Will popular diet pill be banned?

European authorities urged the halt of an Abbott Laboratories Inc diet pill after concluding risks were too high, Reuters Health reported on 21 January 2010. (Read the news report here.)

The drug in question is sibutramine which is the active ingredient in products such as Reductil, Ciplatrim and Meridia. Sibutramine is used for weight loss because it acts as an appetite suppressant and also stimulates metabolism.

In September 2009, Abbott Laboratories and Weigh-Less launched an advertising campaign announcing that Ciplatrim, the generic of Reductil, was now available in South Africa and that it could be used to good effect together with the Weigh-Less regimen to promote weightloss.

This was regarded as good news for slimmers because the generic product usually costs less than the original drug.

The Scout study

The Reuters report states that a study called Scout, which compared Meridia (sibutramine) against placebo (dummy treatment) in 10 000 patients, had found an increased risk for heart attacks or stroke in subjects receiving the active drug.

Preliminary data indicated that 11.4% of the subjects receiving sibutramine had died, or had a heart attack, a stroke or cardiac arrest compared to 10% for subjects who were given the placebo treatment (Richwine, 2010).

The reaction

Understandably various international health organisations that monitor the safety of pharmaceutical treatments, reacted swiftly to the negative results of the Scout study.

On Thursday, the European Commission concluded that the risks of using this medication were too high and urged that sales of the Abbott Laboratories Inc diet pill should be stopped.

The European Medicines Agency advised the medical profession to stop prescribing diet pills containing sibutramine such as Reductil, Reduxane and Zelium in Europe, and Meridia in the USA.

The Food and Drug Administration (FDA) in America have requested that Abbott Laboratories Inc should include a stronger warning that patients with heart and cardiovascular problems should not use medications containing sibutramine (Richwine, 2010). 

The chances are therefore good, that diet pills containing sibutramine may be banned or their use restricted, particularly in Europe. At present we do not yet know how the authorities in South Africa will react.

Abbott Laboratories Inc have promised to make the full results of the Scout study available in March. Presumably the various regulatory bodies listed above will study these results in detail and then make their recommendations.

What should slimmers do?

In view of the Scout study results indicating that the use of diet pills containing sibutramine may cause fatalities, heart attacks, strokes, irregular heartbeats (arrhythmias) and uncontrolled high blood pressure, anyone using or planning to use such diet pills must take the following precautions:

•  The new results obtained with the Scout study should be taken seriously.
   
•  Anyone taking medications for weight loss that contain sibutramine should only do so under the strict supervision of a medical doctor. Do NOT obtain these drugs without first consulting your doctor and NEVER use medications that have been prescribed for someone else, they may harm you.
   
• Until more details of the study are available and the various international organisations such as the European Medicines Agency, the Medicines & Healthcare Products Regulatory Agency in the UK, and the FDA of America have drawn their final conclusions if medicines containing sibutramine should be banned, all patients with a history of heart disease, stroke, high blood pressure (hypertension), palpitations or any other signs or symptoms of heart or circulatory disease should NOT use any medications that contain sibutramine.
  
• Patients wanting to lose weight who are contemplating the use of drugs that contain sibutramine should also mention any problems they may have with other medical conditions (diabetes, kidney disease, etc) to their doctor, as such conditions may also put them at risk. 
   
• Careful evaluation of all patients who intend using sibutramine by a medical doctor or medical specialist experienced in the use of medications containing sibutramine, is essential. 
   
• If such an evaluation has taken place, then careful use of sibutramine-containing medications is probably still safe for patients who do not have heart or circulatory or other medical problems. 
   
• If you are using sibutramine-containing weight loss drugs and you are unsure, make an appointment with your medical doctor immediately so that he/she can assess your health again before you continue with the treatment.
   
• If you are currently using products such as Ciplatrim or Reductil and have not lost weight with these medications, then stop taking them. Some readers have told me that they have been using such medications for 3 months without losing any weight. In such cases it is not sensible to continue with a drug that has potentially harmful side-effects.
   
•  Always consider other safer options for weight loss first before you take weight loss pills, both those prescribed by your doctor or ones that you buy over the counter.
   
•  Individuals who are using Reductil or Ciplatrim successfully for weight loss who do not have any existing or history of heart or circulatory problems can probably continue to use such products in the short-term (3 months).

Safer options

Always first try weight loss options that do not involve the use of any pharmaceutical or herbal slimming pills. A balanced, energy-reduced low-fat, low-GI diet and regular exercise will help you to lose weight safely without having to run any risks associated with diet pills.

If you are struggling to lose weight, consider consulting a clinical dietician to help you with a tailored slimming diet that meets your special needs.

If you visit the Association for Dietetics in SA website at: www.adsa.org.za and click on "Find a Dietician", you should be able to find a dietician in your area.

Consulting a dietician for a slimming diet is particularly valuable if you suffer from health problems such as heart disease, diabetes, kidney disease, or metabolic syndrome. The dietician will take your medical conditions and any medications you may be taking for these conditions into account when working out a slimming diet for you.

At the present moment we do not yet know if sibutramine-containing slimming pills will be banned, but you can apply the precautions listed above to ensure that you do not expose yourself to unnecessary risks.

(Reference: Richwine L, Reuters Health, 21-01-2010: EU agency ban on diet drug)

Any questions? Ask DietDoc

(Dr IV van Heerden, DietDoc, January 2010)

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