Among inpatients with affective disorder, clinical improvement and antidepressant treatment is associated with a significantly reduced risk for suicide during hospitalization and after discharge, study results show.

“The risk of suicide in patients with affective disorders is particularly high immediately after admission to, and discharge from a psychiatric hospital,” explain E Høyer, from the University of Aarhus in Denmark, and team.

However, they add that among such patients, “only few risk factors for suicide have been identified” and “little is known about the protective or other effects of treatment.“

To investigate further, the researchers studied data on 282 Danish patients, aged at least 18 years, who were admitted to hospital with affective disorder between 1994 and 1995. Of these, 141 died because of suicide, either during admission or shortly after discharge.

The researchers assessed the patients’ demographic and socioeconomic factors, family history, psychiatric history, treatment, and history of adverse life events, such as bereavement of close relative or friend, separation/divorce, and loss of a job.

Clinical improvement, or no such improvement, during hospitalization was noted if such information was available in the patients’ case files. If no such information was available, the clinical state of the patient at admission and at censoring date was used to make an evaluation.

The team identified four variables that were independent predictors of suicide.

As expected, a previous history of suicide attempts was associated with the greatest risk for death by suicide (incidence-rate ratio [IRR]=4.9). The team also found that loss of a job during the year prior to the index admission was associated with a significant increased risk for suicide, at an IRR of 2.9. This was the only adverse life event associated with an increased risk for suicide, note the researchers

Conversely, clinical improvement during the index admission and treatment with antidepressant drugs were associated with a reduced risk for suicide, both at IRRs of 0.3.

Høyer and team conclude: “Our interpretation of the findings is that clinical improvement of affective disorder and treatment with antidepressant drugs may reduce the risk of suicide. Therefore, and for clinical reasons in general, all efforts should be made to enhance clinical improvement and prevent further episodes of illness.”

They add: “It is important to be aware of the risk of suicide in patients with no or little clinical improvement during inpatient treatment, especially at discharge and during leave from the hospital.”

MedWire (www.medwire-news.md) is an independent clinical news service provided by Current Medicine Group, a part of Springer Science+Business Media. © Current Medicine Group Ltd; 2009

Free abstract

• Patients With Bipolar Disorder Have Higher Specialty Care Costs Than Patients With Diabetes And Other Chronic Diseases
• Mental Illness Was The Costliest Condition Between 1996 To 2006

Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline ’s (NYSE: GSK) Lamictal® ODT™ (lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand and GSK, Lamictal ODT uses Eurand’s AdvaTab® orally disintegrating tablet (ODT) and Microcaps® taste-masking technologies to provide Lamictal in a pleasant-tasting tablet that disintegrates on the tongue and that may be taken with or without liquid.

Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older who have been treated for mood episodes with other medicine. It is not known if Lamictal ODT is safe or effective in children or teenagers under the age of 18 with mood disorders such as bipolar disorder or depression. Lamictal ODT is also used together with other medicines to treat certain types of seizures (partial seizures, primary generalized tonic-clonic seizures, generalized seizures of Lennox-Gastaut syndrome) in people 2 years or older or alone when changing from other medicines used to treat partial seizures in people 16 years or older. It is not known if Lamictal ODT is safe or effective when used alone as the first treatment of seizures in adults. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and 200 mg strengths and is expected to be available in pharmacies in early July 2009.

“We were delighted to have the opportunity to use our AdvaTab® and Microcaps® proprietary technologies to co-develop Lamictal ODT with GSK, and we look forward to a successful launch,” said Gearóid Faherty, Chairman and Chief Executive Officer. “We see Lamictal ODT, Eurand’s fifth FDA-approved drug since 2001, as another clear demonstration of the breadth of our drug formulation expertise and the depth of our pipeline.”

Eurand will receive an undisclosed milestone payment upon launch, revenue for manufacturing Lamictal ODT tablets for GSK, royalties on net sales of the product and milestone payments in connection with Lamictal ODT achieving predetermined sales levels in the U.S. marketplace.

Net sales of Lamictal®, one of the world’s top 60 pharmaceutical products based on annual sales, were $1.3 billion in the U.S. in 2008. Eurand retains exclusive worldwide manufacturing rights to Lamictal ODT and, subject to certain conditions, either Eurand or GSK may have certain rights to commercialize the product in a particular country outside the U.S.

Lamictal ODT uses a combination of two of Eurand’s novel drug delivery technologies. AdvaTab® orally disintegrating tablet technology uses Eurand’s proprietary granulation and tabletting processes that allow the tablet to disintegrate rapidly in the mouth without chewing or the need for liquid. AdvaTab is distinct from conventional ODT technologies because it can be combined with Microcaps® taste-masking technology. Microcaps® taste-masking technology provides a coating that encapsulates drug particles, forming a barrier between the medication and the taste buds while still allowing the drug to dissolve in the stomach.

Safety Information

Prescription Lamictal ODT Tablets are not for everyone. Lamictal ODT is another form of Lamictal. Lamictal may cause a serious skin rash that may cause the patient to be hospitalized or to stop Lamictal; it may rarely cause death. There is no way to tell if a mild rash will develop into a more serious reaction. These serious skin reactions are more likely to happen when the patient begins taking Lamictal, within the first 2 to 8 weeks of treatment. But it can happen in people who have taken Lamictal for any period of time. Children between 2 to 16 years of age have a higher chance of getting this serious skin reaction while taking Lamictal.

The risk of getting a rash is higher if taking Lamictal while taking valproate (Depakene® (valproic acid) or Depakote® (divalproex sodium)), taking a higher starting dose of Lamictal than a healthcare provider prescribed or increasing the dose of Lamictal faster than prescribed.

Lamictal can also cause other types of allergic reactions or serious problems which may affect organs and other parts of your body like the liver or blood cells. The patient may or may not have a rash with these types of reactions.

The patient should call their healthcare provider right away if they have any of the following: a skin rash, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, yellowing of the skin or eyes, unusual bruising or bleeding, severe fatigue or weakness, severe muscle pain or frequent infections. These symptoms may be the first signs of a serious reaction. A healthcare provider should examine the patient to decide if they should continue taking Lamictal.

Antiepileptic drugs, including Lamictal, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any antiepileptic drug for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior.

Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

Medication errors involving Lamictal have occurred. In particular, the name Lamictal or lamotrigine can be confused with the names of other commonly used medications. Medication errors may also occur between the different formulations of Lamictal. To reduce the potential of medication errors, healthcare professionals should write and say Lamictal clearly. Depictions of the Lamictal Tablets, Chewable Dispersible Tablets, and Orally Disintegrating Tablets can be found in the Medication Guide that accompanies the product to highlight the distinctive markings, colors, and shapes that serve to identify the different presentations of the drug and thus may help reduce the risk of medication errors. To avoid the medication error of using the wrong drug or formulation, patients should be strongly advised to visually inspect their tablets to verify that they are Lamictal, as well as the correct formulation of Lamictal, each time they fill their prescription.

Patients should not take Lamictal or Lamictal ODT if they have had an allergic reaction to lamotrigine or to any of the inactive ingredients.

Common side effects include dizziness, headache, blurred or double vision, lack of coordination, sleepiness, nausea, vomiting, insomnia, tremor, rash, fever, abdominal pain, back pain, tiredness, and dry mouth. Patients should tell their healthcare provider about any side effect that bothers them or does not go away; patients should tell their healthcare provider if they have any changes in their menstrual pattern, such as breakthrough bleeding, while taking Lamictal and birth control pills. These are not all the possible side effects of Lamictal.

* Depakene and Depakote are registered trademarks of Abbott Laboratories

For full prescribing information including Boxed Warning, please visit http://www.lamictal.com and click on “Complete Prescribing Information for Lamictal” to view prescribing information for all formulations, including Lamictal ODT.

About AdvaTab®

Eurand’s AdvaTab® technology utilizes proprietary granulation and tabletting processes to provide an orally disintegrating tablet with superior mouth-feel attributes. When combined with Eurand’s Microcaps® taste-masking technology, AdvaTab ODTs are one of the leading orally disintegrating tablet systems available to the pharmaceutical industry today. Key features of AdvaTab® include: excellent mouth-feel; tablets that can be packaged in bottles or blisters; rapid disintegration in the oral cavity; ability to incorporate microencapsulated drug particles; and the capacity to incorporate larger drug doses than conventional ODT technologies.

About Microcaps®

Eurand’s microencapsulation technology, known as Microcaps®, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste and odor masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps® is incorporated in more than 12 marketed products.

Source
Eurand

View drug information on Lamictal.

• Schizophrenia-Linked Gene Controls The Birth Of New Neurons
• Parents And Researchers To Receive Top Honors At International Conference On Bipolar Disorder
• Optimism For Bipolar Disorder And Schizophrenia If Psychiatrists Abandon 19th Century Dogma, UK
• Two Brown Faculty To Study Brain Development In Infants And Children With Bipolar Disorder
• New National Online Survey Says Bipolar Depressive Symptoms Have Impact On Day-To-Day Tasks As Well As Social Activities

Eurand N.V.
(NASDAQ: EURX), a specialty pharmaceutical company that develops
enhanced pharmaceutical and biopharmaceutical products based on its
proprietary pharmaceutical technologies, announced that the
U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be
marketed as GlaxoSmithKline ’s (NYSE: GSK) Lamictal(R) ODT(TM)
(lamotrigine) Orally Disintegrating Tablets. Co-developed by Eurand
and GSK, Lamictal ODT uses Eurand’s AdvaTab(R) orally disintegrating
tablet (ODT) and Microcaps(R) taste-masking technologies to provide
Lamictal in a pleasant-tasting tablet that disintegrates on the
tongue and that may be taken with or without liquid.

Lamictal ODT is indicated for the long-term treatment of Bipolar I
Disorder to lengthen the time between mood episodes in people 18 years
or older who have been treated for mood episodes with other medicine.
It is not known if Lamictal ODT is safe or effective in children or
teenagers under the age of 18 with mood disorders such as bipolar
disorder or depression. Lamictal ODT is also used together with other
medicines to treat certain types of seizures (partial seizures,
primary generalized tonic-clonic seizures, generalized seizures of
Lennox-Gastaut syndrome) in people 2 years or older or alone when
changing from other medicines used to treat partial seizures in
people 16 years or older. It is not known if Lamictal ODT is safe or
effective when used alone as the first treatment of seizures in
adults. Lamictal ODT will be available in 25 mg, 50 mg, 100 mg, and
200 mg strengths and is expected to be available in pharmacies in
early July 2009.

“We were delighted to have the opportunity to use our AdvaTab(R) and
Microcaps(R) proprietary technologies to co-develop Lamictal ODT with
GSK, and we look forward to a successful launch,” said Gearoid
Faherty, Chairman and Chief Executive Officer. “We see Lamictal ODT,
Eurand’s fifth FDA-approved drug since 2001, as another clear
demonstration of the breadth of our drug formulation expertise and
the depth of our pipeline.”

Eurand will receive an undisclosed milestone payment upon launch,
revenue for manufacturing Lamictal ODT tablets for GSK, royalties on
net sales of the product and milestone payments in connection with
Lamictal ODT achieving predetermined sales levels in the U.S.
marketplace.

Net sales of Lamictal(R), one of the world’s top 60 pharmaceutical
products based on annual sales, were $1.3 billion in the U.S. in 2008.
Eurand retains exclusive worldwide manufacturing rights to Lamictal
ODT and, subject to certain conditions, either Eurand or GSK may have
certain rights to commercialize the product in a particular country
outside the U.S.

Lamictal ODT uses a combination of two of Eurand’s novel drug
delivery technologies. AdvaTab(R) orally disintegrating tablet
technology uses Eurand’s proprietary granulation and tabletting
processes that allow the tablet to disintegrate rapidly in the mouth
without chewing or the need for liquid. AdvaTab is distinct from
conventional ODT technologies because it can be combined with
Microcaps(R) taste-masking technology. Microcaps(R) taste-masking
technology provides a coating that encapsulates drug particles,
forming a barrier between the medication and the taste buds while
still allowing the drug to dissolve in the stomach.

Source
Eurand N.V.

View drug information on Lamictal.

• Buy Seroquel Online
• National Audience Of Psychiatrists Assembling In Chicago For Conference On Bipolar Disorder And ADHD
• Schizophrenia-Linked Gene Controls The Birth Of New Neurons
• DTNBP1 gene mutations linked to bipolar disorder]]>
• FDA Issues Complete Response Letter For RISPERDAL(R) CONSTA(R) For Adjunctive Maintenance Treatment Of Bipolar Disorder