By Margarita Nahapetyan
Medical professionals in Australia are giving pregnant women their warning to avoid Botox injections and other wrinkle treatments made with botulinum toxin. The warning came after the report by the Sydney Morning Herald about a case in which a child born deaf and blind was linked to the mother's use of Dysport, an anti-wrinkle treatment similar to Botox, during her pregnancy.
Several botulinum toxin treatments are presently approved for use in the United States. Even though Botox, which like Dysport is made with botulinum toxin Type A, the most toxic protein known, it is still widely used in a number of cosmetic treatments both in an isolated and a processed form. Mainly, Botox is employed for the anti-wrinkle treatments and is approved for treatment of conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe spasms of neck muscles), and severe primary axillary hyperhydrosis (excess sweating).
Dysport, in its turn, is not yet approved as a treatment in the United States, but the drug's manufacturer has submitted an application to the U.S. Food And Drug Administration (FDA) in hope to get approved by mid-2009 to market the drug as a treatment for cervical dystonia. In addition, the maker of Dysport is seeking approval for Reloxin, another version that is being used to treat wrinkles.
However, last year, the Australian Federal Health and Aging Department released documents that detailed the case of a baby who was born deaf and blind in November 2005 after the mother was given Dysport during the first few weeks of her pregnancy. A 2006 report on the Australian birth defect case, written by the medical services manager for Dysport manufacturer Ipsen, admitted a "possible" connection with the use of the drug.
On Tuesday, The Cosmetic Physicians Society of Australasia (CPSA) gave its warning to the physicians to avoid using Botox and similar products on future mothers-to-be. "Botulinum toxin should not be prescribed to pregnant women and we advise our members to strictly follow these guidelines," said the CPSA's Dr. Gabrielle Caswell in a statement. "... there are some circumstances, such as during pregnancy, breastfeeding, glaucoma and neuromuscular disease where it is not an appropriate medication."
According to Australia's Therapeutic Goods Administration, botulinum type A toxin can have 46 different side effects, and birth defect is listed as one of these 46 side effects. It is important to know that if a woman considers to undertake any kind of beauty treatment that involves the use of Botox, she must consult a doctor or a recognized cosmetician first, Caswell said and also emphasized that such treatments should be taken only from recognized and registered institutes.
"There is information posted on the internet, primarily from other countries where health regulation standards may not be equal to Australia's. It is important that women who are, or may be, pregnant realize that the health of the foetus ought to be of paramount concern," Caswell said.
There is not enough of controlled studies into the effects of Botox on pregnant women and their unborn babes, therefore it is impossible to say for sure whether it is safe or not. For the sake of erring on the side of caution, Botox's manufacturers recommend that it is not used either during pregnancy or while breastfeeding. As with the effects during pregnancy, there is a lack of information on whether Botox injections can pass the toxin into breast milk.
Los Angeles facial plastic surgeon Michael A. Persky, MD said that "there have not been any studies showing that Botox is responsible for birth defects." "With the millions of women who have received Botox injections, it stands to reason that many have received treatment in the first week or two of their pregnancy before they were aware that they were pregnant. That having been said, this is exactly the reason why it is not recommended to have Botox injections when pregnant," he elaborated.
Botox injections beneath the skin work by weakening or paralyzing muscles or blocking nerves, thus causing wrinkles and lines to be less visible. The effects usually last for about three to four months. Part of the reason there is so little research about cosmetic procedures during pregnancy is that in order to weigh the effects of the process, doctors and scientists would have to actually perform the procedures on pregnant women. And "nobody really wants to study drugs during pregnancy, unless it is something that is life saving," said Roxanne Guy, the former president of the American Society of Plastic Surgeons. "This is because you would always worry that there may be some bad outcome for the baby."