Hi Karen: Arimedex is the catabolic of this drug category. So why is
Tamoxfen pushed not only by the drug company; but by the FDA and NCI? The
NCI sponsored the trials, then had it fast track through FDA. So the drug
did not have the oppertunity to go through all the hoops of time for
specific usage as most drugs do. Many free samples were given to doctors
who gave them to their patients and then billed the insurance companies.
Reward incentives were given. I am not sure if this is common practice with
all drugs or not; however I did read that the makers of Tamoxifen spent the
highest in dollar amounts. Realize, this is all information gathered on the
internet and reflects only my opinion. I believe it is more political.
THE HEALTH EFFECTS OF TAMOXIFEN
(Excerpt From Cancer & Hormone Paper)
Tamoxifen has been formally declared by the World Health Organization as a
carcinogen. Under State Proposition 65, California must publish and
maintain a list of all known carcinogens. In 1995, the state's Carcinogen
Identification Committee voted unanimously to list tamoxifen. Tamoxifen's
known side effects include:
Liver Damage : Britain withdrew from studies on the use of tamoxifen when
it was discovered that tamoxifen's manufacturer withheld unpublished data
indicating that the drug may induce liver tumors. Liver damage has occurred
in every animal study using tamoxifen. Animal studies show tamoxifen
produces potentially carcinogenic DNA and alterations in the liver, as well
as eye damage.
Uterine Cancer : Although the drug has had some success in preventing
recurrences in women who have been successfully treated for breast cancer,
it does promote particularly aggressive uterine cancer. A large Swedish
study, and another in the Netherlands, found a 6-fold increase in uterine
cancer among those patients who took tamoxifen. In a University of
Pittsburgh study, 23 out of 1,000 given the drug, contracted uterine cancer.
Endometrial Effects : A Danish/British study detected endometrial
abnormalities. Uterine tumors, endometrial thickenings, and cancers
occurred in a significant number of women taking tamoxifen.
Blood Clots : It is also known to cause fatal blood clots in the lungs,
irritating the walls of the veins, and leading to inflammation.
Osteoporosis : Taxmoxifen users are at risk of developing early symptoms
of menopause, including accelerated bone mineral loss and osteoporosis.
Other adverse reactions which are seen infrequently are hypercalcemia,
peripheral edema, distaste for food, pruritus vulvae (vaginal itching),
depression, dizziness, light-headedness, headache, hair thinning and/or
partial hair loss, and vaginal dryness.
NOLVADEX has been associated with changes in liver enzyme levels, and on
rare occasions, a spectrum of more severe liver abnormalities including
fatty liver, cholestasis, hepatitis and hepatic necrosis.
http://www.worstpills.org/tamoxifen.htmhttp://www.selene.com/healthlink/tamoxifen.htmlhttp://www.all-natural.com/tamox.htmlhttp://www.stopbreastcancer.org/press/tamox.asphttp://207.226.63.9/hrg/PUBLICATIONS/1479.htm
ARIMIDEX ORAL
Adverse Effects List & Discussion
Adverse Effects List from First DataBank
Incidence more frequent Incidence less frequent
CHEST PAIN
DYSPNEA
PERIPHERAL EDEMA
ABDOMINAL PAIN
ASTHENIA
BONE PAIN
COUGH
DIARRHEA
DIZZINESS
DRY MOUTH
FLUSHING
GI DISTURBANCE
HEADACHE
HOT FLASHES
NAUSEA
PELVIC PAIN
SKIN RASH
SWEATING
VOMITING
ANEMIA
HYPERTENSION
LEUKOPENIA (W OR W/O INFECTION)
MENORRHAGIA
THROMBOEMBOLISM
THROMBOPHLEBITIS
ALOPECIA
ARTHRALGIA
BREAST PAIN
MYALGIA
PARESTHESIAS
PRURITUS
RHINITIS
SINUSITIS
VAGINAL DRYNESS
WEIGHT GAIN
Adverse Effects Discussion from AHFS DI T
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----
ARIMIDEX ORAL
Precautions
Label Warnings from First DataBank
Warning: Do not use if you are pregnant, plan to become pregnant or while
breastfeeding. Consult your doctor or pharmacist.
Drug Disease Contraindications from First DataBank
Most Significant
For these conditions, action to reduce the risk of adverse interaction is
usually required
PREGNANCY
Significant
For these conditions, assess risk to patient and take action as needed
HEPATIC FUNCTION IMPAIRMENT
RENAL FUNCTION IMPAIRMENT
Possibly Significant
For these conditions, conservative measures are recommended until more is
known.
ENDOCRINE DISORDERS
HYPERLIPIDEMIA
----------------------------------------------------------------------------
----
Some sites to go to:
http://www.ici.com.pk/html/pharma_arimidex.htm
Side Effects:
Anastrozole or Arimidex's side effects are similar to megestrol's, with one
exception - there is less weight gain. The side effects include enlarged
breasts, phlebitis of veins, hair loss, blood clots in the lungs, and carpal
tunnel syndrome.
Cautions for People:
People with blood clotting or circulation problems must be monitored
closely. Because Anastrozole or Arimidex interferes with female hormones,
women who are or may be pregnant should avoid the drug.
Drug Interactions:
Anastrozole or Arimidex is able to enhance the effects of drugs that affect
blood clotting and circulation.
Further Reading:
ONCOLOGIC PROTOCOL
ANASTROZOLE (ARIMIDEX)
MAJOR INDICATIONS: HORMONAL TREATMENTS FOR BREAST CANCER (ALL STAGES)
IDENTIFICATION: Anastrazole (Arimidex)
This drug has been approved by the FDA (Food and Drug Administration) for
the treatment of metastatic (Stage IV) breast cancer.
Dose: 5 mg (1 tablet) per day.
Route: Given orally
Duration and timing: In the treatment of stage IV disease treatment is
continued until disease progression.
Possible Side effects:
Gastrointestinal: possible nausea and vomiting (which may be decreased or
prevented with medications), abdominal pain, constipation, diarrhea, loss of
appetite.
Systemic: menopausal symptoms (hot flashes, night sweats, menstrual
irregularity), bone or tumor pain.
Fertility: adverse effect on fertility is known; this drug should not be
taken by women who are pregnant or breast feeding.
Respiratory: instances of pulmonary embolism have occurred (blood clot going
to the lung), dyspnea (feeling of shortness of breath), cough and
pharyngitis.
Other: increased risk of developing blood clots, edema, dizziness,
headaches, depression, rash and generalized weakness have all been
encountered.
Side effects:
Some of more important side effects are:
Flu like syndrome
Fever
Neck pain
Fatigue
Weight loss
Abnormal Liver function tests
Lowering of Blood counts
Anxiety and nervousness
Arimidex May Be More Successful Than Tamoxifen in Post-Menopausal Breast
Cancer Patients (dateline December 30, 1999)
A large study presented at the 22nd Annual San Antonio Breast Cancer
Symposium revealed that post-menopausal women with advanced breast cancer
may benefit more from treatment with the drug Arimidex (generic name
anastrozole) than with the commonly prescribed drug, tamoxifen (trade name
Nolvadex). The study combined data from two research groups: the North
American research group and the European group, TARGET (Tamoxifen and
Arimidex Randomized Group Efficacy and Tolerability). Women treated with
tamoxifen were found to have a 13% higher risk of disease progression than
those treated with Arimidex.
The randomized, double-blind study included 1021 post-menopausal women with
Stage IV breast cancer (also called metastatic cancer). Metastatic breast
cancer has spread past the breast and underarm lymph nodes to other areas of
the body such as the bone, lung, liver, or brain. The study marks the first
time researchers have directly compared the effects of tamoxifen and
Arimidex in a clinical trial according to Professor Aman Buzdar of the
University of Texas' M.D. Anderson Cancer Center. Arimidex was approved by
the U.S. Food and Drug Administration (FDA) in January 1996 as treatment for
post-menopausal women with metastatic breast cancer who have not responded
well to treatment with tamoxifen.
Researchers are surprised at the results of the Arimidex study since
tamoxifen and Arimidex fight breast cancer in distinctly different ways.
While tamoxifen blocks estrogen receptors in breast cancer cells, Arimidex
works by interfering with the body's ability to synthesize estrogen.
Arimidex is a non-steroid compound known as a selective aromatase inhibitor.
Since Arimidex inhibits the body's conversion of certain steroid hormones
(androgens) to estrogen by the enzyme aromatase, Arimidex decreases the
overall concentration of estrogen, thus reducing the spread of breast cancer
in post-menopausal women. Since androgens also act as weak estrogens and
participate in the overall production of estrogen, women who produce
adequate levels of androgens often do not need to use hormone replacement
therapy to prevent menopausal symptoms and osteoporosis.
A long-term study comparing Arimidex with tamoxifen in early-stage breast
cancer patients is currently underway. ATAC (Arimidex, Tamoxifen Alone or in
Combination) is the largest study of hormonal treatment ever undertaken and
involves over 9,000 post-menopausal women from cancer centers worldwide. In
addition to evaluating the safety of the two drugs, researchers will also
investigate whether a combined treatment of Arimidex and tamoxifen improves
patient outcomes. Results of the ATAC study are due in 2001.
Most post-menopausal women treated with Arimidex take one 1-mg tablet each
day. Arimidex cannot distinguish between normal cells and cancer cells, and
consequently, may cause some side effects. The most common side effects to
treatment include a general feeling of weakness and a decreased energy
level. Other less common side effects include:
Headache
Nausea
Mild diarrhea
Increased or decreased appetite
Sweating
Hot flashes
Vaginal dryness
Temporary hair thinning
Rare side effects of Arimidex include blood clots with redness or mild
swelling of arms, legs and ankles, pain in leg calves, shortness of breath,
or difficulty breathing. Not all women with advanced breast cancer are
candidates for Arimidex therapy. Because Arimidex decreases the body's
overall estrogen level, women at high risk of osteoporosis may not be suited
for Arimidex therapy. Post-menopausal women are encouraged to discuss
Arimidex with their physician or cancer treatment team.
Additional resources and references
The December 10, 1999 Doctor's Guide report, "Arimidex More Effective Than
Nolvadex For Advanced Breast Cancer," is available at
http://www.pslgroup.com/dg/14FB16.htm
AstraZeneca, the manufacturer of Arimidex, provides full prescribing
information at
http://www.astrazeneca-us.com/cgi-bin/az_pi.cgi?product=arimidex&country=US&
inframe=no
The CancerBACUP organization provides information on Arimidex at
http://www.bacup.org.uk/info/anastrazole.htm
To learn more about tamoxifen, please visit
http://www.imaginis.net/breasthealth/tamoxifen.html
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