Posted tagged ‘medicine’

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 Approves Breast Cancer Medicine

June 9, 2012

(June 9, 2012) The U.S. Food and Drug Administration (FDA) approved a new anti-HER2 therapy, called Perjeta (pertuzumab) to treat patients with HER2-positive late-stage (metastatic) breast cancer.  Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel, a type of chemotherapy.

 

HER2 is a protein involved in normal cell growth, and is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. The increased amount of HER2 protein in these HER2-positive breast cancers contributes to cancer cell growth., as well as survival.

 

Perjeta is intended for patients who have not received prior treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy.

 

Perjeta is administered through an IV, and is a humanized monoclonal antibody, manufactured through biotechnology methods.

 

Currently, breast cancer is the second leading cause of cancer-related death among women. In fact, an estimated 226,870 women will be diagnosed this year, and 39,510 will die from the disease.

 

Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, said,  “given the need for additional treatments for metastatic breast cancer, we made the decision to approve this drug today and not to delay its availability to patients pending resolution of the production issues relating to future supply.”

 

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug and Research, said, “since trastuzumab was first approved more than a decade ago, continued research has allowed us to better understand the role HER2 plays in breast cancer. This research provided the background to combine two targeted drugs – trastuzuman and Perjeta with docetaxel to slow disease progression in breast cancer.”

 

In a study designed to measure the length of time a patient lived without the cancer progressing, progession-free survival (PFS), those treated with the combination containing Perjeta had a median PFS of 18.5 months, whereas those treated with the combination containing placebo had a median PFS of 12.4.

 

Common side effects are diarrhea, hair loss,  a decrease in infection-fighting white blood cells, nausea, fatigue, rash, and nerve damage.

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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Cymbalta May Relieve Chemo-Induced Pain and Tingling, But At What Cost?

June 6, 2012

Cymbalta

 

(June 5, 2012) – The anti-depressant Cymbalta (duloxetine) is the first drug that has been shown to relieve the nerve pain and discomfort that affects up to one third of cancer patients treated with certain chemotherapy drugs, researchers report.

 

In a study of more than 200 people who suffer from the condition known as chemotherapy-induced peripheral neuropathy, 59 percent of those given Cymbalta reported a decrease in pain, compared with 39 percent given placebo.

 

Chemotherapy-induced peripheral neuropathy is caused by damage to nerves, most often in arms and legs. Besides shooting pain, symptoms include burning, tingling, numbness, problems with balance, dropping things, and cold and heat sensitivity.

 

“Peripheral neuropathy is a chronic, debilitating problem, with some patients enduring pain, numbness, and tingling for months, possibly years, after completion of chemotherapy,” says researcher Ellen M. Lavoie Smith, Ph.D., an assistant professor in the School of Nursing at University of Michigan, Ann Arbor.

 

“Until now, we knew of nothing that was effective in treating the condition,” she said. The drug was generally “well tolerated.” The most common side effect was mild fatigue, reported by 11 percent of people taking Cymbalta and 3 percent on placebo. Twelve patients (11%) dropped out of the study due to drug associated side effects.

 

Cymbalta is thought to work by changing levels of brain chemicals linked to pain and nerve function. Cymbalta, which is approved for the treatment of depression and painful diabetic peripheral neuropathy, costs about $150 for a one-month supply.

 

This is great news for patients being treated with chemotherapy drugs. However, Cymbalta has been classified as “Do Not Use” for any form of depression, as well as for all other uses for which it has been approved (such as generalized anxiety or any form of pain, including fibromyalgia). The conclusion that duloxetine should not be used for any purpose also was reached in February 2009 by Prescrire, the French journal of drug safety and efficacy, which stated, “Duloxetine: to be avoided in all circumstances.”

 

The FDA issued a Black Box Warning, which is the strongest type of safety alert the FDA can demand of drug manufacturers, and can be required when there is evidence of serious injuries or death with a drug.

 

Liver toxicity and liver failure, sometimes fatal, have been reported in patients treated with duloxetine.

 

On October 17, 2005, Eli Lilly expanded its warning about potential liver-related problems with Cymbalta and cautioned doctors against prescribing it to patients with chronic liver disease, U.S. health regulators announced. The new label for the drug also contained reports of hepatitis, jaundice, and other liver-related problems in patients using Cymbalta.

 

Soon thereafter, the FDA had issued a warning about the potential for suicidal thinking in adults taking anti-depressants, but the agency specifically singled out Cymbalta because of a higher than expected rate of suicide attempts in recent studies. Cymbalta was a relatively new anti-depressant manufactured by Eli Lilly that had been associated with suicide risk since its clinical trials.

 

The warning came after a review of Cymbalta by Eli Lilly, which found that 11 of nearly 9,000 women taking it for urinary incontinence tried to commit suicide. The fact that these patients were suffering from urinary incontinence and not depression is significant because the drug companies have long argued that anti-depressants are used by depressed people who have a higher likelihood of committing suicide.

 

Cymbalta has been associated with suicidal behavior since Traci Johnson, a healthy volunteer involved in a trial at Eli Lilly’s clinic at Indiana University Medical Center in Indianapolis, killed herself in one of the clinic’s showers. She did not suffer from depression and was taken off the drug and given a placebo four days before she hung herself in the clinic’s showers on February 7, 2004. She was the 5th patient to commit suicide after taking Cymbalta in clinic trials. After her death, 1/5 of the volunteers quit the Cymbalta trial.

 

Many patients who have been treated with Cymbalta today complain that it is almost impossible to go through the withdrawals of this drug. It makes them feel so sickly, some complaints are of “brain surges” or “zaps” that cause dizziness and a shock like feeling. Some patients say this drug should be illegal. There are several complaints of feeling emotionless, gaining weight even though the side effects state “possible weight loss”, making your heart feel like it is coming out of your chest, constant nightmares, and some complaints of manic behavior. There are many that say that after taking just one Cymbalta pill they experienced terrible side effects that took weeks to dissipate. One woman stated that her husband could not take the horrific side effects and his doctor was of no help, so he put a gun to his heart and killed himself.

 

There is currently a Cymbalta Petition , which is demanding that Eli Lilly make the consumers aware of all the terrible side effects and withdrawal complications patients in the U.S., as well as worldwide, have experienced since taking this medication.  It is still not taken off the market and no changes have been made.

 

If Eli Lilly was aware of these terrible side effects, why haven’t the physicians and the consumers been made aware of them? Why is this drug still on the market?

 

So, even though this medication may relieve the pain and discomfort caused by chemotherapy-induced peripheral neuropathy, are these horrible side effects really worth it? Before these cancer patients are given this “wonder drug,” they are entitled to the risks this drug can cause, after all, haven’t they been through enough?

 

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Children Receive $6.41 Million in Malpractice Lawsuit

June 4, 2012

(June 4, 2012) – The five children of a man who died due to his misdiagnosis at Temple University Hospital were awarded $6.41 million in a medical malpractice lawsuit.

 

According to an article in Philly.com, the 38-year-old man was diagnosed with pneumonia after he collapsed with chest pain while playing basketball on May 31, 2009. He was taken to Temple University Hospital, diagnosed with pneumonia, prescribed Motrin and antibiotics, and was released. Three months later, he again collapsed from severe chest pain while playing basketball, suffering a massive heart attack. He died on November 12, 2009.

 

An attorney for the victim’s five children said that the hospital and two doctors who treated him were named in the lawsuit.

 

Frequently, heart attacks are thought to be symptoms of G.E.R.D. (gastroesophageal reflux disease), anxiety attacks, angina, gallstones, as well as several unrelated cardiac issues. Early diagnosis and treatment of heart disease is beneficial in the prevention of more serious conditions and life-threatening complications, such as myocardial infarction (heart attack) or death. Misdiagnosis is dangerous because instead of receiving the necessary treatment for the heart muscle and surrounding arteries, more damage can occur, ultimately resulting in death. Receiving the proper treatment and medications is crucial. Unfortunately, this father of five children was misdiagnosed and never received the proper diagnosis and treatment.

 

I am certain that the victim’s children would much rather their father still be alive than any amount of money. But someone needs to be accountable for his untimely death. This never should have happened. Hopefully, this will help the hospital and physicians be more thorough and careful when diagnosing patients.

 

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Birth Defects Caused by Paxil During Pregnancy

May 27, 2012

(May 27, 2012) – In 2005, the U.S. Food and Drug Administration (FDA) issued a warning that anti-depressant drugs with a Selective Serotonin Reuptake Inhibitor (SSRI), such as Paxil, could put children at risk of birth defects if taken by pregnant mothers.  There are millions of at-risk children born to mothers who were prescribed such medications.

 

This warning came after the FDA reviewed a study conducted by Paxil manufacturer, GlaxoSmithKline. The FDA warned the medication could cause a range of birth defects. Data was collected from more than 3,500 women taking Paxil during the first three months of pregnancy. The medication has not been banned for pregnant women, though the warning has been upped from Class C to Class D, meaning that there is evidence that the drug poses a known risk to unborn children. Although it is not recommended for expectant mothers to take this medication, doctors may continue to prescribe it if the benefits for the mother outweigh the risk posed to the fetus. It is known that there is a common presence of depression in pregnant women.

 

Drugs like Paxil and Zoloft have been found to cause birth defects in children of pregnant mothers taking these drugs by experts with the National Birth Defect Prevention Study of Infants, the FDA, New England Journal of Medicine, University of Ulm and Aarhus University in Denmark, University of California at San Diego, and Boston University.

 

The birth defects, which were found directly related to mothers who took Paxil during pregnancy are:  skull defects, lung conditions, abdominal defects, club foot, brain deformities, heart defects, and spinal defects.

 

Paxil has been on the market in the U.S. since 1992, and is one of the most widely prescribed anti-depressants on the market. Ten years after it became available, the LA times published an article (December 15, 2002) estimating that in that year alone, 37 million prescriptions were filled. Just five years later, in 2007, the FDA calculated that 19.7 million prescriptions of Paxil were filled.

 

In 2010, annual reports showed that Paxil’s manufacturer, GlaxoSmithKline, earned more than $5 billion in profits. GlaxoSmithKline has spent approximately $1 billion to date to settle litigation claims regarding birth defects, according to an article published in Bloomberg News on July 20, 2010. On average, settlements amounted to $1.2 million in approximately 800 individual cases.

 

Even families that have yet to file a claim still retain their legal rights, despite the fact that hundreds of cases have already settled.

 

Paxil birth defects include:

–       Persistent Pulmonary Hypertension in the Newborn (PPHN)

–       Congenital (present at birth) heart defects

–       Neural tube defects (spina bifida)

–       Craniosynostosis

–       Infant omphacele

–       Club foot

–       Anal atresia

–       Lung defects

 

Persistent Pulmonary Hypertension in the Newborn (PPHN) is a life-threatening disorder in which a newborn’s arteries to the lungs remain constricted after birth, resulting in an abnormal blood flow through the heart and lungs, and insufficient oxygen delivery throughout the baby’s body. Surgery is required in serious cases.

 

Spina Bifida – During the first month of pregnancy, the two sides of the spine join together to cover the spinal cord, spinal nerves, and the tissues covering the spinal cord. Spina bifida refers to any birth defects involving incomplete closure of the spine. This requires major surgery, physical therapy for the child, and in some cases, special apparatus.

 

Craniosynostosis – A birth defect in which one or more of the joints between the bones of the infant’s skull close prematurely, before the infant’s brain is fully formed. When the baby has craniosynostosis, his or her brain cannot grow in its natural shape, and the head is misshapen. To treat this, the infant usually needs surgery to separate the fused bones. If there is no underlying brain abnormality, the surgery creates adequate space for the brain to grow and develop. Treatment must be done at birth while the baby’s head is still malleable in order to create proper room for the brain to grow and to relieve pressure and re-mold the skull’s shape.

 

Infant Omphacele – is an abdominal wall defect at the base of the umbilical cord; the infant is born with a sac protruding through the defect, which contains the small intestine, liver, and large intestine. Surgery is required; however, once the omphacele repair is completed, some infants have difficulty eating normally, and may require tube feeding. If the omphacele is large, a caesarean section is necessary.

 

Infant Omphalocele

 

Anal Atresia – is a congenital defect that affects the anus. In this condition, the opening of the anus is blocked or missing entirely. Surgery is the only treatment for anal atresia.

 

Lung Defects – Although there are many types of lung defects from blood flow to deformity to underdevelopment, these are addressed separately, with varying treatments that can be resolved through incubators or surgery. There is a possibility that the child will have breathing problems for their entire life.

 

These are very dangerous side effects, and many of these conditions are life long.  Although depression is a serious disease, is taking Paxil while pregnant worth passing such horrible side effects on to your unborn child?  The manufacturers of these anti-depressants, in this case, GlaxoSmithKline, manufacturer of Paxil, need to warn consumers about the increased risks they are facing when taking these drugs.  They are responsible for causing so much pain and sickness to millions of mothers and their babies. Now they really have something to be depressed about.

 

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Lawsuits Filed Against Manufacturer of Dangerous Pradaxa

May 24, 2012

(May 24, 2012) – Pradaxa, a blood thinning drug which the U.S. Food and Drug Administration (FDA) is investigating for causing serious, possible fatal bleeding in patients. Doctors prescribe Pradaxa to help reduce strokes and prevent blood clots in patients diagnosed with atrial fibrillation (AFib), sometimes referred to as an irregular heart beat. This drug has been linked to bleeding so severe that it can cause heart attacks and possibly result in death. Pradaxa is manufactured by Boehringer Ingelheim Pharmaceutical GmbH & Co. KG of Germany.

 

The FDA issued a safety alert regarding Pradaxa in December 2011. The FDA is conducting a safety review of reports of serious bleeding related to taking Pradaxa. Health agencies in Europe, Japan and New Zealand have also reported cases of severe and sometimes fatal bleeding, which may have been caused by Pradaxa. The drug was introduced as an alternative to warfarin, a commonly used anti-coagulant.  However, unlike warfarin, severe bleeding caused by Pradaxa cannot be stopped by injections of vitamin K.  In addition, there are no good antidotes for bleeding caused by Pradaxa. More than two million Americans have atrial fibrillation, which makes them prone to blood clots, which can cause strokes. Lawsuit claims against drug makers allege that the company failed to completely research its side effects and promoted it as a safe alternative to warfarin. Warfarin (Coumadin) is an established medication that has a reversal agent if bleeding problems occur. These lawsuits also allege that the manufacturer failed to adequately warn about Pradaxa’s lack of any reversal agent. In any case, Boehringer Ingelheim promoted its blood thinners as a more convenient alternative to warfarin because it requires less monitoring.

 

Pradaxa is relatively new to the market, being approved by the FDA in October 2010. Pradaxa is used to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation. From its approval until August 2011, approximately 1.1 million Pradaxa prescriptions were dispensed to 371,000 patients.  There have been 250 deaths associated with Pradaxa as reported in the Bloomberg News.

 

Pradaxa has serious side effects to be concerned about. Serious bleeding incidents may occur in patients, even after minor injuries like a fall or bump to the head, which is a well-known complication of all anti-coagulant therapies.  In addition, a study done in January 2012 showed that Pradaxa patients had a 33 percent greater chance of heart attack or severe heart disease symptoms than those taking warfarin. Patients taking Pradaxa are also warned that bruising may occur more easily and take longer for the bleeding to stop. Patients are instructed to seek immediate care from a doctor if any signs or symptoms of bleeding are noticed:

 

–       unexplained bleeding from the gums

–       frequent nose bleeds

–       heavier than normal menstrual or vaginal bleeding

–       severe or uncontrollable bleeding

–       unexplained bruises that grow in size

–       coughing up blood or blood clots

–       vomiting blood or vomit that looks like coffee grounds

–       urine that is pink or brown

–       stools that are red or black and look like tar

 

The FDA is working with the manufacturer to analyze post market reports to identify possible evidence of inappropriate dosing, drug interactions or other clinical factors that might lead to uncontrollable bleeding.

 

Before patients discontinue use of Pradaxa they should discuss with their doctors. Stopping the use of blood thinning medications can increase the risk of stroke, leading to permanent disability or death.

 

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