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Withdrawal of marketing authorisations for amfepramone medicines within the EU
On 27 October 2022, EMA’s safety committee (PRAC) confirmed its recommendation to withdraw the marketing authorisations for amfepramone obesity medicines. This followed a re-examination of its previous recommendation of June 2022, which was requested by the companies that market these medicines.
The recommendation followed a review which found that measures to restrict the use of these medicines for safety reasons have not been sufficiently effective. It found that the medicines were being used for longer than the recommended maximum period of 3 months, thereby potentially increasing the risk of serious side effects such as pulmonary arterial hypertension (high blood pressure in the lungs) and dependency. The medicines were also being used in patients with a history of heart disease or psychiatric disorders, increasing their risk of heart and psychiatric problems. In addition, there was evidence of use during pregnancy, which could pose risks to the unborn baby.
The review considered all available information relating to these concerns, including data from two studies on the use of amfepramone medicines in Germany and in Denmark. In addition, the PRAC received advice from a group of experts, comprising endocrinologists, cardiologists and a patient representative.
The PRAC considered introducing further measures to minimise the risk of side effects but could not identify any that would be sufficiently effective. The PRAC therefore concluded that the benefits of amfepramone medicines do not outweigh their risks and recommended that the medicines be removed from the market in the EU.
The CMDh1 agreed with the PRAC recommendation and adopted its position by majority on 10 November 2022. The CMDh position was forwarded to the European Commission, which issued a final legally binding decision on 13 January 2023 that is applicable in all EU countries.
Tenuate Retard 75mg is a weight loss medication used in the short term for treatment of obesity. Its generic name is diethylpropion and it is designed to be used for up to four weeks alongside proper diet and physical exercise to help start the weight loss process for people who have been unsuccessful in losing weight without.
Tenuate Retard 75mg is a medication, which is used for treatment of moderate and severe obesity in adults and adolescents aged 12 years and older.
What Are Side Effects Of Tenuate Retard 75mg ?
Side effects are undesirable effects that may occur if the product is used as intended.
What Adverse Effects May Occur?
– nausea
– Dry mouth
– constipation
– A headache
– Dizziness
– drowsiness
– Sleep disorders
– restlessness and tension
– irritability and nervousness
– Depressions
– delirium (confusion)
– seizures
– High blood pressure
– pulse acceleration
– palpitations
– chest painDrugs Interactions
Because Tenuate Retard 75mg are monoamines, hypertension may result when either agent is used with monoamine oxidase (MAO) inhibitors . Efficacy of diethylpropion with other anorectic agents has not been studied and the combined use may have the potential for serious cardiac problems; therefore, the concomitant use with other anorectic agents is contraindicated.
Antidiabetic drug requirements (i.e., insulin) may be altered. Concurrent use with general anesthetics may result in arrhythmias. The pressor effects of diethylpropion and those of other drugs may be additive when the drugs are used concomitantly; conversely, diethylpropion may interfere with antihypertensive drugs (i.e., guanethidine, a-methyldopa). Concurrent use of phenothiazines may antagonize the anorectic effect of diethylpropion.
Important Notes Tenuate Retard 75mg
Advice on the areas of allergies (concerning active ingredients and excipients), interactions, complications with food and beverages, as well as other warnings.
What should you pay attention to?
– Reactivity may also be impaired under normal conditions of use, especially in higher doses or in combination with alcohol. Pay particular attention to it when you are on the road or operating machinery (even in the household), with which you can injure yourself.
– Regular use may lead to psychological dependence.
– In women of childbearing potential, effective and effective contraceptive methods are required during and under certain circumstances. Talk to your doctor or pharmacist.
– Beware of allergy to dyes
– Beware of allergy to iodine
– Beware of intolerance to sucrose. If you have to follow a diabetes diet, you should consider the sugar content. Asenlix is one of best weight loss pills that can help you if you didn’t have satisfaction with Panbesy.
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Tenuate Retard 75mg
75 €
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