January 12, 2022
The U.S. Food and Drug Administration (FDA) issued a warning today about dental problems that have been reported with medicines containing buprenorphine with formulations that are dissolved in the mouth.
What kinds of problems? The dental problems reported included tooth decay, cavities, oral infections, and even loss of teeth.
Whom do they occur in? These dental problems have been reported even in persons with no past history of dental problems.
“The buprenorphine medicines that are associated with dental problems are tablets and films dissolved under the tongue or placed against the inside of the cheek. They are available as single-ingredient products and also in combination with naloxone. Buprenorphine medicines are marketed under the brand names Belbuca, Bunavail, Cassipa, Suboxone, Subutex, and Zubsolv. They are also available as generics.”
“…recommending that prescribers refer patients to dental care services and encourage them to have regular checkups while taking these products.”
“Patients using buprenorphine medicines dissolved in the mouth should take extra steps to help lessen the risk of serious dental problems. After the medicine is completely dissolved, take a large sip of water, swish it gently around your teeth and gums, and swallow. You should wait at least 1 hour before brushing your teeth to avoid damage to your teeth and give your mouth a chance to return to its natural state. Inform your health care professional if you have a history of tooth problems, including cavities. Schedule a dentist visit soon after starting this medicine and inform your dentist that you are taking buprenorphine, and schedule regular dental checkups while taking this medicine. Your dentist can customize a tooth decay prevention plan for you. Notify both your health care professional and your dentist immediately if you experience any problems with your teeth or gums.”
FDA Drug Safety Communication. FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain.
January 1, 2022
The No Surprises Act is now in effect
December 27, 2021
Generic nefazodone is available again according to the Food and Drug Administration website. See the screenshot below.
December 20, 2021
Intra-Cellular Therapies, the manufacturer of lumateperone (Caplyta®) announced that the United States Food and Drug Administration (FDA) has approved lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults—as monotherapy and as adjunctive therapy with lithium or valproate (emphasis added).
The announcement is at this link.
For more information about this medication, please see the following article on this website:
November 20, 2021
Five years ago this day—on November 20, 2016—we sent out our very first daily email with a high-yield, advanced set of tips on a topic in psychopharmacology. Since then, every single day— 365 days a year, 1826 days in a row without missing a single day—our Members have been receiving powerful strategies to better help their patients.
Simple and Practical Medical Education is now read by thousands of mental health clinicians all around the world. What is amazing is that our Membership has grown to this level almost entirely by word-of-mouth, with virtually no advertising! We are truly grateful to our Members for telling colleagues about how unique and helpful our service is to their clinical work and for encouraging their colleagues to join. Thank you so much!
A special thank you to those of you who have posted reviews on our website at https://simpleandpractical.com/reviews. The reviews are mind-blowing and inspire us to work even harder to deliver the best possible service to you.
To those of you who are in the United States, we wish you and your families a Happy Thanksgiving!
Rajnish Mago, MD Editor, Simple and Practical Medical Education
April 2, 2021
The United States Food and Drug Administration (FDA) has approved a new medication for the treatment of ADHD in pediatric patients 6 to 17 years old—viloxazine extended-release (brand name Qelbree®). Viloxazine is a selective norepinephrine reuptake inhibitor, just like atomoxetine (brand name Strattera®), which has been available for a long time as a treatment for ADHD.
Simple and Practical Medical Education has summarized the basic information about this medication at the following link:
October 22, 2020. New Practice Guideline from the American Psychiatric Association
In case you have not heard already, the American Psychiatric Association’s Practice Guideline for the Treatment of Patients with Schizophrenia, Third Edition (2021), has now been published in its final form. It can be downloaded for free as a PDF by both members of the APA and others at THIS LINK.
October 1, 2020. ABPN makes Pilot Project for Maintenance of Certification permanent
The American Board of Psychiatry and Neurology (ABPN) announced today that the “Article Assessment Pathway” that was being tried out as a “Pilot Project” for three years starting in 2019 has been approved as a permanent alternative to the 10-year Continuing Certification (CC/MOC) examination for meeting the CC/MOC Part III program requirements.
September 23, 2020
The United States Food and Drug Administration (FDA) has announced that for all benzodiazepines, the “boxed warning” will now have to include the potential risks of “abuse, misuse, addiction, physical dependence and withdrawal.”
Similarly, changes to other sections of the official Prescribing Information (Warnings and Precautions, Drug Abuse and Dependence, Patient Counseling Information) will also be required. Lastly, revisions to the Medication Guide that pharmacies give to the patient when dispensing a benzodiazepine will also be required. As of today, the actual wording of the required updates is not publicly available.
It is not clear to me what the actual impact of these new changes required by the FDA will be.
April 29, 2020
Visual-spatial learning disorder is more common than was previously thought.
March 17, 2020
controlled substances to patients for whom they have not conducted an in-person medical evaluation” (source)
A comparison of telepsychiatry platforms
October 16, 2019
It’s OCD Awareness Week!
Every year, the second full week in October is celebrated as OCD Awareness Week. Click on the link below to see all the events the International OCD Foundation is organizing this year. #OCDweek
October 8, 2019
Oasis 2019 Psychiatry Conference
Delivered three lectures—two on bipolar disorders and one on pharmacogenomic testing—at the Oasis 2019 psychiatry conference in San Diego last week that was attended by over 500 psychiatrists. All three lectures were very well received and the amazing thing was that I was answering questions outside the conference room for well over one hour after the talks on bipolar disorder ended. 🙂 Clearly, bipolar disorders continue to be very challenging to treat!
September 30, 2019
International Summit on MAOIs
“Was honored to be invited to deliver a lecture in Mumbai, India, last month about practical aspects of how exactly to prescribe MAO inhibitors.
MAO inhibitors have not been available in India so far but tranylcypromine is being introduced later this year. I’m so glad that psychiatrists in India will finally have the option to consider this important medication in their patients who don’t respond to other commonly used antidepressants. Meanwhile, I am concerned that many psychiatrists in the USA feel that they were not given enough training about MAO inhibitors to be able to prescribe them when needed. This is just one of the many dozens of areas of advanced psychopharmacology that simpleandpractical.com provides help with.”
September 23, 2019
Weight Stigma Awareness Week starts today
September 10, 2019
Five horrifying statistics about suicide
1. Suicide is among the top 10 causes of death in the US (Centers for Disease Control and Prevention, 2017).
2. For adolescents and young adults (10- to 34-year-olds), it is the second most common cause of death (Centers for Disease Control and Prevention, 2017).
3. Of the 10 top causes of death, death from suicide did NOT decrease over the last many years (from 2005 to 2017) even though it decreased for ALL the other nine.
4. Instead, the suicide rate in the US has INCREASED nearly 30% since 1999 (Centers for Disease Control and Prevention).
5. Over 47,000 people died by suicide in the US in 2017, up from about 41,000 in 2013.
June 21, 2019
FDA approves a new medication for a subgroup of women with hypoactive sexual desire disorder
The U.S. Food and Drug Administration announced today that it has granted approval of bremelanotide (brand name Vyleesi™) to AMAG Pharmaceuticals for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
A key point to note is that this is a subcutaneous injection to be used on an as-needed basis. It will be available in an autoinjector and the medication would be injected subcutaneously at least 45 minutes before sexual activity is anticipated.
The full wording of the FDA indication is as follows (emphasis added):
“VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
– A co-existing medical or psychiatric condition,
– Problems with the relationship, or
– The effects of a medication or drug substance.”
The Prescribing Information also notes:
“Limitations of Use:
– Not indicated for treatment of HSDD in postmenopausal women or in men.
– Not indicated to enhance sexual performance.”
Note that the FDA indication is for “hypoactive sexual desire disorder (HSDD)” that is “acquired” and “generalized.” Let’s clarify what these terms mean.
What is hypoactive sexual desire disorder (HSDD)?
HSDD is a DSM-IV diagnosis (now subsumed in DSM-5 under “Female Sexual Interest/ Arousal Disorder“) that is characterized by low sexual desire that is associated with marked distress and interpersonal problems and NOT associated with a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other substance.
What is “acquired” HSDD?
The FDA-approved Prescribing Information says that “Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire.” This is not correct as stated. Actually, it is not that the woman can never have had problems with sexual desire in the past. “Acquired” means that the problem has not been lifelong, that is, present since the woman became sexually active. Instead, the woman had at least some period of time during which she had relatively normal desire and THEN she developed this low desire.
What is “generalized” HSDD?
Generalized HSDD is HSDD that occurs irrespective of the type of sexual activity, situation, or partner.
How is bremelanotide to be administered?
Bremelanotide can be self-administered by injecting under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity.
Patients should not administer bremelanotide more than once per 24 hours or more than eight times per month. If no improvement in sexual desire is experienced after 8 weeks of treatment, patients should discontinue treatment.
What are its potential side effects?
Nausea and vomiting, flushing, injection site reactions, and headache are the most common side effects associated with bremelanotide. Nausea was reported by about 40% of patients and 13% needed medications for the treatment of nausea.
Other side effects include darkening of the gums and part of the skin, especially in patients with dark skin, and increase in blood pressure after dosing which usually resolves in 12 hours.
The FDA’s announcement about the approval of bremelanotide (Vyleesi™) is available HERE.
The full Prescribing Information for bremelanotide (Vyleesi™) is available HERE.
April 11, 2019
Women taking “the Pink Viagra” can now drink (with precautions)
The FDA has modified the safety warning regarding alcohol use in patients taking flibanserin (brand name Addyi®).
Flibanserin is an FDA-approved medication for the treatment of premenopausal women with acquired,
generalized hypoactive sexual desire disorder (see https://simpleandpractical.com/flibanserin-addyi/). The media has sometimes referred to it as the “Pink Viagra.”
Before the change: Cases of severe hypotension and syncope had been reported when flibanserin and alcohol were taken together. So, when flibanserin was first approved by the FDA in 2015, it carried a boxed warning stating that alcohol must be avoided by women taking flibanserin. The clinician prescribing the flibanserin was required to counsel the patient, using a Patient-Provider Agreement Form, about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol while taking flibanserin. The pharmacist was also required to counsel the patient about not drinking alcohol while taking flibanserin.
After the change: The FDA has said that the product label should be changed “to clarify that there is still a concern about consuming alcohol close in time to taking Addyi but that it does not have to be avoided completely.”
According to the FDA’s press release (linked to below), postmarketing trials showed that “the risk of severe hypotension and syncope was reduced when women who consumed up to two alcoholic drinks waited at least two hours before taking Addyi.”
The FDA’s press release notes that “women should discontinue drinking alcohol at least two hours before taking Addyi at bedtime or to skip the Addyi dose that evening. Women should not consume alcohol at least until the morning after taking Addyi at bedtime.”
March 20, 2019
First drug approved by the FDA specifically for postpartum depression
Wow! Two new drugs approved by the US Food and Drug Administration (FDA) for depressive disorders in the same month! What is even more interesting is that both of these have pharmacological effects that are different from the antidepressants that we have been prescribing for decades. On March 5, 2019, the FDA had announced the approval of esketamine (brand name Spravato). Yesterday, the FDA announced the approval of brexanolone (brand name Zulresso) injection for intravenous use for the treatment of postpartum depression.
Note that this is the first medication that has been approved by the FDA specifically for the treatment of postpartum depression.
What is so special about brexanolone? Not that it is more effective than other antidepressants but that it works very quickly–in just a couple of days–so that, if it works, the mother could potentially be back quickly with her baby and with less or no depression.
One limitation is that brexanolone will have to be given as a continuous intravenous infusion over 60 hours, that is, 2.5 days. Also, just like esketamine, brexanolone will also carry a Boxed Warning and will have to be prescribed through a special Risk Evaluation and Mitigation Strategy (REMS) program. What this means is that it will only be available at health care facilities that have been specifically certified through the brexanolone REMS program and the patient’s information will have to be registered with the REMS program before the treatment is given. Why? Why is a special REMS program needed? Because there is a concern that excessive sedation or sudden loss of consciousness can occur while the intravenous injection of brexanolone is being given. Because of this risk, patients will have to be carefully monitored during the infusion and continuous pulse oximetry monitoring will have to be done (which is easy to do, of course). Also, while the infusion is being given, the mother will have to be supervised while interacting with her children.
Other than possible sedation and loss of consciousness, other side effects reported with brexanolone were dry mouth and flushing.
Subscribers to Simple and Practical Mental Health will receive brief summaries about what brexanolone is, how it works, how well it works, and so on.
March 5, 2019
FDA approves esketamine nasal spray (brand name Spravato) for “treatment-resistant depression”
The U.S. Food and Drug Administration (FDA) announced today that it has approved esketamine nasal spray (brand name Spravato) for marketing in the US. Here are some basic details about this medication:
– What is esketamine? It is one of the two enantiomers in the medication ketamine, which has been available in the US since 1970 and is FDA-approved for use as a general anesthetic.
– Esketamine nasal spray is approved for the treatment of major depressive disorder in persons who have taken other antidepressant medications but have not benefited from them, so-called “treatment-resistant depression.”
– It is approved not for monotherapy but for adjunctive use along with an oral antidepressant medication.
– It is approved for use in adults only
– Not everyone will be able to prescribe esketamine nasal spray. Similar to medications like clozapine and flibanserin, esketamine nasal spray will only be available by prescription from clinicians registered under a Risk Evaluation and Mitigation Strategy (REMS) program. This is because serious adverse events can occur due to sedation and dissociation caused by esketamine and due to the potential for abuse.
– The manufacturer of Spravato is Janssen Pharmaceuticals, Inc., a division of Johnson & Johnson.
– Members of Simple and Practical Mental Health will receive a detailed review of this medication, the research behind, the potential risks, and so on.
The FDA’s announcement is available at the link below:
The full Prescribing Information is available at the link below:
Disclosure: Dr. Mago bought some J&J stock (less than $7000 worth) and, as in almost all his investments, has lost money on it! 🙂 He does not have any other association, financial or otherwise, with Janssen Pharmaceuticals, Inc, or its parent company, Johnson & Johnson.
Feb 13, 2019
Esketamine nasal spray on verge of being approved by the FDA
The FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee have voted in favor of approving esketamine nasal spray (brand name Spravato) for approval to treat major depressive disorder that not responded to other treatments. The exact wording of the indication will be announced if the drug is approved. What also remains to be seen is what special precautions or Risk Evaluation and Mitigation Strategy (REMS) the FDA will require. The FDA’s decision is expected on March 4, 2019, but the FDA usually follows the advice of its advisory committees. For details of the announcement and for the full document that was presented to the committees, see the links below:
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