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Avandamet Side Effects Lawsuit
Avandamet Side Effects Lawsuit
Avandamet, comprising rosiglitazone and metformin, is a commonly prescribed drug for Type 2 diabetes patients. Approved in 1999, Avandamet works by reducing the amount of sugar produced by the liver, thus making the body more sensitive to the naturally produced insulin. However, avandamet is often linked to heart attacks, primarily because of the presence of Avandia or rosiglitazone. Manufacturer GlaxoSmithKline faces numerous lawsuits, linking the drug to severe side effects.
FDA and Avandamet
In 2010, the Federal Drug Administration first reported the possible risk of cardiovascular events on patients using rosiglitazone and thus restricted its use, allowing only those individuals to continue using the drug who do not respond to other diabetes medications.
Earlier, in 2005, the FDA seized the current Avandamet stock, thus removing the drug from the market, after its inspection team reported violation of good manufacturing norms at a GlaxoSmithKline factory. The FDA inspection team found that some Avandamet tablets had lower than the average dose of rosiglitazone, which might have resulted in poor quality drug products, causing health complications for some patients. Following this, GlaxoSmithKline only recalled some of the affected lots of Avandamet. This prompted the FDA to interfere, whichalong with the Department of Justice seized the drugs, alleging that manufacturing practices for Avandamet did not meet the set standards, which are necessary to ensure product safety, quality, and purity.
Elderly people, people with low levels of haemoglobin should not use the drug without consulting a doctor.
Patients suffering from decreased kidney or liver function, kidney failure, alcoholism, dehydration, heart failure, acute coronary syndrome, severe breathing problems, diabetic pe-coma, and diabetic ketoacidosis should avoid using the drug.
Pregnant women and lactating mothers should consult their doctor before taking the drug. The safety of the drug for pregnant women, their foetuses, or infants has not been established yet.
Children and adolescents should avoid the use of the drug.
People suffering from allergic reactions to any of the Avandamet ingredients or those with heart problems should not use the drug with consulting their physician.
Patients requiring a certain type of X-ray involving an injection with iodinated dye are advised to temporarily discontinue taking this medicine.
Avandamet Adverse Events
In October 2010, Avandamet was withdrawn in the UK following reports from the European Medicines Agency linking rosiglitazone to an increased risk of heart problems. Reports suggest that rosiglitazone might cause fluid retention, which is the cause of heart failure. The medicine poses a risk of ovulation for women who have stopped ovulating.
Cardiovascular Side Effects
Mild to moderate edema is one of the common cardiovascular side effects of Avandamet, especially in patients with congestive heart failure. This is also reported to have caused more cardiovascular deaths, more worsening dyspnea, more myocardial infarctions, and more CHF worsening, requiring cardiovascular hospitalization. Studies indicate that patients with ongoing edema, undergoing insulin and rosiglitazone therapy, are more vulnerable to adverse events linked with edema.
Gastrointestinal Side Effects
Vomiting, anorexia, diarrhea, flatulence, nausea, vomiting, feeling of illness, fatigue, dizziness, metallic taste, dyspepsia, and abdominal pain are some of the gastrointestinal side effects related to Avandamet.
Respiratory Side Effects
A number of reports link Avandamet to upper respiratory tract infection. Some heart patients also experience new or worsening dyspnea on using the drug. Avandamet is also linked to rapid or weak breathing.
Other Avandamet Side Effects
Some common side effects of the drug include loss of appetite, myocardial infarction, myocardial ischaemia, coronary artery disease, cardiac failure, cardiovascular disorder, atrial fibrillation, cardiac arrest, hypotension, dyspnoea, diarrhoea, acute renal failure, chest pain, oedema peripheral, dizziness, lactic acidosis, renal failure, hypertension, hypoglycaemia, haemodialysis, oedema, asthenia, malaise, acute myocardial infarction, fluid retention, anaemia, depression, arrhythmia, upper abdominal pain, anxiety, loss of consciousness, blurred vision, among others.
The drug poses a risk of heart failure if used in combination with insulin.
There is an increased risk of fluid retention in patients taking the drug along with non-steroidal anti-inflammatory drugs.
There is a high risk of hypoglycaemia, fluid retention, and heart failure if the drug is used in triple therapy.
The drug poses a higher risk of hypoglycaemia and lactic acidosis if the patient uses Avandamet while continuing consumption of alcohol. While taking this medicine, alcohol consumption can lower blood sugar and poses a risk of lactic acidosis.
Rosiglitazone might become less effective at lowering blood sugar if used in combination with rifampicin, Phenobarbital, carbamazepine, phenytoin.
Serious adverse events have been reported in patients receiving thiazolidinedione therapy, including pulmonary edema, congestive heart failure, and pleural effusions.
Avandamet is reported to cause reduction of serum vitamin B12 below normal levels.
Avandamet used with drugs that raise blood sugar, including steroids, diuretics, seizure drugs, heart or blood pressure medication, niacin, phenothiazines, thyroid medicine, birth control pills, diet pills, asthma, cold or allergy drugs, poses the risk of hyperglycemia.
Metformin, one of the ingredients in Avandamet, poses the risk of lactic acidosis, a serious condition causing accumulation of an acid in the blood, which can cause death.
Rosiglitazone can cause weight gain as a result of extra body fat or fluid retention. Metformin can cause weight loss.