Thanks for the great info and your quick response, Lillian.
Karen
Lillian wrote:
>
> 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 it was discovered that tamoxifen's manufacturer withheld unpublished data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.htm
>
> http://www.selene.com/healthlink/tamoxifen.html
>
> http://www.all-natural.com/tamox.html
>
> http://www.stopbreastcancer.org/press/tamox.asp
>
> http://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
>
> ----------------------------------------------------------------------------
> ----
>
> 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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