Edmund's Newsletter
May 6, 2008

Issue: #19

Volume 8

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In This Issue

Acute Renal Failure Associated with Cosmetic Soft-Tissue Filler Injections

FDA Approves Relistor for Opioid-Induced Constipation (Drug will help reduce effects of drugs like morphine on bowel function)

Night Club Drug Could Ease Depression

Researchers Devise New Method of Creating Human Antibodies to Flu and Other Illnesses

Scientists Discover Compound That Could Lead to New Blood Pressure Drugs

Anti-fibrotic Mechanism Of A Chinese Medicinal Herb May Inspire Drug Development

Scientists at USC School of Dentistry Investigate Osteoporosis Drug's Unusual Side Effect.

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News From MedWatch

Recently Approved Drugs/Indications

FDA Recalls and Safety Alerts in the Past 60 Days

Drug Shortages

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Acute Renal Failure Associated with Cosmetic Soft-Tissue Filler Injections

Soft-tissue fillers are substances injected to augment or enhance the appearance of lips, breasts, buttocks, or other soft tissues. Previous reports have linked the administration of soft-tissue fillers, usually liquid silicone, by unlicensed practitioners to severe adverse events, including death (1--9). On December 27, 2007, the North Carolina Division of Public Health (NCDPH) was notified of three cases of renal failure occurring among women who had received cosmetic soft-tissue filler injections at a facility in North Carolina (facility A). This report summarizes the clinical findings for these cases and describes the subsequent public health investigation. All injections were administered by a practitioner with no medical training or supervision (practitioner A). Investigators were not able to identify the substances injected. Although records indicated that the injections contained liquid silicone, this substance has not been associated previously with renal failure. These findings underscore the risks posed by cosmetic injections administered by unlicensed practitioners. Public health officials should be alert for adverse events associated with these injections and take all necessary actions to prevent additional injuries.

FDA Approves Relistor for Opioid-Induced Constipation (Drug will help reduce effects of drugs like morphine on bowel function)

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage Chronic Obstructive Pulmonary Disease (COPD) from emphysema, heart failure, Alzheimer's disease with dementia, HIV/AIDS or other advanced illnesses.

Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.

"This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illness." said Joyce Korvick, M.D., deputy director of the Division of Gastroenterology Products, FDA.

Night Club Drug Could Ease Depression

Scientists have unraveled how a horse tranquilizer and hallucinogenic night club drug known as "Special K" can ease depression, researchers said on Friday.

Ketamine, which can also cause feelings of detachment, could pave the way for new treatments for people suffering from depression, the researchers added.

Their study, published in the Archives of General Psychiatry, found ketamine restores to normal the orbifrontal cortex, an area of the brain located above the eyes that is overactive in depressed people.

The area is believed to be responsible for feelings of guilt, dread, apprehension and physical reactions such as a racing heart, said Bill Deakin, who led the study.

Researchers Devise New Method of Creating Human Antibodies to Flu and Other Illnesses

In the fight against infection, the human immune system isn't ready for a war.

Vaccines push the immune system to create defenses against illness, but they take time to work. A new process developed by scientists at the Oklahoma Medical Research Foundation stands to revolutionize the process.

In an advance online publication today in the journal Nature, OMRF researchers describe a method that can identify and clone human antibodies specifically tailored to fight infections. The new technology holds the potential to quickly and effectively create new treatments for influenza and a variety of other communicable diseases.

When an infection invades, the immune system goes to work manufacturing antibodies to fight it. Most of the antibodies created will have no effect, but a very few will bond to the invader and replicate to neutralize the enemy.

Scientists Discover Compound That Could Lead to New Blood Pressure Drugs

University of Florida researchers have identified a drug compound that dramatically lowers blood pressure, improves heart function and - in a remarkable finding - prevents damage to the heart and kidneys in rats with persistent hypertension.

The findings, which appear in today's (May 1) edition of the American Heart Association journal Hypertension, could lead to a new class of antihypertensive drugs designed to address two major problems associated with cardiovascular disease: high blood pressure and the tissue damage associated with it, known as fibrosis.

"When people have heart attacks (or suffer from hypertension) the blood vessels get more rigid," said study author David Ostrov, Ph.D., an assistant professor in the UF College of Medicine's department of pathology, immunology and laboratory medicine. "We discovered a compound that reverses the fibrosis that makes the blood vessels more rigid."

Anti-fibrotic Mechanism Of A Chinese Medicinal Herb May Inspire Drug Development

A team led by Dr. Xue-Hai Tan from the Beijing Genomics Institute has determined that the antifibrotic function of Chinese herbal extract Cpd 861 is mediated by both downregulating the synthesis of collagens and upregulating the degradation of collagens. This effect is evidently different from that of Western antifibrogenic drugs and could allow for the development of effective antifibrogenic drugs from Chinese medicinal herbs.

In human hepatic stellate cells, the key cells involved in both the synthesis and degradation of matrix proteins (mainly collagens) in the liver, the plant extract Cpd 861 can regulate the expression levels of collagen synthesis and degradation-related genes, thus demonstrating an antifibrotic effect.

Hepatic fibrosis, which can lead to portal hypertension or cirrhosis, is a wound-healing response to chronic liver injuries due to a variety of insults. The altered balance between the synthesis and degradation of matrix proteins (mainly collagens) is the major pathogenic feature in the hepatic fibrosis process. Although remarkable progress has been made recently in understanding the mechanisms of hepatic fibrosis and while numerous agents have been studied, very few effective antifibrogenic drugs have been approved for use in humans.

Scientists at USC School of Dentistry Investigate Osteoporosis Drug's Unusual Side Effect.

A group of USC School of Dentistry researchers said it has identified the slimy culprits killing the jawbones of some people taking drugs that treat osteoporosis.

Microbial biofilms, a mix of bacteria and sticky extracellular material, are causing jaw tissue infections in patients taking bisphosphonate drugs, said Parish Sedghizadeh, lead researcher and assistant clinical professor at the school.

Sold under brand names such as Fosamax, Boniva and Actonel, bisphosphonates are prescribed to millions of patients to combat osteoporosis, a bone-wasting disease that increases the risk of fractures.

Sedghizadeh said there have been increasing reports of osteonecrosis (bone death) of the jaw in patients who have been taking the drugs for osteoporosis or for treatment from the bone-wasting effects of cancer.

Believe it or not

California teen gives birth in shower, walks to hospital

A 17-year-old girl gave birth secretly at home, then walked four blocks to a hospital with the baby still attached by its umbilical cord.

"I was just a little nervous" when the labor began, Xochitl Parra said Friday from St. Mary Medical Center as she cradled her 8-pound, 3-ounce son, Alejandro.

The boy was normal and "eating like a champ," said Dr. Jose Perez, director of the Neonatal Intensive Care Unit.

The teenager said she was alone and taking a shower around 5:30 a.m. Wednesday to get ready for school. Then the contractions took over.

"I felt his head coming, so I sit down and pushed so he could come out," she said.

Parra did not call 911 because the home phone was disconnected, and she did not want to wake the neighbors because it was so early. Instead, she wrapped the baby, got dressed and went to the hospital on foot.

"I started walking and jogging to the hospital," she said.

The teen came into the hospital lobby and asked for help, Perez said.

"She still had the placenta and the baby was still attached, so of course everyone said, 'Don't move!'" he said.

Perez praised the girl for taking quick action.

"They could have bled to death; thank God that didn't happen," the doctor said. "She was very clever. She knew what to do. She wrapped the baby up and walked over here."

Parra, a sophomore at Long Beach Poly High, said she had kept her pregnancy a secret because she was afraid her mother would "kick me out of the house." Her mother has now accepted the situation and is going to help the teen care for the baby so she can continue attending school, Parra said.

Perez called the outcome "heartwarming."

"We hear so much negative with teenagers throwing their babies in the Dumpsters," he said. "This baby is fine, and hopefully there will be a happy ending with the extended family."

News From MedWatch

Keep up-to-date on all of the recent MedWatch reports that gives you timely safety information on the drugs and other medical products regulated by the U.S. Food and Drug Administration by CLICKING HERE

Recently Approved Drugs/Indications

Keep up-to-date on all of the recently approved drugs and/or approved new indications on already FDA approved drugs by CLICKING HERE

FDA Recalls and Safety Alerts in the Past 60 Days:

To see a list of all FDA Recalls and product safety alerts for the last 60 days CLICK HERE

Drug Shortages:

As many of you are aware, many drugs in the US are either unavailable or in short supply. To view a list of these drugs CLICK HERE

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