December 2, 2017
On Nov 30, 2017, US Food and Drug Administration (FDA) has granted approval to Indivior Inc. for marketing the first once-monthly buprenorphine injection for moderate-to-severe opioid use disorder. The brand name is Sublocade.
As you know, buprenorphine has been available in three forms for the treatment of opioid use disorder:
1. A sublingual formulation by itself (now only available as a generic but previously under brand name Subutex)
2. A sublingual formulation along with naloxone (brand name Suboxone)
3. A subdermal implant that lasts for six months (brand name Probuphine)
The new, once-monthly injectable formulation (brand name Sublocade) adds to the options available. The FDA-approval of Sublocade is welcome news, especially in view of the ongoing “opioid crisis”. Since medication nonadherence is common and associated with higher relapse rates, some patients may benefit from receiving a once-monthly injection of buprenorphine.
To be on the once-monthly buprenorphine injection, patients have to have been on sublingual buprenorphine for at least seven days.
The once-monthly injection will be available as a pre-filled syringe. The solution forms a deposit or depot in body after being injected subcutaneously. Note: unlike long-acting injections of antipsychotics, this is not an intramuscular injection. The depot of buprenorphine breaks down over time and provides therapeutic levels of buprenorphine over an entire month.
To prescribe Sublocade, the clinician will have to complete training and certification in a Risk Evaluation and Mitigation Strategy (REMS) program.
Here is the link to FDA’s announcement:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587312.htm
Here is the link to Prescribing information:
https://www.sublocade.com/Content/pdf/prescribing-information.pdf
November 15, 2017
On November 15. 2017 United States Food and Drug Administration (FDA) granted Innovative Health Solutions, Inc. approval for marketing their Bridge Neurostimulation System for a new indication of reducing the symptoms of opioid withdrawal.
The introduction of this new indication for this device is significant in view of the current opioid epidemic and the need for more treatments for opioid dependence.
The NSS-2 Bridge (Bridge Neurostimulation System) is a small device that is placed behind the patient’s ear. It works by emitting electrical pulses to stimulate the branches of certain cranial nerves to reduce the symptoms associated with opioid withdrawal. This device is intended for use for up to five days during the acute withdrawal phase to provide relief from opioid withdrawal symptoms such as sweating, gastrointestinal upset, agitation, insomnia, joint pain, etc.
The FDA approval was based on data from single-arm study of 73 patients. Results from the study showed that the device was associated with 31% reduction in clinical opiate withdrawal scale (COWS) score within 30 minutes of using the device in all the patients.
The contraindications to use of the device include presence of a cardiac pacemaker.
Here is a link to the FDA announcement:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm585271.htm
Here is a link to the manufacturer’s website that includes Frequently Asked Questions for patients:
November 14, 2017
On November 13, 2017, the United States Food and Drug Administration (FDA) has approved Abilify MyCite, a pill which can digitally track whether the patients have taken their medication or not.
Abilify MyCite (aripiprazole with sensor) consists of aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. When the tablet containing the drug and the sensor is swallowed and comes in contact with the stomach fluids, the sensor is activated and can send that information as a signal to wearable patch.
The patch can then transmit that information to an app on a smartphone which enables patients to keep track of ingested medication. The patients can also authorize and share with their caregivers or physicians (via a web-based portal), data showing the date and time that they took the pills.
The pill is a collaboration between Otsuka pharmaceuticals, the manufacturer of Abilify and Proteus Digital Health, the company that created the sensor used in the pill.
Abilify MyCite is FDA-approved for the same indications as Abilify is, i.e, treatment of schizophrenia, acute treatment of manic and mixed episode with bipolar I disorder and for adjunctive treatment of major depressive disorder in adults.
Here is a link to the FDA’s announcement:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm584933.htm
Here is a link to the Prescribing Information:
https://www.otsuka-us.com/media/static/ABILIFY-MYCITE-PI.pdf
October 9, 2017
Simple and Practical Mental Health proudly welcomes Anita Clayton, MD, to the Editorial Board of Simple and Practical Mental Health.
For a full list of the members of our Editorial Board, please see https://simpleandpractical.com/editorial-board
October 2, 2017
Effective October 1, 2017, a few small changes have been made to the ICD-10 codes for several Substance Use Disorders and for Avoidant/Restrictive Food Intake Disorder.
The American Psychiatric Association has listed these changes in a simple table format that can be accessed at this link:
https://www.psychiatry.org/Psychiatrists/Practice/DSM/Updates-to-DSM
September 23, 2017
We are delighted to announce the addition of two learned and prominent experts in psychiatry, Dr. Henry Nasrallah, MD and Dr. Mark Zimmerman, MD to the Editorial Board of Simple and Practical Mental Health.
For further details and for a full list of the members of our Editorial Board, please see https://simpleandpractical.com/editorial-board
September 16, 2017
Celebrating the sending out of the first 300 summaries on advanced psychopharmacology by email to members of Simple and Practical Mental Health!
Yes, one per day, 365 days a year. It’s a tremendous amount of work for me to provide simple, short, authoritative answers to these clinical questions, but it saves our members a ton of time and is a huge asset to their clinical work.
What were the topics in advanced psychopharmacology covered in these first 300 summaries? Check it out at:
https://simpleandpractical.com/365
August 30, 2017
On August 30, 2017, the US FDA approved deutetrabenazine (brand name Austedo®) for the treatment of tardive dyskinesia in adults. Deutetrabenazine is already FDA-approved for the treatment of chorea associated with Huntington’s disease.
This is the second medication ever approved the FDA for the treatment of tardive dyskinesia. The first was valbenazine (Ingrezza®), which was approved on April 11, 2017.
What is deutetrabenazine?
Like tetrabenazine and valbenazine, it is a vesicular monoamine transporter 2 (VMAT2) inhibitor. It is actually an isomer of tetrabenazine in which hydrogen is replaced by deuterium. This changes the pharmacokinetic properties of the drug.
For more information on this medication, see Deutetrabenazine (Austedo®): Basic Information
Aug 6, 2017
Should you order genetic tests before prescribing psychotropics? This topic was one of the hotly debated topics in 2017 APA annual meeting in San Diego. Here is an article on important factors to consider when ordering genetic tests before prescribing psychotropics.
http://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2017.pp6a2
July 19, 2017
Atomoxetine (brand name Strattera®) is an important treatment for ADHD in both children and in adults.
On May 30, 2017, with the expiration of the patent, generic atomoxetine was approved by the FDA. Several companies are making it and it is now available in pharmacies.
Once generics are available, the cost of a medication gradually goes down over time. So, I compared the cost of brand name and generic atomoxetine (30 pills) on goodrx.com on July 19, 2017.
Atomoxetine 40 mg: Brand name $450 (approximately); Generic $150 (approximately).
Atomoxetine 80 mg: Brand name $485 (approximately); Generic $170 (approximately)
So, the price has already gone down to a third of what it was. That’s good news!
April 11, 2017
On April 11, 2017, the U.S. Food and Drug Administration (FDA) approved the first medication ever approved for the treatment of tardive dyskinesia–valbenazine (Ingrezza®)–that was developed by Neurocrine Biosciences, Inc. Valbenazine is a selective inhibitor of vesicular monoamine transporter 2 (VMAT2).
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm552418.htm
July 7, 2016
Buprenorphine is a very important treatment for opioid dependence and can be prescribed to outpatients for this purpose. Using medication to treat addiction to various substances is called Medication Assisted Treatment (MAT).
However, under the Drug Addiction Treatment Act (DATA) of 2000, the prescribing clinician needs to undergo special training and use a special license number. Also, until now, one prescribing clinician was not allowed to prescribe buprenorphine for opioid dependence to more than 100 patients.
This week, the US government has nearly tripled that limit to 275 patients per year. This is likely to allow a lot more patients to get MAT with buprenorphine.
This increase will become effective on August 5, 2016.
Unfortunately, each clinician who is licensed to prescribe buprenorphine will have to apply to have the limit increased, which is a bit of a nuisance.
Even under existing rules, the initial limit is only 30 patients per year. After that, clinicians must apply to SAMHSA to request an increase in the limit to up to 100 patients per year. This can only be done one year after the initial licensing.
The form to apply for an increase in the limit is available at the link below:
July 6, 2016
Last week, a Philadelphia jury awarded $70 million to a teenager who sued Johnson & Johnson, blaming their drug risperidone (Risperdal) for causing gynecomastia.
The jury said that the company failed to properly warn the patient and his family that the drug could cause him to grow female-size breasts. The damages were in part for emotional distress cause by this side effect.
J & J has lost several such cases. Last year, a jury awarded another patient $2.5 million for a similar situation.
There are about 1500 cases pending in Philadelphia that are related to risperidone causing gynecomastia.
Prescribing clinicians should be careful to warn patients about this potential adverse effect and to document the risk.
http://www.reuters.com/article/us-health-johnsonandjohnson-verdict-idUSKCN0ZH5UL
May 27, 2016
The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. Probuphine is designed to provide a constant, low-level dose of buprenorphine for six months in patients who are already stable on low-to-moderate doses of other forms of buprenorphine, as part of a complete treatment program.
For details, see:
May 5, 2016
On May 5, 2016, new regulations were announced allowing the FDA to regulate e-cigarettes and other tobacco products (e.g., hookahs) just like cigarettes are regulated.
The definition of tobacco products has been broadened to include e-cigarettes, hookahs, pipe tobacco, premium cigars, etc.
The new rule will require companies to state the ingredients in their products, but products on the market since 2007 are excluded.
Manufacturers of these products are now required to register with the FDA and to put health warnings on their packages and in any advertisements.
For the FDA’s rules about “Vaporizers, E-Cigs, and other Electronic Nicotine Delivery Systems (ENDS)” see:
http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm
March 31, 2016The FDA has declined to add new data to the label for Brintellix (vortioxetine) supporting use of the drug for treatment of cognitive dysfunction in adults with major depressive disorder.
October 10, 2015
On October 5, 2015, the United States Food and Drug Administration approved aripiprazole lauroxil (Aristada) for the treatment of schizophrenia in adults. But, wait a minute! Don’t we already have long-acting aripiprazole – Abilify Maintena? Yes, we do. Abilify Maintena is marketed by Otsuka America Pharmaceutical, Inc in partnership with Lundbeck. Now the product has a competitor: Aristada, long-acting aripiprazole made by another company, Alkermes. Otsuka’s petition to the FDA to block approval of Aristada was denied. Alkermes, by the way, is well-known for its expertise in drug delivery technology, including long-acting injections.
Are there any potential advantages of Aristada over Abilify Maintena? Some small ones:
1. Aristada will come in a pre-filled syringe that does not require reconstitution. It only requires some tapping and shaking to make sure the contents are well mixed prior to injection. On the other hand, Abilify Maintena comes in dual chamber syringe. One chamber contains powder and the other contains the diluent. Prior to administration, the diluent has to be released into the other chamber by twisting the plunger. Thus, Aristada will be a bit easier to administer.
2. Aristada comes in 3 strengths while Abilify Maintena comes in only 2 strengths. So, a bit more dose flexibility with Aristada.
3. At its highest dose (882 mg), there is an option to give Aristada every 6 weeks while Abilify Maintena has to be given every 4 weeks.
According to Reuters, the sales of long-acting injectables for the treatment of schizophrenia in the US is expected to more than double to $3 billion by 2020. It is predicted that Aristada will have 16% of that market, which is still a lot of money!
Long-acting injectable antipsychotics are important mainly because of the widespread problem of non-adherence to medication. For an overview of the six long-acting injectable antipsychotics now available in the US and then for how aripiprazole lauroxil (Aristada) is to be used, see
https://simpleandpractical.com/long-acting-injectable-antipsychotics/
(If you are not already signed up for FREE tips, news, and updates from this website, please enter your email address HERE. Don’t miss out on this opportunity!).
August 18, 2015
The U.S. Food and Drug Administration (FDA) today approved flibanserin (brand name Addyi, pronounced add-ee) for the treatment of “acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.”
For more information what this drug is, what this disorder is, and a big potential problem with use of this drug, see
https://simpleandpractical.com/
August 13, 2015
August 6, 2015
Like other antidepressants, duloxetine (brand name Cymbalta) can be associated with a discontinuation (“withdrawal”) syndrome. While this is usually mild-to-moderate, in many cases the symptoms can be quite distressing and can include suicidal thinking.
Hundreds of lawsuits have been filed against Eli Lilly & Co, the manufacturer of Cymbalta, alleging that patients were not adequately warned about the withdrawal symptoms that may occur when Cymbalta is stopped.
The court cases argue that withdrawal symptoms are much more common than Eli Lilly reported and that Eli Lilly and Co deliberately minimized the risk of withdrawal symptoms.
The first few court cases are always crucial in situations such as these because they usually predict what happens to the other cases. Eli Lilly did win one of these early cases in New York in 2014, but several hundred similar cases have been filed and are starting up all over the country.
So what does the FDA-approved product information about Cymbalta say about discontinuation or withdrawal symptoms? What warnings are provided and what are prescribers encouraged to do? For a short summary, see Antidepressant Discontinuation or Withdrawal
July 16, 2015
I have always been very frustrated by how so little of the published research has any actionable items. The hardest part of my job as editor of GME research review is to find five articles each month that have any actionable utility. So, I was pleased when I got the following message in an email today:
BioMed Central has launched a new journal with a unique peer-review model to recognize the importance of public input in co-producing knowledge. “Research Involvement and Engagement” has an Editorial Board that is representative of both patients and academics, with all articles peer reviewed by both groups and carrying equal weight in the Editorial decision.
For the launch, the journal published a study revealing that research on treatments for health problems, such as diabetes, stroke and schizophrenia, was not being focused on the treatments considered most important by patients and clinicians. Co-authored by Iain Chalmers, one of the founders of the Cochrane Collaboration, the study suggests that current research is instead favoring drug treatments over physical or psychological therapies, the latter of which are priorities for patients and clinicians.
April 28, 2015
The Food and Drug Administration (FDA) today approved the first generic versions of aripiprazole equivalent to Otsuka’s Abilify. The four generic manufacturers who received this approval are: Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals, and Torrent Pharmaceuticals Ltd.
These companies will market generic aripiprazole in a variety of doses and forms. Brand name Abilify is available as:
Aripiprazole Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg
Aripiprazole Oral Solution, 1 mg/mL
Aripiprazole Orally Disintegrating Tablets, 10 mg and 15 mg
Aripiprazole Injection, 7.5 mg/mL
Brand name Abilify has an FDA-approved indication for the treatment of Tourette’s disorder in pediatric patients, which is protected by orphan drug exclusivity. However, the FDA rejected Otsuka’s argument that because of this, generics should not be approved until the orphan drug exclusivity ends. The FDA-approved labeling for the generic versions of aripiprazole will simply have the labeling for pediatric Tourette’s disorder removed from them. We can assume that approval of multiple generics will significantly bring down the cost of aripiprazole.
April 23, 2015
Deaths due to overdose on prescription opioid medications in the USA had quadrupled between 1999 and 2010. Two things were done in 2010 in response to this huge problem. Firstly, OxyContin was changed to a different formulation that is difficult to abuse because it is hard to crush and dissolve for snorting or injecting. Secondly, propoxyphene was withdrawn from the market. What do you think happened?
A study just published in April 2015 found that after these changes, opioid prescribing showed a sudden and significant decrease. The good news is that the (estimated) overdose rate attributed to prescription opioids has decreased by 20%, but the bad news is that (estimated) rate of heroin overdose has increased by 23%.
Larochelle MR, Zhang F, Ross-Degnan D, Wharam JF. Rates of Opioid Dispensing and Overdose After Introduction of Abuse-Deterrent Extended-Release Oxycodone and Withdrawal of Propoxyphene. JAMA Intern Med. 2015 Apr 20. doi: 10.1001/jamainternmed.2015.0914. [Epub ahead of print] PubMed PMID: 25895077.
February 1, 2015
In the last few weeks, those of you who prescribe Concerta may have noticed that many pharmacies either declined to fill it or asked for it to be written as “methylphenidate ER,” or asked you to specifically write that the generic from a particular generics manufacturer could be filled. In the past, when we prescribed Concerta, pharmacies would automatically fill the generic without a problem.
I was told by a pharmacist that this is because the FDA has determined that generics from some manufacturers are not considered equivalent to Concerta. A colleague and friend, Lalit Chaube, MD, has clarified what the real issue is and offered good advice: If you prescribe Concerta, then the pharmacist can only substitute with FDA approved generic. If you prescribe methylphenidate ER, then the pharmacist can substitute with any generic. The catch is that some generics have been found to have a greater variation from brand name and have been downgraded by the FDA but not pulled off the market. That is the real reason why pharmacies want you to write for methylphenidate ER and not Concerta. Dr. Chaube asks how, knowing this background, we can ethically prescribe methylphenidate ER? When a pharmacy tells you that they cannot fill the generic if you wrote for Concerta, it really means that they only carry the generic that has been determined to be inferior! Tell your patient, as Dr. Chaube did, to go to a different pharmacy. Once we stand up for our patients, the pharmacies will be forced to carry better quality generics.
Please share this information with all your colleagues by email and on social media by clicking on the icons to the right or the icons at the bottom of this page. Thanks in advance for doing so!
December 7, 2014
The United States Food and Drug Administration (FDA) is changing some regulations regarding “labeling” (i.e., the FDA-approved description) of prescription drugs and biological products.
The changes are both in the content and the format. I have summarized them here to make the main points easier to understand and have added a few comments of my own.
These changes apply to how information is provided about the risks and benefits of use of these products:
a) During pregnancy and lactation, or
b) By females and males of reproductive potential.
1. Under the “Use in Specific Populations” section, three subsections, “Pregnancy,” “Labor and delivery,” and “Nursing mothers” will be deleted. The new subsections will be called, “Pregnancy,” “Lactation,” and “Females and Males of Reproductive Potential.” The information previously under the “Labor and delivery” subsection will now be included in the “Pregnancy” subsection.
2. The pregnancy categories A, B, C, D, and X have been removed.
Comment: Most people will approve of this change, I think, since for a long time I have heard complaints that these letter categories oversimplify the data and have not kept up with emerging research. The announcement also notes that, “…FDA learned that the pregnancy categories were heavily relied upon by clinicians but were often misinterpreted and misused in that prescribing decisions were being made based on the pregnancy category, rather than an understanding of the underlying information that informed the assignment of the pregnancy category.”
Does it surprise you that the previous law was not that helpful and had unintended consequences? For another obvious example, see the unintended consequences of the FDA’s warnings about increased risk of suicidality with antidepressants. Now, here’s the trick question: are you saying to yourself that the new law makes a lot of sense and will probably be a significant improvement?
3. Anyway, back to summarizing the changes. Instead of the letter categories, there will now have to be:
a) A summary of the risks of using a drug during pregnancy and lactation
b) A discussion of the data supporting that summary
c) Relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and lactation.
d) Relevant information about pregnancy testing, contraception, and infertility for health care providers prescribing for females and males of reproductive potential.
4. There are now quite specific requirements about what the document needs to say. The manufacturers will have to choose the applicable wording from among specific choices given to them by the FDA. Here is an example that I quote without comment:
If the drug is absorbed systemically, require the following under the subheading “Risk Summary”: A description of the presence of the drug in human milk in one of the following ways: (1) The drug is not detectable in human milk, (2) the drug has been detected in human milk, (3) the drug is predicted to be present in human milk, (4) the drug is not predicted to be present in human milk, or (5) the data are insufficient to know or predict whether the drug is present in human milk.
The changes will come into effect on June 30, 2015. These new rules are part of a broader effort by the FDA to improve the content and format of prescription drug labeling. It is claimed that these revisions will help prescribers in counseling these populations.
I didn’t even think of this but these changes involve costs to implement. The FDA estimates a one-time cost of $52.4 million and then $14.4 million every year.
Source: https://federalregister.gov/a/2014-28241
November 21, 2014
Psychiatric Educator of the Year 2014
At the Benjamin Rush Gala on November 21, 2014, Dr. Mago received the Philadelphia Psychiatric Society’s award for “Psychiatric Educator of the Year.”
Photo: At the event, with Dan Gottlieb (host of Voices in the Family on Philadelphia’s NPR station) who received the Benjamin Rush Award.
October 6, 2014
New Rules about Prescribing Vicodin
Hydrocodone is a commonly used opioid analgesic medication. Most commonly, it is an ingredient of Vicodin, which is a combination of hydrocodone with acetaminophen. Apparently, more prescriptions are written in the US for hydrocodone plus acetaminophen than for any other medication. Yes, it seems incredible but it is true. More prescriptions are written for this medication than the next four most commonly prescribed medications: levothyroxine, lisinopril, simvastatin, and metoprolol.
Now, starting on October 6, 2014, the Drug Enforcement Administration (DEA) has moved hydrocodone-containing medications from schedule III to schedule II. (Plain hydrocodone has always been a schedule II drug.) Under the Controlled Substances Act, a schedule II drug is one where a) the drug has a high potential for abuse which may lead to severe dependence AND b) the drug has an accepted medical use. (If there is no current medical use, the drug would be schedule I, e.g., cannabis, LSD, heroin, MDMA.)
The significance of this change is that now for a hydrocodone combination medication:
Tamper-proof prescription forms must be used (unless e-prescribing is being used).
- A 72-hour supply can be called in but then a prescription must be mailed into the pharmacy
- Refills cannot be called in or faxed in
- However, if a patient is on long-term treatment with ahydrocodone combination medication, up to three prescriptions for 30 days each can be given.
September 10, 2014
FYI only, FDA approved a new obesity drug, Contrave, which is a combination of bupropion and naltrexone. We should know the name in case patients come in on it.
In case you want to take a quick look, you can click on the link below:
FDA’s press release about the approval of Contrave
August 31, 2014
My e-book “Side Effects of Psychiatric Medications” is now available. To find out what the e-book covers, go to:
https://simpleandpractical.com/side-effects-psychiatric-medications
August 13, 2014
The United States Food and Drug Administration (FDA) approved suvorexant (brand name Belsomra) for the treatment of insomnia. Suvorexant is an orexin receptor antagonist and is the first approved drug that works through this mechanism. Orexins in the brain are involved in regulating the sleep-wake cycle and wakefulness. Belsomra is not available in pharmacies yet; it is expected to be available at the end of 2014. I am not aware of any advantage of Belsomra over other hypnotics and the adverse effects of new medications often become apparent only after it has been in use for some time. My suggestion is to NOT prescribe Belsomra until we have had a chance to examine the data and a few selected experts have had a chance to use it in clinical practice.
To read the FDA’s statement about the approval, you can click on the link below:
FDA approves new type of sleep drug: Belsomra
August 10, 2014
Which ones are the “top selling” prescription medications in the US? This can be described in two different ways:
1. The number of prescriptions written
2. The total sales (amount of money)
As of mid 2014, guess which psychiatric medication was the NUMBER ONE prescription drug in terms of total sales (amount of money), among ALL prescription medications?
Answer: Abilify (aripiprazole). It has $7.2 billion worth of sales in the year ending June 2014. Wow!
No other psychiatric medication was among the top 10 in terms of total sales.
In terms of number of prescriptions written, guess which psychiatric medications were in the top ten?
Answer: Cymbalta (duloxetine) at number 8 and Vyvanse (lisdexamfetamine) at number 9.