Avandia: Side effects, dosage, alternatives, and more (original) (raw)

**Avandia not currently being sold

According to its manufacturer (Woodward Pharma Services), Avandia is not currently being sold. It’s not known if Avandia will be made available again. If you have questions about an Avandia prescription you may have, talk with your doctor.

Avandia is a brand-name prescription drug. It’s FDA-approved, along with diet and exercise, to treat type 2 diabetes in adults.

If you have type 2 diabetes, your body doesn’t respond to insulin the way it should. This causes high blood sugar, which can damage your eyes, kidneys, nerves, and other organs.

Avandia works by increasing your body’s ability to respond to the insulin it naturally makes. This can lower your blood sugar.

Avandia comes as a tablet that’s taken by mouth. It’s available in two strengths: 2 mg and 4 mg.

Avandia contains the active drug rosiglitazone, which belongs to a class of drugs called thiazolidinediones.

Effectiveness

For information on Avandia’s effectiveness, see the “Avandia uses” section below.

Avandia is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics also tend to cost less than brand-name drugs.

Avandia contains the active drug rosiglitazone.

Avandia can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Avandia. These lists don’t include all possible side effects.

For more information on the possible side effects of Avandia, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Avandia, you can do so through MedWatch.

Mild side effects

Mild side effects of Avandia can include:*

Most of these side effects may go away within a few days or a couple of weeks. But if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects from Avandia. To learn about other mild side effects, talk with your doctor or pharmacist, or view Avandia’s package instructions.

Serious side effects

Serious side effects from Avandia aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

Other serious side effects are explained below in “Side effect details.” These include:

* Avandia has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warning” at the beginning of this article.

Side effect details

You may wonder how often certain side effects occur with this drug_._ Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Avandia.

Allergic reactions to Avandia weren’t reported in clinical studies. However, mild and severe allergic reactions have been reported since the drug came on the market in 1999. It’s not clear how often allergic reactions occur.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

Call your doctor right away if you have a severe allergic reaction to Avandia. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Heart failure

Avandia may cause severe edema (fluid buildup in your body). This can cause or worsen congestive heart failure. If you already have heart failure, treatment with Avandia can raise your risk of making it worse.

In clinical studies of people with existing heart failure:

In the same studies:

People who took Avandia with insulin had a higher risk of developing congestive heart failure than those who took insulin alone. Taking Avandia with insulin is not recommended.

Symptoms of congestive heart failure can include:

Call your doctor right away if you have any of these symptoms, as this could be a sign of new or worsening heart failure.

Heart attack

In some people, Avandia may raise risk of heart attack. In a review that examined 52 clinical studies:

Avandia’s effects on the heart were further studied in a clinical trial. The results showed no difference in how often heart attacks occurred in people who took Avandia and in people who took other diabetes medications.

Symptoms of a heart attack can include:

If you experience any of these symptoms, call 911 or go to the nearest emergency room right away.

Weight gain

Avandia may cause weight gain. This is likely a combination of edema (fluid buildup in the body) and increased fat storage.

A clinical study followed people for 4 to 6 years while they took either Avandia, glyburide (DiaBeta, Glynase), or metformin (Glucophage).

In the study:

Talk with your doctor if you’re concerned about weight gain while taking Avandia. They can recommend ways to help avoid gaining weight.

If you gain weight rapidly while taking Avandia, call your doctor right away. This may be a sign of edema, which can lead to dangerous conditions like congestive heart failure.

The Avandia dosage your doctor prescribes will depend on several factors. These include:

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Avandia comes as a tablet that you take by mouth. It’s available in two strengths: 2 mg and 4 mg.

Dosage for type 2 diabetes

The recommended starting dose of Avandia is 4 mg. This may be taken either once a day or divided into two doses a day (2 mg each). If you respond well to Avandia, your doctor may increase your dose to 8 mg a day.

What if I miss a dose?

If you miss a dose of Avandia, take it as soon as you remember. However, if it’s almost time for your next dose, just skip the missed dose and take your next dose at its regular time. Never take a double dose to make up for a missed dose. This could raise your risk for side effects.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Avandia is meant to be used as a long-term treatment. If you and your doctor determine that Avandia is safe and effective for you, you’ll likely take it long term.

The Food and Drug Administration (FDA) approves prescription drugs such as Avandia to treat certain conditions. Avandia may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Avandia for type 2 diabetes

Avandia is FDA-approved, along with diet and exercise, to treat type 2 diabetes in adults.

With type 2 diabetes, your body doesn’t respond to insulin the way it should. This causes high blood sugar, which can damage your eyes, kidneys, nerves, and other organs.

Avandia works by increasing your body’s ability to respond to the insulin it naturally makes, which can lower your blood sugar.

Effectiveness for type 2 diabetes

In clinical studies, Avandia has been tested on its own and when used with other diabetes medications such metformin (Glucophage). Its use with a sulfonylurea drug like glimepiride (Amaryl) or glipizide (Glucotrol) has also been researched. Each of the studies lasted 26 weeks.

Effectiveness for lowering fasting blood sugar

The clinical studies looked at how Avandia and other treatments affected fasting blood sugar. (This is your blood sugar level after you haven’t eaten for at least 8 hours.)

When Avandia was used alone or with other drugs:

In comparison, when other treatments were taken without Avandia:

Effectiveness for lowering HbA1c

The clinical studies also looked at each treatment’s effect on people’s hemoglobin A1c (HbA1c). (This is measured by a lab test that gives an average blood sugar over the last 3 months.)

When Avandia was used alone or with other drugs:

In comparison, when other treatments were taken without Avandia:

Off-label use for Avandia

In addition to the use listed above, Avandia may be used off-label. Off-label drug use is when a drug that’s approved for one use is used for a different one that’s not approved.

Avandia for PCOS

Avandia isn’t FDA-approved to treat polycystic ovary syndrome (PCOS). However, it’s sometimes used with metformin off-label to control some of the symptoms of PCOS. This drug combination been shown to improve hormone balance in women with PCOS.

Women with PCOS have higher levels of certain hormones that are associated with excessive hair growth, irregular periods, obesity, and cysts in the ovaries. Often, women with PCOS also have some level of insulin resistance. This means their bodies can’t use insulin properly. (Insulin is a hormone that’s naturally produced by the pancreas in response to blood sugar levels.)

Avandia works by increasing your body’s ability to respond to the insulin it naturally makes. Talk with your doctor if you have PCOS and are interested in treatment options for insulin resistance.

Avandia and children

Avandia isn’t approved for use in children. It’s not known if this drug is safe or effective for use in children.

You may need to take other drugs while taking Avandia. This will depend on your doctor’s recommendation and how well your type 2 diabetes is managed.

The most common drug that is given with Avandia is metformin (Glucophage). Other drugs that can be taken with Avandia include:

Other drugs are available that can treat type 2 diabetes. Some may be a better fit for you than others. If you’re interested in finding an alternative to Avandia, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed below are used off-label to treat type 2 diabetes. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Examples of other drugs that may be used to treat type 2 diabetes include:

You may wonder how Avandia compares with other medications that are prescribed for similar uses. Here we look at how Avandia and Actos are alike and different.

Ingredients

Avandia contains the active drug rosiglitazone. Actos contains the active drug pioglitazone. Both drugs belong to a class of medications called thiazolidinediones.

Uses

Both Actos and Avandia are used to help control blood sugar in adults with type 2 diabetes.

Drug forms and administration

Avandia comes as a tablet that’s taken by mouth either once or twice a day. Actos comes as a tablet that’s taken by mouth once a day.

Side effects and risks

Avandia and Actos have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain examples of mild side effects that can occur with Avandia, with Actos, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Avandia, with Actos, or with both drugs (when taken individually).

* Both Avandia and Actos have a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warning” at the beginning of this article.

Effectiveness

Both Actos and Avandia are FDA-approved to improve blood sugar in adults with type 2 diabetes.

These drugs haven’t been directly compared in clinical studies. However, studies have found both Avandia and Actos to be effective for treating type 2 diabetes.

Costs

Avandia and Actos are both brand-name drugs. There is currently a generic version of Actos available called pioglitazone. There is no generic version of Avandia available at this time. Brand-name medications usually cost more than generics.

Avandia is significantly less expensive than Actos. However, pioglitazone (the generic form of Actos) is much less expensive than either brand-name drug.

The actual price you’ll pay for any of these drugs depends on your insurance plan, your location, and the pharmacy you use.

You may wonder how Avandia compares with other medications that are prescribed for similar uses. Here we look at how Avandia and metformin are alike and different.

Ingredients

Avandia contains the active drug rosiglitazone, which belongs to a class of medications called thiazolidinediones.

Metformin is the generic version of a drug called Glucophage. Metformin belongs to a class of drugs called biguanides.

Uses

Both Avandia and metformin are used to help manage blood sugar levels in people with type 2 diabetes. Avandia is FDA-approved for use in adults only. Metformin is FDA-approved for use in adults and in children ages 10 or older.

Drug forms and administration

Avandia and metformin both come as tablets that are taken by mouth either once or twice a day.

Side effects and risks

Avandia and metformin have some similar side effects and others that vary. Below are examples of these side effects.

Mild side effects

These lists contain examples of mild side effects that can occur with Avandia, with metformin, or with both drugs (when taken individually).

Serious side effects

These lists contain examples of serious side effects that can occur with Avandia, with metformin, or with both drugs (when taken individually).

* Avandia has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For more information, see “FDA warnings” at the beginning of this article.

Effectiveness

These drugs haven’t been directly compared in clinical studies. However, studies have found both Avandia and metformin to be effective for treating type 2 diabetes.

Costs

Avandia is a brand name drug, while metformin is a generic. Brand-name medications usually cost more than generics.

Avandia generally costs much more than metformin. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

There are no known interactions between Avandia and alcohol. However, both Avandia and alcohol may have negative effects on your liver, which may lead to liver damage.

If you drink alcohol, talk with your doctor about whether it’s safe to drink while taking Avandia.

Avandia can interact with several other medications.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Avandia and other medications

Below is a list of medications that can interact with Avandia. This list doesn’t contain all drugs that may interact with Avandia.

Before taking Avandia, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Avandia and insulin

Taking Avandia with insulin is not recommended because it can raise your risk for severe water retention and congestive heart failure. It can also increase your risk for severe low blood sugar.

Examples of insulins include:

Avandia and drugs that affect the CYP2C8 enzyme

You should avoid taking Avandia with certain drugs that either inhibit (slow down) or induce (speed up) an enzyme called CYP2C8.

CYP2C8 inhibitors

Drugs that slow down the CYP2C8 enzyme may increase the level of Avandia in your body. This could raise your risk for certain side effects.

Examples of drugs that slow down the CYP2C8 enzyme include:

If you need to take one of these drugs with Avandia, your doctor may need to adjust your dose of Avandia or the other drug. Talk with your doctor about any drugs you take before starting Avandia.

CYP2C8 inducers

Drugs that speed up the CYP2C8 enzyme may decrease the level of Avandia in your body. This could make Avandia less effective.

Examples of drugs that can speed up the CYP2C8 enzyme include:

If you need to take one of these drugs with Avandia, your doctor may need to adjust your dose of Avandia or the other drug. Talk with your doctor about any drugs you take before starting Avandia.

Avandia and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Avandia. However, you should still check with your doctor or pharmacist before using any of these products while taking Avandia.

Avandia and foods

There aren’t any foods that have been specifically reported to interact with Avandia. If you have any questions about eating certain foods with Avandia, talk with your doctor.

Avandia is FDA-approved, along with diet and exercise, to treat type 2 diabetes in adults. With type 2 diabetes, your body doesn’t respond to insulin the way it should. (Insulin is a hormone that’s naturally produced by the pancreas in response to blood sugar levels.)

If your body can’t respond to insulin properly, you may get high blood sugar. This can lead to damage in your eyes, kidneys, nerves, and other organs.

Type 2 diabetes can be caused by a combination of factors. These may include diet, lifestyle, genetics, and insulin sensitivity (your body’s ability to respond to insulin).

What Avandia does

Avandia increases your body’s ability to respond to the insulin it naturally makes. This helps lower your blood sugar. Avandia works by signaling to your cells to make more insulin receptors (docking stations). This allows for insulin molecules to attach to your cells and tell the cells to take in glucose (sugar) from your blood.

When insulin molecules attach to your cells, less sugar is left in the bloodstream. This means your blood sugar levels are lower.

How long does it take to work?

Avandia will start to lower your blood sugar within a few days after you take your first dose, although it can take up to 2 weeks before you notice an effect. However, it may take a few months to see changes in your HbA1c levels.

Here are answers to some frequently asked questions about Avandia.

Is Avandia linked to bladder cancer?

It’s not known whether Avandia is linked to a higher risk of bladder cancer. Actos, another drug in the same class of medications as Avandia, has been linked to bladder cancer in rats. However, a large study conducted over 10 years showed there was no increased risk of bladder cancer in people who took Actos.

One study looked at the risk of bladder cancer in people who took either Avandia or Actos. The results showed that there may be some link between taking Avandia and the development of bladder cancer.

Talk with your doctor if you have a personal or family history of bladder cancer and are concerned about taking Avandia.

Can I take Avandia if I have type 1 diabetes?

No, Avandia isn’t FDA-approved to treat type 1 diabetes. It’s not known if it’s safe or effective for use in people with this condition.

Avandia is only FDA-approved to treat type 2 diabetes.

Can I take insulin with Avandia?

No, taking insulin with Avandia isn’t recommended. Taking them together can raise your risk for severe edema (fluid buildup in your body) and congestive heart failure. (For information about Avandia’s boxed warning for congestive heart failure, see the “FDA warning: Congestive heart failure” section at the beginning of this article.)

Taking insulin and Avandia together can also increase your risk for severe low blood sugar.

Examples of insulins include:

If you currently take insulin and are interested in taking Avandia, talk with your doctor about your treatment options.

If I’m over the age of 65 years, is it safe for me to take Avandia?

Your age shouldn’t affect whether Avandia is right for you to take. In clinical studies, there were no differences in the safety or effectiveness of Avandia in people 65 years or older when compared to those under age 65.

Talk with your doctor if you have concerns about whether Avandia is safe for you to take.

Will Avandia make me pee more than usual?

No, Avandia won’t make you pee more than usual. Certain other drugs used to treat type 2 diabetes lower your blood sugar by having your kidneys filter the sugar out. This causes you to pee more than usual. However, this isn’t how Avandia works.

Avandia increases your body’s ability to respond to the insulin it naturally makes, which helps lower your blood sugar.

Talk with your doctor if you have questions about how Avandia works in your body.

It’s not known whether Avandia is safe to use during pregnancy. The use of this drug hasn’t been studied in pregnant women.

In studies with pregnant rats and rabbits who were given Avandia, there were no negative side effects seen in the fetuses or the mothers. However, animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor before using Avandia.

It’s unknown whether Avandia is safe to take while pregnant.

Avandia may cause ovulation in some women who didn’t previously ovulate. This can greatly increase the chances of getting pregnant.

If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Avandia.

For more information about taking Avandia during pregnancy, see the “Avandia and pregnancy” section above.

Avandia and oral contraceptives

Avandia doesn’t interact with oral contraceptives (birth control pills). You can continue to take birth control pills during your Avandia treatment.

Talk with your doctor if you have questions about taking birth control during your Avandia treatment.

It’s not known whether Avandia is safe to use while breastfeeding. It hasn’t been studied in women who were breastfeeding.

In studies with lactating rats, Avandia was found in the mother’s milk. However, animal studies don’t always predict what will happen in humans.

If you’re currently breastfeeding, talk with your doctor about the best way to feed your child while taking Avandia.

As with all medications, the cost of Avandia can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Avandia. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Avandia, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Avandia, help is available.

GlaxoSmithKlein, the manufacturer of Avandia, offers a program called GSKForYou. This program offers financial support for people without insurance coverage for Avandia. For more information about this program and to find out if you’re eligible for support, visit the program website.

For information on other programs that may help lower the cost of Avandia, visit the Medicine Assistant Tool’s website.

You should take Avandia according to your doctor’s or healthcare provider’s instructions.

When to take

If you take Avandia once a day, you can take it at any time of the day. If you take Avandia twice a day, try to take it as close to 12 hours apart as possible.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Taking Avandia with food

You can take Avandia with or without food.

Can Avandia be crushed, split, or chewed?

It’s not known whether crushing or splitting Avandia affects the way the drug works.

If you have trouble swallowing Avandia tablets, talk with your doctor or pharmacist. They can suggest ways to make it easier for you to take your medication.

This drug comes with several precautions.

FDA warning: Congestive heart failure

This drug has a boxed warning. This is the most serious warning from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Other precautions

Before taking Avandia, talk with your doctor about your health history. Avandia may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Note: For more information about the potential negative effects of Avandia, see the “Avandia side effects” section above.

Using more than the recommended dosage of Avandia can lead to serious side effects. Do not use more Avandia than your doctor recommends.

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Avandia from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Avandia tablets should be stored at room temperature (77°F/25°C) in a tightly sealed container away from light. The drug can also be temporarily stored at 59°F to 86°F (15°C to 30°C) for a short period of time, such as if you’re traveling. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Avandia and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.

The following information is provided for clinicians and other healthcare professionals.

Indications

Avandia is indicated to improve glycemic control in adults with type 2 diabetes mellitus as a part of a healthy lifestyle regimen that includes proper diet and exercise.

Mechanism of action

Avandia contains the active drug rosiglitazone, which is a thiazolidinedione. Rosiglitazone is a selective and potent agonist for peroxisome proliferator-activated receptor-gamma (PPARg), which is found in adipose tissue, skeletal muscle, and the liver. PPARg plays a key role in upregulation of cellular insulin receptors. Upregulation of cellular insulin receptors results in reduced plasma glucose levels.

Pharmacokinetics and metabolism

Peak concentrations of Avandia are seen 1 hour after oral administration. It’s approximately 99.8% bound to plasma proteins (primarily albumin). Avandia is metabolized by via N-demethylation and hydroxylation. CYP2C8 is the predominant enzyme involved. It’s excreted primarily in the urine (64%) and feces (23%). The elimination half-life is approximately 3 to 4 hours.

Contraindications

Avandia is contraindicated in patients with New York Heart Association (NYHA) Class III or IV congestive heart failure. It is also contraindicated in patients who have a history of hypersensitivity to Avandia (rosiglitazone) or any of its excipient ingredients.

Storage

Avandia tablets should be stored at room temperature (77°F/25°C) in a tightly sealed, light-resistant container. Excursions are permitted at 59°F to 86°F (15°C to 30°C).

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.