FDA

Has the FDA Warning for Children Under Three Affected General Anesthesia Use in Dentistry?

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An interesting article titled “Prolonged General Anesthesia in a Pediatric Population” was presented on July 21, 2021, at the virtual session of the 2021 International Association for Dental Research (IADR)/AADR/CADR General Session written by Mary Younan and et al. The research sets to investigate if use of prolonged general anesthesia amongst pediatric dental patients has changed since 2016 when the Food and Drug Administration (FDA) came out with guidance that said 3 or more hours of anesthetic exposure, may be a risk factor for cognitive defects, particularly for pediatric patients under 3 years of age. The researchers attempeted to see if a difference exists in the proportion of pediatric dental cases with general anesthesia time 180 minutes pre-FDA to post-FDA warning and to use a root cause analysis to identify factors that contribute to prolonged general anestehsia exposure of children … Read more

FDA warns about dental problems from buprenorphine

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The U.S. Food and Drug Administration (FDA) has issued a safety concern regarding the medication buprenorphine which is a medication used to treat opioid use disorder, acute pain, and chronic pain. Buprenorphine is often used to reduce opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with abusing opioid. The FDA warning issued on January 12, 2022, states that dental problems have occured when patients take medicines containing buprenorphine that are dissolved in the mouth. In the warning, the FDA said that the dental problems can include those of tooth decay, cavities, loss of teeth, and oral infections, and can occur in those without prior dental issues. As a result of this warning, the risk of dental problems occuring will be added to the prescribing information and the patient Medication Guide … Read more

Dental Amalgam Mercury Poisoning: Why Is It Still an Issue?

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This is a guest post written by Harmon Pearson who is currently pursing a post graduate degree in dental science. He  spends time blogging about his pursuits and writing on dental care. When he is not studying, he enjoys restoring antique pendulum timepieces. How is it that in the 21st century we continue to put a known toxic element—mercury—into our mouths?  The question may seem straightforward, but the answer, curiously, is not.  Mercury remains a primary ingredient in dental amalgam, also known as silver fillings.  Other ingredients include copper, silver, tin, and zinc.  These elements when bound with mercury form what’s typically referred to as a stable compound.  It’s hard and resilient to degradation in the mouth environment making it a seemingly ideal compound for replacing small amounts of decayed or removed tooth material.  Because of this, it’s remained a … Read more

Should There Be a Direct-to-Consumer Pharmaceutical Advertising Ban

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An interesting article is written by Lia Mulligan titled “You Can’t Say That on Television: Constitutional Analysis of a Direct-to-Consumer Pharmaceutical Advertising Ban,” which appeared in the 2011 issue of the American Journal of Law and Medicine (vol. 37, pages 444-467). In the article it is mentioned that the average american will watch around 16 hours of pharmaceutical advertisements on TV a year. As mentioned I believe before on this blog the U.S. and New Zealand are the only 2 countries in the world that even allow direct to consumer pharmaceutical advertising (DTCA). I personally do not like this type of advertising and neither do some of my friends. We often make fun of the advertisements when they come on TV as they sometimes can be quite silly. The article mentions in 1969 when the FDA first issued regulations for … Read more

Darvon and Darvocet banned in U.S.

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I find it interesting to hear that the drug commonly known as Darvocet and also similarly Darvon has been banned in the U.S. as of November 19, 2010. The formal name of the drug is Dextropropoxyphene and is in the opiod category of drugs. If you know someone who wants to help a drug addicted friend or loved one, refer them to this website so they can see what they can do to help. This ban came by the FDA in response to research that suggests the drug Darvocet can lead to heart problems such as heart arrythmias. The drug is also known to be addictive and is associated with some deaths. It is commonly prescribed in the treatment of pain. I personally was prescribed darovcet in 2008 in an attempt to treat my chronic 24/7 headache caused by the … Read more