition, the FDA specifically warned Eli Lilly & Co., which manufactures Strattera, about its sales claims surrounding co-morbid ADHD and anxiety. Eli Lilly has used a professional sales aid for Strattera that includes the phrase “not contraindicated in patients with anxiety” and also includes a graph showing the mean change from baseline, for Strattera and placebo, on the Hamilton Anxiety Rating Scale.
“These presentations are misleading because they suggest or imply that Strattera is safe and effective for the treatment of anxiety, or, at a minimum, for the treatment of anxiety in the distinct sub-population of patients with coexisting ADHD and anxiety, when in fact, Strattera is not indicated for treatment of anxiety in either population,” the FDA’s letter said.
Anxiety has been reported in patients treated with Strattera, the FDA said, “and there is concern that symptoms such as anxiety may represent precursors to emerging suicidal impulses.” Strattera’s label includes a black box warning about the risk of suicidal ideation in children and adolescents.
BY JANE ANDERSON
Contributing Writer
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Pediatric News - Strattera

admin — Fri, 09 Jan 2009 22:51:02 +0000

Strattera (atomoxetine HCl, Eli Lilly & Co.)
The Food and Drug Administration approved Strattera for attention-deficit/hyperactivity disorder maintenance therapy in children and adolescents aged 6 years and older. This is the first FDA-approved agent for maintenance treatment of ADHD.
* Recommended Dosage: The recommended maintenance dosage is 1.2 mg/kg per day to 1.8 mg/kg per day for children aged 6-15 years who have responded to initial treatment with the agent. See package labeling for acute treatment dosages and specific instructions per patient’s weight.

Related Results

Strattera dispensingStrattera now availableStrattera now availableApprovable letter for StratteraNew warning for Strattera

* Special Considerations: Closely monitor pediatric patients for suicidality, clinical worsening, and unusual changes in behavior, especially during the initial few months of a course of Strattera therapy or at times of dosage changes, according to a black box warning on the labeling.
Nausea, vomiting, fatigue, decreased appetite, abdominal pain, and somnolence were the most common adverse reactions in children and adolescents treated with Strattera up to 18 weeks in clinical trials.
Strattera can cause severe liver injury in rare cases and should be discontinued in patients with jaundice or laboratory evidence of liver injury.
Reports of sudden death associated with atomoxetine have been reported in children and adolescents with structural cardiac abnormalities or other serious heart problems. In addition, the agent can increase blood pressure and heart rate, and should be used with caution in patients who have hypertension, tachycardia, or cardiovascular or cerebrovascular disease.
Also, atomoxetine can cause the emergence of psychotic or manic symptoms (hallucinations, delusional thinking, or mania, for example) in children and adolescents with no history of psychotic illness or mania.
* Comment: Maintenance efficacy is based on an outpatient study of patients aged 6-15 years. Children with formally diagnosed ADHD who demonstrated continuous response for 4 weeks during an initial 10-week, open-label trial with 1.2-1.8 mg/kg per day of Strattera were assessed further. In all, 292 participants were randomized to continue the initial Strattera regimen and 124 others were randomized to placebo and monitored for relapse. Researchers then studied those treated with Strattera who showed approximately 8 months of continuous response. Of these, 81 were randomized again to continue the regimen while another 82 were randomized to placebo. Participants who took Strattera throughout the study had significantly longer times to ADHD relapse, compared with participants taking placebo.
The approval “is helpful and reassuring to families,” Dr. Barry Sarvet said in an interview. “The more we can have a validation of FDA approval for child psychiatry indications, the more comfortable everyone can feel.”
“The benefit will be in our communication with parents when obtaining informed consent,” Dr. Mohab Hanna said. “The reassurance will be especially relevant to parents since Strattera has only been available on the market since late 2002.” Dr. Hanna is a board-certified child and adolescent psychiatrist in Lutherville, Md.
“We’ve always considered ADHD to be a chronic mental health issue that requires long-term treatment,” said Dr. Sarvet, chief of child and adolescent psychiatry at Baystate Health Systems in Springfield, Mass. However, “The approval for maintenance therapy will most likely not alter the clinical management of ADHD for most physicians … since most physicians are already treating ADHD on a long-term regimen,” said Dr. Hanna, who specializes in the treatment of ADHD in children and adolescents.
Children and adolescents on Strattera should be monitored every 2-3 months, he said in an interview. Dr. Hanna and Dr. Sarvet have no financial disclosure related to Strattera or Eli Lilly & Co.
“The research shows that [Strattera] really does work, but its effects tend to be more subtle than stimulants,” said Dr. Sarvet, who is also on the psychiatry faculty at Tufts University, Boston. “For some patients, it’s a great choice. For patients with more significant impairment, it may be more appropriate to start treatment with a stimulant. There is some controversy, but most of us consider Strattera to be a second-line drug. There is a larger body of research on the effects of stimulants.”
Dr. Hanna agreed: “Strattera can be an option for some patients, especially for children or adolescents who suffer from anxiety disorders or tic disorders, but for most other patients, stimulants are still the first choice, especially in patients who are hyperactive or impulsive,” he said.
BY DAMIAN McNAMARA, MIAMI BUREAU
COPYRIGHT 2008 International Medical News Group
COPYRIGHT 2008 Gale, Cengage Learning

Pediatric News - Strattera now available

admin — Thu, 08 Jan 2009 01:31:39 +0000

Strattera (atomoxetine), the first non-stimulant approved for the treatment of attention-deficit hyperactivity disorder is now available by prescription in pharmacies nationwide. Strattera also is approved for treating attention-deficit hyperactivity disorder in adults. For more information, contact Eli Lilly & Co. at 800-545-5979 or visit www.strattera.com.

Related Results

StratteraStrattera dispensingStrattera now availableApprovable letter for StratteraNew warning for Strattera

Chain Drug Review - FDA grants approval to Eli Lilly’s Strattera

admin — Mon, 05 Jan 2009 21:42:22 +0000

INDIANAPOLIS — Eli Lilly and Co. has received Food and Drug Administration clearance for Strattera (atomoxetine HCl) for maintenance treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. Strattera, a selective norepinephrine reuptake inhibitor, is the first FDA-approved nonstimulant to treat ADHD in children, adolescents and adults.
“The approval provides physicians and their patients with the first treatment option that is indicated for maintenance of ADHD,” says Thomas Spencer, associate professor of psychiatry at Harvard Medical School. “This is critical, as ADHD may be a lifelong disease, and effective long-term control of symptoms may mean improved outcomes in children and adolescents.”

Related Results

StratteraStrattera dispensingStrattera now availableStrattera now availableApprovable letter for Strattera

The safety and efficacy of Strattera in the maintenance of ADHD were demonstrated in what Lilly describes as one of the largest relapse-prevention studies ever conducted on ADHD, which is among the most common mental health disorders in children and adolescents. The 18-month trial of about 600 children and adolescents from age 6 to to age 15 who met specified criteria for ADHD showed that Strattera was superior to a placebo in maintaining continuous efficacy in patients.
In addition, at the end of the trial patients taking Strattera had lower relapse rates (2.5%, compared with 12.2% for patients taking the placebo).
The drug is said to provide relief from ADHD symptoms throughout the day and into the evening.
Separately, Lilly has submitted a supplemental new drug application to the FDA seeking approval for a new indication for Cymbalta (duloxetine HC1) for the management of chronic pain. The submission is based on outcomes of clinical trials of patients with chronic osteoarthritis pain of the knee and chronic lower-back pain, in addition to data from previously completed studies in diabetic peripheral neuropathic pain (DPNP) and fibromyalgia.
Cymbalta was studied for chronic pain of at least moderate severity in adults who required daily treatment for an extended period.
COPYRIGHT 2008 Racher Press, Inc.
COPYRIGHT 2008 Gale, Cengage Learning

Drug Cost Management Report - Eli Lilly’s new drug for attention deficit hyperactivity disorder , Strattera, may have trouble getting reimbursement from HMO formularies - ADHD - Eli Lilly…

admin — Tue, 30 Dec 2008 03:59:36 +0000

* Eli Lilly’s new drug for attention deficit hyperactivity disorder (ADHD), Strattera, may have trouble getting reimbursement from HMO formularies, according to a study by Decision Resources. The drug is a latecomer to this therapeutic category, which includes some generics, and relationships between HMOs and manufacturers are fairly well-cemented.

Related Results

StratteraStrattera dispensingStrattera now availableStrattera now availableApprovable letter for Strattera

Nevertheless, psychiatrists and PCPs anticipate switching 25% of their patients to Strattera, and pediatricians plan on switching about 10%. The report is entitled “Impact of Strattera’s Launch and Psychostimulant Patent Expiries,” and is based on a survey of 16 HMO pharmacy directors, 43 PCPs, 36 pediatricians, and 20 psychiatrists. Strattera was approved in January 2003 and would normally be expected to appear on HMO formularies in 6-to-12 months. Strattera offers an advantage in that it is not a controlled substance like competing ADHD therapies, yet still offers once-daily dosing. Information: Elizabeth Marshall, Decision Resources, (781) 296-2563.
COPYRIGHT 2003 Atlantic Information Services, Inc.
COPYRIGHT 2003 Gale Group

AScribe Health News Service - Study Shows Treatment With ADHD Medication May Be As Effective in African American Children With ADHD As in Caucasian Children With ADHD; Data Suggests Greater…

admin — Tue, 23 Dec 2008 18:11:40 +0000

Byline: Fleishman Hillard
SAN DIEGO, Calif., Aug. 3 (AScribe Newswire) — African American and Caucasian children with Attention Deficit/Hyperactivity Disorder (ADHD) who took Concerta (methylphenidate HCl) CII demonstrated greater improvement in symptoms such as hyperactivity, impulsivity, and attention than they did with Strattera (atomoxetine), according to a subgroup analysis of results from the first comparative evaluation of the two medications.

Related Results

StratteraStrattera dispensingStrattera now availableStrattera now availableApprovable letter for Strattera

According to results of a study titled Formal Observation of Concerta versus Strattera (FOCUS), response to treatment with …

Read the rest of this article with a Free Trial at HighBeam Research.

Bad and Good News

admin — Thu, 18 Dec 2008 21:43:16 +0000

Only 15% of adults with ADHD have been diagnosed. This is the dismaying statistic that I have been pondering this past month. That means that 85% of the adults with ADHD don’t know it and they continue to live chaotic and difficult lives. The limited number of adults who know they have ADHD was brought home to me when we recently planned an all-day workshop on “Everything, or Almost Everything You Always Wanted to Know About ADHD in the Workplace.” In addition to getting adults with ADHD to attend the workshop, we wanted to get Human Resources personnel to attend. But with only 15% knowing, and assuming lots that know don’t disclose in the workplace, I realize that ADHD is probably not on the radar screens of HR people.
But one the other side of the coin, there are signs that adult ADHD is becoming mainstreamed and recognized. I think much of this can be attributed to Strattera’s prolific ad campaign. But be that as it may, last week I attended the Comedy Underground in Seattle to hear a comic whose gig was having adult ADHD. And then in my local newspaper, there was a syndicated cartoon about adult ADHD. I am chagrined to admit it took me a while to get the joke. . (Sometimes we ADDers are so literal.) Let me know how you do.
www.ucomics.com/nonsequitur March 19, 2005
HINT: A duel is taking place. There is a guy holding the empty box which held the pistols. There is another guy lying on the ground about 4 feet away who has been shot in the back. And then there is the third guy holding a smoking pistol, standing on line with the guy holding the pistol box. He turned and shot without walking back the required 10 paces!”
Cynthia Hammer, MSW, Director
ADD Resources
www.addresources.org
Creators of the National ADHD Directory

For more information on ADD/ADHD visit our website at www.addresources.org
To view a complete listing of national ADD/ADHD events visit www.addresources.org/calendar_natl.php

ADHD Medication Roundup

admin — Sun, 14 Dec 2008 14:24:44 +0000

Once you have been diagnosed with ADHD by a mental health professional, your doctor is likely to recommend treatment with medication. Medication can significantly reduce your ADHD-related symptoms and make your life much easier. The first choice for medication treatments are stimulant medications. Individuals with ADHD have a low amount of dopamine in the frontal part of their brains. Stimulant medications create dopamine, which decreases the symptoms of the disorder.

Ritalin is the often the first choice of stimulant used by doctors. It has to be taken more often, and has rebound effects that can be unpleasant for some people. Ritalin is offered as a time released version that is called Concerta.

Adderall is the stimulant often preferred by mental health professionals for treating ADHD. It is an amphetamine salt, and is chosen because it is only necessary to take it once to twice a day. Additionally, it is also less harsh to come down off of than other stimulant medications. A time released version of Adderall, called Adderall XR, is also available. Dexadrine is another stimulant medication that works similarly to Ritalin. Doctors’ last choice for stimulants is called Cyclert. It is very rarely used because there is a chance of liver toxicity involved. Cyclert is only used if nothing else works and medication is believed to be helpful.

Besides stimulants, there is a fairly new drug called Strattera that works differently than the others. When Strattera was first introduced, it was supposed to be the wonder drug for ADHD. It is not as good as doctors had first hoped, but it is an effective drug for people who do not want to take stimulants. Strattera works like an antidepressant, increasing the level of norepinephrine in your brain when administered over a few days. It also has some antidepressant effects that may be helpful when dealing with both depression and anxiety.

Because of the nature of ADHD, many individuals who suffer from it have issues with anxiety and depression as well. Some decide to take antidepressants along with their other medications to alleviate their symptoms. Commonly prescribed medications for depression and anxiety are called SSRI antidepressants. Popular types of SSRIs are Prozac, Celexa, Wellbutrin, Effexor and others. These drugs can be a lifesaver for people who have to deal with mood problems as part of their lives.

It may take a few tries to find the right medication or the right combination of medications. Do not despair if you do not find the right medication immediately. Although this can be very frustrating, luckily, there are quite a few psychotropic drugs out there that can help. Make sure you are working with an educated and qualified professional, and be patient.

The Latest ADD/ADHD Drug Treatments: What Is Really New and What Is Not New

admin — Fri, 12 Dec 2008 06:15:28 +0000

The latest drugs for ADD/ADHD are, most of them, forms of amphetamines or methylphenidate - which have been used to treat hyperactivity since the 1960s. Here’s a list of the ADD/ADHD medications approved after 2000, and a description of how they are better than the older drugs: 1. Methylphenidate drugs Focalin XR, Ritalin LA, Concerta, and Metadate CD are all long-acting, extended release versions of methylphenidate. They need to be taken just once a day, and because the drug is released slowly into the body, there is also less of a rebound effect (your child gets even more hyperactive and inattentive as the medicine wears off). Ritalin LA can be sprinkled on food, so it is easier to give to children. If your child cannot (or will not) take tablets and capsules, you can use Daytrana, a methylphenidate patch designed to be worn on the hips. 2. Amphetamines The newest amphetamines for ADD/ADHD (Dextrostat, Dexedrine Spansules, Adderall XR) are also all long-acting, and need to be taken just once a day. Also, Dextrostat is so far the only drug approved for children under 6 (though not under 3). 3. Non-stimulant drugs Strattera is the only non-stimulant drug approved for ADD/ADHD, and because it is not a stimulant, it is not included in Schedule II, and can be used by people who have a history of substance abuse. But because the new drugs are all versions of the old ones, they continue to have almost the same problems connected with them: 1. They have not been proved safe for children. Dextrostat is the only ADD/ADHD drug approved for children younger than six, and even this has not been approved for children younger than three. 2. They have the same side-effects Your child will probably eat less and grow more slowly, or have stomach and head aches and be unable to sleep at night. Strattera can cause liver damage. More scary than these is the possibility of mental side effects - a few (very few) of those on amphetamines will psychotic problems, and a few (again, very few) on Strattera will have thoughts of suicide. 3. They can be abused and addictive People continue to find ways to get a high with these drugs, or they use it to study or party late. Any use without a doctor’s supervision can be dangerous, because your child may get quickly dependent on the drugs. So if you have a child with ADD/ADHD, try every other option first before you put your children on medicines. For children below three, medicine should not be even considered.

PR Newswire UK Disclose - LILLY (ELI) & COMPANY - Lilly Announces Important Strattera Label Update.

admin — Sun, 07 Dec 2008 14:03:45 +0000

Most Popular
3 Questions No Job Seeker Ever Wants To Be Asked?
10 Jobs That Pay $30 An Hour
13 Job Interview Mistakes To Avoid
5 Regular Mistakes In Public Speaking
Interpersonal Communication: Styles Of Conflict

re>
Date: September 29, 2005

For Release: Immediately

Refer to: Jennifer Bunselmeyer Tarra Ryker
(317) 655-8808 (office) (317) 276-3787 (office)
(888) 462-2576 (pager) (317) 332-7502 (cell)
Bunselmeyer_Jennifer@Lilly.com ryker_tarra@lilly.com

Lilly Announces Important StratteraA’ Label Update

Indianapolis - Eli Lilly and Company (NYSE: LLY) today announced that it will
update the product label globally for its attention-deficit/hyperactivity
disorder (ADHD) …

Read the rest of this article with a Free Trial at HighBeam Research.