August 20, 2023: New treatment for cervical dystonia; safety update for simvastatin; pain drug shortages; medical mystery; holistic medicine summit; foods for healthy liver; avoiding brain freeze
Also: meds to avoid when you have diverticulitis
Drug Approval and Safety Label Updates
Revance's Daxxify (daxibotulinumtoxinA-Ianm), a cosmetic injectable treatment for reducing frown lines between the eyebrows (glabellar lines), was approved to also treat cervical dystonia, a condition that causes involuntary muscle contractions of the head and neck. Some other BOTULINUM TOXIN TYPE A products, including Botox, have already been approved to treat cervical dystonia.
Daxxify's safety label was also updated to report results of a 52-week clinical trial. Adverse reactions were reported in 138 patients (20%). The label notes that clinical studies did not include sufficient numbers of subjects aged 65 and older to determine whether they responded to the treatment differently than younger subjects. Like other similar products, the Daxxify label includes a black box warning about the distant spread of toxin effect. Daxxify is frequently used off-label to treat other kinds of facial wrinkles.
Check Revance’s website for 2 to 9-month photos of patients who took Daxxify to reduce frown lines:
https://hcp.daxxify.com/see-results
The drug label for cholesterol drug Zocor (simvastatin) was changed to warn of rare reports (either new onset or symptom exacerbation) of myasthenia gravis, including ocular myasthenia. Myasthenia gravis is a disease causing general muscle weakness including in some cases muscles used for breathing, and disease causing eye muscle weakness, ocular myasthenia.
The drug safety lable for the drug Botox (OnabotulinumtoxinA) was changed to inform that the safety and effectiveness of BOTOX for the treatment of overactive bladder have not been established in pediatric patients based on the results of a study. The study showed no difference between Botox and placebo for treating overactive bladder in patients 12 to 17.
Drug Quality
Independent drug testing laboratory Valisure announced that it has entered into a Cooperative Research and Development Agreement with the Department of Defense in order to generate objective drug quality data through independent chemical testing of certain drugs. A proposed a system of independent testing for drugs of high quality concern from China will enable conscientious manufacturers to be able to better compete and allow major purchasers of drugs, like the Department of Defense and Veterans Administration, to reward good manufacturers and exclude substandard medicines from being consumed by the military and veterans, and serve as a model for broader adoption throughout the United States to benefit all American patients.
New Pain Drug Shortages
Recently the opioid pain drug oxycodone has been in short supply. Why? The American Society for Health Systems Pharmacists (ASHP) database can provide answers, although not all manufacturers are providing the reasons for the shortages. Read our special post on the topic of oxycodone shortages:
Oxycodone Drug Shortages in Summer 2023
Medical Mystery
In September 2022, 14-year old "BB" was jumping at an indoor trampoline park in Maryland when he suddenly collapsed. An ambulance brought the unconscious teenager to Children's National Hospital in Washington Dc, where he was received by a team of 20 emergency room specialists. While paramedics initially suspected a heart attack, the boy regained consciousness and had a normal heart rate and blood pressure reading by the time he got to the hospital. But things were not alright. An echocardiogram revealed something very rare and alarming. The boy revealed he had been experiencing symptoms for a couple of years but had not told his family about them. Read about his condition and treatment in Sandra Boodman's latest medical mystery.
Drug Research
A University of Hong Kong clinical trial found that a combination of levonorgestrel - known as “plan B” or the “morning after pill”—and the anti-inflammatory drug piroxicam is more effective in preventing pregnancy compared with levonorgestrel alone. The study involved 860 women who sought emergency contraception within 72 hours of unprotected intercourse at a major community sexual and reproductive health service in Hong Kong between 2018 and 2022. The results showed that the combination regimen prevented 94.7% of expected pregnancies, compared with 63.4% with levonorgestrel alone. The study was published in the Lancet.
https://www.bmj.com/content/382/bmj.p1920
Plan B patient reviews on AskaPatient.com
WHO’s Traditional Medicine Summit
The World Health Organization (WHO) held its first-ever world summit on traditional medicine in Gandhinagar, India starting on August 17, 2023. The WHO considers traditional and complementary medicines to include disciplines as wide-ranging as Ayurveda, yoga, homeopathy and complementary therapies. The event's expert panel published an editorial in the Journal of Ayurveda and Integrative Medicine where they contrasted the “reductionist” approach of Western medicine, which breaks down a phenomenon into its constituent parts, with traditional medicine, which stresses “the interconnectedness of mind, body and spirit.”
The summit agenda will stress high quality research and evidence mapping of medical systems that “until a few years ago were considered fringe alternative medicine”. “It does not at all mean being soft on science," says one of the organizers. “It actually means being hard on traditional medicine and hard on science, to say, do we have the right methods to understand more complex phenomena in the right way?”
https://www.nature.com/articles/d41586-023-02636-z
Psychedelic Treatments Insights
In a recent “Beyond the Prescription” podcast, Dr. Lucy McBride talks with Sunstone Therapies founders and oncologists Dr. Agrawal and Dr. Thambi about the inseparability of physical and mental health; the promise of psychedelic therapy to treat the psychological impact of cancer and other diseases such as PTSD, anxiety, and depression; and their shared excitement about the potential for these drugs to fundamentally expand the standard of care in medicine. (length: 40 minutes; transcript also available.)
Treatment Tips
Natural herbs and foods for promoting liver health include green tea, milk thistle, lemon, turmeric, and a tropical fruit called tamarind. MedShadow Foundation explains the science-backed reasons why these foods help prevent liver disease.
Diverticulosis, a common condition among older adults in which small pouches form on the inside lining of the colon, usually doesn't cause problems. But when the pouches in the large intestine become inflamed and infected, the condition is called diverticulitis. "The Checkup" blog explains causes and symptoms of diverticulitis, and provides a list of some drugs you want to try to avoid if you have diverticulitis, as they may exacerbate the condition. The list includes opioids, corticosteroids like prednisone, antihistamines, tricyclic antidepressants, iron supplements, blood pressure medications, blood thinners, and nonsteroidal anti-inflammatory drugs (like asprin, motrin, ibuprofen, Aleve, naprosyn).
https://www.singlecare.com/blog/drugs-to-avoid-with-diverticulitis/
An ice cold water or frozen drink can provide relief on a sweltering summer day, but watch out for the brain freeze that can strike in the form of a sudden, sharp headache. Experts think that the pain is triggered by rapid vasoconstrction -narrowing of blood vessels followed by rapid widening of the blood vessels in the head and face. Is there a way to stop brain freeze before it has the chance to settle in, or a hack that actually works to mitigate pain as soon as it hits? Ashley Agan, MD, an ear, nose, and throat doctor (ENT) with UT Southwestern Medical Center suggests the best way to mitigate the pain almost instantly is to warm the trigger area by pressing your tongue or thumb to the roof of your mouth. Also, she recommends consuming cold foods and beverages slowly.
https://www.wellandgood.com/what-causes-brain-freeze/
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Thanks for the shout-out!!