There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX in pregnant women. In animal studies, administration of BOTOX during pregnancy resulted in adverse effects on fetal growth (decreased fetal weight and skeletal ossification) at clinically relevant doses, which were associated with maternal toxicity [see Data)].
Botox has also been shown to prevent chronic migraines, but there, it's unclear exactly why Botox works. (For doctors, reaching a firm understanding of how Botox prevents migraines will be tricky, since they don't know for certain what causes the severe headaches in the first place.) "There were multiple clinical trials for migraines, and most of them failed," says Dr. Mitchell Brin, senior vice president of drug development at Allergan and chief scientific officer for Botox. "It took a long time to figure out where to inject and how much." Today people who receive Botox for migraine prevention get 31 injections in different spots on their head and neck. The effects of Botox can last about three to six months depending on the condition.
Botox Cosmetic is FDA-approved and injections are relatively safe when performed by an experienced injector. It has proven to be a successful and valuable therapeutic protein when dosage, frequency of treatment & variety of treated clinical conditions are considered. The best way to ensure you receive the results you are looking for is to only receive injections from a highly experienced provider, such as the medical and nursing professionals at Ideal Image.
In response to the occurrence of these side effects, in 2008 the U.S. Food and Drug Administration notified the public of the potential dangers of the botulinum toxin as a therapeutic. Namely, they warned that the toxin can spread to areas distant from the site of injection and paralyze unintended muscle groups, especially when used for treating muscle spasticity in children treated for cerebral palsy.[28] In 2009, the FDA announced that boxed warnings would be added to available botulinum toxin products, warning of their ability to spread from the injection site.[29] Additionally, the FDA announced name changes to several botulinum toxin products, meant to emphasize that the products are not interchangeable and require different doses for proper use. Botox and Botox Cosmetic were renamed onabotulinumtoxinA, Myobloc was renamed rimabotulinumtoxinB, and Dysport name renamed abobotulinumtoxinA.[29] In conjunction with this, the FDA issued a communication to health care professionals reiterating the new drug names and the approved uses for each.[30] A similar warning was issued by Health Canada in 2009, warning that botulinum toxin products can spread to other parts of the body.[31]

Though botulinum toxin is available under different names, Botox is the only one that is FDA-approved for migraine prevention. To be considered for Botox, patients must have migraines 15 days or more per month, which is considered chronic daily migraine. About 4 million Americans have such migraines, according to the Migraine Research Foundation. Also, patients must have tried and failed on at least 2 other medications first.


Each vial of BOTOX contains either 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride; 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride; or 200 Units of Clostridium botulinum type A neurotoxin complex, 1 mg of Albumin Human, and 1.8 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
BOTOX® can be used on the forehead lines, frown lines, crow’s feet, bunny lines (lines in the nose), chin (for dimpling), skin bands on the neck, and around the mouth (for smoker’s lines and down-turned corners of the mouth). Wrinkles caused by sun damage and gravity often will not respond to BOTOX®. It is important to re-emphasize that BOTOX® is NOT a facial filler (that is, it does not fill existing wrinkles) – it merely relaxes the muscles that are creating those wrinkles.
This site is intended for US consumers. No information on this site is provided with the intention to give medical advice or instructions on the accurate use of Allergan products. Allergan cannot answer unsolicited emails requesting personal medical advice; visitors should always consult a healthcare professional. Please visit the Allergan site of your country of residence for information concerning Allergan products and services available there.
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturi ng processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt -Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever be en reported for albumin.
Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.
The Company provides warranty programs for breast implant sales primarily in the United States, Europe and certain other countries. The United States programs include the ConfidencePlus program, which is limited to saline breast implants that provide lifetime product replacement and contralateral implant replacement. It also include ConfidencePlus Premier warranty programs, which are standard for silicone gel implants and require a low enrollment fee for saline breast implants, and generally provide lifetime product replacement along with financial assistance for both saline and silicone gel breast implants for surgical procedures within 10 years of implantation and contralateral implant replacement.

After a muscle has been injected, the nerves still send the signal to the muscle to contract, and the acetylcholine is still released, but is unable to bind to the muscle, resulting in a reduction of muscle activity and temporarily preventing contraction of the muscles that cause frown lines. The binding process typically begins within about 48 hours from the time it is injected into the muscle, and results typically become noticeable within 7 to 10 days. While results are often most noticeable in dynamic wrinkles (wrinkles that appear when a muscle contracts), it can also help soften wrinkles that are present even without muscle contraction. If you’re serious about improving the appearance of moderate to severe frown lines, it may be just the right treatment option for you.


That said, there are a few things I'd make sure everyone knows before trying it. For one thing, it can be pretty painful. I have a pretty high pain tolerance, but getting 30 to 40 shots every three months is pretty rough — it feels a bit like getting tattooed with a bee's stinger, but once the needle is out of your skin, the pain goes away, and if it works for you, it's worth it. It's also important to know that it can take some time to work. The first treatment barely worked at all for me, and the second round took a few weeks. If you're going to try it out, be patient.


The primary release procedure for BOTOX uses a cell-based potency assay to determine the potency relative to a reference standard. The assay is specific to Allergan's products BOTOX and BOTOX Cosmetic. One Unit of BOTOX corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. Due to specific details of this assay such as the vehicle, dilution scheme, and laboratory protocols, Units of biological activity of BOTOX cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. The specific activity of BOTOX is approximately 20 Units/nanogram of neurotoxin protein complex.
The results showed that 34% of those who responded and tried Botox said it significantly helped them. Sixteen percent reported a slight benefit. Nine percent stated that it didn’t help at all. Eleven percent stated that they would like to try Botox but it is too expensive. About 10% said they had no plans to try Botox, and 18% said they hadn’t tried it yet.
Although one cannot predict exactly who will respond, I find that those patients who are going to respond will note some improvement in headaches following the first set of injections. Repeat injection sets can be performed on the same patient no sooner than every 3 months, as long as a benefit is seen. Most insurers require that you document at least a 50% improvement in the chronic migraine frequency and/or severity for continued coverage. I usually recommend that my migraine patients have a second set of injections before deciding that this treatment modality is of no benefit to them.
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The cost for Botox may range from $125 to $400 per treatment area. Multiple areas may be treated at one time, and repeat treatments are needed every three to four months, on average. When it comes to Botox and other injectables, you get what you pay for. Buyer beware: bargain Botox may increase your risk of complications, including poor cosmetic results. If the cost is prohibitive, ask your doctor about payment plans.
Alternatively, bruising could occur, though is less likely, says Rowe, especially in the hands of an experienced doctor. While he says it's "dumb luck" whether or not one bruises from an injection, he also notes that good technique helps reduce the chances. Sobel says that "if you inject [the needle with Botox] too deep, very often you can hit a blood vessel and bruise." What you do after the injection can also make a difference: Take care not to rub or massage the treated areas, as this can cause the toxin to migrate.
The patient’s neck stability, posture, torsion, and symmetry should be assessed to determine whether he or she may be at increased risk for adverse events prior to the first injection cycle. A patient with preexisting neck pain and/or weakness may be at higher risk for exacerbation of the condition upon injection of the occipitalis, cervical paraspinal, or trapezius muscle groups. Patients with smaller frames may be at higher risk for neck weakness. Indicated injection sites can still be injected with minimal side effects and unwanted outcomes as long as correct injection sites are targeted and treatments are administered using a superficial approach with avoidance of the mid and lower cervical regions. The cervical paraspinal muscle group is made up of multiple muscles including the trapezius, splenius capitis and cervicis, and semispinalis capitus. This group of muscles helps support the neck, including extension of the head.
Postmarketing Experience: The following adverse reactions have been identified during postapproval use of LATISSE®: dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few eyelashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with a deepening of the eyelid sulcus, rash (including macular and erythematous), skin discoloration (periorbital), and vision blurred.

In a recent Facebook Live, our new director Nim Lalvani introduced herself to the migraine community. If you missed our Facebook Live, watch the recording below or read on to learn more about Lalvani’s personal connection to migraine and her plans for the Foundation. [embed]https://www.facebook.com/americanmigrainefoundation/videos/290329171553466/[/embed] In the short time that Lalvani has worked at AMF, she’s been impressed by the strong and vibrant community of doctors, patients and advocates. Lalvani’s background is in public health, and she has dedicated her career to patient engagement. She has worked in the nonprofit and patient advocacy spaces for more than 12 years, helping patients at both the national and international level. “I've specifically focused my career on designing and providing the rights tools and resources for patients at the times that they need it most,” she shared, adding that her goal is to amplify patients’ voices in research and therapeutic development.


But even if the laws remain unchanged, as long as off-label uses are permitted by law, expect doctors to keep pushing the boundaries of Botox's applications--sometimes in the name of medical progress and sometimes with remarkable results.Norman Rosenthal, the Maryland psychiatrist who recommended Botox for his suicidal patient, says he's seen the upside firsthand. The patient, persuaded by Rosenthal, did indeed get Botox shots on his forehead and between his brows. Days later, Rosenthal got an email from the patient. It was a thank-you note. Finally, the patient wrote, he was feeling better.

Normally you would see improvement within a few days. Botox requires two to four days for it to attach to the nerve ending that would normally stimulate the muscle to contract. The maximum effect usually occurs at about 10-14 days. Therefore, whatever effect is obtained two weeks after the injections should be considered the maximum effect that is going to occur.
After an exam by a therapist and doctor, botulinum toxin for focal relief of muscle spasticity can be advised as the best way to address a child's functional problems. The problem muscle groups are identified, and goals for that child are discussed. Then the injection of botulinum toxin can be done if there are no permanent contractures of the muscle groups.
The safe and effective use of BOTOX depends upon proper storage of the product, selection of the correct dose, and proper reconstitution and administration techniques. An understanding of standard electromyographic techniques is also required for treatment of strabismus, upper or lower limb spasticity, and may be useful for the treatment of cervical dystonia. Physicians administering BOTOX must understand the relevant neuromuscular and structural anatomy of the area involved and any alterations to the anatomy due to prior surgical procedures and disease, especially when injecting near the lungs.

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Over the next three decades, 1895-1925, as food canning was approaching a billion-dollar-a-year industry, botulism was becoming a public health hazard. Karl Friedrich Meyer, a prodigiously productive Swiss-American veterinary scientist created a center at the Hooper Foundation in San Francisco, where he developed techniques for growing the organism and extracting the toxin, and conversely, for preventing organism growth and toxin production, and inactivating the toxin by heating. The California canning industry was thereby preserved.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was us ed as the diluent, and consequently the causal agent cannot be reliably determined.

Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.


If going back for additional treatments three or four times a year sounds like a lot of treatments, the good news is that the more Botox treatments you get, the fewer Botox units you'll need. With each repeat Botox session, the frontalis muscle and other facial muscles surrounding Botox injection sites get a little weaker and become "trained" to not contract.
After a muscle has been injected, the nerves still send the signal to the muscle to contract, and the acetylcholine is still released, but is unable to bind to the muscle, resulting in a reduction of muscle activity and temporarily preventing contraction of the muscles that cause frown lines. The binding process typically begins within about 48 hours from the time it is injected into the muscle, and results typically become noticeable within 7 to 10 days. While results are often most noticeable in dynamic wrinkles (wrinkles that appear when a muscle contracts), it can also help soften wrinkles that are present even without muscle contraction. If you’re serious about improving the appearance of moderate to severe frown lines, it may be just the right treatment option for you.
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