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Weight Loss
Dangerous Obesity Drug Gets the Boot
Date: 10/02/10
The suspension of Reductil follows a review by the European Medicines Agency (EMA) which conducted a trial with 10,000 participants and found the risks of taking Reductil far outweigh the benefits. In fact, that’s a massive understatement, as it’s been found to increase the risk of non-fatal heart attacks and strokes... not a trade-off I for one would like to make!
On 21 January 2010, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the suspension of the obesity drug sibutramine which also goes by the names Reductil and Meridia, in the UK and the rest of Europe.
Reductil is a satiety enhancer containing the active ingredient sibutramine hydrochloride monohydrate, which works by affecting neurotransmitters in the brain. In particular it increases levels of noradrenaline and serotonin, which helps you lose weight by enhancing the feeling of fullness you get after eating only small amounts of food.
However, anyone given a prescription for the drug was warned not to take it for longer than a year. But what’s the point of taking a drug which shows modest weight loss benefits which cannot necessarily be sustained after treatment is stopped? Anyway, I digress, as this is not the reason the drug was pulled...
The suspension of Reductil follows a review by the European Medicines Agency (EMA) which conducted a trial with 10,000 participants and found the risks of taking Reductil far outweigh the benefits. In fact, that’s a massive understatement, as it’s been found to increase the risk of non-fatal heart attacks and strokes... not a trade-off I for one would like to make!
Reductil: Alarm bells should’ve been ringing at the EMA and MHRA long before now
When I first read about the suspension of Reductil, my initial gut reaction was: Why did it take so long?
Since Reductil was introduced in 2001 there have been 2094 suspected adverse reactions and 17 deaths linked to the drug. Six out of the 17 deaths were caused by heart problems and stroke.
In addition, placebo-controlled obesity studies showed that Reductil (5 to 20 mg once a day) caused increases in systolic and diastolic blood pressure. Other cardiovascular side effects have included tachycardia vasodilation, migraine, hypertension/increased blood pressure and palpitation, arrhythmias, myocardial infarction, and cardiac arrest.
This point alone should’ve have sealed the case on Reductil, since this drug was only made available to those who were obese and already at a greater risk of developing heart problems.
Reductil: Gift horse
I suppose in this instance we must remind ourselves not to look this ‘gift horse’ in the mouth and to count our blessings... After-all, the drug has been withdrawn and doctors have been told not to issue any new prescriptions for Reductil. They’re also being told to review the health of patients who were taking the drug.
But (and there is always a but...) this is only the case in the UK and Europe. In the US, the drug is still available and prescribed under the name Meridia. From what I read on the website drugs.com, it doesn’t look as if the American Food and Drug Administration (FDA) is planning to issue a retraction of this drug anytime soon. So, for our readers in the US (and anywhere else in the world where this drug may still be available) here is a list of other disturbing side effects associated with this drug:
1. Common side effects – These include:
Back pain, dizziness, dry mouth, flu-like symptoms, headache, joint pain, nervousness, painful menstruation, runny nose, sleeplessness, sore throat, upset stomach, weakness.
2. Severe side effects - seek medical attention right away if you experience any of the following adverse effects:
Severe allergic reactions (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue; unusual hoarseness), agitation, anxiety, blurred vision or other vision changes, change in amount of urine, chest pain, clumsiness, confusion, difficulty breathing, eye pain, fainting, fast or irregular heartbeat, high fever, increased sweating, large unchanging pupils, loss of consciousness, mood or mental changes (e.g. depression, mania, psychosis, thoughts of suicide or suicide attempt), one-sided weakness, restlessness, seizures, severe or persistent dizziness, headache, or weakness; shivering, shortness of breath, stomach pain, swelling of the feet, ankles, or legs; tremors, unusual bruising or bleeding, vomiting.
On the subject of side effects, it may also be useful to specifically highlight the gastrointestinal side effects associated with Reductil/Meridia. These include constipation, increased or decreased appetite, nausea, dyspepsia , gastritis , vomiting , rectal disorder and anorexia... Yes, you read that right, anorexia... Imagine taking a drug that can take you from one extreme to the other?
Here’s a thought for the MHRA and EMA... perhaps this drug should never have been approved in the first place. Let’s just hope the FDA catches on to the notion of suspending it soon. In the meantime, if you know of anyone battling obesity who is taking this prescription medicine, please forward this email to them.
Patients who are currently taking Reductil/Meridia should make an appointment with their doctor straight away and should explore alternative ways to lose weight.
Related Reading:
Obesity reaches crisis point in Britain
Obesity, Gastric Bypass: A Rock Or A Hard Place
Alli: Dangers In A Diet Pill
Sources:
‘Sibutramine (Reductil): marketing authorisation suspended’, published online 29.01.10, nice.org.uk
‘Sibutramine Side Effects’ published online, drugs.com
‘Meridia’ published online, drugs.com
‘Reductil (sibutramine) (discontinued in the UK - January 2010)’ published online, netdoctor.co.uk
Back to topReductil is a satiety enhancer containing the active ingredient sibutramine hydrochloride monohydrate, which works by affecting neurotransmitters in the brain. In particular it increases levels of noradrenaline and serotonin, which helps you lose weight by enhancing the feeling of fullness you get after eating only small amounts of food.
However, anyone given a prescription for the drug was warned not to take it for longer than a year. But what’s the point of taking a drug which shows modest weight loss benefits which cannot necessarily be sustained after treatment is stopped? Anyway, I digress, as this is not the reason the drug was pulled...
The suspension of Reductil follows a review by the European Medicines Agency (EMA) which conducted a trial with 10,000 participants and found the risks of taking Reductil far outweigh the benefits. In fact, that’s a massive understatement, as it’s been found to increase the risk of non-fatal heart attacks and strokes... not a trade-off I for one would like to make!
Reductil: Alarm bells should’ve been ringing at the EMA and MHRA long before now
When I first read about the suspension of Reductil, my initial gut reaction was: Why did it take so long?
Since Reductil was introduced in 2001 there have been 2094 suspected adverse reactions and 17 deaths linked to the drug. Six out of the 17 deaths were caused by heart problems and stroke.
In addition, placebo-controlled obesity studies showed that Reductil (5 to 20 mg once a day) caused increases in systolic and diastolic blood pressure. Other cardiovascular side effects have included tachycardia vasodilation, migraine, hypertension/increased blood pressure and palpitation, arrhythmias, myocardial infarction, and cardiac arrest.
This point alone should’ve have sealed the case on Reductil, since this drug was only made available to those who were obese and already at a greater risk of developing heart problems.
Reductil: Gift horse
I suppose in this instance we must remind ourselves not to look this ‘gift horse’ in the mouth and to count our blessings... After-all, the drug has been withdrawn and doctors have been told not to issue any new prescriptions for Reductil. They’re also being told to review the health of patients who were taking the drug.
But (and there is always a but...) this is only the case in the UK and Europe. In the US, the drug is still available and prescribed under the name Meridia. From what I read on the website drugs.com, it doesn’t look as if the American Food and Drug Administration (FDA) is planning to issue a retraction of this drug anytime soon. So, for our readers in the US (and anywhere else in the world where this drug may still be available) here is a list of other disturbing side effects associated with this drug:
1. Common side effects – These include:
Back pain, dizziness, dry mouth, flu-like symptoms, headache, joint pain, nervousness, painful menstruation, runny nose, sleeplessness, sore throat, upset stomach, weakness.
2. Severe side effects - seek medical attention right away if you experience any of the following adverse effects:
Severe allergic reactions (rash, hives, itching, difficulty breathing, tightness in the chest, swelling of the mouth, face, lips, or tongue; unusual hoarseness), agitation, anxiety, blurred vision or other vision changes, change in amount of urine, chest pain, clumsiness, confusion, difficulty breathing, eye pain, fainting, fast or irregular heartbeat, high fever, increased sweating, large unchanging pupils, loss of consciousness, mood or mental changes (e.g. depression, mania, psychosis, thoughts of suicide or suicide attempt), one-sided weakness, restlessness, seizures, severe or persistent dizziness, headache, or weakness; shivering, shortness of breath, stomach pain, swelling of the feet, ankles, or legs; tremors, unusual bruising or bleeding, vomiting.
On the subject of side effects, it may also be useful to specifically highlight the gastrointestinal side effects associated with Reductil/Meridia. These include constipation, increased or decreased appetite, nausea, dyspepsia , gastritis , vomiting , rectal disorder and anorexia... Yes, you read that right, anorexia... Imagine taking a drug that can take you from one extreme to the other?
Here’s a thought for the MHRA and EMA... perhaps this drug should never have been approved in the first place. Let’s just hope the FDA catches on to the notion of suspending it soon. In the meantime, if you know of anyone battling obesity who is taking this prescription medicine, please forward this email to them.
Patients who are currently taking Reductil/Meridia should make an appointment with their doctor straight away and should explore alternative ways to lose weight.
Related Reading:
Obesity reaches crisis point in Britain
Obesity, Gastric Bypass: A Rock Or A Hard Place
Alli: Dangers In A Diet Pill
Sources:
‘Sibutramine (Reductil): marketing authorisation suspended’, published online 29.01.10, nice.org.uk
‘Sibutramine Side Effects’ published online, drugs.com
‘Meridia’ published online, drugs.com
‘Reductil (sibutramine) (discontinued in the UK - January 2010)’ published online, netdoctor.co.uk
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