An FDA Warning Letter, the Amyloid Hypothesis and Alzheimer Disease, Adverse Events with Triptan Use
Neurology News Network for the week of November 17, 2018.
PUBLISHED November 17, 2018
This week, Neurology News Network covered the issuance of an FDA warning letter to StemGenez Biologic Laboratories for marketing an unapproved purported stem cell therapy, as well as for significant deviations from good manufacturing practices. We also covered Constantino Iadecola's, MD, perspective into the different pathologies that lead to Alzheimer disease and an interview with Richard Lipton, MD, to discuss the management of treatment-related adverse effects associated with the use of triptans for migraine. (Transcript below.)
Welcome to Neurology News Network. I’m Jenna Payesko. Let’s get into the news from this week.
Earlier this week, the FDA issued a warning letter to StemGenex Biologic Laboratories, a San Diego based stem cell therapy clinic, for marketing an unapproved purported stem cell therapy, as well as for significant deviations from current good manufacturing practice requirements including some that could lead to microbial contamination.
In a recent inspection of the facility, the FDA found that the company was processing adipose tissue into stromal vascular fraction for a variety of administrations including intravenous, inhalation and injection into the spinal cord. The product is marketed illegally for a number of conditions that includes Alzheimer disease, Crohn disease, type 1 and type 2 diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson disease, peripheral neuropathy and rheumatoid arthritis.
The FDA requested a response from StemGenex within 15 working days that details how the deviations noted in the warning letter will be corrected. The agency is urging health care professionals and consumers to report any adverse events related to treatments with the product to the FDA’s MedWatch Adverse Event Reporting program.
The amyloid hypothesis has long been believed to be the key to solving the Alzheimer disease puzzle, however, after several failed attempts to develop therapies to address amyloid buildup in the brain, some question the theory.
According to Constantino Iadecola, MD, at Weill Cornell Medicine, amyloid is only a single piece of the puzzle. Iadecola told NeurologyLive in aninterview that his understanding defines Alzheimer not as a disease, but as a syndrome caused by a number of pathologies at play in the brain.
NeurologyLivesat with Richard Lipton, MD, of Albert Einstein University, to discuss the management of treatment-related adverse effects associated with the use of triptans for patients with migraine. Let’s take a look.
For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.