ADHD

NICE urges docs to curtail ADHD meds

Tracy Staton — Thu, 25 Sep 2008 10:59:00 -0400

Can parents treat ADHD? The U.K.'s National Institute for Health and Clinical Excellence says the first line of treatment for attention deficit hyperactivity disorder should be parental management. Moms and Dads--and other caregivers--should receive training in caring for and managing ADHD kids. Next comes counselling, for older kids. Drugs, NICE says, should be reserved for kids with severe ADHD or used as a last resort for other children. And they should never be given to kids under 5 years.

NICE's new treatment guidelines come at a time of intense debate over the prevalence of ADHD drug use among youngsters. Prescriptions in the UK, for instance, doubled between 1998 and 2004. But many parents and teachers hail the drugs for their ability to help difficult children learn and behave in the classroom and at home.

NICE also says that, when drugs are prescribed, they should be part of a treatment plan that includes "psychological and behavioral interventions."

Experts figure that actual drug use won't change much initially. But it seems that growth in ADHD drugs could be curtailed over time. And because NICE's decisions are closely watched in Europe and elsewhere, the policy could spread.

- read the BBC story
- check out The Guardian's coverage
- see the article at CTV

Shire recalls ADHD drug patches

Tracy Staton — Mon, 25 Aug 2008 10:46:13 -0400

Drug patches have had a tough time lately, with recalls coming on everything from too-tight adhesive to slits in active-ingredient reservoirs. Today, the recalled patch in the news is Shire's Daytrana, an attention deficit hyperactivity disorder med. Two lots were withdrawn on concerns about the patch's liner, which could be difficult for patients to remove before applying the patch. Shire recalled a limited number of patches for the same reason just a year ago.

Shire sells the patches on license from Noven Pharmaceuticals, which sent out a statement saying that it has identified the "definitive root cause" of the defect and is now "aggressively testing potential solutions."

- read the Associated Press article

SPOTLIGHT: Shire gets Vyvanse nod for adult use

Thu, 24 Apr 2008 06:59:52 -0400

Shire got its longed-for blessing from the FDA to sell Vyvanse, an ADHD treatment, for use in adults. Some one-third of Vyvanse scrips already go to grownups, off-label, but the FDA OK will let Shire promote the med--and promote it, it will. Release | Report

AHA: Kids need EKG before ADHD meds

Tue, 22 Apr 2008 06:59:54 -0400

The American Heart Association isn't making any friends among ADHD drug makers today. The health charity is recommending that kids get an EKG before taking stimulant drugs like Ritalin for attention-deficit hyperactivity disorder.

These meds, of course, can boost blood pressure and heart rate. For most kids that's not a problem, but those with heart conditions could be more vulnerable to sudden cardiac arrest and other problems, the AHA said. The meds already carry warnings of cardiac risks in those with pre-existing heart problems. "We don't want to keep children from being treated," said a pediatric cardiologist who headed the recommendation committee. "We want to do it as safely as possible."

A spokesman for Shire, the U.K. ADHD specialist, said the drugs' labeling already recommends an EKG and cardiac evaluation as necessary, adding, "There's no new information here."

- read the story in the LA Times

Pros use pills to boost brainpower

Thu, 10 Apr 2008 06:59:57 -0400

Fuzzy-headed today? Then pop a pill. Professionals of all kinds are doing it these days, according to a survey taken by Nature. Young, old, you name it--they're taking various meds to boost their concentration and memory. Some 62 percent prefer Ritalin, the ADHD med made by Novartis. Another 44 percent liked Cephlon's Provigil, the "keep-awake" drug. Others used Adderall or another amphetamine, beta blockers, even centrophenoxine, a dementia med.

Now, the survey was open only to Nature subscribers, who tend to be scientists, engineers, or folks like journalists who follow science closely. So it's not a generalized, randomized bit of research. (Of the 1,400-odd people who responded, about 15 percent were biologists and 15 percent engineers; 12 percent were educators, 8 percent worked in the medical field, and 7 percent in the media.) But it does show a clear trend.

Another thing: Almost 80 percent of the respondents said healthy people should be allowed to take cognitive-enhancing drugs if they choose. But even more--86 percent--felt that kids under 16 shouldn't be on any of these meds.

- read the Washington Post story
- check out the item in the WSJ Health Blog

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FDA panel wants 'black box' on ADHD drugs

What's Shire doing to support Vyvanse?

Fri, 28 Mar 2008 07:59:54 -0400

Are worries about Shire's Adderall successor justified? The Wall Street Journal Health Blog asked CEO-to-be Angus Russell (photo), who said that the company is hot on the sales trail in support of Vyvanse, which is already approved to treat ADHD in children and is up for FDA consideration for that use in adults. The company is hoping to market the med to adults by this summer, Russell said; though the FDA has said it would take action by April 28, he said, the agency hasn't even approved a new indication for an ADHD med without a round of questioning.

Meanwhile, Shire stock is down from its 52-week high last September as investors worry that doctors won't adopt Vyvanse fast enough to replace Adderall, which goes generic next year. And it's been bandied about as a takeover target for Pfizer. For Russell's view on that, you'll have to watch the video.

- see the Health Blog item
- watch the video

Related Articles:
Shire on lookout for acquisitions. Report
FDA hands out two key regulatory approvals. Report
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New drug warnings poised for rollout

Thu, 29 Nov 2007 06:59:57 -0500

New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Here's the latest:

Committee members want a stronger warning against using Cephalon's Provigil drug in children. Used to treat sleep disorders in adults, the drug sometimes is used off-label in for ADHD in kids. Panelists want doctors to know Provigil shouldn't be used in children. Just recently, Provigil's label got a new warning of serious skin reactions and psychological problems.
Novartis added a new warning of birth defects to its organ-rejection treatment Myfortic. The FDA says women who are planning to get pregnant should only use Myfortic if they have no other options.
The FDA's pediatric committee voted for stronger warnings of psychiatric side effects on both Roche's Tamiflu and GlaxoSmithKline's Relenza. Roche already agreed to the warning, though it admits no causal relationship between its drug and the side effects; so far, Glaxo has only blamed the side effects on the flu itself.
Glaxo's Serevent and Advair also got hit with recommendations for more specific warnings on the risk of asthma-related complications in children. Glaxo says it thinks the current black-box warning is sufficient, even though it doesn't specifically mention kids. The FDA also says it plans a new safety review of the drugs.

- read The Motley Fool report on Myfortic
- see the Provigil article from the Associated Press
- read the latest on Tamiflu and Relenza from the Philadelphia Business Journal
- here's more on GSK's asthma drugs

Related Articles:
FDA warns of Provigil risks. Report
FDA staffers question safety of Provigil for ADHD. Report
FDA does a triple-take on Tamiflu. Report
FDA reconsiders Glaxo asthma meds. Report

Shire casts off non-core drugs for $213M

Mon, 08 Oct 2007 06:59:57 -0400

UK-based Shire Pharmaceuticals is selling a block of medicines to Almirall of Spain for $213 million. The remedies--deemed "non-core products"--include two skin treatments, Solaraze and Vaniqa. Company officials say the move will let Shire focus on its core therapeutic areas: attention deficit disorder, gastrointestinal and renal disease, and genetic therapies.

The company also wants to expand its international reach and develop a new specialty in regenerative medicine. Recently Shire licensed the anti-scarring remedy Juvista from Renovo, in its first foray into the regenerative arena.

- see the release from Shire
- check out this article for more

Related Articles:
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FDA signals a quick approval for Shire's ADHD drug. Report
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Shire gambit aimed at delaying generic Adderall XR. Report

Roche to Dr. Reddy's: Back off Boniva

Tue, 25 Sep 2007 06:59:56 -0400

Roche has no intention of letting Boniva go gently into that generic night. On the heels of a patent-infringement suit against Teva last week, Roche has sued Dr. Reddy's Laboratories over the osteoporosis drug. And this after acting against Boniva copycats from Apotex and Mutual Pharmaceutical in recent weeks.

Dr. Reddy's has filed for FDA approval for its version of Boniva, but Roche claims the drug is covered by one patent or another through 2023.

- read this article from India Infoline

Related Articles:
Roche, Teva square off in Boniva patent fight. Report
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Feds to study ADHD drugs for heart risks

Tue, 18 Sep 2007 06:59:58 -0400

Do they or don't they? The feds aim to find out whether drugs for attention deficit hyperactivity disorder actually increase the risk of heart problems. The FDA and the Agency for Healthcare Research and Quality will review clinical data on 500,000 patients who took ADHD meds over a seven-year period ending in 2005, looking for any patterns that indicate the patients also developed high blood pressure or other cardiovascular problems.

This new study stems from concerns raised at an FDA advisory committee meeting last year, when the panel recommended stronger warnings for the drugs because of potential cardiac risks. The FDA then began its own research, but budgetary constraints threatened its completion. Americans spent about $1.5 billion last year on the three top ADHD drugs: Concerta (Johnson & Johnson), Strattera (Eli Lilly), and Adderall (Shire).

- read the statement from the FDA
- check out this Los Angeles Times article

Related Articles:
FDA committee votes against ADHD "black box." Report
FDA panel wants 'black box' on ADHD drugs. Report
FDA committee to review ADHD risks. Report