Chantix

A recent article written in a Canadian medical journal revealed the results of a study done regarding the dangerous health risks associated with Chantix, an industry leader in products that help people quit smoking. The study determined that patients taking Chantix can heighten their risk of heart problems. These problems could lead to heart attacks. Dr. Sonal Singh, who is an assistant professor of general internal medicine working at John Hopkins University School of Medicine found that the drug can increase the chance of patients being diagnosed with irregular heartbeats. These new findings are among a host of other medical concerns that have surfaced through reports by patients, suits filed in court, and other medical studies since the product was released and hit the market in 2006.

In addition to heart problems, side effects associated with Chantix include hostility, depression, changes in mood and behavior and thoughts of suicide. Warnings are listed on the product label as well as a “boxed warning” from the Federal Drug Administration. A “boxed warning” is a label that has the highest safety restrictions issued by the FDA. This is due to the elevated risk of patients suffering from psychological conditions and episodes.

Another side effect that can be caused by Chantix is blackouts and loss of consciousness. This caused the Federal Aviation Administration to prohibit the use of Chantix for its pilots as well as air-traffic controllers. Anyone operating a public transportation vehicle and truck drivers are also banned from using the drug.

The Canadian medical study analyzed data results from clinical trials of more than 8,000 people with no medical conditions and in good health. Members of the study were either given a placebo or they were given the actual drug, Chantix. The findings published state that using Chantix was linked to a greater risk of patients suffering from serious heart conditions. This occurred in 52 out of 4,908 people who took the drug. With the placebo, an increase in heart problems was reported by only 27 out of 3,308 people.

Researchers agree that the risk is as high as 72%. This figure was reached through a statistical method used when reviewing more than one study. Dr. Singh and his associates analyzed and reviewed data from 14 studies that were conducted previously.

In the article, Dr. Singh explained that Chantix actually increased the baseline risk of smoker’s suffering from heart problems including congestive heart failure, heart attacks, and other heart related medical conditions. This contradicts the intent of smokers who want to quit and lower their risk of heart problems.

Pfizer, the company that makes and distributes Chantix, sticks by its product, stating that the drug has been used by over 7 million Americans. Pfizer did not agree with the findings of the study and professes that the actual number of heart-related issues was so low it was insignificant. The companies figures are as low as one quarter of one percent. In addition, Pfizer is working in conjunction with the FDA to review the current research and re-evaluate the safety of the drug.

Mirena

Mirena_200Today there are so many drug companies and doctors introducing women of child bearing age to the many forms of birth control. Often times women are encouraged to have an Intra-uterine device (IUD) or otherwise known as IUC (intra-uterine contraceptive) directly placed within the uterus to avert pregnancy. This is a T-shaped device implanted directly into the uterus by a trained medical professional. This type of contraceptive is a hassle free, no need to remember oral contraceptive preventing pregnancy for up to 5 years.

There are many types of IUCs in the industry today. Although, many women can have the implant and do just fine with them some experience serious, long lasting side effects. Not all medical devices are created equal which leads to manufacture warnings and risks that are associated with certain medical devices that are implanted.

Many women feel like they have been left in the dark when it comes to the possible side effect contraceptives such as Mirena. Mirena is an intra-uterine device that is placed within the uterus. Bayer is manufacturer that produces Mirena. Bayer claims that Mirena is long acting and a successful option that can be reversed for women of child bearing age. It offers a 99% success rate at preventing pregnancy.

Mirena is made up of levonorgestrel (generation synthetic progesterone) which is found in all birth control medications whether it is oral medication, injected medication, or implanted contraceptive devices. The IUD releases the hormone so that the cervical mucus becomes thicker and preventing a clear pathway for sperm to reach its destination. It begins to release the synthetic hormone as soon as it inserted in the correct location. This form of contraceptive claims to last at least 5 years and can be removed at any time although, like all contraceptives is not 100% guaranteed to prevent pregnancy from occurring.

It is not the device itself that can cause serious side effects; it is the levonorgestrel that is released from the device. It is not uncommon and quite normal in the first 90 days to 6 months to have light spotting or bleeding and irregular menstrual cycles. Eventually over 20% of the patients will have little to no bleeding over the course of the first year.

However, there are side effects that a woman may not put in direct correlation with Mirena. As with any intra-uterine devices there is always a risk of developing PID (Pelvic Inflammatory Disease) which can cause a woman to have an ectopic pregnancy. This is a risk that comes with Mirena and needs to be discussed with a healthcare professional. Patients wanting to use Mirena should have no history of ectopic pregnancies.

The light bleeding or spotting is common but what is NOT common is having lower back pain, weight gain, headaches, depression, stuffy nose, and abnormal pap smear which are all the negative side effects associated with Mirena. Most patients do not correlate these symptoms as related to Mirena.

Other side effects from using Mirena are the following but not limited to:

  1. Nervousness
  2. Breast pain
  3. Acne
  4. Decreased sex drive
  5. Skin disorder
  6. Hypertension
  7. Inflamed vagina (Vaginitis)
  8. Painful periods and or cramps
  9. Possible ectopic pregnancy (can cause infertility)
  10. Ovarian cysts
  11. Infertility due to PID (Pelvic Inflammation Disease)
  12. Perforation of the cervix or uterus
  13. Nausea
  14. Breast cancer
  15. Harm to breast feeding infants

Mirena is also marketed to mothers who have just given birth, some literature has encouraged getting Mirena inserted when having a c-section, but nowhere does it state the harmful effects it could have on a breast feeding baby. In fact, it has been reported that the newborns have had a higher incidence of respiratory infections and neurological disorders when mothers have elected to insert Mirena.

Often times after an IUD is placed there is no follow up, it is important to pay close attention to the body’s reaction when a device has been implanted. As with any drug or medication it is important to seek professional help and discuss all warnings and risks associated with the procedure.

Dangerous Cholesterol Medications

Commercials, doctors, medical literature and of course the media stresses that high cholesterol is the cause of heart disease. High cholesterol disease surfaced when cholesterol was available to test with a blood test by a medical provider. The question still remains as to whether or not this is a condition requiring treatment. Having high cholesterol has no symptoms that are noticed outwardly. It can only be detected by a medical professional through testing the blood. Having high cholesterol is not something someone “feels” in fact someone with high cholesterol might feel just fine.

Therefore, a doctor must convince the patient with high cholesterol that something is wrong and they need to be treated. Most people will be convinced that this is life threatening and in order to “save” their lives they will need to treat the high cholesterol for the rest of their lives with medication, lab work and regular checkups in order to stay “healthy”.

Suffering from high cholesterol, is called hypercholesterolemia. Hypercholesterolemia is characterized by having high levels of cholesterol in the blood stream. In 1984 a consensus was taken by the Cholesterol Consensus Conference that having a cholesterol level over 200 indicates a red flag for doctors to diagnose the patient with the new “disease” and prescribe medications to lower the level. Recently the level has been reduced to 180.

A patient who has experienced a heart attack would need to take cholesterol medications to lower the level even if they currently have normal cholesterol levels. When someone has a heart attack, medical professionals generalize that the patient “must” have high cholesterol. Generally male patients that are middle aged are diagnosed the most. The medical argument may often be, why wait until a heart attack happens to test cholesterol levels? There are just as many complications with low cholesterol blood levels.

Cholesterol medications are called Statins. Statins help lower cholesterol and help prevent strokes and heart attack. Statins consist of an enzyme that helps prevent the production of cholesterol in the blood stream. The media and medical providers stress the importance of lowering the high cholesterol levels. But, we do not hear much about too low of cholesterol and its risks and warnings.

We know that Statins effectively help to reduce the cholesterol levels in the blood. However, cholesterol plays a major functional role in the human body. Our cells are waterproof due to the cholesterol in our blood. Cholesterol plays an important role in helping the body “repair” itself; in scar tissue cholesterol is found in high levels.

Cholesterol is essential for proper development of neurological processes. Cholesterol is essential for correct brain function, memory, and assisting with healthy hormones within the brain. Serotonin is a hormone that can be affected if cholesterol is too low and if unbalanced can cause depression and other mood disorders. Cholesterol lowering medications can cause the serotonin receptors to malfunction. Cholesterol has also been examined to act as an antioxidant. This helps protect the aging process that leads to heart disease.

Cholesterol is known for controlling the levels of blood sugar in the blood stream. Having low cholesterol has been attributed to infertility, allergies, difficulty healing, low libido, asthma and other reproductive issues.
Some common side effects from taking statins or cholesterol lowering medications is muscle pain and weakness, neuropathy(numbness or tingling in hands and feet), heart failure, dizziness, cognitive impairment, cancer, pancreatitis, and depression.

Before taking a cholesterol-lowering medication it is important to discuss with your doctor the risks, side effects, and concerns regarding statins. Statins can be effective if used and diagnosed properly however,risks increase over long term usage.

Lowering-cholesterol drugs or otherwise known as Statin drugs help the body to lower the cholesterol in the blood. It helps block the LDL cholesterol that is needed to be made in the liver. LDL cholesterol is known to be the “bad” cholesterol that can cause blockage. Often times having high cholesterol leads to multiple health risks including heart attack or other cardiovascular diseases.

A recent study has shown that statin drugs have significantly increased the chances of type 2 diabetes. Diabetes is metabolic disease that affects the blood. A person who is diagnosed with having diabetes has a high level of sugar in their blood stream. Their body’s cells are not responding appropriately to insulin, not creating enough insulin to cause a balance or both. Insulin is a hormone that helps the food to break down into energy. Diabetes can cause long standing complications such as blindness, kidney failure, and amputation of the leg or foot. The studies argue about the danger of statin drugs versus the benefits they provide.

The question at hand is if taking a statin drug can increase the chances of developing diabetes. Can statin drugs intensify insulin resistance in patients? Vitamin D is combined with cholesterol, if taking a statin to lower the cholesterol then this will directly affect the production of vitamin D in the body. In turn having low vitamin D in the blood stream can worsen the resistance to insulin. It is a vicious cycle. If taking a statin affects the vitamin D, and the vitamin D worsens the resistance to insulin, and when there is a resistance to insulin the body develops Type 2 diabetes. Ironically diabetes increases the chances of developing coronary artery disease. Not only can statins increase insulin resistance, the resistance can also cause the advancement of cancer.

Along with the complications of diabetes, statin drugs have side effects such as muscle aches, liver failure and can even lead to kidney failure. It is reported that if statin drugs are taken for a long period of time it can cause cognitive impairment. It is suggested that older patients and women that were menopausal were at a higher risk as well as obesity and a family history of cardiovascular diseases.

Some common statin drugs:

  1. Liptior
  2. Pravachol
  3. Crestor
  4. Zocor

If taking a statin drug causes diabetes and can contribute to the advancement of cancer one must ask themselves if taking a statin is worth the risk and does it’s benefits out way the negatives.. The suggestion is to treat insulin resistance which will cover the three most important diseases. Statins are relatively safe and has many benefits. It is important to know that the decision to take a statin drug should be ultimately between the patient and the doctor. It is imperative to understand all the risks and benefits that can come from taking a statin drug. The FDA is updating their drug labels to reflect the risks and dangers from using a statin. The statement is not to discourage users from using it; it is just a precaution and suggests careful monitoring of the patient’s blood levels.

Testosterone Therapy Safety

In January 2014, the FDA released information regarding the safety of testosterone products and an ongoing investigation on the risks of heart attack, stroke and death among men using FDA approved testosterone therapy. Recent studies have linked an increase for strokes and heart attacks to men taking testosterone products. AndroGel, Testim, Delatestryl, Fortesta, Bio-T-Gel and Testopel are some of the FDA-approved testosterone drugs currently available by prescription.

Testosterone therapy is marketed toward older men, typically over 65, to increase sex drive and restore energy. The hormone is generally distributed in injection, patch or topical gel form.

According to the FDA, from 2002 to 2013 there were at least 44 cases of pulmonary embolism, 18 cerebral vascular episodes, 42 heart attacks and 12 fatalities reported from users of AndroGel, a topical form of testosterone treatment. A report from Adverse Events, Inc. established testosterone as the primary cause of 479 hospitalizations, 105 of those being linked to heart attack or stroke, and 61 resulting in death.

Five users of AndroGel have filed lawsuits against the drug and its parent company, claiming to have experienced heart attacks or strokes while using the product. Those suing claim the company exaggerated the benefits of testosterone treatments in their television advertisements, and failed to reveal the possible dangers associated with taking the hormone.

While the risk of cardiovascular issues from testosterone drug therapy has not been officially determined by the FDA, the treatment has only been approved for men with little or no testosterone levels and an associated medical condition. Associated medical conditions include hereditary complications, testicle malfunction as a result of chemotherapy, or hypothalamus and pituitary gland issues. The pituitary gland in the brain regulates testosterone production and can sometimes malfunction. A major cause for concern is that many men with regular testosterone levels, who do not have any of these conditions, are using testosterone drug therapy. Prescriptions for testosterone drugs have more than doubled in the past four years, according to a report from CBS News.

PLOS One released a study showing that in 55,000 men using testosterone therapy, the risk for heart attack doubled in men over the age of 65 and tripled for younger men with a history of heart disease. The FDA has encouraged patients and medical professionals to report any side effects experienced from using testosterone therapy.

Transvaginal Mesh Side Effects

Transvaginal mesh is a medical device that has often been used in women who are experiencing problems with pelvic prolapse or incontinence. The device is implanted as a type of sling intended to help improve symptoms associated with urinary incontinence or prolapse of the pelvic organs. The specific problem with lack of control of the urinary muscles occurs for many women involuntarily when they cough, laugh or sneeze.

This can be embarrassing and limit social experiences. In order to address this fairly common issue, medical professionals advised the use of Transvaginal mesh. Additionally the device has also often been used to remedy the issue of a protruding vagina, which can often result after birthing children. Both of these physiological issues are often associated with the results of pregnancy and childbirth. These issues in and of themselves can create some complicated medical problems that interfere with the overall quality of life for many women. Sometimes the problems stem from socially humiliating situations to physiological complications of having the pelvic organs in the wrong place. In either case it makes sense that women have readily submitted themselves to the use of Transvaginal mesh as a trusted resolution to these problems. Unfortunately there have been many lawsuits filed against the manufacturers of Transvaginal mesh because of serious, unforeseen complications.

Complications include but are not limited to the following: painful intercourse, bladder and bowel puncturing, scarring of the vagina and continual drainage. These complications can become so troublesome that additional surgeries have been recommended in an attempt to alleviate the problem. Sadly many times the problems are not corrected as planned. If you or someone you know has suffered from the negative side effects of a Transvaginal mesh implant seek counsel with a medical lawyer. Women who are negatively affected have every right to hold the manufacturers of the Transvaginal mesh accountable. Medical law professionals can help you determine the extent of compensation owed to you.

Many women miss out on work opportunities and there fore suffer the loss of wages, coupled with increasing medical expenses created by the implant itself. Other factors to consider in a Transvaginal mesh legal battle include emotional suffering and damage to marriage and other family relations due to the added stress and physical complications.

Additionally the suffering incurred by the spouse and other family members, which may also include loss of wages or emotional trauma can be considered for possible restitution by professional legal counsel. It is reasonable for a patient to have a clear understanding of all the benefits and possible risks associated with any medical device.

Negligence on the part of the manufacturing company who designed the medical device should not be tolerated. Action taking against this type of problem in the form of a law suit will help to ensure that less women suffer from the consequences of poorly designed implants. These devices that, too often, end up creating more harm than good need to be recalled and the only way to make that happen is to stand up for your legal rights if this has happened to you or someone you love.

What is an SSRI

Antidepressants seem to be a common word in society today. Antidepressants are drugs in a category called SSRI’s (selective serotonin reuptake inhibitors). The purpose of SSRI’s is to balance out chemicals in the brain that are unbalanced and are causing symptoms such as depression, anxiety, and other moods that come with emotions.

Antidepressants are available in many different types and can help you function and feel better. Brand name and generic name medications are equally effective and cost effective. A long with the positives of antidepressants also come the negatives. With the negative effects come the risks of taking these types of drugs.

Risks of taking antidepressants

Antidepressants have been known to be associated with birth defects. Some of the defects they have noted happen at various times of a pregnancy. The defects are an abnormal heart, club foot, uncommon growth of the skull, defects of the brain, irregular lung and spinal formulation, abdominal wall irregularities, cleft lip and palate, limb abnormalities, underweight babies and stillborn, seizures and drug addicted newborns.

In a study 68% of miscarriages were reported from mothers that were on antidepressants throughout the first trimester. Mothers that used SSRI’s further along in their pregnancies were known to have a motor developmental delay in infants. In 2005 it is suggested or warned not to use antidepressants in the first trimester because of acute heart defects.

In 2009 the warning came to not use antidepressants after the 20th week of gestation because it showed 6 times higher the changes of the infant having Persistent Pulmonary Hypertension of Newborns (PPHN) which results in the blood not traveling correctly through the lungs. Before placing a woman on an SSRI it is important to weigh the variable of the risks of the unborn child against the untreated depression in the mother. Untreated depression without the use of SSRI’s can lead to other drug usage, alcoholism and even suicide. “The fetus and the newborn are almost always worse off if the mom is depressed than if…exposed to the vast majority of antidepressants. ” (Sephan Quentzel, psychiatrist at Beth Israel Medical Center, NY)

Other risks of antidepressants include but not limited to:

– Physical symptoms

– Involuntary movements

– Sexual effects

– Loss of effectiveness

– Discontinuation symptoms

Mild, temporary physical symptoms include: insomnia, headaches, stomach upset, nausea and diarrhea. Other symptoms could be more severe such as uterine or stomach bleeding. Patients who take SSRI’s are more likely to need blood transfusions if surgery is needed.

Involuntary movements: This covers tics, muscle spasms, trembling, loss of control of motor skills,and anxiety.

Sexual effects: effects that have been notes are the lack of desire, delay or prevention of orgasm, and the overall loss of interest among other symptoms.

Loss of effectiveness: after being on antidepressants for a continual period of time they tend to be much less effective. The brain has become conditioned to the drug and may need more to get the desired effect. Sometimes switching to a different SSRI can help alleviate this from occurring.

When discontinuing an antidepressant it should be noted that the patient can go through withdrawal symptoms. This can include dizziness, flu-like symptoms, anxiety, nausea, insomnia, and fatigue among other negative side effects.

It is evident through research and study that taking an antidepressant or an SSRI can in fact have risks to one’s health as well an unborn fetus.

FDA Investigating Diabetes Drug

The amount of diabetics has significantly increased over the past 20 years. There are over 200 million people worldwide who suffer from diabetes, leaving many dependent on medication. Recent studies, however, have caused concern that these drugs meant to keep diabetics healthy may instead put them at a higher risk of developing other medical conditions, like the possible link between the drug Avandia and cardiovascular concerns. In fact, some medical professionals have voiced their concern and recommended that the product be removed from the market, but, the drug is still being prescribed and available to patients. Lantus, another medication used to treat diabetes, has raised additional concerns. An article in the medical journal Diabetologia revealed data from studies that may connect Lantus with a greater risk of cancer.

There are a variety of ways and methods used to conduct these studies. For example, the results of the study that revealed a possible link between Lantus and cancer was determined through observational data. This type of data is not always accurate or the most reliable. The issues raised about the drug Avandia, however, is based on data from clinical trials. This is the most widely used and accurate method of research. Warning labels on Avandia state that the drug can cause congestive heart failure in some patients. Some studies have also linked Avandia to cardiovascular risks including heart attacks and even death. In contrast, however, a trial conducted by GlaxoSmithKline, the manufacturer of Avandia, concluded that Avandia did not increase the risk of heart related issues and death.

When consumers learn about safety worries associated with different medications, the natureal reaction can be to panic. The best thing consumers can do is stay calm and get medical advice from their health care professional. Patients using these medications should never stop taking their medication without first discussing discontinuing use with their doctor. A sudden halt to regular doses of medication can cause even greater health risks. For diabetics, it is essential that blood sugar levels are in control. The Food and Drug Administration, the American Diabetes Association, and the American Association of Clinical Endocrinologists support this advice.

Out of four observational studies published in the journal Diabetologia, three have raised concerns about a possible increased risk of cancer in patients using Lantus. Extensive patient databases were used in this study, which should increase reliability of the results. Some experts, however, have found inconsistencies in these studies which cause them to question and even doubt an actual there connection between the drug Lantus and cancer, according to the FDA. The FDA is reviewing safety data derived from these as well as previously conducted studies and clinical trials. This will help them decide if the concerns raised are valid or not. Executives with Sanofi-AVentis, the company that makes the drug Lantus, report that they will monitor and evaluate the safety of their products and will work alongside the FDA as well as other agencies that regulate the safety of prescription drugs.