EMA is wrong to recommend Mysimba drug (weight management in adults)

Prescrire denounces the unacceptable decision of the European Medicines Agency (EMA) to recommend that marketing authorisation be granted for the dangerous combination naltrexone + amfebutamone (Mysimba/Contrave)

Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned.

Prescrire logo
Prescrire denounces the unacceptable decision of the European Medicines Agency (EMA) to recommend that marketing authorisation be granted for the dangerous combination naltrexone + amfebutamone (Mysimba/Contrave).

PRESS RELEASE – Paris, 19 December 2014.

” Today, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced its decision to recommend that marketing authorisation be granted for the combination naltrexone + amfebutamone (also known as bupropion) for use in weight control (MYSIMBA in the EU / CONTRAVE in other parts of the world), despite “uncertainties with regard to cardiovascular outcomes in the longer term”.

A major regression for European patients’ safety. Amfebutamone is an amphetamine drug, as is amfepramone. In 2000, the EMA withdrew the marketing authorisation of several appetite suppressants with a similar mechanism of action to that of amfepramone (clobenzorex, dexfenfluramine, fenfluramine, fenproporex, etc.), in order to protect public health (2). In 2009, sibutramine (Sibutral), an appetite suppressant structurally related to amphetamines, was also withdrawn by the EMA due to disproportionate and serious adverse drug reactions. And benfluorex (Mediator) was also withdrawn from the whole European Union market in 2010.

In addition, in 2013, the EMA rightly refused to authorise the dangerous fixed-dose combination phentermine + topiramate on safety grounds, and the application for the drug lorcaserin (Belviq) was withdrawn by the company following the CHMP’s “provisional opinion that Belviq could not have been approved for weight control in obese and overweight patients”. How is it possible that the CHMP now takes an incongruent decision on the fixed-dose weight-control combination naltrexone + amfebutamone (also known as bupropion) (CONTRAVE/MYSIMBA)?

Health authorities should learn from past public health disasters. A weight loss of a few kilograms achieved through drug therapy cannot in itself justify exposing obese or simply overweight patients to a disproportionate risk of adverse drug reactions, especially since the weight lost is very often regained within months of discontinuing treatment.

Health authorities should learn the lessons from past public health disasters, notably those due to several appetite suppressants subsequently withdrawn from the EU market for disproportionate and serious adverse drug reactions (sibutramine (Sibutral), benfluorex (Mediator), rimonabant (Acomplia)).

Prescrire urges national Drug Regulatory Agencies’ representatives with a seat at the CHMP and who voted against the recommendation on naltrexone + amfebutamone (CONTRAVE/MYSIMBA) to insist that patients’ safety be defended. Member States opposing the recommendation still can and should require arbitration by the European Commission and convene a standing Committee meeting. The EU Commission, as last gatekeeper, also has the possibility of deciding not to follow the CHMP’s  recommendation.

In 2015, weight-control medicines that do more harm than good should no longer be authorised in the European Union. ”

Sources and more information
  • Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned, prescrire, 19 December 2014. See also the press release PDF.
  • Mysimba recommended for approval in weight management in adults, EMA, 19/12/2014. See also the press release PDF.
  • FDA approves weight-management drug Contrave, FDA news, September 10, 2014.

Epilepsy: MHRA Drug Safety Update vol7

Topiramate, Valproate Special reminder on risk of neurodevelopmental delay in children following maternal use—not for use in pregnancy

AntiEpileptic Drugs

New advice on switching between different manufacturers’ products for a particular drug

Drug Safety Update vol7,monthly newsletter by the MHRA
Medicines safety updates from the MHRA, listing medicines information and safety alerts

Different antiepileptic drugs (AEDs) vary considerably in their characteristics, which influences the risk of whether switching between different manufacturers’ products of a particular drug may cause adverse effects or loss of seizure control. AEDs have been divided into three risk-based categories to help healthcare professionals decide whether it is necessary to maintain continuity of supply of a specific manufacturer’s product. Read more via the PDF link below.

Sodium Valproate

Special reminder on risk of neurodevelopmental delay in children following maternal use—not for use in pregnancy

There is new evidence on neurodevelopmental delay in children following maternal use of sodium valproate. A European review is underway to evaluate all currently available evidence on the association between fetal valproate exposure and neurodevelopmental delay or autism spectrum disorder. Healthcare professionals are reminded that sodium valproate should not be used during pregnancy and in women of childbearing potential unless clearly necessary. Read more via the PDF link below.

Full PDF; read and download the MHRA monthly newsletter
Drug Safety Update November 2013 (Volume 7, Issue 4)

For Related Posts, see our Tags:
AEDs – Epilepsy – Drugs – Pregnancy – Topiramate – Valproate

Topamax and Birth Defects: Trial opens in Philadelphia

Janssen’s Topamax Users blame Drug for Birth Defects

Janssen's Topamax Users Blame Drug for Birth Defects
Bloomberg News is the first word in business and finance

Johnson & Johnson’s (JNJ) Janssen Pharmaceuticals failed to inform expectant mothers of risks that its epilepsy drug Topamax could cause birth defects, a lawyer for the mother of a Virginia 6-year-old told a jury. April Czimmer wouldn’t have taken Topamax for more than six months had she known the risks associated with the drug, her attorney Tommy Fibich said in opening statements today in state court in Philadelphia. Czimmer blames the drug for her son’s cleft palate and lip and claims Janssen negligently failed to inform patients about its risks until the U.S. Food and Drug Administration ordered stronger warnings in 2011. ”

Continue reading Janssen’s Topamax Users Blame Drug for Birth Defects, by Sophia Pearson, Bloomberg, 15 Oct 2013

All our posts tagged AEDsTopamaxTopiramateValproate

Topamax Drug: FDA warned that Topiramate could cause Birth Defects

Elevated risk for cleft lip and cleft palate in babies born to women who took topiramate during pregnancy

FDA Warns That Topiramate Could Cause Birth Defects: What to Tell Patients
Elevated risk for cleft lip and cleft palate in babies born to women who took topiramate during pregnancy

The FDA has issued several warnings about the use of topiramate by childbearing woman based on data from two registries, which showed an increased risk of oral clefts in infants exposed to monotherapy during the first trimester of pregnancy.

The FDA said topiramate would now be classified as a “Pregnancy Category D” drug, meaning there is evidence of human fetal risk based on human data.

Read FDA Warns That Topiramate Could Cause Birth Defects: What to Tell Patients
Neurology Today: 07 April 2011 – Volume 11 – Issue 7 – pp 1,8-9

FDA Safety Information for Patients and Providers:
Topiramate (marketed as Topamax) Information, 03 April 2011

Increase in Birth Defects with Topiramate and Valproate Drugs

14-fold increase in birth defects in those taking topiramate in pregnancy

UK Pregnancy Study Finds Slight Increase in Birth Defects with Topiramate
There was a 14-fold increase in birth defects in those taking topiramate with other antiseizure medications

Researchers in the United Kingdom reported in a study – Topiramate in pregnancy: preliminary experience from the UK Epilepsy and Pregnancy Register – an increase in birth defects among children born to mothers taking the antiseizure medications  valproate and/or topiramate (Topomax) – also widely prescribed in the US for migraine.

Read UK Pregnancy Study Finds Slight Increase in Birth Defects with Topiramate, Neurology Today, 2009.

Related posts: