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
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