Posted tagged ‘science’

Diabetes Drugs Avandia and Actos Linked to Vision Problems

June 14, 2012

(June 13, 2012) – A recent study published on June 11th in the Archives of Internal Medicine suggests that use of thiazolidinediones (TZDs), a class of drug used to treat Type 2 diabetes, which includes Avandia and Actos, may include the risk of vision problems. The study followed 103,000 people for ten years and found that:

 

–       Participants taking one of the medications were two-to-three times more at risk of developing macular edema, a swelling in the central part of the retina, which can lead to blindness (although the likelihood of developing the disease was small).

 

–       1.3 percent of participants taking one of the medications developed macular edema, compared to a rate of 0.2 percent among participants not taking either medication.

 

–       Combining the drugs with insulin further increased the risk.

 

Dr. Iskander Idris, one of the study’s authors and a consultant in diabetes and endocrinology at Sherwood Forest Hospitals Foundation Trust in England, speculated one reason the drugs may cause damage to the retina is because of greater sodium and fluid retention or changes in the blood vessels.  Dr. Idris suggests that people who take one of these drugs should have their vision checked regularly, especially if they are also taking insulin or have a history of visual issues.

 

Macular edema occurs when fluid and protein deposits collect on or under the macula of the eye, which is an area on the retina, and causes it to thicken and swell, causing distortion of vision.

 

This is not the first time Avandia and Actos have been scrutinized. Recent studies have confirmed links between Actos usage and bladder cancer. Avandia usage has been linked to an increase in heart attacks.  Consumer Reports says Actos, made by Takeda Pharmaceuticals, is linked to congestive heart failure, bone fractures, and bladder cancer and is a danger to all patients. If you are taking these drugs for diabetes, the publication suggests you ask your doctor if there are safer drugs that would do the same job such as metformin, glipizide or glimepiride, which have been around longer and have fewer consumer complaints.

 

Unfortunately, the risks diabetic drug users are faced with as a result of their prescription medications, continues to grow.

 

Many of the people affected by this have said that if they had just been told about the complications and risks, they would have saved their lives and their vision and taken some of the older, more reliable diabetic medications.

 

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Smoking Hookah May Be More Harmful Than Smoking Cigarettes

June 8, 2012

Hookah

 

(June 7, 2012) One in three college students has smoked hookah. The hookah is a beautiful, decorative piece of polished brass. It is used for smoking when friends get together, and to relax and socialize.

 

Hookah is also known as narghile, shisha, and goza. It is a water pipe with a smoke chamber, a bowl, a pipe, and a hose. Specifically-made tobacco is heated, and the smoke passes through water and is then drawn through a rubber hose to a mouthpiece. The tobacco is no less toxic in a hookah pipe, and the water in the hookah does not filter out the toxic ingredients in the tobacco smoke. Hookah smokers may actually inhale more tobacco smoke than cigarette smokers do because of the large volume of smoke they inhale in one smoking session, which can last as long as 60 minutes.

 

Hookah bars have become popular around the country for the last decade. “It usually attracts 18-20 year olds”, says Lance Freeman, of The Egyptian Café and Hooka Bar in Indianapolis, Indiana. “We are a place to come for people who can’t go to bars.”

 

The problem is that smoking hookah is still dangerous because it delivers the same chemical compounds as smoking cigarettes. One session (from 45-60 minutes) delivers about 100 times the smoke as a single cigarette, with 40 times the tar and 10 times the carbon monoxide. While research about hookah smoking is still emerging, evidence shows that it poses many dangers.

 

Hookah smoke contains high levels of toxic compounds, including tar, carbon monoxide, heavy metals, and cancer-causing chemicals (carcinogens). In fact, hookah smokers are exposed to more carbon monoxide and smoke than are cigarette smokers.

 

As with cigarette smoking, hookah smoking is linked to lung and oral cancers, heart disease, and other serious illnesses.

 

Hookah smoke delivers about the same amount of nicotine as cigarette smoking does, possibly leading to tobacco dependence. Hookah smoke poses dangers associated with second hand smoke. Hookah smoking by pregnant women can result in low birth weight babies.

 

Hookah pipes used in hookah bars and cafes may not be cleaned properly, risking the spread of infectious diseases.

 

Dr. Brian Primack conducted a study which was published in the June issue of the journal Nicotine and Tobacco Research, which found that 1 in 3 current college students has smoked hookah at some point; more than 50% of those students were not cigarette smokers.

 

Primack said that while he was giving a lecture on the dangers of smoking at the University of Pittsburgh School of Medicine, a student interrupted him. “He said, ‘No offense, but nobody really smokes anymore – we all do this hookah thing instead.’” That very moment started Primack’s research into the hookah world. “It’s a very interesting public health puzzle. The same chemicals – in one form are reviled by many people; but the same people will go across the street and take it in this difficult format.”

 

Better education is needed, Primack has said, to show similarities between hookah smoking and cigarette smoking. In a previous study, the research found 92% of videos on You Tube showed hookah in a positive light, compared to just 24% of cigarette videos. The population that participates in hookah smoking tends to be younger, male and white, but is found across all characters.

 

The researchers do not know yet if hookah is addictive. Smokers inhale twice the amount of nicotine in one hookah session as they do with a single cigarette, but long-term studies need to be done to see if it interferes with their life in the same way.

Plague Medication Approved by the FDA

June 7, 2012

(June 7, 2012) At the end of May, the U.S. Food and Drug Administration (FDA) approved a drug to treat patients with plague, a rare and potentially life-threatening bacterial infection.

 

In addition, Levaquin (levofloxacin) was also approved to reduce the risk of getting plague after exposure to a bacterium, which causes the disease, known as Yersinia pestis.

 

Although plague is extremely rare in most parts of the world (only 1,000 to 2,000 cases per year), and is primarily an animal disease, plague may be spread to humans from an infected flea, contact with infected animals, or laboratory exposure.

 

The three most common forms of plague are bubonic plague (infection of the lymph nodes), pneumonic plague (infection of the lungs), and septicemic plague (infection of the blood).

 

The Director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, Edward Cox, M.D., M.P.H., said that this “approval broadens the available therapeutic treatments for plague. It also further demonstrates the usefulness of animal model studies to collect needed efficacy data in cases where human trials are not ethical or feasible.”

 

The agency approved Levaquin under the Animal Efficacy Rule, which allows research on animals in cases where it is not feasible or ethical to conduct trials in humans, so long as the studies are adequate and well-controlled.

 

The study was conducted on African green monkeys infected with the plague bacterium in a lab setting. Animals were randomly selected to receive a 10-day regimen of Levaquin or placebo within six hours of the onset of fever after being infected. 94 percent of the 17 monkeys (roughly 16) treated with Levaquin survived, but none of the seven monkeys treated with the placebo survived.

 

Common side effects of Levaquin, reported in more than three percent of patients, were nausea, headache, diarrhea, insomnia, constipation, and dizziness. In addition, such rare but serious side effects include tendinitis and tendon rupture, worsening of muscle weakness in people with the neuromuscular disorder myasthenia gravis, allergic reactions, liver damage, abnormalities of the blood, effects on the nervous system, and abnormal heart rhythm.

 

As always, when dealing with these FDA-approved drugs, is to determine if taking this medicine is worth it in your situation, and decide if the risks in not taking the medication outweigh the benefits that the medication provides. Since plague is a very serious, potentially deadly condition, it would almost always seem that taking Levaquin outweighs any risk of its side effects.

 

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FDA to Discuss Risks and Benefits of Metal-On-Metal Hip Replacements

May 14, 2012

(May 14, 2012) Next month, the U.S. Food and Drug Administration (FDA) will be seeking expert scientific and clinical advice on the risks and benefits of metal-on-metal (MoM) hip systems, as well as recommendations on their use from patients and practitioners, as well as how patients implanted with these MoM devices manage them. The FDA will discuss these issues at a two-day expert advisory panel meeting on June 27 and 28.

 

In addition, the experts invited to this advisory panel meeting, who are also members of the FDA’s Center for Devices and Radiological Health (CDRH), will discuss failure rates and modes, metal ion testing, imaging methods, local and systematic complications, patient risk factors, and considerations for follow-up after surgery.

 

Hip replacement surgery simultaneously increases mobility and reduces pain by replacing damaged hip joints in patients who have sufficient and sound bone to support the components of these MoM hip systems. Last May, the FDA issued an order for manufacturers of MoM hip systems to conduct post-market surveillance studies to collect more safety data on these devices, in response to an increase of the failure rate of these hip replacement systems.

 

There are two categories of these systems:

1) metal-on-metal total hip replacement systems consisting of a metal ball (femoral head), a metal femoral system in the thighbone, and a metal cup in the hip bone (acetabular component).

2) metal-on-metal hip resurfacing systems, consisting of a trimmed femoral head, capped with a metal covering and a metal cup in the hip bone (acetabular component).

 

Deputy director of science at the FDA’s CDRH, William Maisel, M.D., M.P.H., said that “we are asking outside scientific and medical experts to discuss recent information on these devices so that the agency can continue to make reliable safety recommendations to patients and their health care providers.”

 

Have any of you had hip replacement surgery? Do you think the expert advisory panel is leaving anything out? Does your hip replacement reduce pain and add mobility to your life? We want to hear your feedback. Feel free to comment on this blogpost.

 

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Clomid Use Increases Risk of Serious Birth Defects

May 1, 2012

(May 1, 2012) – A new study from the Centers for Disease Control (CDC) found that Clomid, a fertility drug made by Sanofi Aventis, significantly increases the risk of serious birth defects. Clomid, also known as clomiphene and clomiphene citrate, is one of the most popular fertility drugs on the market, which works like estrogen to induce ovulation in women who have difficulty conceiving. Clomid is in a class of drugs known as ovulatory stimulants. Another brand name is Serophene.

 

The new research, which was published in the online journal Human Reproduction, studied women who had used Clomid from two months prior to conception to the first month of pregnancy. Serious birth defects were observed, which included anencephaly (open cranium lacking a brain), esophageal atresia (closed esophagus), omphalocele (abdominal wall defect), craniosynostosis (premature fusion of skull bones), and gastrointestinal and genital defects.

 

If Clomid is taken during pregnancy, the risks of the following birth defects increase:

 

~  Congenital heart lesions

~  Muscular ventricular septal defects

~  Down’s syndrome

~  Club foot

~  Cleft lip and/or cleft palate

~  Undescended testes in males

~  Blindness

~  Spina bifida

~  Hernia (inguinal and umbilical)

~  Dandy Walker Malformation

~  Lifelong disability

~  Death

 

There were earlier studies conducted which also showed a link between Clomid use and birth defects. According to a study conducted at the Harvard School of Public Health in 2010, ovulation-inducing drugs such as Clomid almost doubled the risk of autism spectrum disorder in children. Other studies showed an increase in craniosynostosis and spina bifida defects.

 

The FDA classifies drugs according to the risk of harm they pose to a fetus in terms of five categories: A, B, C, D, and X.

 

Categories A and B show no evidence of risk to the fetus.

 

Category C indicates a possible adverse effect on the fetus, but the drug’s potential benefits may outweigh the risk. Sufficient studies in humans do not yet exist.

 

Category D shows positive evidence of risk to human fetuses. However, the use of this drug by pregnant women may be warranted in some cases.

 

Category X is the only category that shows both positive evidence of human fetal risk and the warning that women who are, or could become pregnant, should NOT take this drug. Clomid falls into this category.

 

(They also have a Category N for drugs that have not yet been classified by the FDA).

 

Since there are so many birth defect risks associated with the fertility drug Clomid, it is crucial that women be evaluated carefully to exclude pregnancy before each treatment cycle begins. The next course of Clomid therapy should be delayed until pregnancy has been definitively excluded. It is a terrible irony, but the very fertility drug prescribed to help a woman conceive a baby can lead to such serious birth defects, which, in some cases, are fatal. The diagnosis of any of these serious birth defects can be extremely devastating to the mother and family who struggled to become pregnant.  To learn that the fertility drug prescribed to them has caused these abnormalities, or even death of their baby, is so horrific, and someone needs to be held accountable.

 

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In Vitro Babies More Likely to Have Birth Defects

April 21, 2012

(April 21, 2012) – A new study, published in the journal Fertility and Sterility, shows that babies conceived through certain fertility treatment techniques (assisted reproductive technologies or ART) are approximately one-third more likely to develop a birth defect than babies conceived naturally.

 

The researchers involved in this study have not determined why the fertility treatments lead to higher risk of birth defects or whether or not this technology is even the cause at all.

 

For more than three decades, women who have been unable to become pregnant have turned to in vitro fertilization (IVF). This procedure is made possible by fertilizing the mother’s egg outside of her body and then transferring the egg to her womb for the duration of pregnancy. For many years, researchers have studied the possible dangers of IVF.

 

Dr. Zhibin Hu and colleagues at the Nanjing Medical University have collected the results of 46 studies, comparing the number of birth defects among children conceived using an IVF technique to children conceived naturally. 

 

For more than 124,000 children born through IVF procedures, or using ICSI, a procedure in which a single sperm is injected directly into the mother’s egg, the risk of having a birth defect was 37 percent higher than that of the other children, as found from these studies.

 

Additional data reported by the U.S. Centers for Disease Control and Prevention, major birth defects, such as malformation of an organ or a limb, can occur in approximately three out of every 100 babies born in the U.S.

 

William Buckett, professor at McGill University, stated, “(The report) confirms what most people accepted anyway, that, yes, there is an increased risk in congenital abnormality associated with assisted reproductive technology.”

 

The authors of these studies reported that increased birth defect risks were apparent across a range of functions and body systems, including the genitals, skeleton, digestive system, and the nervous system.

 

The main question still remains unanswered: why most studies find birth defects to be more common among IVF-conceived babies. It could be possible that the IVF techniques, the handling of the fragile embryos, or the chemicals that accompany the fertility treatments, may have something to do with these defects.

 

A question Dr. Buckett raised is, whether these birth defects only appear to be more prevalent in IVF babies because they are so closely monitored?  “Couples who have had babies born as a result of IVF are followed up more closely, and therefore subtle abnormalities may be detected that otherwise might not have been detected.”

 

Unfortunately, as far as reducing the risks of birth defects for parents using IVF, it is too early to b determined, since the reasons accounting for the risk are still largely unknown.

 

For the parents who long for a child of their own, they are willing to take the risk and hope for a healthy child. Their chances of producing a healthy child are high.  In the past 30 years, so many children have been brought into this world via in vitro fertilization, and for so many couples, being able to have their own child is worth the risk. Hopefully, they will soon find out what causes the increase in birth defects.

 

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FDA Will Not Ban Bisphenol (BPA)

April 16, 2012

(April 16, 2012) – On March 30, 2012, the FDA made its ruling on a three-year-old petition filed by the National Resources Defense Council (NRDC), but only after the NRDC finally sued the FDA for procrastinating far beyond the 180 days they had to respond to the initial filing.  Noting that the NRDC had not provided strong enough scientific evidence that would support a total BPA ban, the FDA said that their decision was not a reflection on the final determination of the safety of BPA, just a decision on the petition.

 

BPA, or Bisphenol A, is a chemical used in many consumer products, including clear and hard plastics, called polycarbonate, used in water and soda bottles, as well as the linings of food and beverage cans and containers of baby formula. It is also found on the ink transfers on receipts.

 

The Natural Resources Defense Council believes the FDA “made the wrong call.” Dr. Sarah Janssen, a senior scientist in the council’s public health program, stated, “BPA is a toxic chemical that has no place in our food supply.” She added, “The FDA is out of step with scientific and medical research. This illustrates the need for a major overhaul of how the government protects us against dangerous chemicals.”

 

Last month, the Endocrine Society, a group representing 15,000 researchers and endocrinologists, expressed “disappointment” in the FDA for ignoring so much research that has been made in the past three years, demonstrating how truly harmful the chemical is to people’s heart, metabolic, and reproductive health.  BPA has been proven to interfere with the body’s system that is completely responsible for secreting hormones. Endocrinologists have been among the most active researchers with regard to the effects the chemicals have on the body and have asked for better support from our government regulators.

 

Many food manufacturers have removed or are seriously considering removing BPA from their packaging. Campbell Soup Co. announced they would not use BPA in their cans, thanks to a social media campaign, which put pressure on them.  It was consumer demand that finally got BPA out of baby bottles and sippy cups, NOT because of FDA policy.

 

“What was very disappointing was that, in the last three years, the amount of research on BPA has really increased exponentially,” says Andrea Gore, PhD, professor of pharmacology and toxicology at the University of Texas at Austin, and a researcher involved with the Endocrine Society’s evaluation of the science on endocrine-disrupting chemicals. She adds that, rather than look at the whole body of scientific evidence on BPA, the FDA looked only at the three-year-old science presented in NRDC’s petition. “There have been very strong, very convincing studies since then determining that BPA exposure at doses lower than what are considered safe really have the potential to have detrimental outcomes.”

 

“Everybody from the Endocrine Society was concerned that the research had not been taken into consideration,” she adds, particularly because more evidence is showing that it is not just children and babies who suffer reproductive and neurological impairment after being exposed to BPA, or even older adults, in whom BPA has been found to cause higher rates of heart disease, who should be concerned. “We’re particularly concerned about pregnant women, or even couples planning on having children,” she says. “What’s in their diets and in their environments will affect quality of their sperm and eggs, and that can impact the quality of their embryo.” Gore worries that the FDA’s soft stance on BPA will lead to greater confusion among the public as to how bad BPA is.

 

Until the FDA comes to its senses and places a ban on this very dangerous chemical, there are a few things you can do to protect yourself:

–       avoid canned food. BPA is used in the epoxy resins that lines cans. Buy fresh or frozen foods instead.

–       never microwave food in plastics, some can leak BPA into your food when heated

–       never drink from water bottles that have been heated  by the sun, even better, drink from re-usable BPA free water bottles

–       decline receipts. They are coated with high levels of BPA to help with printing and ink transfer and absorb right into your skin

–       Avoid products packaged in #7 plastic (unless marked BPA free)

–       Dental sealants contain BPA

–       If not breastfeeding, feed your newborn powdered formula. Tests on prepared liquid formulas have shown high levels of BPA, but powders are known to be BPA-free.

 

Maybe if we stop buying canned foods, the companies will respond.  It is unfortunate that the U.S. Food and Drug Administration does not care about the safety of Americans. Taking a “wait and see” approach is not the answer. If we are showing the FDA how dangerous and toxic this chemical is, why is it still being used in our food?

 

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