Cequa is a brand-name prescription medication. It’s FDA-approved to help adults with dry eye produce more tears. The medical name for dry eye is keratoconjunctivitis sicca.

Dry eye can affect one or both eyes. If you have this condition, you may experience other symptoms besides dry eyes. They include burning, redness or itching of the eyes, and sensitivity to light.

The active drug in Cequa is cyclosporine, which belongs to a group of medications called calcineurin inhibitor immunosuppressants.

Cequa comes in eyedrop form as a liquid solution in single-use vials. Cequa is available in one strength of 0.09%, and you’ll likely use the medication twice per day.

Effectiveness

For information about the effectiveness of Cequa, see the “Cequa for dry eyes” section below.

Cequa 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 usually cost less than brand-name drugs.

Cequa contains the active drug cyclosporine in a strength of 0.09%. Cyclosporine is also available in a strength of 0.05% as the brand-name drug Restasis.

In addition, cyclosporine comes in oral and injectable forms, but the FDA has not approved them to treat dry eye.

As with all medications, the cost of Cequa can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Before approving coverage for Cequa, your insurance company may require you to get prior authorization. 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 unsure if you’ll need to get prior authorization for Cequa, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Cequa or need help understanding your insurance coverage, help is available.

Sun Pharmaceutical Industries, Inc., the manufacturer of Cequa, offers a program called Cequa Support Pharmacy. For more information and to find out if you’re eligible, call 833-44-Cequa (833-442-3782) or visit the program website.

Generic version

Cequa 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 usually cost less than brand-name drugs.

Cequa contains the active drug cyclosporine in a strength of 0.09%. Cyclosporine is also available in strength of 0.05% as the brand-name drug Restasis.

In addition, cyclosporine comes in oral and injectable forms, but they’re not approved to treat dry eye.

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

Ingredients

The active drug ingredient in both Cequa and Restasis is cyclosporine.

Cequa comes as a liquid solution in a strength of 0.09%. Restasis comes as an emulsion (an oily liquid mixture) in a strength of 0.05%.

Both Cequa and Restasis belong to a class of drugs called calcineurin inhibitor immunosuppressants. (A class of drugs is a group of medications that work in a similar way.)

Uses

The Food and Drug Administration (FDA) has approved Cequa and Restasis to help people with dry eye produce more tears. The medical name for dry eye is keratoconjunctivitis sicca.

Cequa is approved for use in adults, while Restasis is approved for use in adults and children ages 16 years and older.

Drug forms and administration

Both Cequa and Restasis are given as eye drops.

Cequa comes in a single-use vial.

Restasis comes in two forms. One is a single-use vial. The other form is called Restasis MultiDose, and it contains several doses of the medication.

Both Cequa and Restasis are typically taken twice per day.

Side effects and risks

Cequa and Restasis both contain the drug cyclosporine, but they have different concentrations of the drug. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, as well as mild side effects that both drugs may share.

  • Can occur with Cequa:
    • headache
    • inflammation of the conjunctiva (the clear tissue that covers your eye)
  • Can occur with Restasis:
    • discharge from the eye
    • eye pain
    • feeling like something is in your eye
    • itching or stinging of the eye
  • Can occur with both Cequa and Restasis:
    • burning feeling in the eye
    • eye irritation

Serious side effects

These lists contain examples of serious side effects that can occur with Cequa or Restasis, as well as serious side effects that both drugs may share.

Effectiveness

The only condition both Cequa and Restasis are used for is to treat is dry eye.

These drugs haven’t been directly compared in clinical studies, but studies have found both Cequa and Restasis to be effective for treating dry eye.

Costs

Cequa generally costs less than Restasis. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Cequa and Restasis are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

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

For more information about the possible side effects of Cequa, 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 the side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Cequa, you can do so through MedWatch.

Mild side effects

Mild side effects of Cequa can include:*

  • burning feeling in the eye†
  • eye irritation
  • headache†
  • inflammation of the eyelid†
  • inflammation of the conjunctiva (the clear tissue that covers your eye)†

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 Cequa. To learn about other mild side effects, talk with your doctor or pharmacist, or see Cequa’s prescribing information.
† For more information on these side effects, see “Side effect details” below.

Serious side effects

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

Serious side effects can include:

* For more information on these side effects, see “Side effect details” below.

Side effect details

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

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Cequa. However, it’s not known how many people experienced this side effect in Cequa clinical trials.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth, swelling, or redness in your skin)

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

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Cequa, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Burning

Burning in the eye, especially when putting in Cequa eye drops, is the most common side effect that occurred with the drug. The medical term is instillation site pain.

In clinical studies of Cequa, burning in the eye occurred in 22% of people who used the drug. Cequa wasn’t compared with a different medication or a placebo (treatment with no active drug).

If you experience a burning feeling in your eye when using Cequa, talk with your doctor. They may be able to suggest ways to help ease this side effect or recommend a different medication for dry eye.

Conjunctiva inflammation

Inflammation of the conjunctiva is a possible side effect of Cequa use. The conjunctiva is the thin, clear tissue that covers your eye. With conjunctiva inflammation, you may have redness, irritation, or even swelling of your eye. Conjunctiva inflammation is also known as conjunctival hyperemia.

In clinical trials, 6% of people who used Cequa reported conjunctiva inflammation as a side effect. Cequa wasn’t compared with a different medication or a placebo.

If you notice redness, irritation, or swelling of your eye while you’re using Cequa, talk with your doctor. They may be able to suggest ways to help relieve this side effect or recommend a different medication for dry eye.

Eyelid inflammation

Blepharitis (eyelid inflammation) may occur with Cequa use. Inflammation refers to swelling and redness. Your eyelids may also be itchy when you have eyelid inflammation.

In clinical trials of Cequa, eyelid inflammation occurred in between 1% and 5% of people who used the drug. Cequa wasn’t compared with a different medication or a placebo.

If your eyelid becomes swollen or uncomfortable while using Cequa, talk with your doctor. They may be able to suggest ways to help ease this side effect or recommend a different medication for dry eye.

Headache

Headache is a side effect that occurred in people who used Cequa in clinical trials. Although headache isn’t a common side effect of the drug, it did occur in between 1% and 5% of people who took Cequa. Cequa wasn’t compared with a different medication or a placebo.

If you develop headaches when using Cequa, talk with your doctor. They can help determine what’s causing the headaches. Your doctor may also be able to recommend ways to help ease your discomfort. If your headaches don’t go away or if they’re severe, your doctor may recommend a different medication for dry eye.

Urinary tract infection

Some people using Cequa eye drops developed urinary tract infections (UTIs) in clinical trials of the drug. Between 1% and 5% of people who used Cequa reported UTIs. Cequa wasn’t compared with a different medication or a placebo.

UTIs may cause burning while urinating or an urge to urinate more often than usual. You may also have blood in your urine if you have a UTI.

If you develop symptoms of a UTI during your Cequa treatment, tell your doctor. UTIs need to be treated with antibiotics, so they don’t spread to your kidneys. The doctor will see if Cequa or a different condition is causing your symptoms. If the UTI is due to Cequa, they may recommend a different medication for dry eye.

The Food and Drug Administration (FDA) approves prescription drugs such as Cequa to treat certain conditions.

Cequa is FDA-approved to help adults with dry eye produce more tears. The medical name for dry eye is keratoconjunctivitis sicca.

Dry eye can affect one or both eyes. If you have this condition, you may experience other symptoms besides dry eyes. They include burning, redness or itching of the eyes, and sensitivity to light.

Dry eye can occur if your eyes don’t produce enough tears. The condition can also occur if your eye makes tears, but they don’t work properly.

Tears are made up of many parts, such as water, oil, and mucus. If your tears don’t have the correct levels of any of these parts, your tears may not keep your eye lubricated. This means that you may produce the proper amount of tears, but they don’t work well enough to keep your eye moist. This can be what causes symptoms of dry eye.

Dry eye can be a chronic (long-term) condition, which means you may need to keep treating it over a long period.

Cequa increases the amount of tears that your eye produces. This helps prevent your eye from becoming dry. It also helps decrease how often dry eye symptoms occur and how severe they are.

Effectiveness for dry eye

In clinical trials, Cequa was an effective treatment to ease the symptoms of dry eye. To see if the drug was working, researchers measured how many tears the eye produced.

The results showed that over a 3-month period, there was a significant increase in tear production in between:

  • 16.6% and 16.8% of people who used Cequa
  • 8.6% and 9.2% of people who used a placebo, which was an eye drop with no active drug in it

Cequa and children

Cequa isn’t approved for use in children. The drug hasn’t been studied in children, so it’s not known Cequa is safe or effective for that group.

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

  • the type and severity of the condition you’re using Cequa to treat
  • other medical conditions you may have

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

Cequa comes in eyedrop form as a liquid solution in single-use vials. Cequa is available in one strength: 0.09%.

Dosage for dry eye

The usual dosage of Cequa to treat dry eye is one drop into each affected eye twice per day. It’s best to separate the doses by 12 hours.

Be sure to discard your used Cequa vial after taking your dose. You shouldn’t reuse a Cequa vial, even if there’s some medication left. This is because the drug doesn’t contain any preservatives to help keep Cequa fresh. If you reuse a vial, it could become contaminated with bacteria, causing an infection in your eye.

Dosage questions

Here are some questions you may have about taking Cequa.

What if I miss a dose?

If you miss a dose of Cequa, talk with your doctor or pharmacist about when to take your next dose. Depending on how long it’s been since your missed dose, they may recommend:

  • taking your dose of Cequa as soon as possible
  • skipping your missed dose and taking your next dose as scheduled

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

Will I need to use this drug long term?

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

The drug Xiidra has uses similar to those of Cequa. Here’s a comparison of how Cequa and Xiidra are alike and different.

Ingredients

The active drug ingredient in Cequa is cyclosporine, which belongs to a class of drugs called calcineurin inhibitor immunosuppressants. (A class of drugs is a group of medications that work in a similar way.)

The active drug in Xiidra is lifitegrast, which belongs to a class of drugs called lymphocyte function-associated antigen-1 antagonists.

Uses

The Food and Drug Administration (FDA) has approved both Cequa and Xiidra to help people with dry eye produce more tears. The medical name for dry eye is keratoconjunctivitis sicca.

Cequa is approved for use in adults, while Xiidra is approved for use in adults and children ages 17 years and older.

Drug forms and administration

Both Cequa and Xiidra are given as eye drops and come in single-use vials. Both drugs are typically taken twice per day.

Side effects and risks

Cequa and Xiidra both treat dry eye. Therefore, these medications can cause very similar side effects, but some different ones as well. Below are examples of these side effects.

Mild side effects

These lists contain up to 10 of the most common mild side effects that can occur with each drug, as well as mild side effects that both drugs may share.

  • Can occur with Cequa:
  • Can occur with Xiidra:
    • blurry vision
    • eye discharge
    • eye discomfort or itching
  • Can occur with both Cequa and Xiidra:
    • burning feeling in the eye
    • inflammation of the conjunctiva (the clear tissue that covers your eye)
    • eye irritation
    • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Cequa or Xiidra, as well as serious side effects that both drugs may share.

Effectiveness

The only condition both Cequa and Xiidra are used to treat is dry eye.

These drugs haven’t been directly compared in clinical studies, but studies have found both Cequa and Xiidra to be effective for treating dry eye.

Costs

Cequa generally costs less than Xiidra. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Cequa and Xiidra are both brand-name drugs. There are currently no generic forms of either drug. Brand-name medications usually cost more than generics.

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

Alternatives for dry eye

Examples of other drugs that may be used to treat dry eye include:

  • cyclosporine 0.05% (Restasis)
  • lifitegrast (Xiidra)
  • artificial tears (Systane, Refresh, TheraTears)
  • hydroxypropyl cellulose (Lacrisert)

The Food and Drug Administration (FDA) has approved Cequa to help adults with dry eye produce more tears. The medical name for dry eye is keratoconjunctivitis sicca.

Dry eye can affect one or both eyes. If you have this condition, you may experience other symptoms besides dry eyes. They include burning, redness or itching of the eyes, and sensitivity to light.

Dry eye can occur if your eyes don’t produce enough tears. The condition can also occur if your eye makes tears, but they don’t work properly.

Tears are made up of many parts, such as water, oil, and mucus. If your tears don’t have the correct levels of any of these parts, your tears may not keep your eye lubricated. This means that you may produce the proper amount of tears, but they don’t work well enough to keep your eye moist. This can be what causes symptoms of dry eye.

It’s thought that dry eye is caused by inflammation (swelling) in the eye.

What Cequa does

Cequa increases the amount of tears that your eye produces. This helps prevent your eye from becoming dry. It also helps decrease the frequency and severity of dry eye symptoms.

It’s not known exactly how Cequa works to treat dry eye. But it’s thought that the drug decreases the activity of the immune system.

With dry eye, the swelling in your eye may be due to an overactive immune system. When your immune system is less active, there may be less swelling. As a result, your eye may be able to produce more tears, decreasing the symptoms of dry eye.

How long does it take to work?

In people whose dry eye isn’t severe, symptoms may ease after about 1 month of use. However, some studies show that cyclosporine (the active drug ingredient in Cequa) can take between 4 and 6 months to relieve symptoms.

Cequa may take time to treat dry eye. This is why you must keep taking Cequa as often as your doctor recommends, even if you don’t see any improvement right away.

There are no known interactions between Cequa and alcohol.

Cequa isn’t known to interact with other medications, herbs, supplements, or foods.

However, be sure to tell your doctor about any other medications you are taking before starting Cequa treatment. 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.

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

Cequa comes in eyedrop form in single-dose vials. You’ll use one vial for each dose.

When taking a dose of Cequa, be sure that the tip of the vial doesn’t touch your eye or any other surfaces. The tip can become contaminated if it does come into contact with your eye or other surfaces. This makes it easier for bacteria to enter your eye. You can also injure your eye if you touch it with the vial tip.

Be sure to discard your used Cequa vial after taking your dose. You shouldn’t reuse a Cequa vial, even if there’s some medication left. This is because the drug doesn’t contain any preservatives to help keep Cequa fresh. If you reuse a vial, it could become contaminated with bacteria, causing an infection in your eye.

When to take

You’ll likely take Cequa twice a day. It’s best to separate your doses by 12 hours.

If you use artificial tears for dry eye, wait 15 minutes before using Cequa. And if you take a Cequa dose, you should wait 15 minutes before using artificial tears.

To help make sure that you don’t miss a dose of Cequa, try using a medication reminder. This can include setting an alarm on your phone or downloading a reminder app. A kitchen timer can work, too.

It’s not known if Cequa is safe to use during pregnancy. There haven’t been any human studies of Cequa use during pregnancy.

In animal studies, animals were given cyclosporine, the active drug in Cequa, by mouth. (Cequa is given in eyedrop form in humans.) Cyclosporine given in doses 1,800 to 6,400 times higher than the maximum recommended dose of Cequa didn’t affect developing offspring.

However, cyclosporine given at 3,200 and 21,000 times the maximum recommended dose of Cequa did affect developing offspring. They had a greater risk of low birth weight, bone formation problems, and an increased risk of death in rare cases. However, animal studies don’t always indicate what will occur in humans taking the drug.

If you’re pregnant or planning to become pregnant, talk with your doctor before taking Cequa. They can advise you about the risks and benefits of the medication.

It’s not known if Cequa is safe to take during pregnancy. 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 Cequa.

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

It’s not known if Cequa is safe to use while breastfeeding. It’s also not known if the drug passes into breast milk.

In animal studies, lactating animals were given cyclosporine, the active drug in Cequa, by mouth. (Cequa is given in eyedrop form in humans.) The offspring did not appear to develop any side effects. However, animal studies don’t always indicate what will occur in humans.

If you’re breastfeeding or planning to breastfeed, talk with your doctor before using Cequa. They can advise you about the risks and benefits of the medication.

Here are answers to some frequently asked questions about Cequa.

Can I wear contacts while using Cequa?

You shouldn’t use Cequa eye drops when you have contact lenses in your eyes because the lenses can absorb the medication. Be sure to take out your contact lenses before using Cequa. Then wait at least 15 minutes before putting your contact lenses back in.

If you have any questions about using Cequa, talk with your doctor or pharmacist.

Will I be able to use other eye drops during my Cequa treatment?

If you’re using any eye drops or eye medications, talk with your doctor before you start taking Cequa. You may have to space the timing of your doses so that all the medications work effectively. If you don’t space out your doses, one medication may wash out the other, and neither eye medication may work.

Cequa can be used along with artificial tears for dry eye. In this case, be sure to separate the timing of Cequa and artificial tear doses by at least 15 minutes.

If you have any questions about the timing of any eye medications, including Cequa, talk with your doctor or pharmacist.

Why does Cequa come in single-use vials instead of a larger bottle?

Cequa comes in single-use vials instead of a larger multi-use bottle because the drug doesn’t contain any preservatives.

Preservatives help keep bacteria from growing in the bottle. If the bacteria enter your eye through an eye drop, they could cause an infection. Larger bottles that contain more than one dose normally have preservatives in them.

Because Cequa doesn’t contain any preservatives, it comes in a single-use vial. Be sure to discard your used Cequa vial after taking your dose. You shouldn’t reuse a Cequa vial, even if there’s some medication left in the vial. Bacteria could form in or on the vial after the first use.

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

  • Contact lenses. If you wear contact lenses, be sure to take them out before using Cequa. Then wait at least 15 minutes before putting your contact lenses back in. This is to help prevent the lenses from absorbing the medication.
  • Allergic reaction. If you’ve had an allergic reaction to Cequa or any of its ingredients, you shouldn’t take Cequa. Ask your doctor what other medications are better options for you.
  • Pregnancy. It is not known if Cequa is safe to use during pregnancy. For more information, see the “Cequa and pregnancy” section above.
  • Breastfeeding. It is not known if Cequa is safe to use while you’re breastfeeding. For more information, see the “Cequa and breastfeeding” section above.

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

Do not use more Cequa than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Cequa

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 your local emergency number, or go to the nearest emergency room right away.

When you get Cequa 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 with 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.

You should store Cequa eye drops at room temperature (68°F to 77°F/20°C to 25°C). Be sure to keep the single-use vials in the foil pouch they come in until you’re ready to use them. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Cequa and have leftover medication, it’s essential 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.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

After taking your dose of Cequa, dispose of the empty individual use vial immediately.

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

Indications

Cequa is indicated to increase the production of tears in patients with keratoconjunctivitis sicca, which is more commonly known as dry eye.

Cequa is a calcineurin inhibitor immunosuppressant, which works to increase the amount of tears produced by the eye.

Administration

Cequa is an ophthalmic solution of cyclosporine 0.09%. It is administered as an eye drop that is given twice daily, ideally spaced by 12 hours apart.

Mechanism of action

It is not known exactly how Cequa works to increase tear production in patients with keratoconjunctivitis sicca. However, it is believed that patients with keratoconjunctivitis sicca have inflammation of the eyes, which then negatively affects tear production. Cequa is believed to work as an immunosuppressant, which decreases the inflammation in the eye. This then leads to an increases in tear production.

Pharmacokinetics and metabolism

Cequa is not widely absorbed, if at all, into the systemic circulation. After twice daily use for 7 to 8 days, blood levels of Cequa were either not detectable or were only slightly detected at a concentration of 0.100 ng/mL. These levels were measured for only up to 2 hours after a dose or 4 hours after multiple doses were administered.

Contraindications

There are no contraindications to the use of Cequa.

Storage

Cequa should be stored at room temperature (68°F to 77°F/20°C to 25°C). The vials should be kept in the foil pouch that they are dispensed in until they are ready to use.

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.