July 15, 2024: Alzheimer's drug approved, FDA flags generics that might have been approved with false data; insomnia drug causing parkinsonism; promising herbal dietary supplement; more
New Drug Approvals: Kisunla (Donanemab) for Alzheimer’s
Late last month, an FDA advisory committee recommended approval of Eli Lilly's Alzheimer's drug donanemab. July 2, the FDA granted full approval to this new monoclonal antibody treatment, which will be marketed under the brand name Kisunla. Designed to slow Alzheimer's progression by reducing beta amyloid plaque in the brain, Kisunla is administered by I.V. every four weeks. The drug label includes a boxed warning about the risk of amyloid-related imaging abnormalities (ARIA), which is temporary swelling in areas of the brain that may be accompanied by small spots of bleeding in or on the surface of the brain.
While the approval has received much fanfare in the media, many health experts taking a closer look at the clinical trials results are not so enthusiastic. Most important, while the disease progression experienced by the patients taking donaemab may have been statistically significant compared with placebo, it was not clinically meaningful based on the “meaningful within-patient change (MWPC)” scale. As Joe Graedon at People's Pharmacy points out, patients taking the new drug may not experience meaningful changes in quality of life.
https://www.peoplespharmacy.com/articles/kisunla-donanemab-breakthrough-or-boondoggle-against-alzheimers
Check this report from MedShadow Foundation for details about the side effects of donanemab (Kisunla) and lecanemab-irmb (Leqembi), a similar Alzheimer’s drug: https://medshadow.org/side-effects-of-new-alzheimer-drugs/
Approval of treatment for pediatric kidney disease patients
The FDA expanded the approval of Vifor's chewable tablet Velphoro (sucroferric oxyhydroxide) for pediatric patients age 9 and up with chronic kidney disease on dialysis to help control serum phosphorus levels. Previously, the drug was only approved for adults.
https://www.empr.com/home/news/velphoro-approved-for-pediatric-patients-with-hyperphosphatemia-in-ckd/
Case study: a rare side effect for "insomnia" drug trazodone
Qena Faculty of Medicine (South Valley University, Egypt) researchers present the case of a 58-year-old male who was prescribed trazodone for insomnia and developed parkinsons-like symptoms after 14 days. He started to experience difficulty in moving his upper limbs and experienced recurrent falling. He had been taking 50 mg at nighttime, but on his own had increased his dosage to 100 mg the second week. Symptoms resolved upon discontinuing the medication. The side effect is considered to be rare. A chart is included showing results from five similar cases in the medical literature. The study was published in the journal African Health Science.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11217839/
Trazodone is approved to treat depression, but is often prescribed for insomnia for a couple of reasons. For one, it is not a controlled drug (on the DEA schedule) so it is easier to prescribe and is less likely to cause dependence or severe side effects than newer insomnia drugs like Ambien. Second, it is available as a generic and is very inexpensive (as little as $4 for a prescription at Walmart).
https://www.consumerreports.org/health/insomnia/trazodone-for-insomnia-should-you-take-a9455377183
On the Ask a Patient website, some patients reported tremors, wobbly legs, or restless legs when taking Trazodone:
Trazodone movement-related side effects on Ask a Patient
Falsified data submitted to FDA in support of generic drug applications
Bloomberg News reports that Synapse Labs Pvt. Ltd., an Indian contract research company, falsified data used in key studies in support of application approvals for generic medications. The data may have been used to support the approvals of hundreds of drugs, which still remain available for sale. The FDA said companies that used Synapse must respond within 30 days with their plans to either re-do the studies using a different company OR make a voluntary request for the withdrawal of the affected generic drug. The FDA did not release a list of the affected drugs to the public because it says a particular research company for hire is “confidential information,” according to the FDA alert.
https://timesofindia.indiatimes.com/business/india-business/desi-company-faked-generic-viagra-data-us-fda/articleshow/111646081.cms
In its announcement, the FDA explains the limited information available to the public:
“FDA has changed the therapeutic equivalence (TE) rating for the affected generic products in Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the Orange Book) to “BX.” This means that the data are insufficient to show that the generic products affected provide the same therapeutic effect as the brand-name product.”
If you are concerned about whether a generic drug you are taking has a “BX” rating, the FDA says you can go to the FDA’s Orange Book website and look up the drug.
Type in the name of your drug and, in the list that comes up, look for the name of the manufacturer that appears on your medication label. Then look for the row with that drug and manufacturer and find the code in the column “TE Code.” If the code is “BX,” you may wish to consult with your health care provider about continued use of the drug. (The FDA notes that many drugs have a “BX” rating for reasons unrelated to this action, but the drugs affected by this action have had their ratings changed to “BX.”)
We tried that out for the Cialis example mentioned by Bloomberg News. A search for "TADALAFIL" (generic for erectile dysfunction drug Cialis) turns up four products with the "BX" therapeutic equivalence designation, all made by Umedica Labs.
FDA release: https://www.fda.gov/drugs/drug-safety-and-availability/notification-pharmaceutical-companies-clinical-and-bioanalytical-studies-conducted-synapse-labs-pvt
Big Food, Big Pharma, Big Nightmare
Chicago-based writer, editor, critic and satirist Hugh Iglarsh interviewed author Martha Rosenburg about her reissued book, Big Food, Big Pharma, Big Lies, and asks her to reflect on the changes she has witnessed in the drug ("Big Pharma") and agribusiness ("Big Food") industry in the 12 years since the first edition came out.
https://www.counterpunch.org/2024/07/12/big-food-big-pharma-big-nightmare-an-interview-with-martha-rosenberg/
Dietary Supplement Tips: Berberine
Have you heard of the plant-derived dietary supplement called berberine? It's a natural substance found in goldenseal, barberry, Oregon grape, other plants. Berberine has been touted as a natural alternative to prescription weight loss and diabetes drugs like Ozempic. Some clinical trials have also shown benefits of the substance for lowering blood sugar and lipid levels. Dr. Lucy McBride, writer of the newsletter “Are You Okay?” answered a reader question about berberine for weight loss.
https://lucymcbride.substack.com/i/146526643/question-berberine-for-weight-loss
Please visit us at www.AskaPatient.com for patient reviews and ratings of prescription drugs.