FDA Issues Alert to Prevent Lidocaine 2 Percent Solution to Not be Used for Teething Pain for Children
Posted on 23. Aug, 2014 by wisdom.
On June 26, 2014, the FDA issue an alert warning health professionals and providers that “…prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain.” The FDA says that topical pain relievers and other medications that are rubbed on the gums are not useful for infants because they wash out of the mouth within minutes. Furthermore, when too much viscous lidocaine is given to children and is swallowed it can result in brain injury, seizures, heart problems, and even death.
The FDA alert is located over at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402790.htm. In the background information it states
“In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions.”
The FDA advises that parents should follow the American Academy of Pediatrics’ recommendations to treat teething pain. This includes used a chilled teething ring and having the parent gently rub or massage the child’s gums. Furthemore, the FDA advises against using any over the counter topical medication to treat teething pain.
According to DrBicuspid the “The American Academy of Pediatric Dentistry recommends that all children have their first dental visit as soon as teeth begin to come in, and no later than age 1, which provides the dentist with an opportunity to chat with parents and caregivers about proper tooth care…” Further, they remind parents that teething pain is a normal part of childhood. See AAPD issues statement on FDA lidocaine alert, July 1, 2014, http://www.drbicuspid.com/index.aspx?sec=log&URL=http%3a%2f%2fwww.drbicuspid.com%2findex.aspx%3fsec%3dnws%26sub%3dthd%26pag%3ddis%26itemId%3d315995
As a result of the FDA alert, they are also requiring a new Boxed Warning to be added to lidocaine 2 percent solution to highlight the information in their alert. In the alert the FDA also reminds individuals about a previous alert in 2011 where over-the-counter benzocaine teething preparations can cause methemoglobinemia, a rare but serious blood condition. This results in a large decrease in oxygen carried in the blood.
If you keep abreast at all with radiation exposure from medical imaging, you may have heard of the Image Wisely campaign. The Imagely Wisely Campaign was designed to have people aware of the fact that certain medical imaging tests such as CT exams are sometimes over used and do not have to be used in certain instances. The goal is to reduce radiation exposure to patients while still providing good medical care, see http://www.imagewisely.org/. The Image Gently campaign is designed to provide information to parents and others to help reduce exposure to radiation for children, see http://imagegently.org/, and has been around since 2007.
The campaign is supported by the Alliance for Radiation Safety in Pediatric Imaging, which is a coalition of healthcare organizations dedicated to providing safe and high-quality pediatric imaging. Recently, it has been announced that a new Image Gently campaign in dentistry will be launched in September, 2014. The Image Gently alliance partners in dentistry consist of groups such as the American Dental Association and American Association of Oral and Maxillofacial Surgeons.
The campaign states that radiographic selection should be based on professional judgment after taking a history and clinical examination. The campaign says that x-rays should be selected for individual needs and not used routinely. For example, if proximal surfaces of the teeth can be visually inspected then it is not necessary to take bitewing radiographs. The campaign states that imaging should be done that generates images the fastest (while of course preserving quality). For intraoral radiography F-speed should be used and for digital imaging the exposure parameters should be set as low as possible to preserve diagnostic ability. The campaign says that the beam should be collimated to the area of interest.
Other insights from the Image Gently campaign in dentistry include using thyroid collars when imaging children and using less exposure time for children than adults. The campaign also says that cone-beam CT should only be used when it is essential for diagnosis and treatment. This is because it can cause more additional radiation exposure than alternative methods.
I have previously commented on using x-rays for wisdom teeth diagnosis and planning see http://www.teethremoval.com/wisdomteeth.html.
Source: Allan Farman. DrBicuspid. Image Gently in Dentistry: Child-size x-ray dose for kids. July 28, 2014. http://www.drbicuspid.com/index.aspx?sec=log&URL=http%3a%2f%2fwww.drbicuspid.com%2findex.aspx%3fsec%3dnws%26sub%3dkwd%26ItemID%3d316116
Posted on 09. Aug, 2014 by wisdom.
The American Dental Association also know as the ADA, in 2012, update their Principle of Ethics and Code of Professional Conduct document. It is available over at http://www.ada.org/~/media/ADA/About%20the%20ADA/Files/code_of_ethics_2012.ashx. As many Americans make trips to the dentist, it is useful to familiarize yourself with the ADA’s document to better determine if your dentist is being ethical and serving your needs well. If you don’t feel this is the case you have options to report your dentist and of course you can find a new dentist.
Additional comments on the ethics and professional conduct of the ADA and it’s members is over at http://www.ada.org/en/about-the-ada/principles-of-ethics-code-of-professional-conduct. It states
“The dental profession holds a special position of trust within society. As a consequence, society affords the profession certain privileges that are not available to members of the public-at-large. In return, the profession makes a commitment to society that its members will adhere to high ethical standards of conduct… The ADA Code is, in effect, a written expression of the obligations arising from the implied contract between the dental profession and society.”
It should be noted that the position is that ADA members voluntarily agree to abide by the code. Further the code falls into three main components: The Principles of Ethics, the Code of Professional Conduct and the Advisory Opinions. There are five fundamental principles that form the ADA code: patient autonomy, nonmaleficence, beneficence, justice and veracity. The updated 2012 document is 24 pages, so I encourage you to read it, I will just point out a few things below.
Regarding the principle of nonmaleficence (do no harm), there is a description on postexposure, bloodborne pathogens (2E). It states
“All dentists, regardless of their bloodborne pathogen status, have an ethical obligation to immediately inform any patient who may have been exposed to blood or other potentially infectious material in the dental office of the need for postexposure evaluation and follow-up and to immediately refer the patient to a qualified health care practitioner who can provide postexposure services.”
Unfortunately cases have occurred where dentists and/or oral surgeons have exposed patients to bloodbourn pathogens including HIV and hepatitis C. See the Acquired Infection section of the wisdom teeth removal complications page over at http://www.teethremoval.com/complications.html. See also http://blog.teethremoval.com/dental-patients-warned-of-possible-hiv-and-hepatitis-exposure-in-pennsylvania/ for a more recent potential bloodbourn pathogen exposure case occurring in Pennsylvania.
Regarding the principle of nonmaleficence (do no harm), there is a description on patient abandonment (2F). It states
“Once a dentist has undertaken a course of treatment, the dentist should not discontinue that treatment without giving the patient adequate notice and the opportunity to obtain the services of another dentist. Care should be taken that the patient’s oral health is not jeopardized in the process.”
Unfortunately, there have been cases where dentists and/or oral surgeons have abandoned the patient during treatment and jeopardizing their health in the process (beyond just their oral health). See the Other Unfortunate Occurrences section of the wisdom teeth removal complications page over at http://www.teethremoval.com/complications.html. As such, in the past I have advocated for video taping any treatment that occurs as patient abandonment can occur with the idea of preventing a lawsuit see http://blog.teethremoval.com/how-to-improve-your-chances-to-win-a-dental-malpractice-lawsuit/. Further, I also have advocated to have a backup oral surgeon or dentist to visit in case the first stops treating you while you still need treatment.
Going back to the ADA code and the principle of veracity (truthfulness) there is a description of advertising (5F). It states
“Although any dentist may advertise, no dentist shall advertise or solicit patients in any form of communication in a manner that is false or misleading in any material respect”
Later in 5.F.2 some examples of what is false and misleading is provided
“…statements shall be avoided which would: a) contain a material misrepresentation of fact, b) omit a fact necessary to make the statement considered as a whole not materially misleading, c) be intended or be likely to create an unjustified expectation about results the dentist can achieve, and d) contain a material, objective representation, whether express or implied, that the advertised services are superior in quality to those of other dentists, if that representation is not subject to reasonable substantiation.”
Of course, as I have mentioned or at least hinted at in a previous blog post and discussions is the definition of what is considered material see http://blog.teethremoval.com/the-well-informed-patient/. In this post it states
“A risk is material if the physician believes that a reasonable person in the patient’s position ‘would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.”
This is rather subjective and hence a large gray area occurs. Hence it is important to remember what one patient may interpret to be false or misleading in a material respect may be different than another. Further, the law may not be on your side here.
The ADA code later states
“Anyone who believes that a member-dentist has acted unethically should bring the matter to the attention of the appropriate constituent (state) or component (local) dental society. Whenever possible, problems involving questions of ethics should be resolved at the state or local level.”
If you suspect your dentist is not following the ADA code you best familiarize yourself with it to better determine if you are correct or incorrect. It may also help improve your relationship with your current dentist or possibly lead you to a new dentist.
Posted on 01. Aug, 2014 by wisdom.
Recently, it has come to my attention that Elsevier will be bringing some new journal offerings to the dental community.
The first offering is with the open access Oral and Maxillofacial Surgery Cases journal. The website for the journal is over at http://www.oralandmaxillofacialsurgerycases.com/. There is a $500 fee to publish an article in the journal. The site states
“Oral and Maxillofacial Surgery Cases is a surgical journal dedicated to publishing case reports and case series only which must be original, educational, rare conditions or findings, or clinically interesting to an international audience of surgeons and clinicians. Case series can be prospective or retrospective and examine the outcomes of management or mechanisms in more than one patient. Case reports may include new or modified methodology and treatment, uncommon findings, and mechanisms. All case reports and case series will be peer reviewed for acceptance for publication in the Journal.”
There is an online submission system available and the editor in chief of the journal is Janice. S. Lee.
The second offering that Elsevier will bring is by publishing JADA (The Journal of the American Dental Association). This is discussed in an August 1, 2014, JADA article titled “ELSEVIER CHOSEN TO PUBLISH THE JOURNAL OF THE AMERICAN DENTAL ASSOCIATION” (vol. 145, no. 8, pp. 803). Elsevier will begin publishing JADA in January, 2015. Michael Glick, JADA editor since 2005, states in the article
“A publishing relationship with Elsevier will allow JADA to maintain its leading role in guiding and shaping the direction of our profession—furthering dentistry’s efforts in the prevention and treatment of oral disease.”
It is believed that the relationship will help improve JADAs international standing amongst dental journals. Further, it is believed that such a relationship can improve patient care by better serving clinicians and researchers.
I hope that both new offerings by Elsevier to better serve the dental community will be positive and help further advance patient care in dentistry.
A study appearing by researchers in Neurology explores whether migraines limit the educational and career achievements of individuals which can lead to a lower income status. The study also explores whether problems related to low income such as stressful life events and poor access to health care increase the likelihood of developing migraines.
The researchers used data from the American Migraine Prevalence and Prevention Study, a US national sample containing responses of 162,705 men and women aged 12 and older who had some migraine symptoms able to be identified, their age, and household income. The authors defined low income as less than $22,500 per year for the household and high income as $60,000 per year or more.
The researchers found the remission rate when migraines stop occurring for a time or for good was the same regardless of income. The researchers point out though that it is possible migraines start due to different reasons than for stopping.
The researchers confirmed that the percentage of people with migraine is higher among those in lower income groups. Looking at women aged 25 to 34 with migraine the researchers found 20% having achieved high income, 37% having achieved middle income, and 37% having achieved low income. For men aged 25 to 34 with migraine the researchers found 5% having achieved high income, 8% with middle income, and 13% with low income
Walter F. Stewart, one of the study authors states
“New evidence from this study shows that a higher percentage of people have migraine in low income groups because more people get migraine, not because people in lower income groups have migraine for a longer period of time.”
The main conclusion from this study is that the duration of time people have migraine is not dependent on their income; however, it seems plausible that making less money plays a role in the development of migraine. The researchers are interested in finding these possible factors that can be playing a role.
In my opinion, having frequent migraines could potentially prevent people from achieving as much success in their career as someone without any headaches.
Reference: Walter F. Stewart, Jason Roy, and Richard B. Lipton, “Migraine prevalence, socioeconomic status, and social causation,” Neurology, vol. 81, no. 11, pp. 948-955, September 10, 2013.