In December 2007, the US Food and Drug Administration (FDA) announced that it had requested manufacturers of desmopressin acetate to update prescribing information to include information concerning the risk for developing severe hyponatremia, which can result in seizures and death. Desmopressin nasal spray (acetate intranasal formulation) is no longer indicated for treatment of bed-wetting (primary nocturnal enuresis).
The FDA advisory was issued based on a review of 61 postmarketing cases of hyponatremia-related seizures associated with the use of desmopressin. In two of the cases, the patients experienced hyponatremia that led to seizures and death.
Hyponatremia is an electrolyte disturbance characterized by a low sodium concentration in blood plasma. At these low sodium levels, overhydration (water intoxication), an urgently dangerous condition, may result.
Desmopressin tablets may still be used to treat primary nocturnal enuresis (PNE). But according to MedWatch, the FDA's safety information and adverse event reporting program, the therapy should be discontinued during acute illness that can lead to electrolyte and/or fluid imbalance. Fluid intake should also be restricted one hour prior to eight hours after dose administration. All formulations of desmopressin should be used cautiously in patients at risk for hyponatremia. These risk factors include events or conditions that increase water consumption, such as:
* Fever
* Dry mouth (as may occur when other medications are taken concurrently)
* Recurrent diarrhea/vomiting
* Vigorous exercise
* Hot weather
* Psychogenic or habitual polydipsia (drinking abnormally large amounts of fluid)
* Use of tricyclic antidepressants or SSRIs
Friday, May 8, 2009
Cytotec Attorney
Cytotec, made by Searle (now part of Pfizer), was approved in March 1999 by the U.S. Food and Drug Administration (FDA) for the prevention of gastric ulcers induced by non-steroidal anti-inflammatory drugs (NSAID). It is also used off-label, however, to induce labor and to end pregnancies prematurely.
Cytotec works by stimulating increased secretion of the mucus that lines the gastrointestinal tract and increasing mucosal blood flow. The lining of mucus helps protect against the gastric ulceration that results as a common side effect of NSAIDs. Misoprostol also promotes uterine contractions and cervical ripening (softening of the cervix and undertaking of chemical changes which allow it to dilate for the delivery of a fetus).
Its relatively low cost makes it appealing to induce labor. But in August 2000, Searle sent an open letter to physicians reminding them that Cytotec is not approved by the FDA for this purpose. And then in May 2005, the FDA itself issued an alert warning that there were serious potential side effects when misoprostol was used to induce labor or to decrease blood loss after the delivery of a baby.
One of the side effects the FDA alert identifies is a torn uterus (or womb), which can lead to severe bleeding, a hysterectomy (removal of the uterus), and/or death of the mother or baby. It also points out that the side effects are more likely in women who had multiple previous births, a previous C-section (Cesarean delivery), or previous uterine surgery.
Other risks of using the drug to induce labor include hyperstimulation syndrome, tachysystole, and hypersystole, all of which are abnormal and potentially dangerous labor contractions.
Even when used in treatments for which Cytotec is approved, common side effects include:
* Diarrhea
* Abdominal pain
* Nausea
* Flatulence (excess gas)
* Headache
* Dyspepsia (heartburn)
* Vomiting
* Constipation
Cytotec works by stimulating increased secretion of the mucus that lines the gastrointestinal tract and increasing mucosal blood flow. The lining of mucus helps protect against the gastric ulceration that results as a common side effect of NSAIDs. Misoprostol also promotes uterine contractions and cervical ripening (softening of the cervix and undertaking of chemical changes which allow it to dilate for the delivery of a fetus).
Its relatively low cost makes it appealing to induce labor. But in August 2000, Searle sent an open letter to physicians reminding them that Cytotec is not approved by the FDA for this purpose. And then in May 2005, the FDA itself issued an alert warning that there were serious potential side effects when misoprostol was used to induce labor or to decrease blood loss after the delivery of a baby.
One of the side effects the FDA alert identifies is a torn uterus (or womb), which can lead to severe bleeding, a hysterectomy (removal of the uterus), and/or death of the mother or baby. It also points out that the side effects are more likely in women who had multiple previous births, a previous C-section (Cesarean delivery), or previous uterine surgery.
Other risks of using the drug to induce labor include hyperstimulation syndrome, tachysystole, and hypersystole, all of which are abnormal and potentially dangerous labor contractions.
Even when used in treatments for which Cytotec is approved, common side effects include:
* Diarrhea
* Abdominal pain
* Nausea
* Flatulence (excess gas)
* Headache
* Dyspepsia (heartburn)
* Vomiting
* Constipation
Crestor Lawyers
Crestor (rosuvastatin) is manufactured and marketed by AstraZeneca and received United States Food and Drug Administration (FDA) approval in 2003. It is included in the class of drugs known as statins, which are used to lower cholesterol levels in people at risk for or with cardiovascular disease.
The original FDA approval of Crestor had been delayed for a year when in May 2002, the FDA expressed a concern of potential kidney and muscle complications. All statins are associated with rhabdomyolysis, a deadly muscle disorder, and massive kidney failure. In fact another statin, Baycol, was withdrawn from the market by Bayer in 2001.
Those with advanced age, hypothyroidism (under-active thyroid), and kidney disease are likelier to experience rhabdomyolysis, which occurs when a massive amount of muscle protein is released into the bloodstream after a large number of skeletal muscle cells die. The muscle protein becomes trapped in the kidneys and affects their filtering process, which leads them to fail. Potassium released from the damaged muscle cells can also cause malignant heart rhythms and cardiac arrest.
It has turned out that those using Crestor have reported a much higher incidence of kidney problems than for all other statins combined. Some argue that Crestor should never have been introduced in the US market because while Baycol’s side effects appeared only after its approval, Crestor’s had appeared during trials.
Potential side effects of Crestor include:
* Musculoskeletal symptoms – muscle pain, stiffness, joint pain
* Kidney damage
* Rhabdomyolysis - symptoms include muscle pain, tenderness, weakness, dark urine, malaise, fever, nausea, and vomiting
* Liver damage – symptoms include jaundice, abdominal pain, nausea, dark urine, and clay-colored stools
* Malignant heart rhythms and cardiac arrest
* Sexual dysfunction and performance problems
* Memory loss
* Personality changes
* Irritability
The original FDA approval of Crestor had been delayed for a year when in May 2002, the FDA expressed a concern of potential kidney and muscle complications. All statins are associated with rhabdomyolysis, a deadly muscle disorder, and massive kidney failure. In fact another statin, Baycol, was withdrawn from the market by Bayer in 2001.
Those with advanced age, hypothyroidism (under-active thyroid), and kidney disease are likelier to experience rhabdomyolysis, which occurs when a massive amount of muscle protein is released into the bloodstream after a large number of skeletal muscle cells die. The muscle protein becomes trapped in the kidneys and affects their filtering process, which leads them to fail. Potassium released from the damaged muscle cells can also cause malignant heart rhythms and cardiac arrest.
It has turned out that those using Crestor have reported a much higher incidence of kidney problems than for all other statins combined. Some argue that Crestor should never have been introduced in the US market because while Baycol’s side effects appeared only after its approval, Crestor’s had appeared during trials.
Potential side effects of Crestor include:
* Musculoskeletal symptoms – muscle pain, stiffness, joint pain
* Kidney damage
* Rhabdomyolysis - symptoms include muscle pain, tenderness, weakness, dark urine, malaise, fever, nausea, and vomiting
* Liver damage – symptoms include jaundice, abdominal pain, nausea, dark urine, and clay-colored stools
* Malignant heart rhythms and cardiac arrest
* Sexual dysfunction and performance problems
* Memory loss
* Personality changes
* Irritability
Contaminated Heparin Lawyers
Contaminated Heparin in Association with Medical Devices- In an investigation following a February 2008 recall of heparin sodium for injection, the Food and Drug Administration (FDA) identified a previously unknown contaminant in the blood-thinning drug. In a follow-up July 2008 advisory, the FDA revealed that contaminated heparin had also been found in association with certain medical devices, some of which had also been recalled. The FDA is continuing to investigate the situation.
Heparin is an anticoagulant (blood thinner) that makes an anti-clotting protein in the body work better, and is usually given before certain types of surgery to prevent and treat blood clots in arteries, veins, and the lungs. Certain medical devices and diagnostic products contain, are coated with, and/or are manufactured using heparin. Some of the devices that may be affected by the heparin contamination include:
* Heparin solutions in pre-filled syringes and lock flush solutions in vials
* Certain filters, oxygenators, cannulae, and reservoirs used in cardiopulmonary bypass procedures
* Certain vascular access, retransfusion, drainage and thermodilution catheters and oximetry probes
* Certain vascular grafts and stents
* Some assisted reproduction media devices
* Certain In-Vitro Diagnostic media (IVDs) and related devices
Heparin is an anticoagulant (blood thinner) that makes an anti-clotting protein in the body work better, and is usually given before certain types of surgery to prevent and treat blood clots in arteries, veins, and the lungs. Certain medical devices and diagnostic products contain, are coated with, and/or are manufactured using heparin. Some of the devices that may be affected by the heparin contamination include:
* Heparin solutions in pre-filled syringes and lock flush solutions in vials
* Certain filters, oxygenators, cannulae, and reservoirs used in cardiopulmonary bypass procedures
* Certain vascular access, retransfusion, drainage and thermodilution catheters and oximetry probes
* Certain vascular grafts and stents
* Some assisted reproduction media devices
* Certain In-Vitro Diagnostic media (IVDs) and related devices
Cipro Attorney
Ciprofloxacin (Cipro, Ciproxin and Ciprobay) is a synthetic antibiotic in the broad-spectrum family of antibiotics known as fluoroquinolones. Made and sold by Bayer A.G., ciprofloxacin is available for oral, topical and parenteral (other than through the gastrointestinal tract) use.
Ciprofloxacin is used to treat a host of infections, including:
* E. coli
* Urinary tract infections
* Pneumonia
* Lower respiratory infections
* Several sexually transmitted diseases
* Prostatitis (inflammation of the prostate gland)
* Septicemia (blood poisoning)
Its perceived safety and efficacy against a wide range of bacteria made Cipro initially popular as go-to antibiotic when other antibiotics failed (for many reasons, narrower range antibiotics tend to be tried first). But not only has its use led to an increase in ciprofloxacin-resistant infections, other serious adverse effects have also become evident.
Although there is a myriad of ciprofloxacin side effects, most are mild or moderate. The most frequent include nausea, diarrhea, abnormal liver function test results, vomiting, and rash. But although not as frequent, some side effects are serious enough for the FDA to have changed the package insert for Cipro in 2005. The insert acknowledges the potential for tendon ruptures and the development of irreversible neurological conditions.
Symptoms of potential tendon rupture include sudden and severe pain, swelling and bruising, and difficulty moving a limb. Symptoms indicating potential neurological conditions include:
* Abnormal gait
* Anorexia
* Ataxia
* Convulsive seizures
* Depersonalization
* Depression
* Dizziness
* Drowsiness
* Grand Mal convulsions
* Hallucinations
* Insomnia
* Irritability
* Lethargy
* Lightheadedness
* Malaise Manic reaction
* Nightmares
* Paresthesia
* Phobia
* Restlessness
* Tremor
* Weakness
Ciprofloxacin is used to treat a host of infections, including:
* E. coli
* Urinary tract infections
* Pneumonia
* Lower respiratory infections
* Several sexually transmitted diseases
* Prostatitis (inflammation of the prostate gland)
* Septicemia (blood poisoning)
Its perceived safety and efficacy against a wide range of bacteria made Cipro initially popular as go-to antibiotic when other antibiotics failed (for many reasons, narrower range antibiotics tend to be tried first). But not only has its use led to an increase in ciprofloxacin-resistant infections, other serious adverse effects have also become evident.
Although there is a myriad of ciprofloxacin side effects, most are mild or moderate. The most frequent include nausea, diarrhea, abnormal liver function test results, vomiting, and rash. But although not as frequent, some side effects are serious enough for the FDA to have changed the package insert for Cipro in 2005. The insert acknowledges the potential for tendon ruptures and the development of irreversible neurological conditions.
Symptoms of potential tendon rupture include sudden and severe pain, swelling and bruising, and difficulty moving a limb. Symptoms indicating potential neurological conditions include:
* Abnormal gait
* Anorexia
* Ataxia
* Convulsive seizures
* Depersonalization
* Depression
* Dizziness
* Drowsiness
* Grand Mal convulsions
* Hallucinations
* Insomnia
* Irritability
* Lethargy
* Lightheadedness
* Malaise Manic reaction
* Nightmares
* Paresthesia
* Phobia
* Restlessness
* Tremor
* Weakness
Chantix Attorney
Chantix, which is made and distributed by pharmaceutical giant Pfizer, was approved by the US Food and Drug Administration (FDA) in May, 2006 for use as an aid to quit smoking. The drug, which is intended to be used together with behavior modification therapy, showed early promise. Some reports suggested a 44 percent success rate after three months, and a 22 percent success rate after one year versus that of 16 percent for Wellbutrin.
This was welcome news considering that according to the Office of the Surgeon General, smoking harms nearly every organ in the body, not to mention the adverse affects of second hand smoke on non-smokers. Smokers are also finding it increasingly difficult to find places in which they may smoke.
But, the jubilation was tempered soon thereafter by reports of potentially serious side effects. While side effects at first appeared relatively minor, more reports of serious psychological ramifications began surfacing. The suspicion that some users of Chantix were having unique reactions to the drug gained national attention after the death of Dallas musician Carter Albrecht. He apparently experienced a psychotic episode with intense hallucinations after having had a few drinks while on Chantix.
If you are considering taking Chantix, you should first consult with your physician. You should obviously not take it if you are allergic to anything in it. But you should also let your physician know if you have had kidney problems, get kidney dialyses, are pregnant, are trying to get pregnant, are breast feeding or if you are taking any prescription or non-prescription medications, vitamins, or herbal supplements. This is particularly the case if you take asthma medications, insulin, or any kind of blood thinner.
You should also contact a physician if you or a loved one is currently taking Chantix, especially if you are experiencing any of its potential side effects, which include:
* Fatigue
* Dizziness
* Nausea
* Vomiting
* Stomach pain
* Acid reflux
* Constipation
* Gas
* Changes in dreaming
* Chronic feelings of depression
* Chronic feelings of extreme anxiety
* Suicidal thoughts
* Acts of abuse
This was welcome news considering that according to the Office of the Surgeon General, smoking harms nearly every organ in the body, not to mention the adverse affects of second hand smoke on non-smokers. Smokers are also finding it increasingly difficult to find places in which they may smoke.
But, the jubilation was tempered soon thereafter by reports of potentially serious side effects. While side effects at first appeared relatively minor, more reports of serious psychological ramifications began surfacing. The suspicion that some users of Chantix were having unique reactions to the drug gained national attention after the death of Dallas musician Carter Albrecht. He apparently experienced a psychotic episode with intense hallucinations after having had a few drinks while on Chantix.
If you are considering taking Chantix, you should first consult with your physician. You should obviously not take it if you are allergic to anything in it. But you should also let your physician know if you have had kidney problems, get kidney dialyses, are pregnant, are trying to get pregnant, are breast feeding or if you are taking any prescription or non-prescription medications, vitamins, or herbal supplements. This is particularly the case if you take asthma medications, insulin, or any kind of blood thinner.
You should also contact a physician if you or a loved one is currently taking Chantix, especially if you are experiencing any of its potential side effects, which include:
* Fatigue
* Dizziness
* Nausea
* Vomiting
* Stomach pain
* Acid reflux
* Constipation
* Gas
* Changes in dreaming
* Chronic feelings of depression
* Chronic feelings of extreme anxiety
* Suicidal thoughts
* Acts of abuse
CellCept Lawyer
CellCept (mycophenolate mofetil), a drug manufactured by the Swiss company Roche Holding AG, is used to prevent organ rejection in kidney, heart, and liver transplant patients. It has also been shown to help keep the new organ healthy when prescribed after the transplant. Some doctors have prescribed it to lupus patients with a low tolerance for chemotherapy. Since its approval by the U.S. Food and Drug Administration (FDA) in 1995, more than 450,000 patients have been treated with CellCept.
After a review in 2007 of data collected since its approval, however, the FDA identified a risk of birth defects associated with the use of CellCept. Adverse outcomes were voluntarily reported, so it is difficult to determine how common CellCept pregnancy problems are. But with 14 out of 77 pregnant women treated with the drug reporting a deformity in their fetus or newborn, and 25 of the 77 reporting a miscarriage, the FDA opted to issue a black box warning on the drug's labeling.
The boxed warning states that there is an "increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and abnormalities of the distal limbs, heart, esophagus, and kidney."
In addition to the black box warning, an FDA MedWatch alert to renal, cardiac, and hepatic transplantation specialists as well as to obstetricians, gynecologists and other healthcare professionals was issued, and then updated on November 27, 2007. It announced that CellCept's pregnancy category had been changed from a "C" (risk of fetal harm cannot be ruled out) to a "D" (positive evidence of fetal risk) and recommended that women of "childbearing potential" should have a negative urine or serum pregnancy test within a week of beginning any CellCept therapy.
The alert further advises that patients and healthcare professionals should be aware that CellCept might reduce the effectiveness of the oral contraceptive pill, and that women of childbearing potential taking CellCept should get contraceptive counseling and use effective birth control.
After a review in 2007 of data collected since its approval, however, the FDA identified a risk of birth defects associated with the use of CellCept. Adverse outcomes were voluntarily reported, so it is difficult to determine how common CellCept pregnancy problems are. But with 14 out of 77 pregnant women treated with the drug reporting a deformity in their fetus or newborn, and 25 of the 77 reporting a miscarriage, the FDA opted to issue a black box warning on the drug's labeling.
The boxed warning states that there is an "increased risk of first trimester pregnancy loss and increased risk of congenital malformations, especially external ear and facial abnormalities including cleft lip and palate, and abnormalities of the distal limbs, heart, esophagus, and kidney."
In addition to the black box warning, an FDA MedWatch alert to renal, cardiac, and hepatic transplantation specialists as well as to obstetricians, gynecologists and other healthcare professionals was issued, and then updated on November 27, 2007. It announced that CellCept's pregnancy category had been changed from a "C" (risk of fetal harm cannot be ruled out) to a "D" (positive evidence of fetal risk) and recommended that women of "childbearing potential" should have a negative urine or serum pregnancy test within a week of beginning any CellCept therapy.
The alert further advises that patients and healthcare professionals should be aware that CellCept might reduce the effectiveness of the oral contraceptive pill, and that women of childbearing potential taking CellCept should get contraceptive counseling and use effective birth control.
Cardizem Attorney - Diltiazem Hydrochloride Lawyer
Dilatiazem is a popular calcium-channel blocker that works by relaxing blood vessels to reduce stress on the heart and increase its blood and oxygen supply. It is marketed under brand names including Cardizem, Tiazac, Cartia, Tiamate, Tildiem, Adizem, Viazem and Dilatam.
It is used to control hypertension (high blood pressure) and angina pectoris (chest pain), to treat some types of arrhythmia (irregular heart beat) and Raynaud's syndrome (sudden decreased blood circulation in fingers and toes), and for other "off label" uses to treat a variety of conditions.
But, although it controls hypertension and some types of angina, diltiazem does not cure these conditions. And, once chest pain starts, diltiazem cannot stop it, so a second medication is sometimes prescribed for this eventuality.
Studies have found that diltiazem can inhibit the motility of sperm, and it is thought that it raises the cholesterol level in sperm, making sperm less able to bind to an egg. Diatiazem is being used in vas irrigation for vasectomies and has even been considered as a male contraceptive. But while infertility induced by diatiazem is thought to be reversible, some cases of permanent male infertility have been reported.
Other side effects of diatiazem for which you should call your doctor if they persist include:
* Constipation
* Diarrhea
* Dry mouth
* Excessive tiredness
* Flushing or feeling of warmth
* Headache
* Lightheadedness or dizziness
* Loss of appetite
* Slower heartbeat
* Stomach pain
* Upset stomach
* Vomiting
Side effects of diatiazem for which you should call your doctor immediately include:
* Difficulty swallowing or breathing
* Fainting
* Fever
* Increase in severity or frequency of chest pain
* Rash
* Swelling of the face, eyes, lips, tongue, arms, or legs
* Yellowing of the eyes or skin
It is used to control hypertension (high blood pressure) and angina pectoris (chest pain), to treat some types of arrhythmia (irregular heart beat) and Raynaud's syndrome (sudden decreased blood circulation in fingers and toes), and for other "off label" uses to treat a variety of conditions.
But, although it controls hypertension and some types of angina, diltiazem does not cure these conditions. And, once chest pain starts, diltiazem cannot stop it, so a second medication is sometimes prescribed for this eventuality.
Studies have found that diltiazem can inhibit the motility of sperm, and it is thought that it raises the cholesterol level in sperm, making sperm less able to bind to an egg. Diatiazem is being used in vas irrigation for vasectomies and has even been considered as a male contraceptive. But while infertility induced by diatiazem is thought to be reversible, some cases of permanent male infertility have been reported.
Other side effects of diatiazem for which you should call your doctor if they persist include:
* Constipation
* Diarrhea
* Dry mouth
* Excessive tiredness
* Flushing or feeling of warmth
* Headache
* Lightheadedness or dizziness
* Loss of appetite
* Slower heartbeat
* Stomach pain
* Upset stomach
* Vomiting
Side effects of diatiazem for which you should call your doctor immediately include:
* Difficulty swallowing or breathing
* Fainting
* Fever
* Increase in severity or frequency of chest pain
* Rash
* Swelling of the face, eyes, lips, tongue, arms, or legs
* Yellowing of the eyes or skin
Campath (Alemtuzumab) Lawyer
Alemtuzumab, which is marketed as Campath, Campath-1H, and MabCampath, is used to treat chronic lymphocytic leukemia (CLL) (also known as chronic lymphoid leukemia) and T-cell lymphoma. CLL is a cancer of the white blood cells (or lymphocytes). T-cell lymphoma is a disease in which T-cells in the lymphoid system become malignant.
The U.S. Food and Drug Administration (FDA) originally approved Alemtuzumab in 2001 under accelerated approval rules for second-line treatment for B-cell chronic lymphocytic leukemia (B-CLL). In September 2007, it received regular approval after further studies. Alemtuzumab, however, although sometimes used to treat Multiple Sclerosis (MS), was not approved for this purpose.
In November 2005, the FDA issued an alert warning that in a clinical study in which Campath was used to treat MS, three patients had developed severe idiopathic thrombocytopenic purpura (ITP), a bleeding disorder caused by an abnormally low level of platelets in the blood. One of the patients died.
ITP, however, is only one in a number of potential side effects. The more common adverse reactions of Campath include:
* Pyrexia (fever)
* Chills
* Hypotension (low blood pressure)
* Urticaria (hives)
* Nausea
* Rash
* Tachycardia (rapid heart rate)
* Dyspnea (shortness of breath)
* Neutropenia (abnormally low number of a type of white blood cells called neutrophils)
* Lymphopenia (abnormally low number of lymphocytes)
* Thrombocytopenia (abnormally low number of blood platelets)
* Anemia (abnormally low number of red blood cells or abnormally low quantity of hemoglobin in the blood)
* CMV viremia (passage of the cytomegalovirus into the blood)
* CMV infection (infection by the cytomegalovirus)
* Other infections
* Emesis (vomiting)
* Abdominal pain
* Insomnia (loss of sleep)
* Anxiety
The U.S. Food and Drug Administration (FDA) originally approved Alemtuzumab in 2001 under accelerated approval rules for second-line treatment for B-cell chronic lymphocytic leukemia (B-CLL). In September 2007, it received regular approval after further studies. Alemtuzumab, however, although sometimes used to treat Multiple Sclerosis (MS), was not approved for this purpose.
In November 2005, the FDA issued an alert warning that in a clinical study in which Campath was used to treat MS, three patients had developed severe idiopathic thrombocytopenic purpura (ITP), a bleeding disorder caused by an abnormally low level of platelets in the blood. One of the patients died.
ITP, however, is only one in a number of potential side effects. The more common adverse reactions of Campath include:
* Pyrexia (fever)
* Chills
* Hypotension (low blood pressure)
* Urticaria (hives)
* Nausea
* Rash
* Tachycardia (rapid heart rate)
* Dyspnea (shortness of breath)
* Neutropenia (abnormally low number of a type of white blood cells called neutrophils)
* Lymphopenia (abnormally low number of lymphocytes)
* Thrombocytopenia (abnormally low number of blood platelets)
* Anemia (abnormally low number of red blood cells or abnormally low quantity of hemoglobin in the blood)
* CMV viremia (passage of the cytomegalovirus into the blood)
* CMV infection (infection by the cytomegalovirus)
* Other infections
* Emesis (vomiting)
* Abdominal pain
* Insomnia (loss of sleep)
* Anxiety
Avonex (Interferon beta-1A) Attorney
Interferon beta-1a (trade name Avonex, Rebif, or CinnoVex) is used to treat relapsing forms of multiple sclerosis (MS). It is genetically engineered to simulate a naturally occurring protein produced by mammalian cells. In February 2003, the US Food and Drug Administration (FDA) approved Avonex, which is made by Biogen Incorporated, for early treatment of the disease. It has been on the market since 1996, however, and over 130,000 patients have used it.
MS is a chronic disorder that affects movement, sensation, and bodily functions. Although it occurs when the protective sheath (myelin) surrounding nerve fibers (neurons) is destroyed, its cause is unknown. It is nevertheless considered an autoimmune disease of the central nervous system.
About 30 percent of MS patients experience a relapsing-remitting form of the disease. In these cases, symptoms disappear or lessen for months or even years between flare-ups.
Interferon-based medications have been shown to reduce relapses by about 30-35 percent and to slow the progression of MS's resulting disabilities. It is believed that these beneficial effects are due to the medications' anti-inflamatory properties and ability to improve the integrity of the blood-brain barrier (BBB).
Unfortunately interferons, as these medications are known, also have side effects. The principal ones are flu-like symptoms and injection-site reactions, but they may also include:
* Elevation of liver enzymes
* Blood cell abnormalities
* Headache
* Fever
* Fatigue
* Chills
* Vomiting
* Nausea
* Depression
MS is a chronic disorder that affects movement, sensation, and bodily functions. Although it occurs when the protective sheath (myelin) surrounding nerve fibers (neurons) is destroyed, its cause is unknown. It is nevertheless considered an autoimmune disease of the central nervous system.
About 30 percent of MS patients experience a relapsing-remitting form of the disease. In these cases, symptoms disappear or lessen for months or even years between flare-ups.
Interferon-based medications have been shown to reduce relapses by about 30-35 percent and to slow the progression of MS's resulting disabilities. It is believed that these beneficial effects are due to the medications' anti-inflamatory properties and ability to improve the integrity of the blood-brain barrier (BBB).
Unfortunately interferons, as these medications are known, also have side effects. The principal ones are flu-like symptoms and injection-site reactions, but they may also include:
* Elevation of liver enzymes
* Blood cell abnormalities
* Headache
* Fever
* Fatigue
* Chills
* Vomiting
* Nausea
* Depression
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