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because it was Dr. Harvey Cushing's Birthday.
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Growth Hormone (Norditropin)
FDA Safety Labeling Changes: Norditropin, Agrylin, and Lac-Hydrin
Feb. 24, 2005 — The U.S. Food and Drug Administration (FDA) approved in November and December 2004 revisions to safety labeling to advise healthcare professionals of the following changes: use of somatropin injection is contraindicated in the presence of active neoplasia or proliferative/preproliferative diabetic retinopathy, and pituitary and other brain tumors should be ruled out prior to initiation of somatropin therapy; dose reductions are required when prescribing anagrelide for patients with moderate hepatic impairment; sun exposure should be avoided for areas of the skin treated with ammonium lactate 12% cream.
Somatropin Injection (Norditropin) Contraindicated in Presence of Active Neoplasia
On Nov. 1, the FDA approved revisions to the safety labeling for somatropin [rDNA origin] injection (Norditropin Cartridges, made by Novo Nordisk Pharmaceuticals, Inc.) to advise of contraindications and warnings associated with its use.
Use of somatropin injection is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients, including histidine, poloxamer 188, phenol, and mannitol.
Somatropin injection should not be used to promote growth in patients with closed epiphyses.
Somatropin therapy is contraindicated in the presence of active neoplasia. Preexisting neoplasia should be inactive and treatment complete prior to initiation of somatropin therapy; therapy should be discontinued upon recurrence.
Because growth hormone deficiency may be an early sign of pituitary and other brain tumors, these should be ruled out prior to somatropin therapy initiation. The FDA notes that somatropin should not be used in patients with any evidence of progression or recurrence of an underlying lesion occupying intracranial space. Somatropin use has not been linked to an increased rate of tumor recurrence.
Somatropin use is also contraindicated in patients with proliferative or preproliferative diabetic retinopathy.
Somatropin injection is indicated for long-term replacement therapy in adults with confirmed growth hormone deficiency of either adult or childhood onset, and in children with growth failure due to inadequate secretion of endogenous growth hormone.
Anagrelide (Agrylin) Dose Reductions Required in Hepatic Impairment
On Dec. 17, the FDA approved revisions to the safety labeling for anagrelide HCl (Agrylin capsules, made by Shire Pharmaceutical Development, Inc.) to warn that dose reductions are required when prescribing the product for patients with moderate hepatic impairment.
The warning was based on the results of a pharmacokinetic study showing that total exposure (AUC) to anagrelide was increased eightfold in patients with moderate hepatic impairment.
The FDA notes that anagrelide has not been studied in patients with severe hepatic impairment and that its use in this population is contraindicated.
In patients with moderate hepatic impairment, anagrelide therapy should be initiated at a reduced dose of 0.5 mg/day (normal: 2 mg/day in divided doses) and be maintained for a minimum of one week with careful monitoring for adverse cardiovascular effects. As with anagrelide regimens for patients with normal hepatic function, incremental dose increases should not exceed 0.5 mg/day in any one week.
The FDA recommends that potential risks and benefits of anagrelide therapy be assessed prior to initiation of anagrelide therapy in patients with mild to moderate hepatic impairment.
Anagrelide is indicated for the treatment of thrombocythemia secondary to myeloproliferative disorders to reduce platelet count and the risk of thrombosis, and to improve associated symptoms such as thrombohemorrhagic events.
Avoid Sun Exposure for Skin Treated With Ammonium Lactate 12% Cream (Lac-Hydrin)
On Dec. 13, the FDA approved revisions to the safety labeling for ammonium lactate 12% cream (Lac-Hydrin, made by Bristol-Myers Squibb Co.) to advise of contraindications and warnings associated with its use.
Use of ammonium lactate cream is contraindicated in patients with a history of sensitivity to the active ingredient or other product excipients, including cetyl alcohol, glycerin, glyceryl stearate, laureth-4, light mineral oil, magnesium aluminum silicate, methylcellulose, methyl and propyl parabens, PEG-100 stearate, polyoxyl 40 stearate, and propylene glycol.
The FDA warns that sun exposure should be avoided or minimized for skin areas treated with ammonium lactate cream. Treatment should be discontinued if hypersensitivity develops.
Although clinical studies and postmarketing experience have not identified age-related differences in response to therapy, the FDA advises caution in selecting doses of ammonium lactate cream for elderly patients.
Ammonium lactate 12% cream is indicated for the treatment of ichthyosis vulgaris and xerosis.
Reviewed by Gary D. Vogin, MD
Tercica Submits New Drug Application for Increlex(TM) as a Treatment for Short Stature Caused by Primary IGF-1 Deficiency
SOUTH SAN FRANCISCO, Calif., Feb. 28 /PRNewswire-FirstCall/ -- Tercica,
Inc. (Nasdaq: TRCA) announced today that it has submitted a New Drug
Application (NDA) in the electronic Common Technical Document (eCTD) format to
the U.S. Food and Drug Administration (FDA) to market Increlex(TM) (mecasermin
[rDNA origin] injection), recombinant human Insulin-like Growth Factor-1
(rhIGF-1), for the long term treatment of growth failure in children with a
severe form of primary IGF-1 deficiency (Primary IGFD).
Insulin-like Growth Factor-1 (IGF-1) is the principal hormone necessary
for statural growth. IGF-1 is released in response to stimulation by growth
hormone. Primary IGFD is a disease characterized by lack of IGF-1 production
in the presence of normal or elevated levels of endogenous growth hormone.
Primary IGFD afflicts an estimated 30,000 children evaluated for short stature
in the United States. Approximately 6,000 children suffer from a more severe
form of this disease, called Severe Primary IGFD, and could become eligible
for Increlex therapy if approved by the FDA.
"This NDA submission represents a significant achievement for Tercica,
which could lead to an important advance for the pediatric endocrine
community," said John Scarlett, M.D., President and Chief Executive Officer of
Tercica. "For more than 30 years, physicians have had only one drug to treat
children with growth failure. Increlex will give physicians a potential new,
targeted therapy that may help children with non-growth hormone-deficient
Tercica's NDA for Increlex is based upon the results of a Phase III
clinical trial of rhIGF-1 for the treatment of short stature caused by Severe
Primary IGFD. Data from the study, presented in June 2004 at the 86th Annual
Meeting of The Endocrine Society, demonstrated a statistically significant
increase (p<0.001) in growth rate over an eight-year period in response to
therapy. Compared to pre-treatment growth patterns, on average, children
gained an additional inch per year for each year of therapy over the course of
eight years. In addition, an analysis of safety in the study concluded that
long-term treatment with rhIGF-1 appears to be well tolerated and has an
acceptable safety profile. The most common adverse events were hypoglycemia,
lipohypertrophy and tonsillar hypertrophy. No patients withdrew from the
study due to side effects.
About Short Stature and Primary IGFD
Short stature is defined by being shorter than 97.5 percent of children of
the same age and gender. Primary IGFD, a cause of short stature that is
1.5 times more common that growth hormone deficiency, is diagnosed in children
who have normal or elevated secretion of endogenous growth hormone and whose
height and serum IGF-1 levels are more than two standard deviations below
normal. A sub-set of these children, whose height and serum IGF-1 levels are
more than three standard deviations below normal, are diagnosed with Severe
Primary IGFD can be caused by abnormalities of either the growth hormone
receptor or growth hormone signaling pathway. If untreated, Primary IGFD may
lead, in children and adults, to a range of other metabolic disorders
including lipid abnormalities, decreased bone density, obesity and insulin
Tercica, Inc., acquired exclusive rights to develop, commercialize and
manufacture Increlex from Genentech, Inc. Tercica is currently conducting a
broad-scale Phase IIIb clinical study to evaluate the safety and efficacy of
Increlex in children with Primary IGFD. These patients will have less severe
disease than the patients in Tercica's Phase III studies included in the
Tercica, Inc. is a biopharmaceutical company focused on the development
and commercialization of rhIGF-1 for the treatment of short stature and other
metabolic disorders. For more information on Tercica, Primary IGFD and
Increlex, please visit http://www.tercica.com.
Safe Harbor Statement
Except for the historical statements contained herein, this press release
contains forward-looking statements, including without limitation the
following: (A) that Primary IGFD afflicts an estimated 30,000 children and
Severe Primary IGFD afflicts approximately 6,000 children evaluated for short
stature in the United States; (B) that the approximately 6,000 children with
Severe Primary IGFD could become eligible for Increlex(TM) therapy if approved
by the FDA; and (C) that Increlex(TM) will give physicians a potential new,
targeted therapy that may help children with non-growth hormone-deficient
short stature. The forward-looking statements are subject to the following
risks and uncertainties: (1) with respect to (A) above, there may be fewer
children than Tercica estimates; (2) with respect to (B) and (C) above, if the
FDA: refuses to file the company's NDA, does not grant a marketing approval or
grants a marketing approval covering so few patients that it is not
commercially reasonable for the company to launch the product; and (3) with
respect to all the forward-looking statements, including (A) (B) and (C), (i)
the risky and uncertain drug development process and (ii) those risks and
uncertainties disclosed from time to time in reports filed by Tercica with the
SEC, most importantly, Tercica's Form 8-K filed on February 17, 2005 updating
its Risk Factors. Tercica assumes no obligation and does not intend to update
these forward-looking statements.
SOURCE Tercica, Inc.
Web Site: http://www.tercica.com
From New Zealand: Source: http://www.scoop.co.nz/stories/GE0503/S00006.htm
Director-General's Privileged Statement
Tuesday, 1 March 2005, 5:11 pm
Press Release: Ministry of Health
1 March 2005
Director-General's Privileged Statement Under Section 98 Of The Medicines Act 1981
Director-General of Health Dr Karen Poutasi is today warning people about three herbal products after investigation and testing revealed they contain undeclared prescription medicines.
These products are the Herbs Health brand of: Joint Plus capsules S.E.N Plus capsules Multistress capsules
The Ministry of Health's medicines safety authority (Medsafe) is ordering the recall of these three products because they illegally contain the prescription medicines frusemide, piroxicam or betamethasone.
These herbal products are not approved as medicines in New Zealand and pose a safety risk to consumers if taken without medical supervision.
The Herbs Health Joint Plus capsules and Herbs Health S.E.N Plus capsules both contain frusemide and piroxicam. Consumers are being warned to immediately stop taking these products.
Dr Poutasi says people using the Herbs Health brand of Joint Plus or S.E.N Plus should also seek medical advice from their doctor: if symptoms return or worsen if they feel unwell after stopping to discuss whether alternative treatment options are required if they have any concerns about their health
The Herbs Health Multistress capsules contain betamethasone, which is a potent steroid (corticosteroid) used to treat various inflammatory conditions, such as rheumatoid arthritis. Each Multistress capsule contains approximately 1.6mg of betamethasone.
Dr Poutasi urges anyone taking Multistress to contact their doctor for advice.
"It is important that people do not suddenly stop taking this Multistress, because it can be harmful to stop steroids abruptly," she said.
"It is also essential that any person who has been taking Multistress continuously AND is about to have surgery must tell their surgeon and anaesthetist. This is because there is a risk of complications during surgery such as a sudden drop in blood pressure for anyone who has recently taken steroids. People who have recently stopped taking Multistress should also see their doctor for a check-up".
The Ministry has provided advice to doctors on the Medsafe website about how to wean patients off Herbs Health Multistress, because of the risk associated with sudden cessation of prolonged use of steroids in some patients.
The long-term or high-dose use of oral steroids is associated with side effects such as increased susceptibility to infection, skin damage, acne, osteoporosis, diabetes, fluid retention and weight gain.
Frusemide is a diuretic used to increase urine output. It is used to treat circulatory conditions such as fluid retention (oedema) and heart failure. The amount of frusemide in each capsule is about 4mg, which is a sub-therapeutic adult dose.
Piroxicam is a non-steroidal anti-inflammatory medicine used to treat pain, swelling and inflammation due to musculo-skeletal conditions such as arthritis. Each capsule contains approximately 11mg, which is a therapeutic dose.
Consumer information about all three products is available on the Medsafe website www.medsafe.govt.nz/hot.htm.
Dr Karen Poutasi Director-General of Health
Background information The Herbs Health products were investigated following information received by Medsafe that the products may contain prescription medicines; subsequent testing has confirmed this.
As the three Herbs Health products all contain prescription medicines, these products are considered to be medicines distributed without the consent of the Minister in contravention of the Medicines Act 1981. For the Minister to give consent to the distribution of a medicine, its quality, safety and efficacy must be assessed against and meet international guidelines; this has not occurred with these products.
Consequently, Medsafe has required the distributors of the Herbs Health products to immediately stop supplying them. Where relevant, the products have been recalled from retail outlets. Further investigations are underway into the importation and supply of the products.
Questions and Answers
Which products are being recalled? Herbs Health Joint Plus and Herbs Health S.E.N Plus: both contain the prescription medicines frusemide and piroxicam.
Frusemide is a diuretic used to treat disorders relating to the circulatory system such as oedema and chronic heart failure. The amount of frusemide in each capsule of these products is about 4mg, which is substantially below the usual dose for an adult.
Piroxicam is a non-steroidal anti-inflammatory medicine used to treat pain and inflammation in various musculo-skeletal conditions such as arthritis. The amount of piroxicam in each capsule of these products is about 11mg, which constitutes a therapeutic dose. Consumers taking these capsules may have noticed an improvement in their symptoms.
Joint Plus is intended to help with joint mobility and flexibility. S.E.N Plus is indicated for smooth or healthy skin, and for immune support.
Herbs Health Multistress: contains the prescription medicine betamethasone.
Betamethasone is a potent steroid (corticosteroid), which should only be used under medical supervision, for the treatment of conditions where a strong anti-inflammatory medicine is needed to control symptoms.
Why are these products being removed from the market? It is a breach of the Medicines Act 1981 for herbal products to contain undeclared prescription medicines. There is also potential for harm to occur when prescription medicines are unknowingly used by consumers, particularly in the absence of medical supervision. Piroxicam can cause gastro-intestinal problems such as indigestion, abdominal pain and bleeding. Frusemide may cause dehydration or electrolyte disturbances. Betamethasone can reduce the body's ability to fight infection; long-term use can cause osteoporosis or weight gain.
What is the usual dose range for oral betamethasone? The usual dose range for oral betamethasone is between 0.5 and 5mg per day. Testing has indicated that Multistress contains approximately 1.6mg of betamethasone per capsule.
What are the risks associated with weaning a patient off steroids too quickly? The use of steroids can suppress the body's normal production of its own adrenal steroid hormones. Therefore, some patients may need to be slowly weaned off these products under the supervision of their doctor. If weaned too quickly, patients may become seriously unwell.
If a consumer is taking any of these products what should they do? Anyone who is taking Herbs Health Joint Plus or Herbs Health S.E.N Plus should stop taking them now. Some consumers will also need to seek medical advice from their doctor, particularly if: their symptoms return or worsen they feel unwell after stopping they want to discuss whether alternative treatment options are needed they have any concerns about their health.
If consumers are taking Herbs Health Multistress they should not stop taking them suddenly and should go to their doctor as soon as possible for assessment.
How many people take these products in NZ? There is no reliable information about how many people take these products but it appears that about 780 bottles of Herbs Health Joint Plus, 450 of Herbs Health S.E.N Plus and 500 of Herbs Health Multistress have been distributed in New Zealand.
Who is responsible for recalling the products? Distributors and importers are required to recall the products. Distribution had mainly occurred through direct sales by the company. The retailers involved no longer have stock for sale.
Can these products still be sold? No. Medsafe has required the distributors of these products to immediately cease supplying them. The products have also been recalled from retail outlets.
What responsibilities do distributors and importers have? Distributors and importers are responsible for ensuring products they import or sell do not contain any prescription medicines. Also, it is illegal to provide prescription medicines without a prescription from a registered medical practitioner. Under the food and medicine legislation, sponsors/distributors/importers are required to list all active ingredients on the packaging, and to include the strength of each active ingredient.
How should doctors manage patients who have been taking Multistress? Detailed advice is provided on the Medsafe web site: http://www.medsafe.govt.nz/hot.htm
Is there information available for consumers? Advice to consumers is available on the Medsafe web site: http://www.medsafe.govt.nz/hot.htm
What do the products look like? There are photographs on the Medsafe web site: http://www.medsafe.govt.nz/hot.htm
Female Health Care and Tips for Women
Publish Date : 2/28/2005 9:48:00 AM
Khalsa News Network Pvt. Ltd.
How hypothyroidism is tested?
Hypothyroidism: The under-activation of the thyroid gland is called hypothyroidism. This condition is very harmful and causes many more health problems.
Now there are many methods that could help in the diagnosis even at an early stage. What is required is complete history of symptoms and physical examination of the patient. The diagnosis is done by patient?s blood. Some physicians believe that because thyroid problems are so common in the elderly and thyroid hormone tests are so inexpensive, blood tests for thyroid function should be routine. One study reported that in elderly patients who require emergency surgery and have undiagnosed hypothyroidism, the consequences can be very serious, even fatal. The American College of Physicians now recommends that women over 50 years old should be screened every five years. Researchers in one study, in fact, reported that screening men and women at age 35 and every five years afterward would be cost-effective and would prevent progression to hypothyroidism in people with mild thyroid failure but no symptoms (subclinical hypothyroidism).
A goiter (an enlarged thyroid) may be evident on examination. A rubbery, painless goiter may be an indication of Hashimoto's disease. If the thyroid is tender and enlarged but not necessarily symmetrical, the physician may suspect subacute thyroiditis. A diffusely enlarged gland may occur in hereditary hypothyroidism, in postpartum patients, or from use of iodides or lithium. The physician will check the heart, eyes, hair, skin, and reflexes.
Measuring Thyroid Hormone Levels
Thyroid-stimulating hormone (TSH) and thyroxine (T4) levels are usually both measured using blood samples, although TSH is the more sensitive indicator of hypothyroidism. Its function is to stimulate thyroxine production when levels drop, and so the pituitary gland secretes more TSH as soon as it senses even slight reductions in thyroxine levels. In fact, thyroxine may still be within normal range when the pituitary begins to increase the supply of TSH. If TSH levels are elevated above 6 mU/L regardless of thyroxine levels -- the physician can still make a diagnosis of hypothyroidism, although the condition is considered to be subclinical if thyroxine levels are normal and the patient has no symptoms. In the very elderly or seriously ill patients and during pregnancy both thyroxine and TSH levels may be extremely variable; in such patients measurements of the hormones should be repeated before starting thyroid-hormone therapy. Tests called sensitive thyroid-stimulating hormone (sTSH) assays and so-called free thyroxine (fT4) assays have been developed and are believed to be very accurate; one study reported that sTSH was so accurate that the fT4 test was not needed.
Almost all newborns with hypothyroidism are identified shortly after birth through an effective national screening program using a thyroid blood test. Each year over 1,500 children are now saved from subnormal intelligence.
Testing during Pregnancy
Because untreated hypothyroidism is a serious problem for the unborn child, all pregnant women should be tested for thyroid function. Elevated levels of estrogen during pregnancy cause thyroid hormone levels to rise. Therefore, a pregnant woman with an under-active thyroid may have what appears to be normal levels of thyroid hormones, but she may actually be hypothyroid. A blood test showing elevated TSH levels, however, is a reliable indicator of an under-active thyroid, even in pregnancy.
A blood test for antithyroid antibodies is sometimes used to detect Hashimoto's thyroiditis, particularly in patients who have knobby goiters. If high levels of antibodies are present Hashimoto's thyroiditis is a certain diagnosis. Even if patients have no symptoms at the time of the test, a positive result usually means that a patient has a 4% to 8% chance of developing symptoms each year.
Imaging procedures including x-rays and ultrasound may be used to visualize the thyroid, but they do not measure the thyroid gland's function. Thyroid scans are then used to determine whether the thyroid is producing normal amounts of hormone. The patient drinks a small amount of radioactive iodine or technetium and waits until it has been through the thyroid. Images of a properly functioning thyroid would show uniform levels of absorption throughout the gland. Overactive areas would show up white and under-active areas would appear dark. Thyroid scans are usually unnecessary unless the physician needs to rule out suspected cancer.
If laboratory tests suggest that a pituitary or hypothalamus problem is causing hypothyroidism, the physician will usually order brain imaging procedures using computed tomography (CT) scans or magnetic resonance imaging (MRI).
Needle Aspiration Biopsy
Needle aspiration biopsy is a common procedure performed in a doctor's office and used to obtain thyroid cells for microscopic evaluation. Much like drawing blood, the physician injects a small needle into the thyroid gland and draws cells from the gland into a syringe. The cells are put onto a slide, stained, and examined under a microscope.
Other Blood Tests
Other blood tests may be performed to detect levels of calcitonin, calcium, prolactin, thyroglobulin and to check for anemia and liver function, all of which may be affected by hypothyroidism.
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have any questions you may contact her at
do not have to be a member of CUSH to fill out this
questionnaire, as long as you are a Cushing’s patient. We do not
believe that the world has an accurate accounting of Cushing’s
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numbers. Your help will be appreciated. Thank you."