Drugs Log

The popular anti-wrinkle drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children given the drugs for muscle spasms have died, the government warned Friday.

The Food and Drug Administration’s warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.

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

Botox is best known for minimizing wrinkles by paralyzing facial muscles — but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.

The FDA said the deaths it is investigating so far all involve children, mostly cerebral palsy patients being treated for spasticity in their legs. The FDA has never formally approved that use for the drugs, but some other countries have.

However, the FDA warned that it also is probing reports of illnesses in people of all ages who used the drugs for a variety of conditions, including at least one hospitalization of a woman given Botox for forehead wrinkles.

The FDA wouldn’t say exactly how many reports it is probing.

“We’re not talking hundreds. It’s a relative handful,” said Dr. Russell Katz, FDA’s neurology chief.

But the agency warned that patients receiving a botulinum toxin injection for any reason — cosmetic or medical — should be told to seek immediate care if they suffer symptoms of botulism, including: difficulty swallowing or breathing, slurred speech, muscle weakness, or difficulty holding up their head.

“I think people should be aware there’s a potential for this to happen,” Katz said. “People should be on the lookout for it.”

Friday’s warning came two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen warnings to users of Botox and Myobloc — citing 180 reports of U.S. patients suffering fluid in the lungs, difficulty swallowing or pneumonia, including 16 deaths.

Nor is it the first warning. The drugs’ labels do warn about the potential for botulinum toxin to spread beyond the injection site and occasionally kill, but the warnings link that side effect to patients with certain neuromuscular diseases, such as myasthenia gravis.

That’s what’s different about these latest cases, said FDA’s Katz: The botulism toxin seems to be harming people who don’t have that particular risk factor. (Cerebral palsy involves a brain injury, not a disease.)

Still, the FDA cautioned that its investigation is in the early stages. It has asked Botox maker Allergan Inc. and Myobloc maker Solstice Neurosciences Inc. to provide additional safety records.

Allergan spokeswoman Caroline Van Hove said children with cerebral palsy receive far larger doses injected into their leg muscles than the doses given adults seeking wrinkle care.

In a statement, Solstice said it supports FDA’s probe but stressed that the agency hasn’t concluded the drug poses any new risk.

While the FDA said the problems may be related to overdoses, it also has reports of side effects with a variety of doses.

Public Citizen’s Dr. Sidney Wolfe criticized FDA’s warning as falling short. He asked that the agency order a black-box warning, the FDA’s strongest type, be put on the drugs’ labels and require that every patient receive a pamphlet outlining the risk before each injection.

“Every doctor needs to notified about this, every patient needs to be notified,” Wolfe said. “Children are showing the way, unfortunately some dead children.”

He said drug regulators in Britain and Germany last year required that sterner warnings be sent to every doctor in those countries.

Do anti-wrinkle creams work?

Anti-wrinkle creams could help reduce the appearance of aging. Generally, these creams are not permanent wrinkle removers, but either help remove the dead outer layer of skin or hydrate the skin and plump it up, giving the appearance of removing wrinkles. Some results can be seen after about 30 days. But, once you stop using the product, the wrinkles return, so ongoing product use can become expensive depending on which cream you buy. In addition, the effectiveness of particular brands have not been scientifically studied and published in medical journals.

Given the limitations as to their success, here are some recommended products that have been reviewed:

1. Products with Vitamins C & E: The American Academy of Dermatology, published a paper, “Facing the Age Old Question…How to Turn Back the Hands of Time.” Dermatologist, Arielle N.B. Kauvar, recommended “over-the-counter topical products with ingredients such as the anti-oxidants vitamins C & E.” However, Dr. Kauvar did not specify any particular brand.

2. Products with AHA (alpha hydroxy acid): According to Dr. Kauvar, products with alpha hydroxy acid (AHA) can “help remove the dead outer layers of skin, leaving the face with a fresh, younger appearance. AHAs are particularly beneficial for wrinkles around the mouth and eyes.”

Dr. Kauvar did not recommend any particular brand, and pointed out that the most important way to prevent aging skin is to protect it with sunscreen that blocks both UVA and UVB rays and has an SPF (Sun Protection Factor) of 15 or higher. According to the American Academy of Dermatology, sun exposure is the number 1 cause of aging skin.

3. Avotone and Hydroderm: A website that claims to have examined over 17 different wrinkle treatment products ranked the two most effective. Avotone was ranked #1, and Hydroderm was #2. Avotone uses acetyl hexapeptide in their cream and costs about $90 for 1 oz. Hydroderm’s ingredients include collagen and costs about $80 for 1 oz.

4. Prescriptives Intensive Rebuilding Moisturizer: The Oprah Winfrey Show featured a segment on anti-aging. Guest dermatologist, Dr. Karyn Grossman, recommended Prescriptives Intensive Rebuilding Moisturizer, a product that she helped develop. Dr. Grossman says, “the progressive build and fill technology of the product works within the skin to strengthen, firm and lift while it also works on the outer layer of the skin to decrease the appearance of surface line and wrinkles.”

5. Neutrogena Healthy Skin Anti-Wrinkle Cream with SPF 15: Neutrogena had high ratings from consumers and is also recommended by a website that claims to review the reviews at consumersearch.com. Neutrogena’s product contains Retinol and a Sun Protection Factor, SPF 15. The cost is about $10 for a 1 oz. tube which is considerably less expensive than the other products listed above.

You could try a less expensive anti-wrinkle cream like Neutrogena rather than spend a lot of money on expensive products whose effectiveness has not been substantiated by scientific studies.

It’s best to prevent aging of the skin by having a healthy lifestyle and protect the skin from the sun. Below are 12 ways below to help prevent wrinkles.