There is a new safety warning in Canada linked to pre-filled saline and heparin syringes.  MedXL Incorporated has received complaints about visible particles and solution discoloration of the syringes according to Health Canada.

Syringes with a lot number between 6892 and 8180 and catalog number 3704, 37043, 37043B, 37043BNC, 3705C, 3705NC, 3706, 3780, 3781, 3786, and 3787 have been subject to the complaints.

The probability of finding a defective syringe is very small, about 12 in a million.  Still, people are being warned to take safety precautions like using aseptic techniques, visually inspect the product for particulate matter and discoloration, and do not use if the solution is discolored or contains a precipitate.

There have been no reported cases of bad reactions linked to the syringes.  The agency has stated that they have implemented the necessary corrective actions to correct the problem.

The average sperm count of the American male is dropping, and at an alarming rate.

According to Mark Castleman, managing editor of Medical Self-Care, the proportion of men who have 100 million sperm per milliliter of semen has dropped from 80 percent in 1929 to 22 percent in 1977, and it is not entirely known why.

While the media often said the lowered sperm count might be related to a society-wide increase in sexual activity or the use of tight-fitting underwear, Florida State University professor Robert C. Dougherty suggested that toxic chemicals were the main cause of the sperm count decrease. He found high levels of four toxins in semen samples taken from 132 student volunteers: polychlorinated biphenyls (PCBs), DDT, hexachlorobenzene (all known carcinogens) and teratogens (known to cause birth defects). The most frequent sperm count of the students was 20 million per milliliter; a sperm count below that number indicates fertility problems.

What causes this toxic exposure, and why are sperm so susceptible to these toxins? Carcinogens (cancer causing substances) cause tumors most quickly in tissues composed of rapidly dividing cells, and the cells that divide most in adult men are those involved in sperm production.

Chemical pesticides and herbicides have been linked to sperm depletion, as well as other manmade chemicals such as plutonium (which is carried in detectable amounts by all living people today), as well as the synthetic estrogen DES that was added to about 80% of the animal feed produced in the US from the 1950s to 1980.  The nausea combatant drug Phenobarbital, if taken during pregnancy, has been found to cause birth defects in the offspring of the children who were born while the mothers were taking the drug.

Also, many antibiotics such as penicillin and tetracycline suppress sperm production. Smoking, tobacco or marijuana, has also been found to reduce sperm counts, regular intake of caffeine, and consumption of soy products may have sperm- and offspring-damaging impacts

What are some of the effects of low sperm counts? Evidence suggests that men with low sperm counts are more likely to produce offspring with birth defects. It has been noted that artificial insemination of women with frozen sperm from third-party donors results in a birth defect rate of 1percent or less, as opposed to the overall American birth defect rate of 4.5 – 6 percent. The most important reason for that decline in birth defect rates is that artificial insemination laboratories accept only men with high sperm counts.

Some American soldiers are accusing the military contractor Kellogg Brown and Root (KBR) of  putting their lives at risk by exposing them to toxic substances.

In April of 2003, James Gentry arrived in Southern Iraq to take command of more than 600 Indiana National Guardsmen who were protecting KBR contractors working at a local watering plant.

“We didn’t question what we were doing, we just knew we had to provide a security service for the KBR,” said Battalion Cmdr. Gentry. But today, James Gentry is dying from a rare form of lung cancer as a result of months of inhaling hexavalent chromium, an orange dust that is part of a toxic chemical found all over the plant.

At least one other Indiana guardsman has already died from lung cancer, and others are suffering from tumors and rashes consistent with exposure to the toxin.

There is evidence that indicates KBR knew about the deadly exposure danger months before the soldiers were informed. Depositions from KBR employees addressed concerns about the toxin in one part of the plant as early as May of 2003. KBR minutes from a later meeting state that “60 percent of the people … exhibit symptoms of exposure,” including bloody noses and rashes.

In a statement, the multi-billion dollar contractor told CBS News: “We deny the assertion that KBR harmed troops and was responsible for an unsafe condition.”

KBR says it notified the Army as soon as it identified the toxin, but some Indiana guardsmen say they only just learned of the risk. “I didn’t know I was exposed to a deadly carcinogen until five years later when I received a letter,” said Indiana National Guardsman Jody Aistrop.

The major defense contractor KBR Inc is being sued by 16 Indiana National Guard soldiers. The suit claims its employees knowingly allowed the soldiers to be exposed to a toxic chemical in Iraq five years ago.

The suit alleges the soldiers from a Tell City-based unit were exposed to a sodium dichromate, a known carcinogen, while protecting an Iraqi water pumping plant shortly after the U.S. invasion in 2003. The suit also claims that the Houston-based KBR knew at least as early as May 2003 that the plant was contaminated, but concealed the danger from civilian workers and 139 soldiers.

The chemical, used to remove pipe corrosion, is especially dangerous because it contains hexavalent chromium, which is known to cause birth defects and cancer, particularly lung cancer, the lawsuit said. The cancer can take years to develops. Some of the soldiers who served at the site now have respiratory system tumors associated with hexavalent chromium exposure.

When Guard members and American civilians working at the plant began to have nosebleeds, KBR managers told them they were simply caused by the dry desert air, the lawsuit says.

The work was not shut down until September 2003 after KBR managers in full environmental protective gear inspected the plant while workers and Guard members remained unprotected.

Could drug companies be cooking the books where it comes to getting FDA approval for new drugs?

Recent research published in the journal Public Library of Science Medicine shows that many drug studies submitted to and read by the U.S. Food and Drug Administration go unpublished.

In addition to that, some that are published sport inconsistencies between the study that was submitted and the study that was subsequently released. Changes included additions and/or deletions, statistical alterations of outcomes and changes in trial conclusions.

In general, reports that show the studied drug in a favorable light are much more likely to be published. Of forty-three trials that showed no benefit to the test drug, only half were published.

This kind of dishonesty in the medical field can be very dangerous, possibly misleading doctors and patients alike while they make important decisions about the patient’s health. Unfortunately, discrepancies such as these can be very hard to detect or prosecute.

The Texas defective drug attorneys at Cappolino, Dodd & Krebs are concerned about your health. Have you been injured by a defective drug? Contact us today.

The US Food and Drug Administration (FDA) is trying to determine if television drug advertisements should be required to include a toll-free number that consumers can use to report side effects associated with their medications.

While this seems to be a good idea, opponents believe that the information could “distract” consumers away from important drug safety information.  Print ads currently contain the toll-free number, and the FDA is now required by law to include the number on their TV ads. However, the FDA has had an extension in testing the effects of the number and is expected to being a study shortly. They plan on showing fictitious ads to consumer groups and then interview those groups to determine comprehension levels.

Critics of the current advertising practices claim that situations in which medications are over-prescribed before full effects are known occur too frequently. They contend that educating consumers on how to report side effects to the FDA will lead to quicker action in addressing safety problems. Right now, consumers generally tell their prescribing physician of a drug side effects, and that information is not always reported to the FDA.

The dangerous chemical melamine that has recently been found in several goods originating from China has also been found in an infant formula made by an American manufacturer.

The discovery was found in late November, and involves a single sample of infant formula that was found to contain trace amounts of the dangerous chemical.

The US Food and Drug Administration (FDA) quickly pointed out that the amounts of the chemical were too low to be considered a heath threat, but it should be noted that the increased testing for melamine is a result of a rise in tainted products from around the globe.

Earlier this year, thousands of pets had been sickened or killed by the presence of melamine in pet food, and the source of this melamine was linked to imported wheat gluten from China. Also this year, China has had serious children’s toys, tainted toothpaste, heparin, pet food, and milk recalls. 50,000 infants became ill from the tainted milk, and 4 died.

In the past month, the FDA has issued an import alert detaining ALL milk products, milk derived ingredients and finished food products containing milk from China due to the presence of melamine.

These foods include both human foods (bakery products, cereals, cheese, ice cream, soft drinks, and candy) as well as several types of pet foods (pet cat foods, pet dog foods, pet fish foods, other pet foods, laboratory animal feeds, pet and laboratory animal foods, byproducts for animals, dairy byproducts for animals, and animal waste feed products) imported from China.

According to the FDA, the melamine milk contamination started in infant formula but “these contaminated milk components appear to have been dispersed throughout the Chinese food supply chain…Reports of contamination have come from more than thirteen countries in Asia, Europe, and Australia, in addition to the United States.”

Time magazine has reported that the Chinese government continues to downgrade the severity of the problem. Some believe that the contaminated foods are “one of the most important factors resulting in the soaring number of birth defects in China.”

The dangerous diet drug fenfluramine, an ingredient in Fen-Phen, may continue to damage the heart years after a patient stops taking it, according to a study published in BMC Medicine.  The study has shown  that people who stopped using Fen-Phen 11 years ago had damaged heart valves up to seven years later.

The study, conducted by researchers at the Central Utah Clinic, involved both fenfluramine and dexfenfluramine, another diet drug that is closely related to fenfluramine.  The Food & Drug Administration (FDA)  ordered fenfluramine and dexfenfluramine off the market in September 1997 after those drugs were linked to heart valve problems. Since its withdrawal, tens of thousands of lawsuits have been filed against the maker of fenfluramine by people injured by the drug.

This is the largest study to examine duration of exposure to the drug and the first to estimate the incidence of heart valve surgery among prior users. The researchers looked at 5,743 former users of fenfluramine and/or dexfenfluramine.

The patients were seen by doctors at the Central Utah Clinic between July 1997 and February 2004.  Each patient got an echocardiogram and 1,020 patients got two or more echocardiograms 30 months apart, on average.

When the study started, nearly 20% of the women and almost 12% of the men had at least mild regurgitation through the aortic valve or moderate regurgitation through the mitral valve.  Women, and people  who used the drugs the longest were most likely to have such problems.

Follow-up echocardiograms showed that aortic and mitral regurgitation usually stayed about the same or worsened, but improved in some cases. Thirty-eight patients — less than 1% — got heart valve surgery. Such surgery wasn’t common, but it was more common than in the general public, and in 25 cases, heart valve damage was linked to the drugs.

“We found clear evidence for a strong, graded association between duration of exposure to fenfluramines and prevalence of aortic regurgitation and for mild or greater mitral and tricuspid regurgitation,” lead researcher Charles Dahl, told Science Daily.