Undeclared pharmacological substance sibutramine on the labelling in food suplements from Tûrkiye

RASFF

Identification and classification

Reference

2024.6313

Notification ID

705331

Classification

information notification for attention

Risk decision

serious

Product type

food

Notification basis

official control on the market

Status

ec_validated

RASFF

Product

Description

Complemento alimenticio/// food supplement

Distribution status

Description

information on distribution not (yet) available

Notification ID

221

Notification ID

25305790

Category

Description

dietetic foods, food supplements and fortified foods

Notification ID

18439

Product descriptions

1. Notification ID

   25306309

2. Notification ID

   25306308

3. Notification ID

   25306310

4. Notification ID

   25332818

5. Notification ID

   25332819

RASFF

Risk and analytical results

hazardObserved

La sibutramina produce un aumento de la frecuencia cardiaca y la presión sanguínea, que pueden ser clínicamente significativas en algunos pacientes, habiéndose registrado casos de arritmias, cardiopatías isquémicas y accidentes vasculares graves con su consumo. Otros efectos adversos que pueden presentarse con su consumo son, entre otros, sequedad de boca, dolor de cabeza, insomnio, estreñimiento, etc. Además, presenta gran cantidad de interacciones con otros medicamentos//Unofficial translation. Sibutramine causes an increase in heart rate and blood pressure, which may be clinically significant in some patients, and cases of arrhythmias, ischaemic heart disease and serious vascular accidents have been reported with its use. Other adverse effects that may occur with its use include dry mouth, headache, insomnia, constipation, etc. In addition, there are a large number of interactions with other medicines

Notification ID

106890

RASFF

Measures

1. Action taken

   Description

   withdrawal from the market

   Notification ID

   18837

   Notification ID

   25306751

   takenBy

   Notification ID

   5010

   isoCode

   ES

   organizationName

   Spain

2. Action taken

   Description

   public warning - press release

   Notification ID

   18838

   Notification ID

   25332835

   takenBy

   Notification ID

   5010

   isoCode

   ES

   organizationName

   Spain

   url

   https://www.aemps.gob.es/informa/la-aemps-retira-productos-por-contener-sibutramina/ ↗

3. Action taken

   Description

   public warning - press release

   Notification ID

   18838

   Notification ID

   25892771

   takenBy

   Notification ID

   5010

   isoCode

   ES

   organizationName

   Spain

   url

   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/ampliacion/2024_58.htm ↗

RASFF

Published territorial roles

1. Roles

   1. Role

      FOR_ATTENTION

      notificationId

      706524

   Organisation

   code

   INFO

   countryNetworkOrganizationId

   5680

   Description

   INFOSAN

   Notification ID

   10340

2. Roles

   1. Role

      FOR_FOLLOW_UP

      notificationId

      716394

   Organisation

   code

   IS

   countryNetworkOrganizationId

   5019

   Description

   Iceland

   Notification ID

   56

3. Roles

   1. Role

      NOTIFYING

      notificationId

      705331

   2. Role

      NOTIFYING

      notificationId

      705331

   3. Role

      FOR_FOLLOW_UP

      notificationId

      705331

   Organisation

   code

   ES

   countryNetworkOrganizationId

   5010

   Description

   Spain

   Notification ID

   2

4. Roles

   1. Role

      FOR_FOLLOW_UP

      notificationId

      708287

   2. Role

      FOR_ATTENTION

      notificationId

      711847

   3. Role

      ORIGIN

      notificationId

      705331

   4. Role

      OPERATOR

      notificationId

      705331

   5. Role

      OPERATOR

      notificationId

      706524

   Organisation

   code

   TR

   countryNetworkOrganizationId

   5223

   Description

   Türkiye

   Notification ID

   10218

RASFF

Follow-ups

1. fupDate

   21-08-2024 14:35:49

   fupId

   706524

   fupNumber

   1

   fupType

   Description

   corrigendum

   Notification ID

   27663

   networkOrganizationId

   13501

   organizationCode

   ES

   organizationDescription

   FOOD AESAN

2. fupDate

   30-08-2024 09:48:44

   fupId

   708287

   fupNumber

   2

   fupType

   Description

   request

   Notification ID

   27665

   networkOrganizationId

   1

   organizationCode

   EU

   organizationDescription

   European Commission

3. fupDate

   18-09-2024 12:37:20

   fupId

   711847

   fupNumber

   3

   fupType

   Description

   outcome of investigations

   Notification ID

   27674

   networkOrganizationId

   13501

   organizationCode

   ES

   organizationDescription

   FOOD AESAN

4. fupDate

   08-10-2024 14:04:50

   fupId

   716394

   fupNumber

   4

   fupType

   Description

   outcome of investigations

   Notification ID

   27674

   networkOrganizationId

   13501

   organizationCode

   ES

   organizationDescription

   FOOD AESAN

5. fupDate

   08-10-2024 18:30:31

   fupId

   716486

   fupNumber

   5

   fupType

   Description

   follow-up from non-member country

   Notification ID

   27671

   networkOrganizationId

   1

   organizationCode

   EU

   organizationDescription

   European Commission

6. fupDate

   22-10-2024 12:59:47

   fupId

   720010

   fupNumber

   6

   fupType

   Description

   corrigendum

   Notification ID

   27663

   networkOrganizationId

   1

   organizationCode

   EU

   organizationDescription

   European Commission

RASFF

Public links

5010

1. countryNetworkOrganizationId

   5010

   Notification ID

   35

   link

   http://aplicaciones.magrama.es/silum/web/novedades/novedades.jsp

2. countryNetworkOrganizationId

   5010

   Notification ID

   36

   link

   https://www.aesan.gob.es/AECOSAN/web/seguridad_alimentaria/seccion/alertas_alimentarias.htm ↗

5019

1. countryNetworkOrganizationId

   5019

   Notification ID

   22

   link

   https://www.mast.is/is/um-mast/frettir/innkallanir ↗