NetNews Usenet Archive 1992 #31/NN_1992_31.iso/spool/bit/listserv/mednews/107

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immunocompromised persons in a correctional system--New York, 1991.  MMWR
1992;41:507-9.

3. CDC. Prevention and control of tuberculosis in correctional institutions:

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Volume  5, Number  6                                         December 20, 1992

recommendations of the Advisory Committee for the  Elimination of
Tuberculosis. MMWR 1989;38:313-20,325.











































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Volume  5, Number  6                                         December 20, 1992

                               Notice to Readers
             Availability of Parenteral Isoniazid -- United States

Because parenteral isoniazid is unavailable commercially, a limited supply of
this drug will now be made available through CDC under an investigational new
drug agreement for the treatment of patients with active tuberculosis for whom
the oral formulation of the drug cannot be prescribed.  Clinicians and other
health-care  providers interested in obtaining this drug for their patients
should contact CDC's Clinical Research Branch, Division of Tuberculosis
Elimination, National Center for Prevention Services, telephone (404) 639-
2530.
     The Food and Drug Administration is working with  pharmaceutical
manufacturers to reestablish a supply of this drug; the drug is expected to
become commercially available in the United States early next year.































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Volume  5, Number  6                                         December 20, 1992



::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
                        Food & Drug Administration News
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

                           FDA APPROVES DEPO PROVERA
                           ------------------------

                    FDA News Release P92-31, Oct. 29, 1992
                   FDA Contact: Susan Cruzan, [phone]

  The Food and Drug Administration today announced the approval of Depo
Provera, an injectable contraceptive drug.

  The drug, which contains a synthetic hormone similar to the natural hormone
progesterone, protects women from pregnancy for three months per injection.
The hormone is injected into the muscle of the arm or buttock where it is
released into the bloodstream to prevent pregnancy. It is more than 99 percent
effective.

  "This drug presents another long-term, effective option for women to prevent
pregnancy," said FDA Commissioner David A. Kessler, M.D. "As an injectable,
given once every three months, Depo Provera eliminates problems related to
missing a daily dose."

  Depo Provera is available in 150 mg. single dose vials from doctors and
clinics and must be given on a regular basis to maintain contraceptive
protection. If a patient decides to become pregnant, she discontinues the
injections.

  As with any such products, FDA advises patients to discuss the benefits and
risks of Depo Provera with their doctor or other health care professional
before making a decision to use it.

  Depo Provera's effectiveness as a contraceptive was established in extensive
studies by the manufacturer, the World Health Organization and health agencies
in other countries. U.S. clinical trials, begun in l963, also found Depo
Provera effective as an injectable contraceptive.

  The most common side effects are menstrual irregularities and weight gain.
In addition, some patients may experience headache, nervousness, abdominal
pain, dizziness, weakness or fatigue. The drug should not be used by women who
have acute liver disease, unexplained vaginal bleeding, breast cancer or blood
clots in the legs, lungs or eyes.

  The labeling advises doctors to rule out pregnancy before prescribing the

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Volume  5, Number  6                                         December 20, 1992

drug, due to concerns about low birth weight in babies exposed to the drug.
Recent data have also demonstrated that long-term use may contribute to
osteoporosis. The manufacturer will conduct additional research to study this
potential effect.

  Depo Provera was developed in the l960s and has been approved for
contraception in many other countries. The UpJohn Company of Kalamazoo, Mich.,
which will market the drug under the name, Depo Provera Contraceptive
Injection, first submitted it for approval in the United States in the l970s.
At that time, animal studies raised questions about its potential to cause
breast cancer. Worldwide studies have since found the overall risk of cancer,
including breast cancer in humans, to be minimal, if any.

































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Volume  5, Number  6                                         December 20, 1992

              FDA WARNS AGAINST HISMANAL (ASTEMIZOLE) INTERACTION
              ---------------------------------------------------

                    FDA News Release P92-30, Oct. 28, 1992
                  FDA Contact: Monica Revelle, [phone]

  The Food and Drug Administration today warned doctors against the use of the
prescription antihistamine drug Hismanal (astemizole) in combination with the
anti-fungal drugs ketoconazole or itraconazole or the antibiotic drug
erythromycin.

  Janssen Pharmaceutica, manufacturer of Hismanal, has agreed to send a "Dear
Doctor" letter to physicians and other health professionals cautioning them
about the risk of serious cardiac arrhythmias -- heart rhythm abnormalities --
in patients who used any of these drugs with Hismanal.

  Hismanal is a nonsedating antihistamine prescribed for the treatment of
seasonal allergies and hives. FDA in July had issued a warning about exceeding
Hismanal's recommended dose of 10 mg (1 tablet) per day because of the
increased risk of cardiac arrhythmias. Hismanal is known to cause cardiac
arrhythmias when present at excessive levels in the blood.

  FDA recently received reports of serious arrhythmias in two patients who
took Hismanal with erythromycin, or erythromycin plus ketoconazole, alerting
FDA to a possible interaction between Hismanal and these drugs, as a cause of
arrhythmias. Subsequently, Janssen submitted preliminary information
indicating that blood levels of Hismanal are greatly increased in patients
taking ketoconazole. Itraconazole, recently approved by FDA, was included in
the warning primarily because of its chemical and pharmacologic similarity to
ketoconazole.

  FDA issued a similar warning in July for other nonsedating antihistamine
drug products, Seldane and Seldane-D.

  "Because of the potentially serious nature of these interactions, we must be
extremely cautious, and we urge doctors and patients to avoid combining these
drugs," said FDA Commissioner David A. Kessler, M.D.

  The new labeling for Hismanal includes the following boxed warning:

  "Concomitant administration of astemizole (Hismanal) with ketoconazole
tablets, itraconazole or erythromycin is contraindicated."



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Volume  5, Number  6                                         December 20, 1992

              NEW FOOD SAFETY EDUCATION PROGRAM FOR NURSING HOMES
              ---------------------------------------------------

                    FDA News Release P92-34, Nov. 17, 1992
                    FDA Contact: Brad Stone, [phone]

  The Food and Drug Administration, the Centers for Disease Control and
Prevention and the Health Care Financing Administration today announced the
start of a new food safety education program for nursing homes to help reduce
the incidence of serious and life-threatening foodborne diseases that can pose
particular problems in the elderly.

  The agencies are distributing two instructional videos that explain how to
avoid foodborne illnesses, particularly among the elderly, by proper food
handling and preparation. The videotape/training kits also provide information
on the illnesses themselves.

  A joint FDA-CDC study, "Foodborne Disease Outbreaks in Nursing Homes, 1975
to 1987," published last year in the Journal of the American Medical
Association, said that, while nursing home residents accounted for just 2.4
percent of cases of foodborne illness in this country, they accounted for 19.4
percent of the deaths from foodborne illness.

  "A high proportion of nursing home residents may have weakened immune
systems, so they have a greater susceptibility to these diseases and are 10
times more likely to die from them than are younger adults," said HHS
Assistant Secretary for Health James O. Mason, M.D., head of the U.S.  Public
Health Service.

  The new video package follows one developed three years ago by FDA and CDC
showing how people infected with AIDS can protect themselves from foodborne
illnesses. The current program expands this effort to the elderly and others
in nursing homes.

  The videotape series takes a two-tiered approach. One videotape is directed
toward informing nursing home administrators and medical directors about the
scientific aspects of foodborne illness, such as the causative agents of
disease, symptoms and diagnosis. It also outlines methods for reducing the
risk of outbreaks.

  The other videotape is targeted to nursing home food service managers and
workers. It instructs food service personnel on proper food storage, handling
and preparation techniques, and is illustrated with case studies.

  The videotapes and case studies are being provided to the agencies' field

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Volume  5, Number  6                                         December 20, 1992

offices throughout the country, and a limited number are also available to
state and local public health agencies on a first-come, first-served basis.
Nursing homes and others may order the videotape training kit directly for
$39.00 plus $3.00 handling from:

National Technical Information Service 5285 Port Royal Road Springfield, VA
22161 Phone [phone]

When ordering, refer to # PB92-780857.




































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Volume  5, Number  6                                         December 20, 1992

           SOTALOL HYDROCHLORIDE APPROVED FOR VENTRICULAR ARRHYTHMIA
           ---------------------------------------------------------

                     FDA News Release P92-32, Nov. 5, 1992
                   FDA Contact: Susan Cruzan, [phone]

  The Food and Drug Administration today announced the approval of sotalol
hydrochloride, a new drug for treatment of life-threatening ventricular
arrhythmias (irregular heartbeats) which affect approximately 150,000 patients
a year.

  Like other anti-arrhythmic drugs, sotalol is not recommended for use in less
severe circumstances because it can itself induce serious arrhythmias.  In
patients with life-threatening arrhythmias, however, this risk is outweighed
by the drug's benefits.

  "The drug will provide an option for doctors to treat patients who have been
diagnosed with serious arrhythmias," said FDA Commissioner David A.  Kessler,
M.D. "It can also benefit people who have failed other treatments."

  FDA's approval was based on the results of trials comparing sotalol with
other anti-arrhythmic drugs in safety studies involving more than 3,000
patients.

  Studies of the drug's effectiveness involved a total of approximately 1,300
patients who had life-threatening arrhythmias. In a small comparison study,
conducted under controlled hospital conditions, sotalol proved about 30
percent effective in preventing these arrhythmias -- somewhat better than
procainamide, a widely used anti-arrhythmic drug. In a larger comparison
study, conducted by the National Institutes of Health, sotalol was more
effective in preventing recurrent arrhythmias, even over the long term, than a
group of six other drugs.

  Sotalol has two properties important to its therapeutic action: It decreases
the effects of nerve impulses that excite the heart tissues, and it alters the
way the heart conducts electrical signals that generate arrhythmias.

  In studies of sotalol, one of the major adverse effects was a new life-
threatening arrhythmia called torsades de pointes. This was observed in about
4 percent of patients who were treated for their life-threatening arrhythmias
and more than 1 percent of patients treated for less serious arrhythmias.

  Patients given sotalol must be carefully observed to ensure that the drug is
having the desired effect but not the undesired ones. In addition, as the drug
has no known benefit in patients with less serious arrhythmias, it should not

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Volume  5, Number  6                                         December 20, 1992

be used in such patients.

  Some of sotalol's other adverse effects include labored breathing, worsening
of existing congestive heart failure, fatigue and excessive slowing of the
heart rate.

  Sotalol will be sold under the trade name Betapace and marketed by Berlex
Laboratories of Wayne, N.J.





































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Volume  5, Number  6                                         December 20, 1992

          FDA ADVISORY COMMITTEE RECOMMENDS TAXOL FOR OVARIAN CANCER
          ----------------------------------------------------------

                    FDA News Release T92-56, Nov. 18, 1992
                   FDA Contact: Susan Cruzan [phone]

  We have had some media interest concerning the Nov. 16 recommendation by the
FDA Oncology Drugs Advisory Committee that Taxol (paclitaxel) be approved for
treatment of refractory ovarian cancer (cancer that is unresponsive to
conventional therapy).

  The committee, a group of outside experts, considered data presented by
representatives of FDA, the National Cancer Institute (NCI) and Bristol-Myers
Squibb Co., manufacturer of Taxol. The committee's recommendations were based
on its conclusion that the data showed evidence of Taxol's effectiveness that
is strong enough to allow its use in patients who have failed first line
chemotherapy.

  Clinical trials conducted by NCI at five centers around the country, plus
multi-center trials in Europe sponsored by the manufacturer, were reported to
have confirmed that Taxol shrinks tumors by at least one-half in 20 to 30
percent of patients with refractory ovarian cancer, for an average of five
months. In these studies Taxol, like many other cancer drugs, was associated
with serious side effects including a decrease in white blood cells (which may
cause susceptibility to infections), hair loss and numbness of the fingers and
toes.

  FDA has completed its initial review of information on Taxol, the agency is
awaiting further data relating to manufacture of the drug and completion of an
environmental assessment, required by law. Because taxol is obtained from the
Pacific yew tree, this involves an assessment of the effect of yew harvesting
on U.S. forests. The environmental assessment is being prepared in cooperation
with the U.S. Forest Service.

  NCI and Bristol-Myers Squibb are also working under a collaborative
agreement to find new sources of the active ingredient and to further develop
Taxol as an anti-cancer drug.








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Volume  5, Number  6                                         December 20, 1992

                       FDA BANS 415 OTC DRUG INGREDIENTS
                       ---------------------------------

                    FDA News Release P92-27, Aug. 25, 1992
                  FDA Contact: Sharon Snider, [phone]

  The Food and Drug Administration today proposed banning 415 ingredients from
seven categories of nonprescription drugs because they have not been shown to
be safe and effective for their stated claims. The action affects a wide
variety of nonprescription (OTC -- Over The Counter) products including
remedies for digestive disorders, menstrual problems, fever blisters and
poison ivy.

  Use of most of the ingredients named has already been discontinued, but
several products containing one or more of the ingredients remain on the
market. Manufacturers will have to reformulate or remove such products from
the market before the proposed rules are published in final form and become
effective. "We are taking this action because no proof has been submitted to
FDA that shows the ingredients are effective for the conditions claimed," said
FDA Commissioner David A. Kessler, M.D.

  The ban on some ingredients is not total, however; some ingredients banned
for one use may be allowed for another. For example, salicylic acid is being
banned as an external pain reliever in insect bite and sting treatment drug
products but has been found effective for removal of warts, corns and
calluses. In some cases ingredients known to be safe but which would not be
allowed for certain claims could be used as inactive ingredients. For example,
peppermint, while not effective as a digestive aid, could be used as a
flavoring agent.

  Most of the ingredients have been in use since before 1962, when a change in
the law required that manufacturers submit proof of effectiveness for new drug
products as well as drug products already on the market. To implement the part
of the law dealing with nonprescription drugs, FDA set up a process to
evaluate all ingredients contained in OTC drug products.  Since that review
began, products and ingredients found harmful were removed from the market.
Products believed safe, but for which evidence of effectiveness was lacking,
were allowed to remain in use until proof of their effectiveness could be
finally established or until final rules, such as the one that will follow the
proposal announced today, become effective.

  In recently announced similar actions, FDA banned 223 ineffective
ingredients from 19 categories of products in November 1990, and 111
ineffective weight control ingredients in August 1991.


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Volume  5, Number  6                                         December 20, 1992

  The agency began reviewing ingredients contained in an estimated 300,000
nonprescription drug products sold in this country in 1972. Under the review,
FDA evaluates reports prepared by advisory panels of outside experts together
with comments from industry and the public. It then publishes a proposed rule
with another comment period which includes an opportunity for a public
hearing. Ultimately, FDA issues a final regulation (monograph) that is, in
effect, a standard or recipe of acceptable ingredients, doses, formulations
and instructions as well as permitted claims.

  Comments on the current proposal, published in today's Federal Register, may
be sent within 60 days to: FDA Dockets Management Branch (HFA-305), 12420
Parklawn Drive - Room 1-23, Rockvile, Md. 20857.

                      INGREDIENTS COVERED BY THIS NOTICE:

       [ NOTE: If only one form of the ingredient is banned, this form ]
       [ appears in parentheses; i.e., "Myrrh (Fluid Extract)."        ]

(1) Digestive Aid Drug Products:

Alcohol, Aluminum hydroxide, Amylase, Anise Seed, Aromatic Powder, Asafetida,
Aspergillus Oryza Enzymes, Bacillus Acidophilus, Bean, Belladonna Alkaloids,
Belladonna Leaves (Powdered Extract), Betaine Hydrochloride, Bismuth
Subcarbonate, Bismuth Subgallate, Black Radish Powder, Buckthorn, Calcium
Gluconate, Capsicum, Capsicum (Fluid Extract), Carbon, Cascara Sagrada
Extract, Catechu (Tincture), Catnip, Chamomile Flowers, Charcoal (Wood),
Chloroform, Cinnamon Oil, Citrus Pectin, Cnicus benedictus (blessed thistle),
Diastase, Diastase Malt, Dog Grass, Elecampane, Ether, Fennel Acid, Galega,
Ginger, Glycine, Hectorite, Horsetail, Huckleberry, Hydrastis Canadensis
(Golden Seal), Hydrastis Fluid Extract, Hydrochloric Acid, Iodine, Iron Ox
Bile, Johnswort, Juniper, Kaolin (Colloidal), Knotgrass, Lactic Acid, Lactose,
Lavender Compound (Tincture), Linden, Lipase, Lysine Hydrochloride, Mannitol,
Mycozyme, Myrrh (Fluid Extract), Nettle, Nickel-Pectin, Nux Vomica Extract,
Orthophosphoric Acid, Papaya (Natural), Pectin, Peppermint, Peppermint Spirit,
Phenacetin, Potassium Bicarbonate, Potassium Carbonate, Protease, Prolase,
Rhubarb Fluid Extract, Senna, Sodium Chloride, Sodium Salicylate, Stem
Bromelain, Strawberry, Strychnine, Tannic Acid, Trillium, Woodruff.

(2) Topical Antifungal Drug Products:

  A) General Use -

Alcloxa, Alum (Potassium), Aluminum Sulfate, Amyltricresols (Secondary), Basic
Fuchsin, Benzethonium Chloride, Benzoic Acid, Benzoxiquine, Boric Acid,
Camphor, Candicidin, Chlorothymol, Coal Tar, Dichlorophen, Menthol,

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Volume  5, Number  6                                         December 20, 1992

Methylparaben, Oxyquinoline, Oxyquinoline Sulfate, Phenol, Phenolate Sodium,
Phenyl Salicylate, Propionic Acid, Propylparaben, Resorcinol, Salicylic Acid,
Sodium Borate, Sodium Caprylate, Sodium Propionate, Sulfur, Tannic Acid,
Thymol, Tolindate, Triacetin, Zinc Caprylate, Zinc Propionate.

  B) Diaper Rash Drug Products -

Any ingredient(s) labeled with claims or directions for use in the treatment
or prevention of diaper rash.

(3) External Analgesic Drug Products:

  A) Diaper Rash Drug Products -

Any ingredient(s) labeled with claims or directions for use in the treatment
or prevention of diaper rash.

  B) Fever Blister and Cold Sore Treatment Drug Products -

Allyl Isothiocyanate, Aspirin, Bismuth Sodium Tartrate, Camphor, Capsaicin,
Capsicum, Capsicum Oleoresin, Chloral Hydrate, Chlorobutanol, Cyclomethycaine
Sulfate, Eucalyptus Oil, Eugenol, Glycol Salicylate, Hexylresorcinol,
Histamine Dihydrochloride, Menthol, Methapyrilene Hydrochloride, Methyl
Nicotinate, Methyl Salicylate, Pectin, Salicylamide, Strong Ammonia Solution,
Tannic Acid, Thymol, Tripelennamine Hydrochloride, Trolamine Salicylate,
Turpentine Oil, Zinc Sulfate.

  C) Insect Bite and Sting Drug Products -

Alcohol, Alcohol (Ethoxylated Alkyl), Benzalkonium Chloride, Calamine, Ergot
Fluidextract, Ferric Chloride, Panthenol, Peppermint Oil, Pyrilamine, Maleate,
Sodium Borate, Trolamine Salicylate, Turpentine Oil, Zinc Oxide, Zirconium
Oxide.

  D) Poison Ivy, Poison Oak, and Poison Sumac Drug Products -

Alcohol, Aspirin, Benzethonium Chloride, Benzocaine (0.5 to 1.25 Percent),
Bithionol, Calamine, Cetalkonium Chloride, Chloral Hydrate, Chlorobutanol,
Chlorpheniramine Maleate, Creosote (Beechwood), Cyclomethycaine Sulfate,
Dexpanthenol, Diperodon Hydrochloride, Eucalyptus Oil, Eugenol, Glycerin,
Glycol Salicylate, Hectorite, Hexylresorcinol, Hydrogen Peroxide, Impatiens
Biflora Tincture, Iron Oxide, Isopropyl Alcohol, Lanolin, Lead Acetate,
Merbromin, Mercuric Chloride, Methapyrilene Hydrochloride, Panthenol,
Parethoxycaine Hydrochloride, Phenyltoloxamine Dihydrogen Citrate, Povidone-
Vinylacetate Copolymers, Pyrilamine Maleate, Salicylamide, Salicylic Acid,

Health InfoCom Network News                                            Page 26
Volume  5, Number  6                                         December 20, 1992

Simethicone, Sulfur, Tannic Acid, Thymol, Trolamine, Turpentine Oil, Zirconium
Oxide, Zyloxin.

(4) Internal Analgesic Drug Products:

Aminobenzoic Acid, Antipyrine, Aspirin (Aluminum), Calcium Salicylate,
Codeine, Codeine Phosphate, Codeine Sulfate, Iodoantipyrine, Lysine Aspirin,
Methapyrilene Fumarate, Phenacetin, Pheniramine Maleate, Pyrilamine Maleate,
Quinine, Salsalate, Sodium Aminobenzoate.

(5) Orally Administered Menstrual Drug Products:

Alcohol, Alfalfa Leaves, Aloes, Asclepias Tuberosa, Asparagus, Barosma,
Bearberry (Extract Of Uva Ursi), Bearberry Fluidextract (Extract Of
Bearberry), Blessed Thistle (Cnicus Benedictus), Buchu Powdered Extract
(Extract Of Buchu), Calcium Lactate, Calcium Pantothenate, Capsicum Oleoresin,
Cascara Fluidextract, Aromatic (Extract Of Cascara), Chlorprophenpyridamine
Maleate, Cimicifuga Racemosa, Codeine, Collinsonia (Extract Stone Root), Corn
Silk, Couch Grass, Dog Grass Extract, Ethyl Nitrite, Ferric Chloride, Ferrous
Sulfate, Gentiana Lutea (Gentian), Glycyrrhiza Glabra (Licorice Root),
Homatropine Methylbromide, Hydrangea (Powdered Extract) (Extract Of
Hydrangea), Hydrastis Canadensis (Golden Seal), Hyoscyamine Sulfate, Juniper
Oil (Oil Of Juniper), Magnesium Sulfate, Methapyrilene Hydrochloride,
Methenamine, Methylene Blue, Natural Estrogenic Hormone, Niacinamide, Nutmeg
Oil (Oil Of Nutmeg), Oil Of Erigeron, Parsley, Peppermint Spirit, Pepsin
(Essence), Phenacetin, Phenindamine Tartrate, Phenyl Salicylate, Piscidia
Erythrina, Pipsissewa, Potassium Acetate, Potassium Nitrate, Riboflavin, Saw
Palmetto, Senecio Aureus, Sodium Benzoate, Sodium Nitrate, Sucrose, Sulferated
Oils Of Turpentine, Taraxacum Officinale, Theobromine Sodium Salicylate,
Theophylline, Thiamine Hydrochloride, Triticum, Turpentine (Venice) (Venice
Turpentine), Urea.

(6) Pediculicide Drug Products:

Benzocaine, Benzyl Alcohol, Benzyl Benzoate, Chlorophenothane
(Dichlorodiphenyltrichloroethane), Coconut Oil Soap (Aqueous), Copper Oleate,
Docusate Sodium, Formic Acid, Isobornyl Thiocyanoacetate, Picrotoxin,
Propylene Glycol, Sabadilla Alkaloids, Sulfur (Sublimed), Thiocyanoacetate.

(7) Skin Protectant Drug Products:

  A) Astringent Drug Products -

Acetone, Alcohol, Alum (Ammonium), Alum (Potassium), Aluminum Chlorhydroxy
Complex, Aromatics, Benzalkonium Chloride, Benzethonium Chloride, Benzocaine,

Health InfoCom Network News                                            Page 27
Volume  5, Number  6                                         December 20, 1992

Benzoic Acid, Boric Acid, Calcium Acetate, Camphor Gum, Clove Oil, Colloidal
Oatmeal, Cresol, Cupric Sulfate, Eucalyptus Oil, Eugenol, Honey, Isopropyl
Alcohol, Menthol, Methyl Salicylate,  Oxyquinoline Sulfate, P-T-Butyl-M-
Cresol, Peppermint Oil, Phenol,  Polyoxytheylene Laurate, Potassium
Ferrocyanide, Sage Oil, Silver Nitrate,  Sodium Borate, Sodium Diacetate,
Talc, Tannic Acid Glycerite, Thymol,  Topical Starch, Zinc Chloride, Zinc
Oxide, Zinc Phenolsulfonate, Zinc  Stearate, Zinc Sulfate.

  B) Diaper Rash Drug Products -

Aluminum Hydroxide, Cocoa Butter, Cysteine Hydrochloride, Glycerin, Protein
--------- end of part 2 ------------

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