Avandia (rosiglitazone) is an anti-diabetic drug in the class of drugs known as thiazolidinediones. It is manufactured and marketed by GlaxoSmithKlein and used primarily to treat type 2 diabetes mellitus, also known as adult onset diabetes. It works by helping the body make better use of naturally occurring insulin.
Avandia is prescribed as a standalone preparation or in combination with sulfonylurea, insulin, metformin as Avandamet, or glimepiride as Avandaryl. It is also sometimes prescribed "off-label" to treat Alzheimer's disease.
In March 2000, the U.S. Food and Drug Administration (FDA) recalled Rezulin, another drug in the same class as Avandia. Avandia was intended to replace Rezulin as a safer alternative. Since Avandia's approval, however, the list of potential side effects has continued to grow, and some argue that it has not proved to be an improvement over its predecessor.
Potential side effects of Avandia listed by the FDA include:
* Hepatitis and other serious liver injury, including liver failure leading to transplant or death
* Cardiovascular problems and congestive heart failure
* Macular edema, or swelling in the back of the eye, leading to decreased or blurry vision
* Dangerously low blood sugar
* Recurrence of ovulation in women who had stopped having periods but who had not reached menopause nor use effective birth control
Thursday, May 7, 2009
Antacids That Increase Risk of Bone Fracture
The prescription of proton pump inhibitors (PPIs) such as omeprazole (Prilosec), esomeprazole (Nexium), lansoprazole (Prevacid), rabeprazole (Aciphex), and pantoprazole (Protonix) has surged in popularity. But patients and physicians may need to curb their enthusiasm for such drugs. Drugs of this type, which are used to treat Dyspepsia, Peptic ulcer disease, GORD/GERD, Laryngopharyngeal Reflux Disease, Barrett's esophagus, gastrinomas, and Zollinger-Ellison syndrome, and to prevent stress gastritis, have come under scrutiny for increasing the risk for osteoporosis-related fractures.
While the mechanism by which the use of PPIs increases the risk of fracture is unknown, it is generally thought that the extended use of these drugs accelerates the rate of bone mineral loss due to their acid-inhibiting effects.
A study published in August, 2008 in the Canadian Medical Association Journal found that those who took PPIs for more than seven years quadrupled their chance of hip breaks and nearly doubled their chance of osteoporosis-related fractures overall. It was the third large study that found an increase in osteoporosis-related fractures in patients who took PPIs.
Physicians may need to begin considering on a patient-by-patient basis whether PPIs should continue to be prescribed at the same dosages and frequencies. Dr. Schnoll-Sussman, a gastroenterologist and Director of Research at The Jay Monahan Center for Gastrointestinal Health points out that seven years is “enough time for any type of peptic ulcer disease to improve."
For patients who need to continue taking PPIs, adding osteoporosis medications should be considered along with a possible change in lifestyle. Dr. Elton Strauss, Chief of Orthopedic Trauma and Adult Reconstruction at Mt. Sinai Medical Center in New York City remarked that patients on PPIs who “drink or smoke or take drugs like prednisone, ...don't do well orthopedically."
While the mechanism by which the use of PPIs increases the risk of fracture is unknown, it is generally thought that the extended use of these drugs accelerates the rate of bone mineral loss due to their acid-inhibiting effects.
A study published in August, 2008 in the Canadian Medical Association Journal found that those who took PPIs for more than seven years quadrupled their chance of hip breaks and nearly doubled their chance of osteoporosis-related fractures overall. It was the third large study that found an increase in osteoporosis-related fractures in patients who took PPIs.
Physicians may need to begin considering on a patient-by-patient basis whether PPIs should continue to be prescribed at the same dosages and frequencies. Dr. Schnoll-Sussman, a gastroenterologist and Director of Research at The Jay Monahan Center for Gastrointestinal Health points out that seven years is “enough time for any type of peptic ulcer disease to improve."
For patients who need to continue taking PPIs, adding osteoporosis medications should be considered along with a possible change in lifestyle. Dr. Elton Strauss, Chief of Orthopedic Trauma and Adult Reconstruction at Mt. Sinai Medical Center in New York City remarked that patients on PPIs who “drink or smoke or take drugs like prednisone, ...don't do well orthopedically."
Advair Attorney
With over 62 million prescriptions since its introduction, and over $5.6 billion in annual sales, Advair, a popular asthma medication, was the fourth best-selling drug in the world. GlaxoSmithKline, the drug's manufacturer, spent nearly $200 million to market Advair each year.
But then in November 2005, the U.S. Food and Drug Administration (FDA) issued an alert warning health care professionals and patients that Advair is connected to an increase of severe bronchospasms (wheezing). The FDA additionally requested that GlaxoSmithKline, update the warnings on Advair's product label.
And, only a few months after the FDA approved the new labels for Advair and Serevent (which along with fluticasone makes up Advair), the results of a joint study by Cornell University and the Stanford University School of Medicine raised concerns over whether Advair may be causing an increase in death among its users.
The study, which was published in June 2006, suggested that while Advair and Serevent (salmeterol) relieve asthma symptoms, they also promote bronchial sensitivity and inflammation. It also suggested that salmeterol and formoterol, a similar asthma medication manufactured by Novartis, may more than triple the risk of death from asthma-related complications to patients who inhaled these medications. The study also found that adding an anti-inflammatory drug (like fluticasone) does little to decrease the risk of severe complications or death.
In May 2006, the FDA issued an updated heath advisory taking the findings of the study into account. In addition to requesting that the manufacturers of Advair Diskus, Serevent Diskus, and Foradil Aerolizer update these products' labels to warn of their potential for causing severe asthma episodes and death, the advisory recommends using these medications only when others fail to control a patient's symptoms.
GlaxoSmithKline has since shifted its sales force strategy for Advair to stress its treatment for chronic obstructive pulmonary disease (COPD), a use for which the FDA gave the drug its approval in 2003. In fact, about 42% of the sales of Advair were already for use in treating COPD in 2005. There is currently at least one trial intended to study the effects of Advair in outpatients with COPD with acute exacerbation. But, in addition to the adverse effects of Advair for use in treating asthma, the following are already known additional potential side effects of the drug:
* Bronchitis
* Cough
* Sore throat
* Hoarseness
* Difficulty speaking
* Fungal infection of the mouth
* Headaches
* Nausea
* Vomiting
* Stomach pain
* Diarrhea
* Bone and muscle pain
* Sinus pain
But then in November 2005, the U.S. Food and Drug Administration (FDA) issued an alert warning health care professionals and patients that Advair is connected to an increase of severe bronchospasms (wheezing). The FDA additionally requested that GlaxoSmithKline, update the warnings on Advair's product label.
And, only a few months after the FDA approved the new labels for Advair and Serevent (which along with fluticasone makes up Advair), the results of a joint study by Cornell University and the Stanford University School of Medicine raised concerns over whether Advair may be causing an increase in death among its users.
The study, which was published in June 2006, suggested that while Advair and Serevent (salmeterol) relieve asthma symptoms, they also promote bronchial sensitivity and inflammation. It also suggested that salmeterol and formoterol, a similar asthma medication manufactured by Novartis, may more than triple the risk of death from asthma-related complications to patients who inhaled these medications. The study also found that adding an anti-inflammatory drug (like fluticasone) does little to decrease the risk of severe complications or death.
In May 2006, the FDA issued an updated heath advisory taking the findings of the study into account. In addition to requesting that the manufacturers of Advair Diskus, Serevent Diskus, and Foradil Aerolizer update these products' labels to warn of their potential for causing severe asthma episodes and death, the advisory recommends using these medications only when others fail to control a patient's symptoms.
GlaxoSmithKline has since shifted its sales force strategy for Advair to stress its treatment for chronic obstructive pulmonary disease (COPD), a use for which the FDA gave the drug its approval in 2003. In fact, about 42% of the sales of Advair were already for use in treating COPD in 2005. There is currently at least one trial intended to study the effects of Advair in outpatients with COPD with acute exacerbation. But, in addition to the adverse effects of Advair for use in treating asthma, the following are already known additional potential side effects of the drug:
* Bronchitis
* Cough
* Sore throat
* Hoarseness
* Difficulty speaking
* Fungal infection of the mouth
* Headaches
* Nausea
* Vomiting
* Stomach pain
* Diarrhea
* Bone and muscle pain
* Sinus pain
Accutane Lawyer
Accutane is used to treat a severe form of acne called resistant nodular cystic acne. It is made by Roche Laboratories and was approved by the FDA in 1982. The drug is effective in treating acne patients who have not responded well to antibiotic or topical agent treatments.
Accutane, however, has some adverse reactions, so doctors need to carefully monitor patients being treated with the drug. Frequent blood tests are needed to make sure that Accutane is not damaging the liver. Women who are pregnant should not use the drug at all because severe birth defects may ensue.
Accutane has recently received attention for causing potential psychological effects. At least 240 cases of suicide have been linked to the drug’s use. Roche has added warnings on the drug’s packaging concerning the potential for Accutane-induced depression.
Side effects that have been linked to Accutane include:
* Psychosis
* Suicide
* Severe birth defects and fetal death
* Lupus
* Irritable Bowel Syndrome (IBS)
* Inflammable Bowel Disease (IBD)
Accutane, however, has some adverse reactions, so doctors need to carefully monitor patients being treated with the drug. Frequent blood tests are needed to make sure that Accutane is not damaging the liver. Women who are pregnant should not use the drug at all because severe birth defects may ensue.
Accutane has recently received attention for causing potential psychological effects. At least 240 cases of suicide have been linked to the drug’s use. Roche has added warnings on the drug’s packaging concerning the potential for Accutane-induced depression.
Side effects that have been linked to Accutane include:
* Psychosis
* Suicide
* Severe birth defects and fetal death
* Lupus
* Irritable Bowel Syndrome (IBS)
* Inflammable Bowel Disease (IBD)
Why Are Drugs Recalled?
When a drug is taken off the market, it is not unreasonable to ask why the drug was approved for sale in the first place. After all, aren't drugs supposed to be safe? Did someone make a horrible mistake somewhere along the way?
The US Food and Drug Administration's (FDA) mission is to ensure that drugs are "safe and effective". But what does this really mean? When it comes to drugs, a safe drug is one whose benefit outweighs its risks for its intended use and for the population it is intended to treat. Cancer drugs, for example, tend to be highly toxic, but they also save lives.
All drugs, in fact, have potential adverse effects. When a pharmaceutical company develops a new drug, the FDA approves the drug if the agency deems that its benefits outweigh its risks. And to make such a determination, the FDA reviews results of clinical trials and other tests that are usually conducted over several years.
But despite the rigorous and lengthy testing that a drug undergoes prior to it even being submitted for FDA approval, not all risks and adverse effects of the drug can be known before it is made available on the market. For this reason, drugs continue to be evaluated after their approval.
When the FDA receives reports of serious side effects, it assesses them for their seriousness and the probability that they were caused by the drug. The FDA then compares the efficacy and toxicity of other treatments for the same condition. A determination of whether the benefits of the drug continue to outweigh the risks for the intended condition and population is then made and, if so, the drug continues to be tested and monitored.
The US Food and Drug Administration's (FDA) mission is to ensure that drugs are "safe and effective". But what does this really mean? When it comes to drugs, a safe drug is one whose benefit outweighs its risks for its intended use and for the population it is intended to treat. Cancer drugs, for example, tend to be highly toxic, but they also save lives.
All drugs, in fact, have potential adverse effects. When a pharmaceutical company develops a new drug, the FDA approves the drug if the agency deems that its benefits outweigh its risks. And to make such a determination, the FDA reviews results of clinical trials and other tests that are usually conducted over several years.
But despite the rigorous and lengthy testing that a drug undergoes prior to it even being submitted for FDA approval, not all risks and adverse effects of the drug can be known before it is made available on the market. For this reason, drugs continue to be evaluated after their approval.
When the FDA receives reports of serious side effects, it assesses them for their seriousness and the probability that they were caused by the drug. The FDA then compares the efficacy and toxicity of other treatments for the same condition. A determination of whether the benefits of the drug continue to outweigh the risks for the intended condition and population is then made and, if so, the drug continues to be tested and monitored.
What is the FDA's Role in Drug Recalls?
Although the US Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (1938) to "order" a recall or confiscate a product, it very rarely does so. Over the years, a cooperative effort between the FDA and the industries it regulates has been shown to be a quick and reliable approach to removing unsafe products from the market. After all, it is in the interest of both to get dangerous products out of consumers' hands as soon as possible.
I some cases, a manufacturer discovers that one of its products is unacceptably dangerous and recalls it on its own. In other cases, the FDA will share its findings with a manufacturer that a drug is more dangerous than previously thought, and may suggest or request a recall if it deems that the drug's benefits no longer outweigh its risks. In all but one case, drug manufacturers have complied. The manufacturer then keeps the FDA updated on the status of any drugs remaining on the market.
A drug recall for a drug the FDA previously certified can bring bad publicity to the agency. In part for this reason, the FDA often refrains from issuing "safety-based" recalls. If a drug continues to have a place in treatment, the FDA will instead usually work with doctors and pharmaceutical companies to change warning labels.
When a drug is recalled, however, the FDA categorizes the recall into one of three classes according to the level a hazard involved:
* Class I recalls - this is the most severe type of recall. They are issued for defective or dangerous products with a potential for serious injury or death.
* Class II recalls - these are issued for products with a lower chance of causing major health problems or death, but could also cause temporary health problems.
* Class III recalls - these are reserved for products unlikely to cause adverse health consequences, but violate manufacturing regulations or FDA labeling recommendations (or now mandates).
I some cases, a manufacturer discovers that one of its products is unacceptably dangerous and recalls it on its own. In other cases, the FDA will share its findings with a manufacturer that a drug is more dangerous than previously thought, and may suggest or request a recall if it deems that the drug's benefits no longer outweigh its risks. In all but one case, drug manufacturers have complied. The manufacturer then keeps the FDA updated on the status of any drugs remaining on the market.
A drug recall for a drug the FDA previously certified can bring bad publicity to the agency. In part for this reason, the FDA often refrains from issuing "safety-based" recalls. If a drug continues to have a place in treatment, the FDA will instead usually work with doctors and pharmaceutical companies to change warning labels.
When a drug is recalled, however, the FDA categorizes the recall into one of three classes according to the level a hazard involved:
* Class I recalls - this is the most severe type of recall. They are issued for defective or dangerous products with a potential for serious injury or death.
* Class II recalls - these are issued for products with a lower chance of causing major health problems or death, but could also cause temporary health problems.
* Class III recalls - these are reserved for products unlikely to cause adverse health consequences, but violate manufacturing regulations or FDA labeling recommendations (or now mandates).
What is a Black Box Warning?
Short of being taken off the market, a black box warning (aka. boxed warning and black label warning) is the most severe type of warning the U.S. Food and Drug Administration (FDA) issues over safety concerns about a medication. Black box warnings alert consumers and healthcare providers that a medication may cause serious side effects or poses life-threatening risks.
The warning appears on printed materials inside the drug's packaging, on materials made available to doctors who may prescribe the medication, and on print advertising such as in magazines. It is surrounded by a printed black rectangle, thus its name.
Prior to the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA could only request that black box warnings be implemented. The FDA, however, can now mandate these warnings, and the economic implication of this for drug companies is significant. A drug that gets a black box warning is often prescribed about 90 percent less frequently than prior to the warning. This is in large part because doctors are more reluctant to prescribe black box labeled drugs because of the increased likelihood of a malpractice lawsuit based on practicing medicine "outside the norm".
One of the FDA's first uses of the new authority was to require a black box warning for older, conventional antipsychotics. Other examples of drugs for which a black box warning has been required under the FDA's new authority include:
* Flouroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin) for an increased risk of tendon ruptures (July 2008)
* Rosiglitazone (Avandia), a diabetes medication, for an increased chance of heart failure or heart attack in certain cases (November 2007)
* SSRI antidepressants such as sertraline (Zoloft), paroxetine (Paxil), escitalopram (Lexapro), and other antidepressants for an increased risk of suicidality in young adults ages 18 to 24 (May 2007)
The warning appears on printed materials inside the drug's packaging, on materials made available to doctors who may prescribe the medication, and on print advertising such as in magazines. It is surrounded by a printed black rectangle, thus its name.
Prior to the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA could only request that black box warnings be implemented. The FDA, however, can now mandate these warnings, and the economic implication of this for drug companies is significant. A drug that gets a black box warning is often prescribed about 90 percent less frequently than prior to the warning. This is in large part because doctors are more reluctant to prescribe black box labeled drugs because of the increased likelihood of a malpractice lawsuit based on practicing medicine "outside the norm".
One of the FDA's first uses of the new authority was to require a black box warning for older, conventional antipsychotics. Other examples of drugs for which a black box warning has been required under the FDA's new authority include:
* Flouroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin) for an increased risk of tendon ruptures (July 2008)
* Rosiglitazone (Avandia), a diabetes medication, for an increased chance of heart failure or heart attack in certain cases (November 2007)
* SSRI antidepressants such as sertraline (Zoloft), paroxetine (Paxil), escitalopram (Lexapro), and other antidepressants for an increased risk of suicidality in young adults ages 18 to 24 (May 2007)
Drug Recalls
The pharmaceutical industry is both lucrative and cut-throat. Many companies face strong pressure to get their drugs on the market as soon as possible and to market them as broadly as they can. Pharmaceutical companies need to balance this pressure with the ethical obligation to exercise caution so that drugs are adequately tested before reaching the market. While some drug manufacturers scrupulously adhere to this ethical responsibility, others do not.
The Food and Drug Administration (FDA) is responsible for guaranteeing that drugs released on the market are safe for consumption. The process to receive FDA approval for a new drug is rigorous and can take a long time. In spite of this, it is still difficult to ascertain the long-term effects of a particular drug.
Furthermore, there are occasions when these tests are financed and carried out by the drug manufacturer's laboratories, which is clearly a conflict of interest.
When problems and harmful side effects develop in relation to an approved drug, the FDA can issue a recall. Recalls can be either voluntary or mandatory. If it is voluntary, the drug manufacturer decides to remove it from the market on its own. In mandatory recalls, the FDA orders a drug to be removed.
When a drug has the potential to cause serious or possibly fatal side effects, the FDA will issue a black box warning. It will appear either on the drug's label or in the literature accompanying the product. This is the most severe warning the FDA can issue for a drug.
Pharmaceutical drugs have contributed to more than 1,000 deaths since 1993. Some of the most serious drug recalls include:
* Fen-phen - More than six million Americans took this diet drug in the 1990's. Approximately 30% of women taking it developed heart valve abnormalities.
* Heparin - Heparin sodium is used as a blood thinner for patients who need heart surgery or kidney dialysis. Many patients who received large doses of the drug exhibited side effects including nausea, sweating, oral swelling, vomiting, and shortness of breath.
* Accutane - Accutane is an acne medication that was very successful in severe cases that did not respond well to other treatments. However, the drug can cause liver damage, birth defects, suicidal tendencies, and irritable bowel syndrome.
The Food and Drug Administration (FDA) is responsible for guaranteeing that drugs released on the market are safe for consumption. The process to receive FDA approval for a new drug is rigorous and can take a long time. In spite of this, it is still difficult to ascertain the long-term effects of a particular drug.
Furthermore, there are occasions when these tests are financed and carried out by the drug manufacturer's laboratories, which is clearly a conflict of interest.
When problems and harmful side effects develop in relation to an approved drug, the FDA can issue a recall. Recalls can be either voluntary or mandatory. If it is voluntary, the drug manufacturer decides to remove it from the market on its own. In mandatory recalls, the FDA orders a drug to be removed.
When a drug has the potential to cause serious or possibly fatal side effects, the FDA will issue a black box warning. It will appear either on the drug's label or in the literature accompanying the product. This is the most severe warning the FDA can issue for a drug.
Pharmaceutical drugs have contributed to more than 1,000 deaths since 1993. Some of the most serious drug recalls include:
* Fen-phen - More than six million Americans took this diet drug in the 1990's. Approximately 30% of women taking it developed heart valve abnormalities.
* Heparin - Heparin sodium is used as a blood thinner for patients who need heart surgery or kidney dialysis. Many patients who received large doses of the drug exhibited side effects including nausea, sweating, oral swelling, vomiting, and shortness of breath.
* Accutane - Accutane is an acne medication that was very successful in severe cases that did not respond well to other treatments. However, the drug can cause liver damage, birth defects, suicidal tendencies, and irritable bowel syndrome.
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