Posted tagged ‘research’

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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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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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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Lilly May Not Challenge Jury’s Findings in DES Exposure Case

April 15, 2012

(April 15, 2012) – On February 3, 2012, Eli Lilly filed a Motion for Reconsideration, asking the Judge to reconsider and reverse her prior decision denying their Daubert motion and ordering both parties to mediate.

 

A Daubert motion, named after the outcome of the 1993 Supreme Court case Daubert v. Merrell Dow Pharms., is a motion raised to the judge which excludes the testimony of an expert witness who does not possess the requisite level of expertise. This motion, however, was denied sua sponte, meaning without prompting from the other party. Eli Lilly, in filing this Motion for Reconsideration, is stating that the court has overlooked or misunderstood the events which led to the exclusion of expert witness testimony. The Judge scheduled mediation planning and organization between the parties, which occurred on April 3-4th, and was unsuccessful.

 

The Fecho sisters are a family of four DES daughters (daughters of women who were given DES while pregnant) from Pennsylvania, and their lawsuit will be the first DES breast cancer case to be tried in court, next January 7, 2013.

 

DES, or Diethylstilbestrol, is a synthetic form of estrogen, and was prescribed to pregnant women for thirty years, starting in 1940, to prevent complications with pregnancy. Unfortunately, nobody could predict the potentially life-threatening side effects.

 

The four Fecho sisters were all exposed to DES while in utero, all suffered infertility, as well as many signature DES reproductive tract abnormalities. In addition, all four of these sisters contracted breast cancer on or before age 50. The eldest, fifth sister, who is not part of this lawsuit, was not exposed to DES. She was able to have a child of her own and has not contracted breast cancer.

 

During their trial, the DES victims plan to present scientific evidence from the National Cancer Institute, the New England Journal of Medicine, and from experts from Harvard and other prestigious institutions around the world to prove that prenatal DES exposure increases the risk of breast cancer.

 

DES was given in the 1950s to early 1970s, thinking it would help prevent miscarriages. It was proven to be carcinogenic to the unborn fetus. It is not thought that DES had any effect in the prevention of miscarriages.  The pharmaceutical companies, Eli Lilly and Bristol Myer-Squibb, failed to test or warn of the potential dangers of DES or its known carcinogenic effects on the fetus.

 

These drug companies withheld vital information during its approval for pregnancy use from the FDA. Today, it is known that DES daughters who were exposed in utero are at an increased risk for clear-cell adenocarcinoma of the cervix, they suffer infertility, subfertility, as well as breast cancer. It is so important that DES daughters obtain yearly mammograms and remain under their doctor’s care. These DES daughters should check with their doctors with regard to the avoidance of female hormones (birth control pills or hormone replacement) to reduce risk of cancers. Early detection of breast cancer can save the lives of DES daughters and it is so important that they are vigilant about their preventive health.

 

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Early Dental X-Rays Linked to Brain Tumors

April 11, 2012

(April 10, 2012)  The results of a study were reported online Tuesday, in the American Cancer Society’s journal, Cancer, linking dental x-rays with an increased risk of a common brain tumor in adults.

 

The study was led by Dr. Elizabeth B. Claus, a professor at the Yale School of Public Health in New Haven, CT, and a neurosurgeon at Brigham and Women’s Hospital in Boston. The findings suggest that dental “bite wing” x-rays are linked to meningiomas. These meningiomas are tumors, which arise in the meninges, the membrane surrounding the brain and spinal cord, and they account for approximately one third of detected brain tumors in the U.S.  Most of the meningiomas are benign, slow-growing tumors, but they exert pressure on the brain, causing debilitation. Dr. William Curry, a neurosurgeon at Massachusetts General Hospital, said that although meningiomas are only cancerous in 1-2 percent of cases, even the benign tumors could cause significant impairment and become difficult to remove.

 

X-rays, which expose a small piece of film placed between the teeth to a beam of radiation, raised the risk of meningiomas 1.4 to 1.9 times, Claus and her colleagues found.

 

The study also found an association between the less-commonly used panorex x-rays, which are taken outside the mouth, around the entire head, providing a panoramic view of the full set of top and bottom teeth, and meningioma. Panorex x-rays are often used to assess the need for braces. This x-ray increased the risk of developing a meningioma, if performed before age 10, by almost five times.

 

The study reports that ionizing radiation is the major environmental risk factor for meningioma, and that dental x-rays are the most common source of ionizing radiation among U.S. residents.

 

Dr. Claus noted that the risk factors for meningioma, the most commonly diagnosed brain tumor, remain poorly understood, partly due to the fact that meningioma was only added to brain tumor registries in the United States in 2004.  She indicated that it generally takes about 20 to 30 years after radiation exposure for the meningioma to develop. 

 

The meningioma can grow larger than a baseball. The pressure on the brain and spinal cord can cause headaches, vision problems, and impairment and/or loss of speech and motor control.

 

Although this study is very alarming and should not be taken lightly, Dr. Keith L. Black, neurosurgeon at Cedars-Sinai Medical Center in Los Angeles, states that the risk of meningioma is only 3 cases for every 100,000 people.

 

Patients can refuse dental x-rays if they are not experiencing any problems. With this new study going public, most dentists should understand patients’ justified fear of x-rays. The American Dental Association recommends that healthy children have x-rays about every one to two years, and healthy adults, every two to three years. The study did acknowledge that some of the patients had received dental x-rays decades ago, when radiation exposure was greater.

 

Today, we have the advantage of improved technology and modern x-ray equipment.  However, I would definitely think twice if I saw an old-fashioned x-ray machine in a dentist’s office, before having an x-ray performed!

 

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FDA Finds Another Fake Cancer Drug, Avastin, in the U.S.

April 5, 2012

(April 5, 2012)  The U.S. Food and Drug Administration has confirmed another counterfeit supply of the cancer drug bevacizumab, known as Avastin, being sold in the U.S.  The batch of 120 vials of fake Avastin was shipped through the U.K. from Turkey.  Less than two months ago, the FDA announced an investigation into a different batch of fake Avastin distributed to doctors in several states.

The counterfeit drug, which the FDA says contains no active ingredient, is posing as the injectable cancer medication Altuzan (bevacizumab) 400 mg/16ml. Altuzan is a Roche cancer medication approved for use in Turkey, but not in the United States. Reuters said that authentic Altuzan has Turkish language on the packaging, whereas the counterfeit version has English language on the package. The FDA said packaging or vials that claim to be Altuzan with lot number B6021 are counterfeit.

Avastin is used to treat colorectal, lung, kidney, breast, and ovarian cancer, and is among Roche’s top selling drugs, with sales at $5.8 billion, $5.3 billion Swiss francs, or $4.4 billion euros in 2011.

“Medical practices that purchase and administer illegal and unapproved foreign medications are putting patients at risk of exposure to drugs that may be fake, contaminated, improperly stored and transported, ineffective, and dangerous,” the FDA said in a statement. Some of the problem may be that the drug has no active ingredient, or the problem could be that all the ingredients are bad.  “Even if the identified drugs were not counterfeit, Altuzan is not approved by the FDA for use in the United States,” the FDA statement said.

Doctors bought the counterfeit drugs through Richards Pharma, a distributor that also does business as Richards Services, Warwick Healthcare Solutions, and Ban Dune Marketing Inc.  Richards Pharma is based in Britain, while Ban Dune is a now defunct company from LaJolla, California. Earlier this year, the head of Ban Dune was indicted and pleaded guilty to a felony count of conspiring to distribute counterfeit prescription drugs. British authorities said U.K. based Richard’s Pharma Ltd. purchased 120 packs of the counterfeit medicine from a Turkish wholesaler. He sent 38 packs directly to the U.S. Then, an additional 82 counterfeit vials were shipped to the U.S. by River East Supplies, which is owned by Canadian businessman Tom Haughton. Haughton is already under investigation from the first incident of fake drugs entering the U.S. in February. He is accused of selling the drug for $2,000 a vial, which is $400 less than the manufacturer’s price.

The Turkish outfit isn’t the only tough-to-find middleman that handled the fake Avastin. Hadicon AG, a Swiss drug distributor, said they ordered what they thought was the real drug from an Egyptian company called Sawa, and he provided a phone number for Sawa, even though Egypt’s health ministry said it has no record of Sawa.

It is so unfair that innocent cancer patients could be endangering their lives by receiving bogus cancer drugs from their very own physicians. If these injectable cancer medications are not FDA approved, the physicians have no business treating their sick patients with it.  Especially since this is not the first time this has happened.  Is this justice?

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Propecia Linked to Serious Sexual Dysfunction

March 13, 2012

(March 12, 2012) Propecia, also known by its active ingredient, Finasteride, was originally developed by Merck as a treatment for enlarged prostate. The FDA approved Proscar (5 mg) in 1992 for the treatment of benign prostate hyperplasia, and Propecia (1 mg) in 1997 for the treatment of baldness. Both drugs contain Finasteride, the same active ingredient that helps prevent hair loss.

 

Sales of Propecia brought in $429 million in revenue in 2008 (sixteen years later).

 

In order to maintain the results from Finasteride, it must be taken on an ongoing basis.

 

A lawsuit has been filed against Merck & Co. for failing to fully disclose the serious side effects of their drug, Propecia. The lawsuit is seeking compensation on behalf of all the men who have taken Propecia and suffered from the severe side effects in the form of sexual dysfunction and mental impairment. In some cases, the side effects were permanent.

 

Those patients who were affected claim that if Merck had stronger warnings on the label, they would never have taken this drug. Further, the lawsuit claims that European regulators had warned Merck about these dangers, but the company did nothing to protect the American market. It also asserts that once Propecia is discontinued, the side effects will go away. This is untrue.

 

The lawsuit claims that the patients started using the drug as a remedy for baldness, hoping that the drug would help with hair growth. However, the suit alleges that after just one month of use, they noticed obvious changes in their behavior, loss of sexual desire, as well as extreme anxiety in social situations.

 

The victims claim that the negative effects of Propecia have destroyed their lives, and are still experiencing the horrible side effects five years after having stopped this drug completely. One victim claimed the he suffered such severe symptoms, it ruined his marriage and his wife left him. Another lawsuit claims that a victim suffered loss of concentration, forcing him to drop out of law school.  The lawsuit claims that despite the numerous complaints from patients and physicians, Merck continued marketing this drug, still without a strong warning on its label, risking the safety of unsuspecting new patients who had no idea of the serious risks.

 

One of the victims experienced trouble breathing, hypertension, anxiety attacks and memory loss three years after he stopped taking the drug. Many of the victims experienced breathlessness, insomnia, depression, loss of libido, erectile dysfunction, impotence, nipple discharge after using the drug.  However, they all agree that the drug worked so well as far as rejuvenation of new hair growth, but ruined their sex lives, practically leaving them impotent for the rest of their lives. Ironic that these men took this drug to gain the confidence to talk to women, yet this very drug made them impotent.

 

The victims claim that they have experienced sexual anesthesia, sexual anhedonia, which is the worst of all the sexual dysfunctions, not going away during the lifetime of an individual. Most of the victims have also experienced psychiatric, neurocognitive, and neurological side effects, suicidal ideation, bipolar mood disorder, hypersensitivity, cognitive dysfunction, social withdrawal, and lethargy. The lawsuit asserts that most of the victims suffered irreversible side effects in the form of crashed endocrine systems, breast enlargement, male breast cancer, and swelling of the lips and face.

 

The lawsuit claims that these side effects have affected the lives of many, young men in their twenties, as they are now infertile and would require medical intervention if they wish to produce children.

 

Due to the intense influence on hormones, Propecia can cause severe birth defects in unborn children. The drug’s label warns that women should not handle crushed tablets if there is a chance they can be pregnant.

 

Propecia has recently been linked in studies to high-grade prostate cancer, the most deadly form of the disease. The FDA has required that the Warnings and Precautions section of the labels of Propecia and other 5-alpha reductase inhibitor (5-ARI) drugs be updated to include information about this risk.

 

Just about all drugs, (prescription, as well as over the counter medications), come with the risk of side effects, but some are more serious than others.  Taking a drug like Propecia to treat some hair loss should not lead to permanent sexual dysfunction or cancer.  These pharmaceutical companies should be held accountable for their negligence. They knew Propecia caused serious and potentially permanent side effects in patients, especially after European regulators informed them, yet they still did not change the warning labels, which could have protected the public. Is this justice?

 

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