Avandia Side Effects
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REVIEW
Avandia (Rosiglitazone) is generally well tolerated with the incidence of adverse effects similar to placebo. Upper respiratory tract infections, injury, headache, back pain and hypoglycemia were reported slightly more frequently than placebo in clinical trials.
Avandia has been studied thoroughly in clinical trials, with many people having been evaluated. In these studies, the avandia side effects occurring in a group of people taking the avandia drug were documented and then compared to side effects that occurred in a similar group of people not taking the medicine. This way, it was possible to see what kind of avandia side effects occurred, how common they were, and how they compared to the group not taking the medicine.
Based on these studies, the most common avandia side effects included:
General avandia side effects:
Check with your doctor if any of these most COMMON avandia side effects persist or become bothersome when using Avandia:
Upper respiratory infections (similar to the common cold) -- in up to 9.9 percent of people
Broken bones in women (especially in the arm, hand, or foot) -- up to 9.3 percent of women
Injury -- up to 7.6 percent
Headache -- up to 5.6 percent
Swelling or water weight gain (edema) -- up to 4.8 percent (see Avandia and Weight Gain)
Back pain -- up to 4 percent
Anemia -- up to 1.9 percent.
Seek medical attention right away if any of these SEVERE side effects occur when using Avandia:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; fainting; numbness of an arm or leg; severe headache, stomach pain, or vomiting; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, or feet); symptoms of liver problems (eg, dark urine; yellowing of the skin or eyes; unexplained nausea, vomiting, or loss of appetite; stomach pain); symptoms of low blood sugar (eg, anxiety, increased sweating, dizziness or drowsiness, headache, chills, tremors, increased hunger); unusual bone pain; unusual tiredness or weakness.
Cardiovascular avandia side effects:
Healthy volunteers receiving avandia (rosiglitazone) 8 mg once daily for 8 weeks experienced a statistically significant increase in median plasma volume compared to placebo. Patients with ongoing edema are more likely to have adverse events associated with edema if started on combination therapy with insulin and avandia (rosiglitazone).
Dose-related weight gain was seen with avandia (rosiglitazone) alone and in combination with other hypoglycemic agents. The mechanism is unclear but probably involves a combination of fluid retention and fat accumulation.
In a 26-week study, edema was reported with higher frequency in the avandia (rosiglitazone) plus insulin combination trials (insulin, 5.4%; and avandia (rosiglitazone) with insulin 14.7%). Reports of new onset or exacerbation of congestive heart failure occurred at a rate of 1% for insulin alone, and 2% (4 mg) and 3% (8 mg) for insulin in combination with avandia (rosiglitazone).
In postmarketing experience, there have been rare reports of usually rapid increases in weight. Patients should be assessed for fluid accumulation and volume-related events such as edema and congestive heart failure.
Cardiovascular Avandia side effects have included mild to moderate edema. Patients with congestive heart failure have experienced new or worsening edema. Hypertension has also been reported.
According to a new Avandia Study from the journal Endocrine Practice, "In patients who received combination therapy, and who had laboratory values in both pre- and post-discontinuation periods, significant increases were observed in both fasting blood glucose and A1c."
For many patients that stopped taking the diabetes drug Avandia because of concerns about the drug's safety overall received less treatment and developed higher blood glucose levels, U.S. researchers report.
The first study and overall analysis of scientific evidence released in 2007 found avandia side effects is the increased risk of cardiovascular disease and heart attack, which led many doctors and patients to discontinue use of the drug.
Of the diabetes patients in this new study, 89 percent were using combination therapy before discontinuing use of Avandia Drug. After discontinuation, 33 percent of patients were on combination therapy. Another 13 percent of patients weren't prescribed any diabetes medications.
This study reaffirms that patients who discontinue use of Avandia and another thiazolidinedione (TZD) called pioglitazone (Actos) are at increased risk for higher fasting blood glucose and hemoglobin A1c levels, which may increase their cardiovascular risk, cardiologists Dr. Stuart Zarich of Yale Medical School and Dr. Richard Nesto of the Lahey Clinic, wrote in an accompanying journal editorial.
Hematologic avandia side effects:
These changes may be related to the increased plasma volume observed during treatment with Avandia (rosiglitazone) and have
not been associated with any significant hematologic clinical effects.
Hematologic Avandia side effects have included decreases in hemoglobin and hematocrit. White blood cell counts also decreased
slightly.
Hepatic avandia side effects:
Hepatic Avandia side effects have included postmarketing reports of hepatitis and of hepatic enzyme elevations to three or
more time the upper limit of normal. Very rarely, reports have involved hepatic failure with and without fatal outcome.
Avandia (Rosiglitazone) is structurally related to troglitazone, a thiazolidinedione no longer marketed in the United States,
which was associated with idiosyncratic hepatotoxicity and rare cases of liver failure, liver transplants, and death during
clinical use. It is recommended that liver enzymes be checked in all patients prior to the initiation of therapy and every
two months for the first twelve months and periodically thereafter.
Metabolic avandia side effects:
Metabolic avandia side effects have included increases in total cholesterol, LDL, and HDL and decreases in free fatty acids.
These changes were statistically significantly different from placebo or glyburide controls. Dose related weight gain has
been reported in patients treated with avandia (rosiglitazone) alone and in combination with other hypoglycemic agents.
Endocrine avandia side effects:
Endocrine avandia side effects have included the resumption of ovulation in premenopausal, anovulatory women with insulin
resistance. These patients may be at risk for pregnancy if adequate contraception is not used.
Hypersensitivity avandia side effects:
Hypersensitivity avandia side effects have included rare postmarketing reports of urticaria and angioedema. Postmarketing
experience has included rare reports of anaphylactic reactions.
Ocular avandia side effects:
Ocular avandia side effects have included rare postmarketing reports of new onset or worsening (diabetic) macular edema with
decreased visual acuity. In some cases, symptoms improved following discontinuation of avandia (rosiglitazone). Physicians
should consider the possibility of macular edema if a patient reports decreased visual acuity.
Dermatologic avandia side effects:
Dermatologic avandia side effects have included angioedema and urticaria. Rash, pruritus, and Stevens-Johnson syndrome have
been reported rarely postmarketing.
Respiratory avandia side effects:
Respiratory avandia side effects have included new or worsening dyspnea in patients with congestive heat failure.
Musculoskeletal avandia side effects:
Musculoskeletal avandia side effects have included arthralgia and fractures of the upper arm, hand and foot in women.
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