Freedom of Information request on the number of times yohimbe/yohimbine, synephrine and ephedrine have been reported to the Yellow Card Scheme since 2011 (FOI 21-779)

0

August 5, 2021 FAITH 21/779

Expensive

Thank you for your Freedom of Information request dated July 6, 2021, in which you requested information about the following: • Please confirm repeatedly that yohimbe/yohimbine (please search for both spellings), synephrine and ephedrine have been reported to the Yellow Card Scheme since 2011. ?

• For each of these cases, please provide the year as well as details of the side effects reported and any information about the product, where it was purchased and how/why was it taken (i.e. say bought as a diet pill).

• For each of these cases, please also state any action taken by the MHRA or the responsible regulatory body.

As of 01/01/2011, the MHRA has received a total of 6 spontaneous suspected adverse reaction reports in the UK associated with Yohimbe/Yohimbine, 2 adverse reaction reports associated with Synephrine and 34 adverse reaction reports associated with ephedrine. This includes a total of 41 unique reports. Please note that the sum of reports in each of the attached tables may not equal the number of unique reports, as one report may contain more than one suspect drug and one product may contain more than one active substance. Yellow card data may be released to members of the public provided patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000, the data for this request was provided as Category Ib. For this FOI, the row lists contain the fields below. Please note that all empty cells in the table are fields that were not provided to us by the registrant. Case number Patient age category (35-44, 45-54, 55-64, 65-74, 75-84, >85 years) Patient gender Suspect drug(s) Indication(s) for Suspect Drug(s) Suspect Drug Route(s) Treatment Duration (days) Suspected Adverse Drug Reaction(s) Onset of Reaction First Dose (days) Outcome(s) of the reaction Medical history ). The information is presented in list form (Table a) and aggregated patient age and sex (Tables b and c). The MHRA will not release any subset of data in which there are five or fewer cases. As we have only received 2 reports associated with Synephrine, we have provided a written summary of the case below. The second case is contained in the Yohimbe/Yohimbine data set (Case 6) because the reported product, Katana contains several active substances, including yohimbine and synephrine. Synephrine – Case 1 of 2: A patient taking ciprofloxacin, melanotan, and T500 Fury presented with right upper quadrant pain (outcome unknown), hepatotoxicity (outcome retrieved). Please note that it is not compulsory to provide the indication of the suspected drug when submitting a yellow card report to the MHRA. The yellow card system does not ask the registrant for information on where the product was purchased, so we are unable to provide this information. The MHRA continuously monitors the safety of medicines and vaccines through a variety of pharmacovigilance processes, including the yellow card system. As part of our signal detection processes, all adverse reaction reports received by the Yellow Card program are assessed individually and cumulative information is reviewed at regular intervals. Using specialized software, the Yellow Card data is subjected to statistical analysis of all drug-reaction combinations in the database. This identifies “signals” – drug-reaction combinations that occur more frequently than expected relative to the background frequency of other drug-reaction combinations in the database. Signals that meet the defined criteria are further evaluated by a team of safety experts to assess the likelihood of a causal link between the drugs and the reported reactions. Examples of regulatory action include restrictions on use, refining dosing instructions, or introducing specific side effect warnings in product information, which allow medicines to be used more safely. and more efficient. As you may know, products containing these substances would normally be subject to controls as prescription-only medicines. The majority of products marketed as weight loss/slimming products or nutritional supplements are unlicensed drugs or are regulated as foods and therefore fall outside the remit of the MHRA. However, after investigation, the MHRA determined that Katana, OxyElite Pro, Shredabull and T500 Fury were drugs. As the products do not have marketing authorisation, in these cases Medicines Borderline has issued urgent notices in accordance with Regulation 165 Part 9 of the Medicines for Human Use Regulations 2012 (SI 2012/1916). This notice has been issued to the company placing the product on the market to inform them that they must cease selling, supplying or advertising the product in the UK. The notices were issued to various companies that had come to our attention as sellers of the products. You may also be interested in reading some of the work done by the MHRA in the areas of slimming and sports nutrition, which can be found at the following links:

https://www.gov.uk/government/news/dodgy-diet-pills-dying-to-lose-weight

https://www.gov.uk/government/news/new-research-shows-desperate-dieters-in-danger-the-secret-world-of-online-slimming-pills

https://www.gov.uk/government/news/mhra-review-shows-sports-supplement-industry-improvement

It is important to note that due to the nature of the Yellow Card Scheme, neither the incidence nor the prevalence of a reaction can be inferred from this data, as neither the total number of reactions occurring nor the number of patients using the drug are only included in these data. Many factors influence the number of reports received. Reporting rates are influenced by the severity of adverse drug reactions, their ease of recognition, the extent of a product’s use, and can also be boosted by product promotion and advertising. Additionally, it is also important to note that a report of a reaction does not necessarily mean that it was caused by the drug in question. We encourage reporters to report suspected adverse reactions, ie the reporter does not have to be sure of a causal link between the drug and the reactions – a mere suspicion is enough. Therefore, reports submitted to the MHRA may be genuine side effects or they may be due to concurrent diagnosed or undiagnosed illness, other medications, or they may be purely coincidental events which would have occurred anyway. in the absence of treatment. I hope the information provided is helpful. The MHRA encourages the use of yellow card data, but would like to ensure that the data is studied and applied appropriately, and that any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we ask that you engage with the MHRA during this process and provide a copy of the report. If you are not satisfied with the handling of your request, you have the right to request an internal review. Requests for internal review must be submitted within two months of the date of this response; and can be sent to this e-mail address. Sincerely, FOI Team, Vigilance and Medicines Risk Management Division


Source link

Share.

Comments are closed.