IMPORTANT SAFETY INFORMATION (continued)

BOTOX and BOTOX Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of receiving BOTOX or BOTOX Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Do not receive BOTOX or BOTOX Cosmetic if you are allergic to any of its ingredients (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc^® (rimabotulinumtoxinB), Dysport^® (abobotulinumtoxinA), or Xeomin^® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Do not receive BOTOX for the treatment of urinary incontinence if you have a urinary tract infection (UTI) or cannot empty your bladder on your own and are not routinely catheterizing. Due to the risk of urinary retention (difficulty fully emptying the bladder), only patients who are willing and able to initiate catheterization posttreatment, if required, should be considered for treatment.

Patients treated for overactive bladder: In clinical trials, 36 of the 552 patients had to self-catheterize for urinary retention following treatment with BOTOX compared to 2 of the 542 treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 100 Units (n = 36) was 63 days (minimum 1 day to maximum 214 days), as compared to a median duration of 11 days (minimum 3 days to maximum 18 days) for patients receiving placebo (n = 2). Patients with diabetes mellitus treated with BOTOX were more likely to develop urinary retention than nondiabetics.

Adult patients treated for overactive bladder due to neurologic disease: In clinical trials, 30.6% of adult patients (33/108) who were not using clean intermittent catheterization (CIC) prior to injection required catheterization for urinary retention following treatment with BOTOX 200 Units, as compared to 6.7% of patients (7/104) treated with placebo. The median duration of postinjection catheterization for these patients treated with BOTOX 200 Units (n = 33) was 289 days (minimum 1 day to maximum 530 days), as compared to a median duration of 358 days (minimum 2 days to maximum 379 days) for patients receiving placebo (n = 7).

Among adult patients not using CIC at baseline, those with MS were more likely to require CIC postinjection than those with SCI.

The dose of BOTOX and BOTOX Cosmetic is not the same as, or comparable to, any other botulinum toxin product.

Serious and/or immediate allergic reactions have been reported, including itching; rash; red, itchy welts; wheezing; asthma symptoms; dizziness; or feeling faint. Get medical help right away if you experience symptoms; further injection of BOTOX or BOTOX Cosmetic should be discontinued.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig’s disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects, including difficulty swallowing and difficulty breathing from typical doses of BOTOX or BOTOX Cosmetic.

Tell your doctor if you have any breathing-related problems. Your doctor may monitor you for breathing problems during treatment with BOTOX for spasticity or for detrusor overactivity associated with a neurologic condition. The risk of developing lung disease in patients with reduced lung function is increased in patients receiving BOTOX.

Cornea problems have been reported. Cornea (surface of the eye) problems have been reported in some people receiving BOTOX for their blepharospasm, especially in people with certain nerve disorders. BOTOX may cause the eyelids to blink less, which could lead to the surface of the eye being exposed to air more than is usual. Tell your doctor if you experience any problems with your eyes while receiving BOTOX. Your doctor may treat your eyes with drops, ointments, contact lenses, or with an eye patch.

Bleeding behind the eye has been reported. Bleeding behind the eyeball has been reported in some people receiving BOTOX for their strabismus. Tell your doctor if you notice any new visual problems while receiving BOTOX.

Bronchitis and upper respiratory tract infections (common colds) have been reported. Bronchitis was reported more frequently in adults receiving BOTOX for upper limb spasticity. Upper respiratory infections were also reported more frequently in adults with prior breathing-related problems with spasticity. In pediatric patients treated with BOTOX for upper limb spasticity, upper respiratory tract infections were reported more frequently. In pediatric patients treated with BOTOX for lower limb spasticity, upper respiratory tract infections were not reported more frequently than placebo.

Autonomic dysreflexia in patients treated for overactive bladder due to a neurologic disease. Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in adult patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).

Tell your doctor about all your medical conditions, including if you have or have had bleeding problems; have plans to have surgery; had surgery on your face; have weakness of forehead muscles, trouble raising your eyebrows, drooping eyelids, and any other abnormal facial change; have symptoms of a UTI and are being treated for urinary incontinence (symptoms of a UTI may include pain or burning with urination, frequent urination, or fever); have problems emptying your bladder on your own and are being treated for urinary incontinence; are pregnant or plan to become pregnant (it is not known if BOTOX or BOTOX Cosmetic can harm your unborn baby); are breastfeeding or plan to (it is not known if BOTOX or BOTOX Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX or BOTOX Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX or BOTOX Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc^®, Dysport^®, or Xeomin^® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX and BOTOX Cosmetic include dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; eye problems such as double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes; drooping eyebrows; and upper respiratory tract infection. In adults being treated for urinary incontinence, other side effects include UTI and painful urination. In children being treated for urinary incontinence, other side effects include UTI; bacteria, white blood cells, and blood in the urine. In patients being treated for urinary incontinence, another side effect includes the inability to empty your bladder on your own. If you have difficulty fully emptying your bladder on your own after receiving BOTOX, you may need to use disposable self-catheters to empty your bladder up to a few times each day until your bladder is able to start emptying again.

Botox injections

Botox injections are shots that use a toxin to prevent a muscle from moving for a limited time. These shots are often used to smooth wrinkles on the face. They’re also used to treat neck spasms, sweating, overactive bladder, lazy eye and other conditions. Botox shots also may help prevent migraine.

The medicine in Botox injections is made from the same toxin that causes a type of food poisoning called botulism. But the forms of purified botulinum toxin used by licensed health care providers meet medical control standards. These standards were approved by the U.S. Food and Drug Administration. As a rule, the bacteria toxins used for medical purposes are not harmful if used correctly.

Why it’s done

Botox shots block certain chemical signals from nerves that cause muscles to contract. The most common use of these injections is to relax the facial muscles that cause frown lines and other facial wrinkles.

Botox injections also are used to ease symptoms of some health conditions. It’s not a cure. Examples of medical conditions that might be treated with Botox injections include:

• Neck spasms. In this painful condition, the neck muscles contract in an uncontrolled way. This causes the head to twist or turn into an uncomfortable position. The condition also is called cervical dystonia.
• Other muscle spasms. Cerebral palsy and other conditions of the nervous system can cause the limbs to pull in toward the center of the body. Muscle spasms also can cause eye twitching.
• Lazy eye. The most common cause of lazy eye is an imbalance in the muscles used for moving the eye. Lazy eye also is called crossed eyes or misaligned eyes.
• Sweating. Botox might be used for a condition in which people sweat a lot even when they’re not hot or working up a sweat. It’s called excessive sweating or hyperhidrosis.
• Migraine. Botox injections may help reduce how often you get a migraine. This treatment is used mainly for people who have headaches 15 or more days a month. When you get serious headaches that often, the condition is called chronic migraine. Treatment is needed about every three months to retain the benefit.
• Bladder problems. Botox shots can also help reduce urinary incontinence caused by an overactive bladder.

Risks

Botox injections are usually safe when you’re under the care of a licensed and skilled health care provider. The procedure can result in unwanted results or even cause harm if it’s given incorrectly. Possible side effects and unwanted results include:

• Pain, swelling or bruising at the injection site.
• Headache or flu-like symptoms.
• Droopy eyelids or crooked eyebrows.
• A crooked smile or drooling.
• Watery or dry eyes.
• Infection at the injection site.

Rarely, the medicine may spread to parts of the body where it isn’t supposed to go. It can cause symptoms there. Call your health care provider right away if you have any of these symptoms hours or weeks after your procedure:

• Muscle weakness.
• Vision problems.
• Trouble talking or swallowing.
• Breathing problems.
• Allergic reaction.
• Loss of bladder control.

As a rule, health care providers don’t recommend Botox if you’re pregnant or breastfeeding.

Select your health care provider carefully

Botox is a prescription medicine and must be used only under the care of a licensed and skilled health care provider. Talk with your health care provider about whether the procedure fits your needs.

To find an expert in Botox injections, ask for a referral from your primary care provider.

How you prepare

Which type of botulinum injection is right for you depends on your needs and condition. Talk with your health care provider about the treatment best suited to you.

Tell your health care provider if you’ve had any type of Botox injection within the past four months. Also tell your health care provider if you take blood thinners. You may need to stop taking them several days before your injection to reduce the risk of bleeding or bruising. Talk with the health care provider who prescribes these medicines as soon as you can.

What you can expect

Before the procedure

Most people don’t feel much pain during the procedure. But you may want your skin numbed beforehand, especially if your palms or feet are being treated for heavy sweating. Your health care provider might use one or more of the following methods to numb the area: anesthetic applied to the skin, ice and massage. The massage method also is called vibration anesthesia.

During the procedure

Botox injections are usually performed in a medical office. Your health care provider uses a thin needle to inject tiny amounts of botulinum toxin into your skin or muscles. The number of shots needed depends on the size of the treatment area and other things. Sometimes ultrasound is used to guide the needle to the right spot.

Botulinum toxin is available in two forms:

• Type A. Type A is mainly used for treating facial wrinkles. Type A products include onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), daxibotulinumtoxinA (Daxxify) and prabotulinumtoxinA (Jeuveau).
• Type B. Type B is often the first choice for treating neck spasms. It’s sold as rimabotulinumtoxinB (Myobloc).

After the procedure

Do not rub or massage the treated areas for 24 hours. And don’t lie down for 2 to 4 hours after getting the shots. Following this advice helps prevent the toxin from spreading to an area where it isn’t needed. You’ll likely be able to return to your usual activities right after the procedure — check with your health care provider.

Results

Botox injections usually begin working 1 to 3 days after treatment, though it can take a week or more to see full results. Not all people have visible results or relief from symptoms.

Depending on the problem being treated, the effect may last 3 to 4 months. To maintain the effect, you’ll likely need regular follow-up injections spaced at least three months apart.