Reuters

The U.S. Food and Drug Administration said on Friday that fraudulent versions of the wrinkle treatment Botox, which is made by Allergan Inc and also used to treat headaches, underarm sweating and overactive bladder, are being sold in the United States.

The FDA said in an alert posted on its website that the outer carton of the fraudulent Botox is counterfeit, and the vial inside is foreign and not approved for sale in the United Sates.

"FDA cannot confirm that the manufacture, quality, storage, and handling of these products follow U.S. standards," the agency said.

Allergan said that in addition to violating federal law, products that are illegally imported may either be counterfeit or the quality may have been compromised.

"Therefore, healthcare professionals purchasing products from a non-Allergan supplier are purchasing products that are fraudulently diverted and sold through unauthorized channels," the company said in a statement.

Authentic Botox is stored and transported by Allergan according to rigorous specifications, the company said. 

Botox is a sterile, purified version of the same toxin that causes botulism, which can cause potentially deadly swallowing and breathing difficulties, and when injected, acts to temporarily smooth certain frown lines. It generated sales in 2012 of $1.77 billion, of which roughly half came from cosmetic use.

In 2004, four people were hospitalized with poisoning after being injected with unapproved botulinum toxin, which a doctor had passed off as Botox.

The case prompted a wide scale investigation of more than 200 clinics throughout the United States and dozens of convictions of people who injected patients with unapproved, cheaper substitutes for Botox.

The FDA's alert comes as lawmakers are seeking to create a national set of standards for tracking prescription drugs through the distribution chain to help prevent counterfeit or contaminated products from reaching the public. 

By Reuters.com

The popular Botox wrinkle treatment made by Allergan Inc has been approved to treat adults with overactive bladder who cannot tolerate or failed to be helped by other drugs for the condition, the U.S. Food and Drug Administration said on Friday.

Botox injected into the bladder muscle causes the bladder to relax, increasing its storage capacity and reducing episodes of urinary incontinence, or leakage.

"Clinical studies have demonstrated Botox's ability to significantly reduce the frequency of urinary incontinence," Hylton Joffe, director of the FDA's Division of Reproductive and Urologic Products, said in a statement. "Today's approval provides an important additional treatment option for patients with overactive bladder, a condition that affects an estimated 33 million men and women in the United States."

Botox had previously been approved for other non-cosmetic uses, such as migraine headaches, severe underarm sweating and loss of bladder control due to nerve damage.

Allergan, which has yet to report full year financial results, said it expects 2012 Botox sales of $1.76 billion to $1.8 billion. Analysts have said that approval for overactive bladder could add more than $200 million a year to Botox sales.

The treatment can be repeated when the effect wears off, but with a gap of at least 12 weeks between treatments, the FDA said.

About 3.2 million Americans suffering from overactive bladder take oral medications from a class of drugs called anticholinergics, such as Pfizer Inc's Detrol. The Botox approval is for those who are not helped by, or cannot take, those drugs, the FDA said.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine, feeling a sudden and urgent need to urinate, and frequent urination.

Common side effects for Botox injected into the bladder reported during clinical trials included urinary tract infections, painful urination, and incomplete emptying of the bladder, or urinary retention.

People being treated for overactive bladder with Botox should not have a urinary tract infection and should take antibiotics before, during, and for a few days after Botox treatment to lower the chance of developing an infection from the procedure, the FDA said.

If you feel like you need to run for the restroom all the time, maybe you should try Botox. A new study suggests that the injections more often used to fight facial wrinkles might prevent bladder leaks just as well as commonly prescribed oral medications.

In fact, the study showed that compared to a daily anticholinergic pill, an injection of onabotulinumtoxinA -- the drug most commonly used against those pesky lines -- was more than twice as likely to completely fix urgent, leaky bladders, according to the report published in the New England Journal of Medicine.

The researchers hope that their findings will make it easier for patients to get Botox treatments paid for by insurance companies.

“Women don’t need to suffer in silence,” says the study’s co-author Dr. Linda Brubaker, dean and professor at the Loyola University Chicago Stritch School of Medicine. “There are effective treatments available and more options now than ever.”

Up to 19 percent of American women suffer sudden bladder contractions that lead to urine leakage, experts estimate.  Men can also develop urinary urgency incontinence, but usually not until they are older. While severe leaky bladders can be related to nerve damage, stroke or a combination of problems, doctors often don't really know the cause. By the time they are in their 80s and 90s, an equal number of men and women suffer from the problem, Brubaker says.

The new study followed 241 women with urinary urgency incontinence for six months, with half the women receiving daily oral medication along with a placebo saline injection. The rest of the women were given a Botox injection into the detrusor muscle, a layer of the bladder wall, and a daily placebo pill. (Doctors inject the drug directly into the bladder wall using a small, special needle passed through a tiny tube.)

The women in the study all had moderate to severe symptoms, which meant that, on average, they were suffering five episodes of urgency a day.

These aren’t women who spill just a drop or two of urine from time to time, Brubaker says. “How much urine they lose is variable” she adds. “Some can lose almost an entire bladder full, drenching their office chair with urine running down their legs. It can be very embarrassing in an office setting, let alone in the private setting.”

For these women, a powerful need to urinate comes on suddenly, with no warning. 

“Normally you should be able to ignore the sensation a few times and then swing by the bathroom,” Brubaker explains. “Their first warning is strong and urgent and even if they respond quickly, it’s not fast enough. If you’re on a bus that’s stuck in traffic with no restroom, you’re in trouble.”

At the end of six months, 71 percent of the women who took oral medication and 70 percent of those who got a Botox injection had marked improvement. Symptoms completely resolved in 27 percent of those who received the Botox, compared with only 13 percent of those taking the drugs. Almost half of the women who got oral medication experienced dry mouth, while 5 percent of those who received Botox had trouble urinating and needed to have a catheter inserted to drain their bladders. There was also a higher rate of urinary tract infections in those treated with Botox (33 percent versus 13 percent).

The procedure could be performed by a urogynecologist, a gynecologist who specializes in pelvic floor dysfunction, about every 12 months, Brubaker says.

Doctors usually won’t turn to medication right away. They usually check to see if behavioral modifications can improve the situation, says Dr. Alan J. Wein, a professor and chief of urology at the Perelman School of Medicine at the University of Pennsylvania.

One good place to start is to make sure you’re not taxing your bladder by over filling it, Wein says. “Surprisingly most people don’t understand that the more you drink the more symptomatic you will be.”

And make sure you’re visiting the restroom often enough, Brubaker says. A good rule of thumb, she says, is to empty your bladder eight times a day.

If you’re having problems at night, consider cutting back on beverages consumed after 4 pm, Wein counsels.  It’s also a good idea to keep a diary to see if there are any specific foods or beverages that seem to routinely trigger sudden bladder contractions

At the University of Pennsylvania, patients are also taught pelvic floor exercises that give them better control over the muscles that surround the urethra, Wein says. “So when you feel like you really have to go, the routine is to stand still, relax and then contract the muscles -- and then relax them as quickly as you can. Often that makes the urgency pass long enough for you to safely get to the bathroom.”

This kind of therapy can help empower a patient, Wein says. “It’s something you can do yourself that requires no medications at all.”

Even when the behavior modifications aren’t enough, patients still have a sense of empowerment. “Regardless of whatever else they do, patients who feel empowered do better,” Wein says.

The good news is that the new study shows that a large number of patients can be helped, whether it’s through oral medication or Botox, Wein says.   

More from NBC News Health:

• Four dead from suspected fungal meningitis; 26 cases reported
• New spray bottle designed to prevent chemical injuries
• Illegally labeled diet pills 'potentially dangerous'