January 22, 2023: New asthma treatment; label changes for benzo, statin, and diabetes drugs; gabapentin phenomenon; cannabis-related research; preventing blood clots after fracture
FDA Approvals & Announcements
- The U.S. FDA approved Airsupra inhalation aerosol for as-needed prevention and treatment of asthma attacks in adults. Airsupra combines albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid), the first such combination to be approved in the U.S. According to clinical trial results submitted to the FDA, treatment with Airsupra, compared with albuterol, demonstrated a 28% reduction in the risk of a severe asthma attack as assessed by the time to first severe asthma attack. The New Drug Application (NDA) was filed by U.K. company Avillion LLP, which has a clinical co-development partnership with drug maker AstraZeneca. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-combination-treatment-adults-asthma
- The FDA approved Luye Pharma's Rykindo, a new long-acting, intramuscular injectable form of the schizophrenia and bipolar drug risperdone. It is administered every two weeks.
https://www.prnewswire.com/news-releases/fda-approves-luye-pharmas-rykindo-for-the-treatment-of-schizophrenia-and-bipolar-1-disorder-301721891.html
- The FDA updated safety warnings for multiple benzodiazepine drugs, including Valium, Ativan (lorazepam), diazepam, clonazepam, clobazam, and others, to warn of the risk of neonatal sedation (respiratory depression, lethargy) and withdrawal symptoms (such as irritability, tremors, inconsolable crying, and feeding difficulties) in the babies exposed to the drug in-utero. Benzodiazepines are often used to treat anxiety, panic disorders, or muscle spasms. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to these drugs, which are considered "Class D" (risk established) during pregnancy.
Klonopin (clonazepam) safety label update
Label updates are the same for each of the benzodiazepines. Look them up by name here:
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/
- Cholesterol drug rosuvastatin calcium (brand name Crestor) had a safety label update to warn of risk of myopathy (muscle pain, tenderness, or weakness) and rhabdomyolysis (death of muscle tissue) and includes a table of “Drug Interactions that Increase the Risk of Myopathy and Rhabdomyolysis.” Multiple other changes to the label for specific populations are also noted.
Crestor (rosuvastatin calcium) safety label update
- Novo Nordisk's diabetes drug Rybelsus (semaglutide) had its label changed to indicate that it may now be used as a first-line treatment for Type 2 diabetes in adults. It is the only drug in its category (GLP-1) available in pill form, and is taken once daily. Semaglutide is also the active ingredient in Novo Nordisk’s Ozempic and Wegovy.
https://medcitynews.com/2023/01/novo-nordisks-diabetes-pill-rybelsus-gets-fda-o-k-as-first-line-therapy/
Patient reviews for Rybelsus
New Podcast
- "Pharmanipulation" is a new audio show created by PharmedOut, a Georgetown University Medical Center "rational prescribing project." Episode 1 covers pharmaceutical marketing tactics, industry influence on medical knowledge, and invented diseases. Join hosts Caroline Renko and Patricia Bencivenga as they interview Adriane Fugh-Berman MD, the Director of PharmedOut. (19 minutes)
https://www.stitcher.com/show/pharmanipulation
Promise and Problems with Gabapentin
- Gabapentin (brand name Neurontin) has increasingly become a popular drug for treating a wide variety of conditions, despite only being approved to treat seizures and shingles nerve pain. Doctors prescribe it "off-label” to treat anxiety, Parkinson's, pain, fibromyalgia, and more. However, some patients, particularly those with past substance abuse problems, have found that the drug is addictive, despite it being marketed as a non-addictive drug. One in 10 U.S. overdose deaths in 2019 and 2020 included the presence of gabapentin in the drug mix. A study in Scotland found gabapentin and a related drug were responsible for one third of accidental drug-related deaths.
In a recent Full Measure program, host Sharyl Attkisson interviews a patient who became addicted to gabapentin after it was prescribed for his anxiety. She also interviews Michael Abrams, health researcher at Public Citizen, who explains why the organization petitioned the Drug Enforcement Administration (DEA) to make gabapentin a Schedule 5 drug (the least harmful level of the 1-5 schedule levels; Schedule 1 drugs are illegal). A University of Michigan neurologist explains why he is opposed to making the drug a controlled substance.
View the program, which runs 7 minutes:
https://fullmeasure.news/news/cover-story/gabapentin
- In 2021, the anticonvulsant/nerve pain drug gabapentin was the fifth most-prescribed generic drug in the U.S., with 70.7 million prescriptions dispensed. Check out Ask a Patient's article on gabapentin, along with facts about the drug and links to patient reviews based on various reasons for treatment.
https://www.askapatient.com/news/increase-in-gabapentin-prescriptions.asp
Research Studies
- States that permit recreational use of cannabis have seen reduced demand for prescription codeine, an opioid with a high potential for misuse, according to a new multi-institutional study led by University of Pittsburgh and Cornell University. Twenty-one U.S. states have passed recreational cannabis laws and legislatures in other states are considering similar measures. The study is among the first to separately examine the impact of recreational cannabis laws on shipments of opioids to hospitals, pharmacies and other endpoint distributors. The study was published in Health Economics.
https://news.cornell.edu/stories/2023/01/when-recreational-cannabis-legal-codeine-demand-drops
- When it comes to policies regulating cannabis advertising and marketing, there is a stark contrast between Canada and the U.S., according to a University at Buffalo study. The government of Canada legalized the drug at the federal level several years ago. In the U.S., however, cannabis remains illegal at the federal level, while 37 states now have legalized it for medical and/or recreational use. Most states do not address many of the cannabis advertising activities that are prohibited in Canada. There are 11 illegal advertising tactics — such as glamorization and testimonials — in Canada’s policy that are not specifically addressed in any of the state policies in the U.S. The study was published in Cannabis and Cannabinoid.
https://www.eurekalert.org/news-releases/977046
(Image from a collection of pictures of more than a dozen marijuana billboards across Los Angeles. Source: https://oohtoday.com/billboards-cannabis-marketing-marijuana-advertising-2/)
- Patients hospitalized with fractures typically receive an injectable blood thinner, low-molecular-weight heparin, to prevent life-threatening blood clots. A clinical trial by the Department of Orthopaedics at the University of Maryland School of Medicine (UMSOM) and the Major Extremity Trauma Research Consortium (METRC) based at the Johns Hopkins Bloomberg School of Public Health found that inexpensive over-the-counter aspirin is just as effective as blood thinners for preventing blood clots after fracture. The multi-center randomized clinical trial, which included more than 12,000 patients at 21 trauma centers in the U.S. and Canada, is the largest trial ever conducted on orthopedic trauma patients. “Many patients with fractures will likely strongly prefer to take a daily aspirin over receiving injections after we found that both give them similar outcomes for prevention of the most serious outcomes from blood clots,” said the study’s principal investigator Robert V. O’Toole. The study was published in New England Journal of Medicine.
https://richmond.com/lifestyles/health-med-fit/aspirin-noninferior-to-low-molecular-weight-heparin-after-fracture/article_2da447d0-cdd2-5a90-8846-da99ee9fa0c0.html
Reminder
Starting this month, Medicare patients who get their insulin through vials and pens will see their copays capped at $35 each month. Also starting this month, vaccines, including the Shingles vaccine, are now free for Medicare patients.
Thank you for reading the second issue of Ask a Patient Health News: Drugs & Treatments. We hope you like the new format, which uses Substack, a publishing platform that is geared for newsletter content rather than for marketing emails. Visit us at www.askapatient.com for more medication information and to subscribe to the health edition of Ask a Patient® Health News.