BOTOX WARNINGS

Yesterday’s article dealt with illegal silicone treatments. Today we will mention the most popular “legal” cosmetic treatment – that of Botox.

You have probably read the news articles and perhaps heard rumors about recent Botox complications. While Botox is best known for clearing wrinkles by paralyzing facial muscles, the botulin-based drug also is widely used for muscle-spasm conditions. Botox and Myobloc, are designed to block nerve impulses to certain muscles, causing them to relax. Both drugs are approved to treat cervical dystonia, or uncontrolled muscle contractions of the neck and shoulder muscles.

In addition, Botox is approved for cosmetic use to treat wrinkles between the eyebrows and to help control excessive underarm sweating. Lower doses are used by professionals for cosmetic purposes than those used to treat limb spasticity.

In rare cases, however, the toxin can spread beyond the injection site to other parts of the body. This will cause paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect.

Signs of botulism can appear just hours after injection and include
• difficulty swallowing or breathing,
• slurred speech and
• muscle weakness.

The FDA said it uncovered 225 cases of botulism related to the drugs during its analysis and 17 deaths for which its analysis seemed to suggest botulism as a cause.
Botox, Botox Cosmetic, and Myobloc are approved for "temporary improvement in the appearance of glabellar lines, treatment of strabismus, blepharospasm, cervical dystonia, and primary axillary hyperhidrosis.

An FDA statement, however, reassured the public. To date, none of the cases...reported have been associated with use of botulinum products in cosmetic or dermatological procedures, such as clearing furrows between the eyebrows, according to the FDA.

Indeed the FDA has just approved sales of new Botox like drug.

Ipsen SA and Medicis Pharmaceutical Corp. won US Food and Drug Administration approval to sell their product, Dysport [botulinum toxin type A], for both aesthetic and therapeutic uses. Like Botox [botulinum toxin type A], the new injection uses a type of botulinum toxin to relax the muscles that cause forehead lines and a neck-twisting disorder called cervical dystonia. The company will start selling the drug for aesthetic uses in the US within 30 to 60 days." Dysport injections may take effect more quickly than Botox, which typically takes three to 10 days before patients notice that wrinkles begin smoothing.

The FDA stated that even though "there have been reports of symptoms consistent with distant spread of the toxin effects following dermatologic use...no definitive serious adverse-event reports of this effect were associated with use of Botox at the labeled dose of 20 units for glabellar lines or 100 units for severe primary axillary hyperhidrosis."

How Should Botox be Given?

First make sure it’s given by a medical professional.

Botox parties given in peoples homes may be dangerous when given by non authorized personnel.

Patients should know that the practitioner must follow the FDA’s recommendations made in the 2008 Early Communication; that healthcare professionals who use botulinum toxin products should:

• Understand that dosage strength (potency) expressed in “Units” or “U” are different among the botulinum toxin products.
• Clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.
• Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including:
• unexpected loss of strength or muscle weakness,
• hoarseness or trouble talking
• (dysphonia), trouble saying words clearly
• (dysarthria), loss of bladder control,
• trouble breathing,
• trouble swallowing,
• double vision, blurred vision and drooping eyelids.

Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.

Patients must seek immediate medical attention if they develop any of these symptoms.

The FDA urges both healthcare professionals and patients to report side effects from the use of Botox and Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B), and Dysport (abobotulinumtoxinA) to the FDA's MedWatch Adverse Event Reporting program.

• online at www.fda.gov/medwatch/report.htm
• by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
• faxing the form to 1-800-FDA-0178
• by phone at 1-800-332-1088


Please remember, as with all our articles we provide information, not medical advice.

For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.

SILICONE WARNING. A Cheap, Fast and Possibly Deadly Route to Beauty

The New York Times documents that nationally, reports of buttock enhancement using silicone and similar thick liquids have surfaced from the Northeast to Miami.Across the Internet, chat rooms, Web sites and blogs have sprung up discussing buttock injections. The injections are administered at home, in motel rooms, in makeshift offices or at “pumping parties,” where the guests take turns injecting one another.”

In the last 10 months, New York City's health department-- the city's poison control center has received three calls...from doctors who have treated patients injected with silicone elsewhere."

This seems to be kind of an underground occurrence, so it's difficult to get numbers of actual events and to know exactly what these people are being injected with. ... It's important to note that none of the products that are reportedly being used are approved for this purpose.

Silicone was not approved for injection into tissues at all, only for use in the eyes and in certain implants where it is contained and cannot leak into tissue.The victims-usually women- may be unable to afford conventional plastic surgery and tap into it through unlicensed practitioners working through word of mouth and the internet.

The danger is that silicone can migrate through tissues, leading to ugly lumps and chronic pain as well as death if it migrates into vital tissue like lung and kidney. Industrial-grade silicone usually is bought at a hardware store. But there have been reports of the use of substitutes like castor oil, mineral oil, petroleum jelly and even automobile transmission fluid.

A Word of Warning on Cosmetic Surgery:

I recently read that “Hospital anesthesiologists were negligent in multiple cosmetic surgeries, causing three deaths”: A hospital and attending anesthesiologists have recently settled a malpractice lawsuit regarding errors during a face-lift procedure. A 56 year-old-woman died of cardiac failure caused by an overdose of local anesthetic. Alarms that monitored the woman’s blood oxygen “were accidentally turned down so that they were inaudible”. That same year, famous author Olivia Goldsmith died during cosmetic surgery at the prestigious hospital as a result of errors and still another woman suffered brain damage after a face-lift.

Even when performed by leading physicians the same risks of necessary surgery are not that much different than for other surgical procedures. One begins to think of a “nip and tuck” surgery with light humor. But when you review some of these reports you should realize you are taking a risk with any cosmetic surgery and should fully discuss this with your doctor.

In the next column we will deal with Botox warnings.

Please remember, as with all our articles we provide information, not medical advice.
For any treatment of your own medical condition you must visit your local doctor, with or without our article[s]. These articles are not to be taken as individual medical advice.