A thiazolidinedione - treats Diabetes Mellitus Type II
FDA Alerts
CHF
Thiazolidinediones, including rosiglitazone, cause or exacerbate CHF in some patients. Monitor patients for signs and symptoms of CHF (e.g., dyspnea, rapid weight gain, edema) after initiation of therapy and dosage titration. If signs and symptoms of CHF develop, manage disorder according to current standards of care; in addition, consider discontinuance or reduction in dosage of rosiglitazone.
Not recommended in patients with symptomatic CHF (NYHA class I or II).
Initiation of rosiglitazone in patients with NYHA class III or IV CHF contraindicated. (See Heart Failure and Other Cardiac Effects under Cautions.)
Myocardial Ischemia
Potential risk for myocardial ischemia (e.g., angina, MI); available data on such risk inconclusive. Findings from a meta-analysis of short-term clinical trials (6 months; 42 clinical trials, majority placebo-controlled) indicate the risk of myocardial ischemia is increased in patients receiving rosiglitazone. Data from 3 large long-term clinical trials that compared rosiglitazone with placebo or active comparators did not confirm or exclude this risk.
You may be more likely to have hyperglycemia (high blood sugar) if you are taking
rosiglitazone with other drugs that raise blood sugar. Drugs that can raise blood sugar include:
isoniazid;
diuretics (water pills);
steroids (prednisone and others);
phenothiazines (Compazine and others);
thyroid medicine (Synthroid and others);
birth control pills and other hormones;
seizure medicines (Dilantin and others); and
diet pills or medicines to treat asthma, colds or allergies.
You may be more likely to have hypoglycemia (low blood sugar) if
you are taking rosiglitazone with other drugs that lower blood sugar. Drugs that can lower blood
sugar include:
nonsteroidal anti-inflammatory drugs (NSAIDs);
aspirin or other salicylates (including Pepto-Bismol);
sulfa drugs (Bactrim and others);
a monoamine oxidase inhibitor (MAOI);
beta-blockers (Tenormin and others); or
probenecid (Benemid).
Some medications may interact with rosiglitazone. Tell your doctor if
you are using any of the following drugs:
gemfibrozil (Gemcor); or
rifampin (Rifater, Rifadin, Rimactane).
This list is not a complete and there may be other drugs that can
interact with rosiglitazone. Tell your doctor about all the prescription and over-the-counter
medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by
other doctors. Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using rosiglitazone and call your doctor at once if you have any of these serious
side effects:
feeling short of breath, even with mild exertion;
swelling or rapid weight gain;
chest pain or heavy feeling, pain spreading to the arm or
shoulder, sweating, general ill feeling;
nausea, stomach pain, low fever, loss of appetite, dark
urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
blurred vision;
increased thirst or hunger, urinating more than usual; or
pale skin, easy bruising or bleeding, weakness.
Less serious side effects may include:
sneezing, runny nose, cough or other signs of a cold;
headache;
gradual weight gain;
mild diarrhea; or
back pain.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect.
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