NEW YORK — Allergan, the maker of the Botox wrinkle treatment, challenged the government’s ban on off-label drug marketing to doctors, saying it violates the company’s right to freedom of speech.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses.

Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

While physicians can legally prescribe a drug for unapproved uses, companies are forbidden from marketing the product, especially to physicians, for any use not sanctioned by the FDA.

The FDA said it doesn’t comment on pending litigation. The lawsuit was filed in U.S. District Court for the District of Columbia against the U.S. government and the FDA.

The catalyst for the lawsuit is a requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment.

“Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment,” Allergan spokeswoman Caroline Van Hove said in a statement.

Drug developers often walk a tight line with off-label drug practices and getting caught on the wrong side can be expensive. New York-based Pfizer Inc. paid a $2.3 billion settlement last month over allegations it marketed drugs for off-label use.

Part of the logic behind the FDA rule is this: The agency has reviewed detailed clinical trial data, spanning years, before approving a drug’s use for a specific purpose. That same level of scientific, controlled review has not gone into unapproved uses.

In a statement Thursday, Allergan said some of Botox’s off-label uses are medically accepted and commonly prescribed.

“Once a drug is approved, physicians may exercise their informed medical judgment to prescribe the drug for any use, including off-label uses,” the company said, estimating that about 20 percent of Botox use is off-label.
The ban on off-label marketing to doctors is particularly difficult for Allergan, the company said, since the FDA has required safety updates to Botox’s label.

In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

In general, the new labeling urges physicians to tell patients about the risks of botulin-based drugs and to seek medical care if they develop any symptoms.

“To ensure that physicians are equipped to treat patients as safely and successfully as possible, Allergan believes it is important to proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique,” the company said. “Without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution.”

The Irvine company stressed that the lawsuit doesn’t challenge the government’s ability to prohibit pharmaceutical companies from lying or distributing misleading information. Rather, the company said, it seeks to permit Allergan to proactively provide the medical community with truthful, important information about common off-label uses of Botox.

Allergan is represented in its lawsuit by Paul D. Clement, a partner at King & Spalding in Washington, D.C., and formerly the Solicitor General of the United States.

Source: http://www.dailynews.com/ci_13471325

The injections are used to get rid of wrinkles by partially freezing muscles.

But scientists have now discovered that they can also stop people being able to express their feelings visually.

That could lead to them keeping their emotions bottled up inside and they could end up perceiving the world in a negative way, researchers said.

Dr Judith Grub, who led the research into the injections in Holland, told The Sun: “Suppressing negative emotions is something we do every day to be polite.

“However, my research shows that paralysing muscles that help you to express emotion leads to internalising these feelings.”

In the study 30 people were shown a series of gruesome images.

Some were allowed to show their emotions while others were asked to keep a blank face as they looked at them.

Those who did not show their feelings perceived the world as a worse place, and felt negative emotions for longer.

Dr Grub added: “Many people think ‘Oh, it’s just Botox - I can get it in my lunch break.’ But they forget that there may be side-effects.”

But British cosmetic treatment expert Dr Patrick Bowler said: “Botox shouldn’t paralyse the face and you should still be able to make facial expressions.”

In February 2008, the Food & Drug Administration (FDA) announced that Botox, Botox Cosmetic and Myobloc would undergo a safety review following reports of serious side effects, including the deaths of some children.  Botox, Botox Cosmetic and Myobloc are injectable drugs that contain botulinum toxin.  According to the FDA, most of the severe reactions occurred in children treated for limb spasticity associated with cerebral palsy, an off-label use of the drugs.

Botox, which is made with botulinum toxin type A, is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).  Botox Cosmetic, which also uses botulinum toxin Type A, is approved for temporary improvement in the appearance of moderate to severe facial frown lines. Myobloc, which is made from botulinum toxin Type B, is approved for the treatment of adults with cervical dystonia.

Botox, Botox Cosmetic, and Myobloc Side Effect Reports

In January 2008, the consumer advocacy group Public Citizen petitioned the agency two weeks ago to strengthen warnings on the products’ labels because of serious adverse reactions. An analysis conducted by Public Citizen of FDA data found that between Nov. 1, 1997, and Dec. 31, 2006, the makers Botox, Botox Cosmetic and Myobloc had reported 180 U.S. cases of people developing serious conditions after receiving injections. Those 180 cases included 16 deaths, four of which occurred in children.

According to the FDA the Botox, Botox Cosmetic and Myobloc reactions reported resemble botulism.   The reactions have occurred when botulinum toxin spreads beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. The FDA said that the adverse reactions may be due to overdosing

The reports of adult botulism cases described symptoms including patients experiencing difficulty holding up their heads, dysphagia and ptosis.  Some reports described systemic effects that occurred distant from the site of injection and included weakness and numbness of the lower extremities.  Among the adult cases that were serious, including hospitalization, none required intubation or ventilatory support. No deaths were reported.

Legal Help

If you or a loved one has been seriously injured as a result of Botox, Botox Cosmetic or Myobloc, you have valuable legal rights.  Please fill out our online form for a free case evaluation by a qualified drug side effects attorney.

Make sure you are receiving Botox Cosmetic

Before you receive your treatment, don’t hesitate to ask to see the box and bottle of the Botox, to confirm that it’s the real thing. Of course, an unscrupulous person could always put something other than Botox Cosmetic in the bottle, so you need to make sure you are at a trustworthy practice. If you’ve heard about the deaths or paralysis of people that had Botox injections, they were not injected with Botox Cosmetic. Here in Nevada, a doctor has recently been accused of injecting his patients with something other than Botox Cosmetic, but telling them it was the real thing, and he faces serious jail time if he’s found guilty.

Ask if the results are guaranteed

While every patient is different and won’t get the same exact results, there are several factors that can effect your treatment. Botox needs to be mixed with sterile saline, but some unscrupulous places may dilute the Botox too much, which can make it less effective, or it can wear off faster. Botox also needs to be used within a few days after it’s mixed, so if you aren’t getting fresh Botox, you might not get good results. You also want to get an ample amount of units, so it’s best to pay per unit, rather than per area. Some place may charge $99 an area, but who knows how much Botox they are injecting. You need to tell a skilled injector what results you are hoping to achieve, and you need to let him or her decide how many units you will need to achieve those results. If you only have $100 and want “some” Botox, save your money til you can afford to get the units you need. If you are being treated at a reputable place, you should be really happy with your results. But see if you can get some sort of guarantee in writing, so that you don’t get Botox that fades after two weeks, and you’re out a lot of money.

Botox Marketing Tips

Botox marketing makes sense as injections for wrinkles are one of the largest-expanding cosmetic treatments in the industry. In 2001, Botox advertising delivered very well, as even more than 1.6 million clients took injections, an explosion of 46 percent beyond the previous year. Even more demanded than breast enhancement treatments, Botox is regarded by some as the ultimate of providing young appearances. The increasing demand simply means that individuals are looking for botox and similar facial injectables, like collagen, Radiesse, Juvederm, Artefill, Restylane, Perlane and Cosmoderm.

Is Botox Safe?
Botox and Botox Cosmetic are FDA-approved drugs. Both are a naturally-derived protein called botulinum toxin. Toxins are naturally occurring substances that at defined doses are capable of causing illness. When injected properly with appropriate dosing, the risk of Botox complications is extremely low. However, as with any medical treatment, there is potential for adverse effects, and therefore, prior to treatment patients must be informed about the potential risks of these treatments.

Botox vs. Botox Cosmetic

Botox is a botulinum type A that has been reviewed by the FDA and approved to treat specific medical disorders such as cervical dystonia, strabismus and cerebral palsy. Botox Cosmetic is a botulinum type A that has been reviewed by the FDA and approved to treat frown lines; it is also used off-label to treat other cosmetic indications.

Botox used to reduce wrinkles is a sterile and purified version of the Botulinum Toxin A. When the toxin is injected into the muscle, it works to block the nerve impulses, temporarily paralyzing the muscles that cause wrinkles, thereby causing them to relax more. The net result is that the process of wrinkle formation is reduced. A smoothing effect is seen almost immediately and it continues to improve over the next few days.

The full effects of Botox injections can be seen in 5-7 days. Results may vary on individuals, depending on the severity of wrinkles and the strength of muscles treated. The results last from three to six months after which most patients gradually return to their former state. Normally, Botox Injections should be repeated every 3-4 months. Patients who have had Botox treatments over 12 months may only require further treatments every 6 months.

Tim Shadbolt says his first experience with Botox was also his last. The Invercargill Mayor - a former Aucklander - received two Botox injections near his eyes after volunteering for an extreme makeover competition organised by a beauty clinic in his adopted town.

Sarah Jessica Parker stars as Carrie Bradshaw in New Line Cinema’s “Sex and the City”.

Invercargill Mayor Tim Shadbolt turns up his nose at face creams but has stepped up for Botox — albeit for charity.

Believing it would take nitroglycerine to remove all the wrinkles on his face caused by his trademark grin, Tim Shadbolt said his first experience with botox was likely to be his last.