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神经网络昆斯林的新闻组分类2006

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HICNet Medical Newsletter                                              Page 13
Volume  6, Number 11                                           April 25, 1993



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                        Food & Drug Administration News
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              FDA Approves Depo Provera, injectable contraceptive
                      P92-31 Food and Drug Administration
              FOR IMMEDIATE RELEASE 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 1963, 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 in 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 
drug, due to concerns about low birth weight in babies exposed to the drug. 

HICNet Medical Newsletter                                              Page 14
Volume  6, Number 11                                           April 25, 1993

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 1960s 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 1970s. 
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.


































HICNet Medical Newsletter                                              Page 15
Volume  6, Number 11                                           April 25, 1993

       New Rules Speed Approval of Drugs for Life-Threatening Illnesses
                      P92-37 Food and Drug Administration
                        Monica Revelle - [phone]

The Food and Drug Administration today announced that it will soon publish new 
rules to shed the approval of drugs for patients with serious or life-
threatening illnesses, such as AIDS, cancer and Alzheimer's disease. 

"These final rules will help patients who are suffering the most serious 
illnesses to get access to new drugs months or even years earlier than would 
otherwise be possible," said HHS Secretary Louis W. Sullivan, M.D. "The effort 
to accelerate FDA review for these drugs has been a long-term commitment and 
indeed a hallmark of this administration." 

These rules establish procedures for the Food and Drug Administration to 
approve a drug based on "surrogate endpoints" or markers. They apply when the 
drug provides a meaningful benefit over currently available therapies. Such 
endpoints would include laboratory tests or physical signs that do not in 
themselves constitute a clinical effect but that are judged by qualified 
scientists to be likely to correspond to real benefits to the patient. 

Use of surrogate endpoints for measurement of drug efficacy permits approval 
earlier than if traditional endpoints -- such as relief of disease symptoms or 
prevention of disability and death from the disease -- are used. 

The new rules provide for therapies to be approved as soon as safety and 
effectiveness, based on surrogate endpoints, can be reasonably established. 
The drug's sponsor will be required to agree to continue or conduct 
postmarketing human studies to confirm that the drug's effect on the surrogate 
endpoint is an indicator of its clinical effectiveness. 

One new drug -- zalcitabine (also called ddC) -- was approved June 19, using a 
model of this process, for treating the human immunodeficiency virus, HIV, the 
cause of AIDS. 

Accelerated approval can also be used, if necessary, when FDA determines that 
a drug, judged to be effective for the treatment of a disease, can be used 
safely only under a restricted distribution plan. 

"The new rules will help streamline the drug development and review process 
without sacrificing goad science and rigorous FDA oversight," said FDA 
commissioner David A. Kessler, M.D. "While drug approval will be accomplished 
faster, these drugs and biological products must still meet safety and 
effectiveness standards required by law." 


HICNet Medical Newsletter                                              Page 16
Volume  6, Number 11                                           April 25, 1993

The new procedures also allow for a streamlined withdrawal process if the 
postmarketing studies do not verify the drug's clinical benefit, if there is 
new evidence that the drug product is not shown to be safe and effective, or 
if other specified circumstances arise that necessitate expeditious withdrawal 
of the drug or biologic.








































HICNet Medical Newsletter                                              Page 17
Volume  6, Number 11                                           April 25, 1993



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                                   Articles
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               Research Shows Promise for Preventing or Slowing
                       Blindness due to Retinal Disease

                   National Retinitis Pigmentosa Foundation

        Neutrophilic Factors Rescue Photoreceptor Cells in Animal Tests

     Baltimore, MD - Researchers at the University of California San Francisco 
and Regeneron Pharmaceuticals, Inc. [NASDAQ: REGN] have discovered that 
certain naturally occurring substances known as neurotrophic factors can 
prevent the degeneration of light-sensing cells in the retina of the eye. The 
degeneration of these cells, known as photoreceptors, is a major cause of 
visual impairment 
     This research, published to in the December issue of the Proceedings of 
the National Academy of Science (PNAS), holds promise for people who may lose 
their sight due to progressive retinal degeneration -- currently, no drug 
treatment for retinal degeneration exists. It is estimated that 2.5 million 
Americans have severe vision loss due to age-related macular degeneration and