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Business Wire - Corixa and GlaxoSmithKline Respond to FDA; Complete Review Letter for BEXXAR

admin — Thu, 11 Dec 2008 18:21:02 +0000

Business Editors & Health/Medical Writers
BIOWIRE2K
SEATTLE & PHILADELPHIA–(BW HealthWire)–March 25, 2002
Corixa Corporation (Nasdaq:CRXA) and GlaxoSmithKline (NYSE:GSK), today announced that Corixa has notified the U.S. Food and Drug Administration (FDA) that it intends to amend its Biological License Application (BLA) for BEXXAR(R) (tositumomab, iodine I-131 tositumomab), an investigational radioimmunotherapy for the treatment of low-grade or transformed low-grade non-Hodgkin’s lymphoma.
The companies also announced that they have formally requested a meeting with the FDA to discuss the complete review letter and potential next steps regarding this application. A meeting is expected to occur within the next 45 days.

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BEXXAR is being co-developed by Corixa and GlaxoSmithKline in the United States.
As previously announced, Corixa received a complete review letter regarding the BEXXAR BLA on March 12, 2002. In the letter, the FDA stated that it believed additional data would be required to approve BEXXAR and gave Corixa the options of amending its application, notifying the Agency of its intent to file an amendment, withdrawing the application, or requesting an opportunity for a hearing on whether there are grounds for denying approval of the application.
About Corixa
Corixa is a developer of immunotherapeutics with a commitment to treating and preventing autoimmune diseases, cancer and infectious diseases by understanding and directing the immune system. Corixa is focused on immunotherapeutic products and has a broad technology platform enabling both fully integrated vaccine design and the use of its separate, proprietary product components on a stand-alone basis. Corixa currently has 18 programs in clinical development and 22 programs in preclinical development.
The company partners with numerous developers and marketers of pharmaceuticals, targeting products that are Powered by Corixa(TM) technology with the goal of making its potential products available to patients around the world. Corixa was founded in 1994 and is headquartered in Seattle, Washington, with additional operations in Hamilton, Montana and South San Francisco, California. For more information, please visit Corixa’s Website at www.corixa.com or call the company’s investor relations information line at 1.877.4CORIXA or 877.426.7492.
About GlaxoSmithKline
GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. GlaxoSmithKline is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products for hematology and oncology patients. Currently, GlaxoSmithKline Oncology markets Zofran(R) (ondansetron), Hycamtin(R) (topotecan HCl), Navelbine(R) (vinorelbine tartrate) Injection, Argatroban Injection, Alkeran(R) (melphalan), Leukeran(R) (chlorambucil), Compazine(R) (prochlorperazine), Purinethol(R) (mercaptopurine), Myleran(R) (busulfan), and Thioguanine. GlaxoSmithKline Oncology has novel agents in late-stage development, including a radioimmunotherapy BEXXAR.
Forward Looking Statements
Except for the historical information presented, certain statements in this press release relating to the FDA’s approval of Bexxar are forward-looking statements. Forward-looking statements are based on the opinions and estimates of management at the time the statements are made. They are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Factors that could affect Corixa’s actual results include, but are not limited to, the failure of FDA to approve the commercial sale of Bexxar, as well as the “Factors Affecting Our Operating Results, Our Business and Our Stock Price,” described in Corixa’s Annual Report on Form 10-K for the year ended December 31, 2001, copies of which are available from Corixa’s investor relations department. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release.
COPYRIGHT 2002 Business Wire
COPYRIGHT 2008 Gale, Cengage Learning

FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs

admin — Wed, 10 Dec 2008 08:06:03 +0000

ROCKVILLE, Md., June 16, 2008–The U.S. Food and Drug
Administration today exercised its new authority under the Food and
Drug Administration Amendments Act of 2007 (FDAAA) to require
manufacturers of “conventional” antipsychotic drugs to make
safety-related changes to prescribing information, or labeling, to
warn about an increased risk of death associated with the off-label
nuse of these drugs to treat behavioral problems in older people
with dementia.
In 2005, the FDA announced similar labeling changes for
“atypical” antipsychotic drugs. At that time, Boxed Warnings, the
FDA’s strongest, were added. The Boxed Warning will now be added to
an older class of drugs known as “conventional” antipsychotics. The
warning for both classes of drugs will say that clinical studies
indicate that antipsychotic drugs of both types are associated with
an increased risk of death when used in elderly patients treated
for dementia-related psychosis.
“It is important that health care professionals and consumers
have the most up-to-date drug safety information,” said Thomas
Laughren, M.D., director of the FDA’s Division of Psychiatry
Products in the Center for Drug Evaluation and Research. “The
prescribing information for all antipsychotic drugs will be updated
to describe the risk of death in elderly patients being treated for
symptoms associated with dementia.”
Antipsychotic drugs commonly are categorized into two classes,
the older “conventional” antipsychotics and the newer “atypical”
antipsychotics. Both classes of drugs are dopamine receptor
antagonists that work by blocking the action of naturally occurring
dopamine in the brain. They differ primarily in their side effects,
with the atypical drugs having a lower incidence of neurological
side effects such as involuntary movements or “tics.”
Neither class of antipsychotic is FDA-approved for use in the
treatment of dementia-related symptoms, which can include
forgetfulness, poor memory, and an inability to recognize familiar
objects, sounds, or people. The drugs are FDA-approved primarily
for the treatment of symptoms associated with schizophrenia. The
decision to use antipsychotic medications in the treatment of
patients with symptoms of dementia is left to the discretion of the
physician. Such use is often called “off-label” use and falls
within the practice of medicine.
Recently, two observational epidemiological studies were
published that examined the risk of death in elderly patients with
dementia who were treated with conventional antipsychotic drugs.
The investigators compared the risk for death with use of an
atypical antipsychotic versus either no antipsychotic or the use of
a conventional antipsychotic. These studies have limitations that
preclude reaching a definitive conclusion about comparative death
rates for atypical and conventional antipsychotic drugs.
Nevertheless, the FDA has concluded that these studies, along with
the earlier evidence for atypical antipsychotic drugs, suggest that
both classes of drugs should be considered to have an increased
risk of death when used in elderly patients treated for
dementia-related psychosis.
An explanation of the data and advice for treating patients is
available in an FDA notice to health care professionals being
issued today.
The FDA today issued letters to the manufacturers of both types
of antipsychotic drugs, under the new authority of FDAAA, notifying
the manufacturers that they should make changes to drug labeling.
Manufacturers of both classes of drugs are being asked to change
labeling so that all of the drugs carry uniform warning language.
Manufacturers of these drugs are required to submit new language to
the FDA within 30 days, or to provide a reason why they do not
believe such labeling changes are necessary. If they do not submit
new language, FDAAA provides strict timelines for resolving the
issue and allows the agency to initiate an enforcement action if
necessary.
People taking antipsychotic drugs should not abruptly stop
taking them. Caregivers and patients should talk to the patient’s
health care professionals about any concerns.
The medications involved in this action are:

Conventional Antipsychotic Drugs
Atypical Antipsychotics

Compazine (prochlorperazine)
Abilify (aripiprazole)

Haldol (haloperidol)
Clozaril (clozapine)

Loxitane (loxapine)
FazaClo (clozapine)

Mellaril (thioridazine)
Geodon (ziprasidone)

Moban (molindrone)
Invega (paliperidone)

Navane (thiothixene)
Risperdal (risperidone)

Orap (pimozide)
Seroquel (quetiapine)

Prolixin (fluphenazine)
Zyprexa (olanzapine)

Stelazine (trifluoperazine)
Symbyax (olanzapine and fluoxetine)

Thorazine (chlorpromazine)

Trilafon (perphenazine)

For more information, see
FDA Information for Healthcare Professionals:
Antipsychotics

http://www.fda.gov/cder/drug/InfoSheets/HCP/antipsychotics_conventional.htm
FDA Historical Information on Atypical Antipsychotic Drugs

http://www.fda.gov/cder/drug/infopage/antipsychotics/antipsychotics_historical.htm
#
Media Inquiries:
Sandy Walsh, 301-827-3418
Consumer Inquiries:
888-INFO-FDA

OB/GYN News - Atypical antipsychotics

admin — Fri, 05 Dec 2008 05:16:04 +0000

The reproductive safety of the older typical antipsychotics, such as haloperidol, is supported by extensive data that have accumulated over the past 40 years, at least with respect to teratogenic risk. Much of the data come from their use in treating nausea, particularly with prochlorperazine (Compazine). While long-term neurobehavioral data have been somewhat sparse, no particular indications of risk have been raised in more than 4 decades of use.

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We have far less reproductive safety data on the newer “atypical” class of antipsychotics that have become widely used over the past decade because they lack some long-term side effects associated with the typical antipsychotics. These drugs–olanzapine (Zyprexa), risperidone (Risperdal), quetiapine (Seroquel), aripiprazole (Abilify), ziprasidone (Geodon), and clozapine (Clozaril)–are approved for schizophrenia; several are approved for acute mania indications as well.
But they are also being used widely across psychiatric disease states, including anxiety, agitation in the elderly, generalized anxiety disorder, and obsessive-compulsive disorder, and as adjunctive treatment of depression.
What data are available on the atypicals have been largely limited to manufacturers’ accumulated case series or spontaneous reports, which have their inherent biases with respect to overreporting of adverse outcomes.
To date, such information has not suggested any “signals” with respect to concerns regarding their use in pregnancy, but we can make limited conclusions based on such information. Clinicians have been in a bind with respect to use of atypicals in pregnancy.
A study published in April, the first prospective study of the reproductive safety of the atypicals in the literature, provides some reassuring data regarding the risk of malformations, albeit in a relatively small sample of 151 patients. Investigators from the Motherisk Program in Toronto prospectively followed these women who took olanzapine, risperidone, quetiapine, or clozapine during pregnancy. All of the women had taken one of these agents during the first trimester, and 48 were exposed throughout pregnancy. A total of 151 pregnant women who had taken a non-teratogenic drug also were followed.
In the atypical-exposed group, one child was born with a major malformation (0.9%), a rate lower than the 1%-3% background rate in the general population, versus two (1.5%) in the control group, an insignificant difference.
Differences between groups in the rate of spontaneous abortions, stillbirths, or gestational age at birth were not statistically significant. Women taking atypical antipsychotics did have significantly higher rates of low-birth-weight babies (10% vs. 2%) and therapeutic abortions (10% vs. 1%) (J. Clin. Psychiatry 2005;66:444-9).
The sample was relatively small, the study was statistically underpowered, and long-term neurobehavioral outcomes were not evaluated. Still, this is the first prospective study that complements spontaneous reports from the manufacturers.
The authors noted the number of spontaneous reports of pregnancy exposures to atypicals, provided by the respective makers, with the exception of newer atypicals. Of 242 reports of olanzapine-exposed pregnancies, there was no increase of major malformations or other abnormal outcomes above baseline. Of 523 clozapine exposed pregnancies, there were 22 “unspecified malformations.”
Of the 446 quetiapine-exposed pregnancies, 151 outcomes were reported, of which 8 were different congenital anomalies. Eight malformations were reported among the approximately 250 reports of pregnancies and lactation exposed to risperidone, but no pattern of abnormalities was noted.
If a patient can do without the medication, it is appropriate to discontinue it. In other cases, these decisions have to be made on a case-by-case basis.
For a patient planning a pregnancy who has a severe psychiatric illness and who is maintained on an atypical antipsychotic to sustain functioning, switching to a typical antipsychotic may be prudent. However, we often see women who present when they are already pregnant and on an atypical agent. At this point, a switch may not be wise if the patient is at a risk of relapse. In that case, the Motherisk data are not a guarantee of safety but do provide information that is moderately reassuring. Although this study is encouraging, given the prevalence of reproductive-age women on these agents, it would be ideal if the industry did postmarketing studies to provide the amount of cases we need to reliably estimate risks. Such studies may soon be mandated by the Food and Drug Administration in this post-Vioxx era, with increased emphasis on the safety of marketed drugs.
DR. COHEN directs the perinatal psychiatry program at Massachusetts General Hospital, Boston, which offers information on pregnancy and mental health at www.womensmentalhealth.org. He is a consultant to AstraZeneca, Eli Lilly, and Janssen, manufacturer of atypical antipsychotics.

Business Wire - Coulter Pharmaceutical And SmithKline Beecham Combine Bexxar With CVP Chemotherapy in a New First-Line Clinical Trial

admin — Mon, 01 Dec 2008 00:11:03 +0000

Business Editors & Health/Medical Writers
SOUTH SAN FRANCISCO, Calif./PHILADELPHIA–(BW HealthWire)–April 26, 2000
Coulter Pharmaceutical (Nasdaq:CLTR) and SmithKline Beecham (NYSE:SBH) today announced a Phase II multicenter investigational trial of Bexxar(TM) (tositumomab, iodine I 131 tositumomab) in combination with CVP, a commonly used chemotherapy regimen for the treatment of previously untreated low-grade non-Hodgkin’s lymphoma (NHL). The companies have initiated this new combination trial to further investigate the first-line clinical use of Bexxar while simultaneously preparing a Biologics License Application (BLA) to the FDA for the marketing approval of Bexxar as a single agent in the treatment of relapsed or refractory, low-grade or transformed low-grade NHL.

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“We believe that our single-agent data to date demonstrates the clinical potential of Bexxar,” said Michael F. Bigham, president and chief executive officer of Coulter. “By pursuing the clinical development of Bexxar in combination with chemotherapy, we hope to provide oncologists with safe and effective options in their therapeutic armamentarium to battle this devastating disease.”
The Phase II multicenter, open-label trial will include 30 previously untreated low-grade NHL patients who will receive six cycles of CVP (cyclophosphamide, vincristine, and prednisone) followed within 56 days by Bexxar. The primary endpoint of the trial is to determine overall response of the sequential combination.
In a separate first-line clinical trial in previously untreated low-grade NHL, Bexxar was evaluated in sequential combination with fludarabine, a chemotherapy approved for use in chronic lymphocytic leukemia and often used for the treatment of NHL. This single-center study is fully enrolled and is being conducted at the Center for Lymphoma and Myeloma at the Weill Medical College of Cornell University and New York-Presbyterian Hospital. Preliminary results from this study were presented in December 1999 at the American Society of Hematology. At the time of the presentation, 38 patients were enrolled of which 14 were evaluable for response. Following initial treatment with fludarabine, 14 percent of patients (two out of 14) experienced a complete remission. After subsequent treatment with Bexxar, 71 percent of patients (10 of 14) had experienced a complete response, a five-fold increase compared to initial treatment with fludarabine alone.
Treatment with fludarabine in combination with Bexxar was well tolerated. The principal side effects were hematologic, including a decrease in blood counts, which were reversible. Non-hematologic side effects experienced with Bexxar were mild to moderate, including nausea, fatigue, headache and rhinitis. In this study with fludarabine, only one patient developed human anti-mouse antibodies (HAMA).
Bexxar is a radioimmunotherapy involving an antibody conjugated to iodine 131 that attaches to a protein found only on the surface of B-cells, including non-Hodgkin’s lymphoma B-cells. Bexxar is believed to work through multiple mechanisms of action resulting in immune system activity of the monoclonal antibody and the therapeutic effects of the iodine 131 radioisotope. Through the targeted approach of Bexxar, the tumor cells receive a greater concentration of the therapeutic radiation whereas the radiation to normal tissues is minimized.
Non-Hodgkin’s lymphoma is a form of cancer that affects the blood and lymphatic tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute, approximately 300,000 people are afflicted with NHL in the United States alone. It is estimated that approximately 140,000 people have low-grade or transformed low-grade disease.
Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of cancer and autoimmune diseases. The company currently is developing a family of therapeutics based upon two drug development programs: therapeutic antibodies and targeted oncologics. The company’s most advanced product candidate is Bexxar(TM), a monoclonal antibody conjugated to a radioisotope. The company’s therapeutic antibodies program also includes an interferon receptor antagonist. Initial efforts in the targeted oncologics program are based on tumor activated prodrug (TAP) and tumor-specific targeting (TST) technologies. For more company information, visit Coulter Pharmaceutical’s web site at http://www.coulterpharm.com.
SmithKline Beecham — one of the world’s leading healthcare companies — discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at
http://www.sb.com.
SmithKline Beecham Oncology is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products in oncology. Currently, SB Oncology markets Hycamtin(R) (topotecan hydrochloride), Kytril(R) (granisetron hydrochloride) and Compazine(R) (prochlorperazine), and has novel agents in development.

Preparation for - Tummy Tuck / Abdominoplasty, Body Lift, or Thigh Lift

admin — Thu, 27 Nov 2008 10:26:03 +0000

How Should I Prepare for Tummy Tuck or Body Lift Surgery?

Prior to Surgery

The surgeon will provide very specific instructions prior to surgery so you will have an optimal and safe experience. These include- what medications to avoid to prevent excessive bleeding and bruising, required medical exams, what to eat and drink prior to surgery, and the prescription of an anti-nausea pill to take on the morning of the surgery. In all cases, you will be asked to have a reliable friend or family member take you home after the surgery, as you will not be allowed to drive. Some procedures do require overnight stay in an aftercare facility or a hospital.

Also, tend to all of your chores and to do things before your surgery so you dont have to worry about taking care of things early during your recuperation. This means if you usually clean the house, you should do so in advance of your surgery. Have your hair cut and colored, wax your legs, pay your bills, and take your dog to the vet before your planned day of surgery!

Pre-operative Instructions: Tummy Tuck/ Abdominoplasty; Body Lift, Thigh Lift

If you are older than 45 years, or have heart disease or diabetes, we require a pre-operative EKG, which would either be done by your internist, cardiologist, or at our facility. Heart disease and all other medical illnesses need to be optimized, and you be cleared by an internist or specialist prior to surgery.

Pre-operative laboratory blood and urine tests are done usually within 10 days of your surgery date. If you do have health insurance this might be covered, otherwise, the laboratory will charge you.

If you are a smoker, live with a smoker, or use Nicotine products (patch, gum, or nasal spray) notify your plastic surgeon well in advance of your surgery. You are not allowed to smoke or use Nicotine products for two weeks prior to and two weeks after your surgery, because it greatly increases your risk of having complications including loss of abdominal skin after surgery.

If you are anemic, or have a low blood count, please notify our office well in advance of surgery so that we can start you on Iron supplement. You cannot have a Tummy Tuck if you are anemic.

In order for you surgical incisions to heal, your nutritional state must be satisfactory. You cannot be on any diets for several weeks before surgery. Also, if you have had any prior surgery (i.e. bariatric surgery) that reduces your ability to absorb vitamins and nutrition, you must be on adequate supplements as per your primary physician.

If you have had a history of forming blood clots in your legs, deep venous thrombosis (DVT), Pulmonary Embolism (PE), or are known to have hypercoagulability, you need to notify your surgeon prior to surgery, so that necessary precautions can be taken for your surgery.

Do not use birth control pills or any type of estrogen hormone replacement or supplement for several weeks before your surgery, because they can increase your risk of developing blood clots, DVT or PE.

If you have specific medical illnesses, allergies, or physical handicaps, please notify our staff during your pre-operative visit.

Please refrain from taking any Aspirin, Aleve, Advil, Motrin or other NSAID for ten days before your surgery. These drugs can increase the incidence of bleeding and bruising.

Do not drink or eat after midnight, the night before your surgery. This means no coffee or breakfast on the morning of your surgery. You should take all your medications with a little water. If you have to take diabetic medication or insulin, be sure to have instructions from our office on how much of it to take the morning of surgery.

Please remove and leave behind all jewelry, watches, and body rings before you come in for your surgery. Please do not wear any makeup or perfume.

Prior to your surgery you will be given a prescription for pain medication, antibiotics, and nausea medicine. Get these filled in advance and bring them with you to surgery.

Some patients elect to purchase a “Pain Pump” for their surgery. Pain Pumps are new devices that can help patients with post-operative pain. Pain Pumps are small reservoirs (size of a walkman) of local anesthetic which infuse Lidocaine or Marcaine into the wounds for the first 24-48 hours after surgery. Pain Pumps are sent home with the patient. Because they help keep the surgical areas anesthetized, they reduce the need for narcotics, therefore, lessening the post-operative incidence of nausea. While some patients like using them, others feel that they are not that effective and are instead cumbersome and hinder their mobility. Therefore, Dr. Younai gives his patients the choice of purchasing a Pain Pump at cost if they wish to have them.

Before leaving home for your surgery, take one “nausea pill”- COMPAZINE - with a little water.

Please wear comfortable and loose clothing the day of surgery. It would be helpful if you wear front open tops and loose sweat pants.

We ask you to check the fit of your compression garments in advance, and to bring two with you to surgery.

Set up your bed in an area that is easily accessible and that you dont have to climb multiple stairs. Have bunch of pillows or cushions available so that you can place them behind your back and under your knees after the surgery.

You must make arrangements for a responsible adult friend or family member to take you home after surgery. You are not allowed to drive yourself home or take a taxi. After surgery, this caregiver is required to stay with you and to monitor and assist you for at least the first 24 hours after surgery. If you dont have such a person, or live far away, or are having extensive or multiple procedures please let us know in advance so that we can help you make arrangements for a stay at an after-care facility or hospital.

Information for Healthcare Professionals: Antipsychotics

admin — Fri, 21 Nov 2008 11:21:03 +0000

ROCKVILLE, Md., June 16, 2008-FDA ALERT
[6/16/2008]: FDA is notifying healthcare professionals that
both conventional and atypical antipsychotics are associated with
an increased risk of mortality in elderly patients treated for
dementia-related psychosis.
In April 2005, FDA notified healthcare professionals that
patients with dementia-related psychosis treated with atypical
antipsychotic drugs are at an increased risk of death. Since
issuing that notification, FDA has reviewed additional information
that indicates the risk is also associated with conventional
antipsychotics.
Antipsychotics are not indicated for the treatment of
dementia-related psychosis.
This information reflects FDAs current analysis of data
available to FDA concerning these drugs. FDA intends to update this
sheet when additional information or analyses become available.
To report any unexpected adverse or serious events associated
with the use of these drugs, please contact the FDA MedWatch
program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm
or report by fax to 1-800-FDA-0178, by mail using the postage-paid
address form provided on line, or by telephone to
1-800-FDA-1088.
FDA is requiring the manufacturers of conventional antipsychotic
drugs to add a Boxed Warning and Warning to the drugs
prescribing information about the risk of mortality in elderly
patients treated for dementia-related psychosis similar to the
Boxed Warning and Warning added to the prescribing information of
the atypical antipsychotic drugs in 2005.* See the last page
of this document for a list of conventional and atypical
antipsychotic drugs.
Considerations for Healthcare Professionals
Elderly patients with dementia-related psychosis treated with
conventional or atypical antipsychotic drugs are at an increased
risk of death. Antipsychotic drugs are not approved for the
treatment of dementia-related psychosis. Furthermore, there
is no approved drug for the treatment of dementia-related
psychosis. Healthcare professionals should consider other
management options. Physicians who prescribe antipsychotics to
elderly patients with dementia-related psychosis should discuss
this risk of increased mortality with their patients,
patients families, and caregivers.
Background Information and Data
Previously, in April 2005, FDA informed healthcare professionals
and the public about the increased risk of mortality in elderly
patients receiving atypical antipsychotic drugs to treat
dementia-related psychosis (April
2005 Public Health Advisory and
Information for Healthcare Professionals). At that time,
the analyses of 17 placebo-controlled trials that enrolled 5377
elderly patients with dementia-related behavioral disorders
revealed a risk of death in the drug-treated patients of between
1.6 to 1.7 times that seen in placebo-treated patients.
Although the causes of death were varied, most of the deaths
appeared to be either cardiovascular (e.g., heart failure, sudden
death) or infectious (e.g. pneumonia) in nature. Based on
this analysis, FDA requested that the manufacturers of atypical
antipsychotic drugs include information about this risk in a Boxed
Warning and the Warnings section of the drugs prescribing
information.
Recently, two observational epidemiological studies1,2 were
published that examined the risk of death in patients who
were treated with conventional antipsychotic drugs.
Gill et al.1 performed a retrospective cohort study in Ontario,
Canada of 27,259 adults, 66 years of age or older, with a diagnosis
of dementia between April 1997 and March 2002. The
investigators compared the risk for death with use of an atypical
antipsychotic versus no antipsychotic and the risk for death with
use of a conventional antipsychotic versus an atypical
antipsychotic. They found that atypical antipsychotics were
associated with increased mortality as compared to no antipsychotic
use as early as 30 days and persisting until study end at 180 days.
The investigators found that conventional antipsychotic use showed
a marginally higher risk of death compared with atypical
antipsychotic use. The causes of death were not reported in this
study.
Schneeweiss et al.2 performed a retrospective cohort study in
British Columbia, Canada of 37,241 adults, 65 years of age or
older, who were prescribed conventional (12,882) or atypical
(24,359) antipsychotic medications for any reason between January
1996 and December 2004. The investigators compared the 180-day all
cause mortality with use of a conventional antipsychotic versus an
atypical antipsychotic. They found that the risk of death in the
group of patients treated with conventional antipsychotic
medications was comparable to, or possibly greater than, the risk
of death in the group of patients treated with atypical
antipsychotic medications. The causes of death with the highest
relative risk were cancer and cardiac disease.
FDA considers that the methodological limitations in these two
studies preclude any conclusion that conventional
antipsychotics have a greater risk of death with use than atypical
antipsychotics. FDA has determined, however, that the overall
weight of evidence, including these studies, indicates that the
conventional antipsychotics share the increased risk of death in
elderly patients with dementia-related psychosis that has been
observed for the atypical antipsychotics. The prescribing
information for all antipsychotic drugs will now include the same
information about this risk in a Boxed Warning and the Warnings
section.
References
1. Gill SS et al. Antipsychotic drug use and
mortality in older adults with dementia. Ann Intern
Med. 2007;146:775-786
2. Schneeweiss S et al. Risk of death associated
with the use of conventional versus atypical antipsychotic drugs
among elderly patients. CMAJ. 2007;176:627-632.

Conventional Antipsychotic Drugs
Atypical Antipsychotics

Compazine (prochlorperazine)
Abilify (aripiprazole)

Haldol (haloperidol)
Clozaril (clozapine)

Loxitane (loxapine)
FazaClo (clozapine)

Mellaril (thioridazine)
Geodon (ziprasidone)

Moban (molindrone)
Invega (paliperidone)

Navane (thiothixene)
Risperdal (risperidone)

Orap (pimozide)
Seroquel (quetiapine)

Prolixin (fluphenazine)
Zyprexa (olanzapine)

Stelazine (trifluoperazine)
Symbyax (olanzapine and fluoxetine)

Thorazine (chlorpromazine)

Trilafon (perphenazine)

Business Wire - Coulter Pharmaceutical and SmithKline Beecham Expand Proprietary Position With Second U.S. Patent Grant This Year

admin — Fri, 14 Nov 2008 20:21:02 +0000

Business Editors, Health/Medical Writers
SOUTH SAN FRANCISCO, Calif. & PHILADELPHIA–(BW HealthWire)–July 26, 2000
Coulter Pharmaceutical (Nasdaq:CLTR) and SmithKline Beecham (NYSE:SBH) today announced that the U.S. Patent and Trademark Office has issued another patent relating to CD20 antibody therapy for the treatment of lymphoma.
The newest patent, number 6090365, is a method-of-use patent relating to the administration of antibodies that bind to the CD20 antigen present on lymphoma cells and used in a combination protocol. The combinations may include a CD20 antibody with a chemotherapeutic agent, an antibody-radioisotope conjugate, or external beam radiation.

Get Rid of Migraines

admin — Sun, 09 Nov 2008 11:04:50 +0000

Migraine is a type of headache and a recognised medical condition. Migraine is widespread in the population. In the U.S., 18% of women and 6% of men report having had at least one migraine episode in the previous year. Migraines afflict about 30 million people in the United States. They may occur at any age, but usually begin between the ages of 10 and 40 and diminish after age 50. Some people experience several migraines a month, while others have only a few migraines throughout their lifetime. Approximately 75% of migraine sufferers are women. Migraines’ secondary characteristics are inconsistent. Triggers precipitating a particular episode of migraine vary widely. The efficacy of the simplest treatment, applying warmth or coolness to the affected area of the head, varies between persons, sometimes worsening the migraine. Migraines are classified as either “with aura” or “without aura.” Migraine is a neurological disorder that generally involves recurring headaches. Other symptoms may occur with the headaches. Migraines are often classified based on whether they include an early symptom called an aura. Visual aura is the most common of the neurological events.

Migraine is a true organic neurological disease. Migraine with aura is characterized by a neurological phenomenon (aura) that is experienced 10 to 30 minutes before the headache. Most auras are visual and are described as bright shimmering lights around objects or at the edges of the field of vision (called scintillating scotomas) or zigzag lines, wavy images, or hallucinations. Migraine without aura is the most prevalent type and may occur on one or both sides (bilateral) of the head. Tiredness or mood changes may be experienced the day before the headache. Nausea, vomiting, and sensitivity to light (photophobia) often accompany migraine without aura. Migraine headaches affect about 11 out of 100 people. They are a common type of chronic, recurring headache. They most commonly occur in women and usually begin between the ages of 10 and 46. In some cases, they appear to run in families. A migraine is caused by abnormal brain activity, which is triggered by stress, food, or some other factor.

Migraine-specific therapies are designed specifically to treat migraine attacks. Ergotamine preparations are no longer readily available. Several medications may need to be tried before you find one that works. A class of drugs known as triptans can relieve a migraine once it starts. Rest in a quiet, darkened room. Drink fluids to prevent dehydration, especially if vomiting occurs. Several medications may help relieve symptoms. However, the effectiveness of migraine medications is highly variable in different people. Some medicines can prevent migraines. These include propranolol, amitriptyline, ergonovine, cyproheptadine, clonidine, methysergide, calcium channel antagonists, valproic acid, carbamazepine, topiramate (Topamax), and many others. Ergotamine tartrate preparations constrict the arteries of the head and may be used alone or in combination with other drugs such as caffeine (Cafergot), phenobarbital, or Fioricet. Propoxyphene or other medications that relieve pain or inflammation may provide relief for some people. Nausea should be treated early with Reglan, Compazine, or other anti-emetics.

Migraines Treatment Tips

1. Conventional treatment focuses on three areas: trigger avoidance, symptomatic control, and preventive drugs.

2. Moderation in alcohol and caffeine intake, consistency in sleep habits, and regular meals may be helpful.

3. Triptans are a mid-line treatment suitable for many migraineurs with typical migraines.

4. Ergot drugs can be used either as a preventive or abortive therapy, though their relative expense.

5. Sumatriptan and related selective serotonin receptor agonists are now the therapy of choice for chronic migraine attacks.

6. Anti-emetics by suppository or injection may be needed in cases where vomiting dominates the symptoms.

7. Amidrine is sometimes prescribed for migraine headaches.

8. Intravenous chlorpromazine has proven very effective in treating status migrainosusintractable and unremitting migraine.

9. Diet, visualization, and self-hypnosis are also alternative treatments and prevention approaches.

10. Massage therapy and physical therapy are often very effective forms of treatment to reduce the frequency and intensity of migraines.

11. Massage therapy of the jaw area can also reduce such pain.

12. Botox is being used by many headache specialists for patients with frequent or chronic migraines with encouraging results.

13. Try to avoid any factors that have triggered a migraine in the past.

Shake Off the Shakes

admin — Tue, 04 Nov 2008 06:05:33 +0000

You don’t have to be Michael Jackson to experience tremors or shaking hands. Most people have them at one time or another and their causes are as varied as the moves Jackson can make.

If your hands tremble, it could be the result of fatigue or tension. Mine usually does after long hours of writing. Others get the shakes after ironing clothes or doing heavy manual labor.

Some shake when they are anxious or enraged. Try holding up a flower to your favorite movie star or cover girl and you’ll see what I mean. In those instances, however, the tremors are transient and should not concern you a bit. Those that do need a doctor’s attention are the tremors that won’t go away or involve other parts of the body such as the tongue and head. This could signal serious diseases.

Parkinson’s disease is a neurological disorder that produces uncontrollable shaking of the limbs in addition to stiff muscles, drooling, and a mask-like face. The tremor it brings is worst at rest and least with movement or during sleep.

No one knows what causes Parkinson’s disease but people who have it usually lack a brain chemical called dopamine. Medical treatments with levodopa help the brain to manufacture its own dopamine and control symptoms.

Tremors can also follow the toxic action of certain chemicals or drugs. This is true with the excessive intake of coffee or alcohol. The use of non-prescription drugs containing caffeine produces a similar effect as do certain medicines your doctor dishes out.

“Medications taken by asthmatics to relax their constricted air passages (theophylline) and by epileptics to control their seizures (Dilantin) may also induce tremors. Compazine, an excellent tranquilizer and antinauseant, will every now and then produce tremor and head-bobbing, especially in older people - symptoms frighteningly similar to Parkinson’s disease. Simple withdrawal of the drug eliminates the shaking,” according to Dr. Isadore Rosenfeld of the New York Hospital - Memorial Sloan-Kettering Cancer Center in Symptoms.

In other people, the presence of tremors is an inherited tendency. Such a condition is called a benign or essential tremor and is common in old people. Unlike Parkinson’s disease, an essential tremor is almost absent when the hand is at rest and becomes apparent when you do something. People who have this problem are not sick but they should learn to deal with stress.

The condition is often present in several family members. It can start early in life and then clear up, or it can get worse with age. It does not reflect an underlying disease,” Rosenfeld said.

Tremor can accompany a variety of diseases, including advanced liver trouble, kidney malfunction and an overactive thyroid. Any brain disorder, whether it’s Parkinson’s, multiple sclerosis, a head injury with concussion or a stroke, can also cause the shakes. But in these conditions, the tremor is usually the least of the problem and not the singular telltale or clinching symptom.

For example, in the case of an overactive thyroid, there’s usually a constellation of other symptoms: nervousness, palpitations, warm skin, rapid pulse, bulging eyes, fine hair and quivering of the extended tongue. If you suspect that’s what you have, extend your hands palm down, spread the fingers and put a piece of thin tissue paper over the backs of the hands. A fine vibration is typical of hyperthyroidism,” Rosenfeld explained.

In summary, taming the tremor lies in correcting any underlying disorder. Bo sure to see a doctor to determine if youre shaking is a real problem or simply stress-related.

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Business Wire - Coulter Pharmaceutical and SmithKline Beecham Announce the Submission of a Biologics License Application for Bexxar to FDA

admin — Sat, 01 Nov 2008 00:36:01 +0000

Business Editors/Health Writers
SOUTH SAN FRANCISCO, Calif. & PHILADELPHIA–(BW HealthWire)–Sept. 18, 2000
Coulter Pharmaceutical, Inc. (Nasdaq:CLTR) and SmithKline Beecham (NYSE:SBH) today announced the re-submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Bexxar(TM) (tositumomab, iodine I 131 tositumomab). The companies are seeking marketing approval of Bexxar for the treatment of patients with relapsed or refractory, low-grade or transformed low-grade B-cell non-Hodgkin’s lymphoma (NHL).

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“We are pleased to have responded to all questions from the FDA that followed from our original submission,” said Michael F. Bigham, president and chief executive officer of Coulter. “We look forward to continue working closely with our partner SmithKline Beecham and the FDA to make Bexxar commercially available to the many NHL patients who may benefit from the therapy.”
Kevin Lokay, vice president and director of Oncology for SmithKline Beecham, said, “We are proud to be working in partnership with Coulter on such an important and novel therapy as Bexxar. As a company committed to oncology, we look forward to providing a new treatment option to patients with non-Hodgkin’s lymphoma.”
Bexxar has been designated a Fast Track Product by the FDA because one of the targeted indications for the therapy is transformed, low-grade non-Hodgkin’s lymphoma, a life-threatening disease representing an unmet medical need. Because Bexxar is designated as a fast track product, the companies will request a Priority Review.
Bexxar is a radioimmunotherapy involving an antibody conjugated to iodine 131 (I-131) that attaches to a protein found only on the surface of B-cells, including non-Hodgkin’s lymphoma B-cells. The properties of the I-131 radioisotope allow an appropriate patient-specific dose to be easily determined and administered. Bexxar is believed to work through multiple mechanisms of action resulting from immune system activity of the monoclonal antibody and the therapeutic effects of the I-131 radioisotope. Through the targeted approach of Bexxar, the tumor cells receive a greater concentration of the therapeutic radiation whereas the radiation to normal tissues is minimized.
Non-Hodgkin’s lymphoma is a form of cancer that affects the blood and lymphatic tissues. NHL currently is the sixth leading cause of death among cancers in the United States and has the second fastest growing mortality rate. According to statistics from the National Cancer Institute, approximately 300,000 people are afflicted with NHL in the United States alone. It is estimated that approximately 140,000 people have low-grade or transformed low-grade disease, and 120,000 people have intermediate-grade disease.
Coulter Pharmaceutical, Inc. is engaged in the development of novel drugs and therapies for the treatment of cancer and autoimmune diseases. The company currently is developing a family of therapeutics based upon two drug development programs: therapeutic antibodies and targeted oncologics. The company’s most advanced product candidate is Bexxar(TM), a monoclonal antibody conjugated to a radioisotope. The company’s therapeutic antibodies program also includes an interferon receptor antagonist. Initial efforts in the targeted oncologics program are based on tumor activated prodrug (TAP) and tumor-specific targeting (TST) technologies. For more company information, visit Coulter Pharmaceutical’s web site at http://www.coulterpharm.com.
SmithKline Beecham — one of the world’s leading healthcare companies — discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.
SmithKline Beecham Oncology is committed to the research, development, manufacturing and marketing of therapeutic and supportive care products in oncology. Currently, SB Oncology markets Hycamtin(R) (topotecan hydrochloride), Kytril(R) (granisetron hydrochloride) and Compazine(R) (prochlorperazine), and has novel agents in development.
Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements for Coulter Pharmaceutical, Inc. that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of Bexxar(TM) or the company’s other product candidates and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission (SEC). In particular, see “Risk Factors” in the company’s Registration Statement on Form S-3 filed Aug. 30, 2000, and Annual Report on Form 10-K for the year ended Dec. 31, 1999.
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, SmithKline Beecham cautions investors that any forward-looking statements or projections made by the company, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the company’s operations are discussed in Exhibit 99 to the company’s Annual Report on Form 20-F for 1999, filed with the U.S. Securities and Exchange Commission.
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