Adverse Events Archives - Supplement Safety Solutions https://www.supplementsafetysolutions.com/tag/adverse-events/ Expert safety, compliance and risk management services Thu, 06 Aug 2020 20:32:59 +0000 en-US hourly 1 Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience https://www.supplementsafetysolutions.com/serious-adverse-events-reported-with-dietary-supplement-use-in-the-united-states-a-2-5-year-experience/ Thu, 06 Aug 2020 20:22:24 +0000 https://www.supplementsafetysolutions.com/?p=2345 Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience Dietary supplement marketers assure the safety of their products by complying with current good manufacturing practices and a host of federal regulations, including those enforced by the Food and Drug Administration (FDA). Post-market surveillance is a key part of…

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]]> Serious Adverse Events Reported with Dietary Supplement Use in the United States: A 2.5 Year Experience

Journal of Dietary SupplementsDietary supplement marketers assure the safety of their products by complying with current good manufacturing practices and a host of federal regulations, including those enforced by the Food and Drug Administration (FDA). Post-market surveillance is a key part of identifying safety problems associated with dietary supplement products. FDA requires dietary supplement marketers to provide a domestic address or phone number on product labels for consumers, family members, or health care professionals to report adverse events (AEs) associated with product use and to report all serious adverse events (SAEs) to the agency within 15 business days of receipt. We aimed to evaluate the characteristics of AEs reported with dietary supplement use, including dietary supplement type and Medical Dictionary for Regulatory Activities (MedDRA) system organ class (SOC) that occur with reported SAEs. A total of 41,121 unique adverse event cases reported to two large, U.S.-based dietary supplement marketers in a 2.5-year period (March 1, 2014–August 31, 2016) were assessed for seriousness using established criteria. Each SAE was assigned one or more MedDRA preferred terms and system organ classes (SOC). The types of supplements most responsible for SAEs were assessed. Of the 41,121 AE cases reported, 203 (0.48%) were SAEs. SAEs tended to occur with products marketed for weight loss (69.0%) and glycemic control (19.2%). SAEs occurred most commonly in the cardiovascular, gastrointestinal, and nervous system disorder SOCs. The percentage of SAEs reported to dietary supplement marketers is low, predominantly among consumers of two types of supplements. Further study is needed among a larger cohort of supplement users to determine causal associations between types of supplement products and serious adverse events.

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]]> Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects https://www.supplementsafetysolutions.com/effects-of-hemp-extract-on-markers-of-wellness-stress-resilience-recovery-and-clinical-biomarkers-of-safety-in-overweight-but-otherwise-healthy-subjects/ Wed, 27 May 2020 00:00:22 +0000 https://www.supplementsafetysolutions.com/?p=2351 Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers…

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]]> Effects of Hemp Extract on Markers of Wellness, Stress Resilience, Recovery and Clinical Biomarkers of Safety in Overweight, But Otherwise Healthy Subjects

Journal of Dietary Supplements

We determined the effects of a commercially available, GRAS (Generally Recognized As Safe) by independent conclusion, CBD-containing hemp oil extract on stress resilience, perceived recovery, mood, affect, body composition, and clinical safety markers in healthy human subjects.

Methods: Using a randomized, placebo-controlled, double-blind design, 65 overweight, but otherwise healthy men and women (35.2 ± 11.4 years, 28.5 ± 3.3 kg/m2) ingested either Hemp Oil Extract [Hemp, 60 mg/d PlusCBDTM Extra Strength Hemp Extract Oil (15 mg hemp-derived CBD)] or a placebo (PLA) every day for six weeks while continuing to follow their normal diet and physical activity patterns. Outcome variables included changes in stress resilience, a 14-item panel of various psychometric parameters, heart-rate variability, plasma chromogranin A, body composition, and general markers of health. Data were analyzed using mixed factorial ANOVA, t-tests with 95% confidence intervals, and effect sizes (ES).

Results: HDL cholesterol significantly improved in the Hemp group (p = 0.004; ES = 0.75). No other statistically significant group x time interaction effects were observed. Statistical tendencies for between-group differences were found for ‘I Get Pleasure From Life’ (p = 0.06, ES = 0.48) and ‘Ability to Cope with Stress’ (p = 0.07, ES = 0.46). Sleep quality (Hemp, p = 0.005, ES = 0.54) and sleep quantity (Hemp, p = 0.01, ES = 0.58) exhibited significant within-group changes. All values for hepato-renal function, cardiovascular health, fasting blood lipids, and whole blood cell counts remained within normal clinical limits with no between-group differences over time being identified.

Conclusions: Hemp supplementation improved HDL cholesterol, tended to support psychometric measures of perceived sleep, stress response, and perceived life pleasure and was well tolerated with no clinically relevant safety concerns. Registered at clinicaltrials.gov: NCT04294706.

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]]> Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience https://www.supplementsafetysolutions.com/serious-adverse-events-study-published-in-the-journal-of-dietary-supplements-2/ Mon, 25 May 2020 00:00:03 +0000 http://new.supplementsafetysolutions.com/?p=2113 Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience The market for products featuring hemp extracts is large and growing larger. However, safety concerns have been raised by medical and regulatory agencies. Post marketing surveillance of full spectrum hemp extract (FSHE) products manufactured and distributed by CV Sciences (CVSI)…

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]]> Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience

Journal of Dietary SupplementsThe market for products featuring hemp extracts is large and growing larger. However, safety concerns have been raised by medical and regulatory agencies. Post marketing surveillance of full spectrum hemp extract (FSHE) products manufactured and distributed by CV Sciences (CVSI) and traded under the brand PlusCBD™ was conducted over a 2-year period (2018-2019). The safety of these products was assessed by analyzing adverse events reports. From a total of approximately five million product units sold during the 2-year period, 1,429 (0.03%) adverse events (AE) were reported in 1,151 unique customers. Of those, only two were classified as serious AEs. For orally ingested products, the most common types of AEs reported were gastrointestinal (e.g. abdominal discomfort), while for topically applied products, the most reports mentioned dermatological symptoms (e.g. rashes). There has been no evidence of liver toxicity associated with CVSI products. Based on this longitudinal dataset, the products manufactured using CVSI’s proprietary processes are safe and well tolerated at the recommended doses.

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]]> Adverse Event Reporting Requirements During a Pandemic https://www.supplementsafetysolutions.com/adverse-event-reporting-requirements-during-a-pandemic/ Thu, 02 Apr 2020 20:27:57 +0000 https://www.supplementsafetysolutions.com/?p=2313 In March 2020, FDA released a new guidance regarding the enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic. Recognizing that the COVID-19 pandemic is likely to reduce a firm’s capacity to comply with adverse event reporting requirements, this guidance was provided to help firms strategize the use of…

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]]> Covid-19 pandemic and adverse event reporting

In March 2020, FDA released a new guidance regarding the enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic. Recognizing that the COVID-19 pandemic is likely to reduce a firm’s capacity to comply with adverse event reporting requirements, this guidance was provided to help firms strategize the use of their resources and the FDA prioritize their focus to reports related to medical products indicated for the treatment or prevention of the pathogen causing COVID-19.

Please note that although this guidance may relax some of the timeframes for adverse event reporting required by statute and regulation, the FDA still encourages all firms to plan to maintain the highest possible level of adverse event monitoring and reporting throughout the pandemic period. All adverse event data should be handled using the usual standard operating procedures, and regulatory and statutory requirements for adverse event reporting should be met to the maximum extent possible.

We’re here to help

Let Supplement Safety Solutions be your regulatory partner during these uncertain times. We can help you maintain the highest level of adverse event monitoring and reporting while you navigate the impact of the COVID-19 pandemic on your business operations. We’ll review all Adverse Events associated with the use of your supplement.  review all follow up on selected cases — including interaction with the consumer when necessary — maintain source documentation, and assess and document every Adverse Event report. When the pandemic is resolved, we’ll serve as your Responsible Person to the FDA, reporting all Serious Adverse Events on MedWatch Form 3500A or the Safety Reporting Portal (SRP) and interacting with the FDA on your behalf. Contact us today for a free consultation.

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]]> Responsible Person: A Big Responsibility https://www.supplementsafetysolutions.com/responsible-person-a-big-responsibility-2/ Tue, 30 Apr 2019 20:43:15 +0000 http://new.supplementsafetysolutions.com/?p=2105 Being the “Responsible Person” (RP) is a big responsibility ( no pun intended). Whomever takes on that position needs to take it very seriously, because that person is responsible for interacting with and reporting to FDA adverse events (AE) and serious adverse events (SAE). This is not a “check box” type position, to be performed by anyone…

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]]> Responsible Person: A Big Responsibility

Being the “Responsible Person” (RP) is a big responsibility ( no pun intended). Whomever takes on that position needs to take it very seriously, because that person is responsible for interacting with and reporting to FDA adverse events (AE) and serious adverse events (SAE). This is not a “check box” type position, to be performed by anyone at the company with some free time.

Although FDA is not explicit about the professional qualifications of the RP, manufacturers are encouraged to “use trained health care professional to elicit information from reporters.” The RP may also use computer-assisted interview technology, targeting questionnaires and other methods. At the very minimum, the RP should document efforts to obtain the minimal elements, and seek the injured person’s permission to contact their health care practitioner (HCP).

The RP is a kind of medical detective, seeking to gain a clear understanding of what happened with the AE or SAE. This will involve asking questions of the person reporting the AE, and going beyond merely regurgitating what this person presented. The benefit of having a medical background is that there are many things that can cause an AE, such as medical conditions, medications or other supplements. In addition, in my opinion, people reporting an AE are more likely to give additional information if they are speaking with a qualified health care professional .

Aside from creating a high-quality narrative and mailing the MedWatch 3500 or 3500A form to FDA, realize that the RP may be required to talk or communicate in writing with FDA about a particular case or supplement. All correspondence for a particular case should be saved electronically or in hard-copy, and be accessible should the FDA auditor request it (they can and will!). Such a request to communicate with FDA may come completely out of the blue, so you need to be prepared.

As the RP, your first duty is to gather as much information as you can about the case and then write the narrative. At the core of your work is the safety of a supplement in a typical user. You need to communicate to the company that employs you that this is your primary responsibility. While you don’t want to communicate the AE in the worst possible light for a company, you must be factual and provide clear, concise information about the case, and not sugarcoat an AE. You will also communicate to your employer (the Supplement Company) that FDA expects to see AE, and if you consistently write high-quality narratives, FDA will have more confidence in the company. Over time, that will pay dividends.

So take your job as RP seriously – it’s an important one.

Key Learning: Being the RP is an important position, one to be taken seriously. Do your job by carefully investigating and documenting cases, by going beyond the minimal elements approach, and by writing high-quality narratives that give the FDA reviewer a clear picture of the AE you are reporting.

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