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Following reports of cardiac valve abnormalities in patients given phentermine and / or amfepramone in combination with other anorectic agents, Belgium referred the matter to the Belgium referred the matter under Article 15a of Council Directive 75/319/EEC, including amendments, to the CPMP on November 7, 1997.
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Therapeutic, effective treatment of obesity requires a substantial and long-term (at least one year) reduction in body weight. This finding is based on the scientific experience Phentermine over the counter years and is reflected in current medical current medical recommendations; for example, the Note for Guidance on Clinical Investigation of Drugs Used in Weight Control. of Drugs Used in Weight Control) (CPMP/EWP/281/96). Furthermore, this finding is also reflected in current guidelines, e.g., the Scottish Guideline (1996), a guideline from the Royal College of Physicians (1998), and a guideline from the American Society for Clinical Nutrition (1998) is reflected.
In a number of short-term studies with relatively few patients, weight loss has been has been noted. Overall, these studies have not been conducted recently and meet methodologically no longer meet the scientific criteria that are standard in this field today:
- Only a slight reduction in body weight was achieved with phentermine.
- No studies have been conducted on the effects of Phentermine over the counter on cardiovascular or other recognized risk factors of obesity available (i.e., blood pressure, cardiac functions, biochemical parameters such as serum lipid or glucose concentrations).
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The results of a new, unpublished clinical study have been presented by some marketing Marketing Authorization holders have been presented. This study does not provide any additional relevant information. It has been suggested by some marketing authorization holders that a short-term reduction in body weight as part of a program to treat obesity may be useful. Obesity might be useful. After treatment is discontinued, there is Buy adipex 37.5 mg a return to rapid weight gain and there are no controlled studies to show that a limited short-term effect has a long-term, clinically relevant impact on body weight or Provides a clinical benefit in the context of an obesity treatment program. Phentermine has not been studied in long-term studies, and data on the long-term effects of the substance and, in particular, its effect on the maintenance of reduced weight are not available.
Given the fact that obesity is now considered a chronic disease and its treatment should be considered a long-term strategy, phentermine has been shown to produce only modest short-term weight reductions of dubious and unproven relevance to disease progression. Buy phentermine online loss pills. Furthermore, the claim that phentermine, if used for supportive treatment, facilitate or improve longer-term strategies, has not been substantiated with appropriate evidence. Based on the available evidence of efficacy, phentermine can no longer be assumed to have therapeutic value in the treatment of therapeutic efficacy in the treatment of obesity
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The main safety concerns discussed relate to serious side effects on the central nervous system, primary pulmonary hypertension, and valvular Cardiac valve changes when used as directed. Central Nervous System (CNS) Effects. Phentermine, as a substance similar to amphetamine, has typical effects on the central nervous system, such as stimulation and sleep disturbances, as well as other serious side effects, such as psychotic reactions or psychosis, depression, and Seizures. Centrally acting amphetamine-like substances are known to have drug abuse and dependence potential. Where to buy phentermine. The marketing authorization holders pointed out in their objection statements and during the hearing at the July 1999 CPMP meeting, rejected the adoption of the CPMP, phentermine as a substance similar to amphetamine and attributing to it the same side effects as amphetamine.
After discussing this point, the CPMP felt that the reported cases of abuse and dependence with phentermine are the best data available to demonstrate that data to demonstrate that the substance may have such potential. No epidemiological study has been conducted to quantify the risk. The evidence suggested overall, however, suggest that the risk of drug abuse and dependence, although apparently lower drug Where to buy phentermine, although apparently lower than that of amphetamine itself, is indeed present is present and must be considered accordingly. Because of the risk of drug abuse and dependence, long-term treatment with phentermine is prohibited. long-term treatment with phentermine is prohibited.
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Primary Pulmonary Hypertension (PPH). In March 1995, the report on the International Primary Pulmonary Hypertension Study confirmed (IPPHS) confirmed that a strong association exists between the use of anorectic agents and an increased risk and primary pulmonary hypertension (PPH). Specific factors that increase the risk of primary pulmonary hypertension have been Online Diet pills, including a BMI of >30kg/m2 as well as A cumulative treatment duration of more than three months. This risk had been discussed in discussed in detail during the previous Article 12 process and had been included in the CPMP's the amendments to the summary of product characteristics adopted by the CPMP. reflected in the amendments adopted by the CPMP.
Regarding data from spontaneous acquisition systems, it can be said that some cases of primary pulmonary hypertension have been reported, but this information is not indicative of the the incidence.
In the opposition statements, the marketing authorization holders challenged marketing authorization Online Diet pills challenged the scientific justification for directly applying the esults of the IPPH study to phentermine. The CPMP acknowledged that phentermine was not mentioned in the IPPH study as an as an active ingredient administered in the IPPH study and that formal evidence from epidemiological are lacking. However, review of the available data did not provide confirmation that there was no association between phentermine and PPH, and consequently, the possibility of an increased risk of PPH associated with phentermine cannot be excluded.
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After consideration of the marketing authorization holders' submitted Eopposition Submissions and all available data, the CPMP came to the following Conclusions regarding efficacy and safety: In terms of efficacy, given that obesity is obesity is now considered a chronic disease and its treatment should be viewed as a long-term Adipex without prescriptions. should be considered as a long-term strategy, phentermine has been shown to produce only modest short-term weight loss of dubious and unproven relevance to the course of the disease. Furthermore, the claim that phentermine can facilitate or improve longer-term strategies if it were used as supportive treatment would be used, has not been substantiated with appropriate evidence. On the basis of available evidence on efficacy, it is no longer reasonable to assume that phentermine has any has therapeutic efficacy in the treatment of obesity or (consequently) a Adipex without prescriptions risk-benefit ratio.
With respect to safety, although the available data suggest that the risk of drug dependence is lower with phentermine than with amphetamine, some risk is in fact risk is indeed present and must be considered accordingly. Furthermore, the concerns regarding a possible association between Adipex without prescriptions and primary pulmonary hypertension or valvular heart disease have not been substantiated in planned epidemiologic studies. studies, these potential risks cannot be excluded. Further clinical trials would not only have to demonstrate the long-term efficacy of phentermine, but would also have to provide phentermine, but also evidence that the safety concerns (especially with regard to the (particularly with respect to abuse potential) do not conflict with the potential benefits.
One clinical trial alone would likely not be sufficient; a clinical research program would be required that would extend over several years. Based on these considerations, it must be concluded that phentermine-containing drugs have an unfavorable risk-benefit ratio.