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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by ed_uk on February 3, 2005, at 10:04:28
MESSAGE FROM PROFESSOR G DUFF, CHAIRMAN, COMMITTEE
ON SAFETY OF MEDICINES.2 February 2005
Dear Colleague,
Strattera (Atomoxetine) – Risk Of Hepatic Disorders
I am writing to inform you about the risk of rare, but sometimes severe, cases of hepatic
disorders in association with the use of Strattera (atomoxetine). The risk is estimated at
below 1 in 50,000 patients treated.
Strattera has been marketed in the UK since July 2004 but has been available in the
United States since November 2002. It is an effective treatment for Attention-
Deficit/Hyperactivity Disorder (ADHD), and is authorised for use in children of 6 years
and older and in adolescents as part of a comprehensive treatment programme.
Worldwide exposure is estimated at 2.3 million patients.A total of 41 reports of hepatic disorders have been received worldwide, including two
cases of severe acute hepatitis with markedly elevated hepatic enzymes (up to 40 times
the ULN) and bilirubin (up to 12 times the ULN). There is no clear pattern in terms of
onset time, and the reactions may occur after several months of treatment. In some
cases liver function continues to worsen after the drug has been stopped. This does not
appear to be a dose-related reaction.
In the UK, a total of 67 reports of suspected adverse drug reactions in association with
atomoxetine have been received through the Yellow Card Scheme, including 3 reports
of hepatic disorders (one case each of hepatitis, jaundice and elevated bilirubin levels).Advice to prescribers:
• Due to the seemingly idiosyncratic nature of these reactions, routine monitoring
of liver function is unlikely to be helpful in minimising the risk and is not
recommended.
• All suspected hepatic reactions should be investigated. Atomoxetine should be
discontinued in patients with jaundice or laboratory evidence of hepatic injury,
and should not be restarted.
• Patients and the parents of children currently receiving atomoxetine should be
advised of this risk and made aware of the possible signs and symptoms. An
information sheet for parents and patients is attached.The Committee on Safety of Medicines and the Medicines and Healthcare products
Regulatory Agency are monitoring closely the safety of Strattera (atomoxetine). This
particular safety signal is being actively investigated and any new information will be
evaluated urgently.Please report any suspected adverse reactions to atomoxetine via the Yellow Card
Reporting Scheme to the Committee on Safety of Medicines/ Medicines and Healthcare
products Regulatory Agency
Posted by Phillipa on February 3, 2005, at 16:57:07
In reply to UK government warns doctors of risk of Strattera, posted by ed_uk on February 3, 2005, at 10:04:28
Hi Ed! It seems like the UK is far more cautious and informed than the USA. Do you have the pressure from the Drug companies for incentives to the pdoc's that use these drugs? Fondly, Phillipa O
Posted by ed_uk on February 4, 2005, at 7:13:33
In reply to Re: UK government warns doctors of risk of Strattera » ed_uk, posted by Phillipa on February 3, 2005, at 16:57:07
Hi,
The UK is different to the US in several ways...
1. UK pdocs almost never prescribe drugs which have a high abuse potential - such as Ritalin.
2. The amount of money which pharmaceutical companies spend on advertising is much less in the UK. It is illegal to advertise prescription drugs to the general public.
3. There is much less emphasis on putting people into diagnostic categories.
4. Very few people go to private psychiatrists, most people just go to NHS doctors. The NHS is paid for via tax. Prescriptions cost £6.40 unless you have an exemption, in which case they are free.
5. Few people take more than one psychotropic drug at once.
6. English psychiatrists generally only prescribe a very limited range of drugs.
7. The % profit that the pharmaceutical companies are alowed to make from NHS drug sales is restricted. If they make too much profit (out of the NHS) they are forced to return some of their profit to the government!!
8. You are right that UK pdocs are generally quite cautious. They are not better informed though!
9. People tend to use different names to describe their conditions eg. bipolar disorder is called manic-depression.
Ed.
Posted by banga on February 4, 2005, at 8:54:03
In reply to UK government warns doctors of risk of Strattera, posted by ed_uk on February 3, 2005, at 10:04:28
I wonder if there have been any studies of how supplements and herbs could protect patients taking meds from liver problems?....first and foremost I think of milk thistle etc. I am taking several meds that may tax the liver when combined, I will add a liver-supporting and cleansing regimen of supplements and herbs--I dont know if it would help.
Posted by Phillipa on February 4, 2005, at 17:26:45
In reply to Re: help to avoid hepatic disorders, posted by banga on February 4, 2005, at 8:54:03
Ed; Glad to know I had something right for once! About l0yrs ago, bi-polar was called manic depression here too. They keep revising the DSM codes. I guess it is good and bad that they only rx one psychotropic at a time. Some may be helped this way but others hurt. I was always amazed, when I worked on the psych ward that pts came into the hospital on few drugs, and everyday more were added until their drug card was three pages long. Fondly, Phillipa O
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