Qsymia quality assessment

Today, Qsymia is sold only on certified online pharmacies (such as Walmart and Walgreens) and the US pharmacy networks. Qsymia slimming capsules passed all appropriate clinical studies and were approved by the FDA in 2012.

However, before to approve Qsymia at the US market, the FDA demanded from a company Vivus – the manufacturer of this drug to conduct additional studies additional studies under Risk Evaluation and Mitigation Strategies (REMS) program.

Special REMS program has helped to assess risks and to establish requirements and recommendations to mitigate any possible consequences of Qsymia use by patients of different groups.

The main purpose of REMS program after Qsymia approval was to inform women of childbearing age about:

potential risk of congenital abnormalities in children exposed to this medication during the first trimester of mother’s pregnancy
need to finish a Qsymia course immediately after positive results of pregnancy test
importance of taking pregnancy test regularly by women of childbearing age who are taking Qsymia to get rid of excess weight

Unique Risk Evaluation and Mitigation Strategy (REMS) program for Qsymia includes:

making up and clearance of guidelines on Qsymia use for obese women of childbearing age
training of medical professionals to prescribe this drug for obesity treatment
dissemination of information on benefit / risk ratio of Qsymia through selling systems, including pharmacy chains

The manufacturer of Qsymia – Vivus company has a certificate of compliance of Good Manufacturing Practice (GMP). This certificate testifies that Qsymia is produced and controlled strictly in accordance with the set international quality standards.

In particular, the presence of GMP certificate in the Qsymia manufacturer confirms that:

  • Vivus company has appropriate facilities for production and storage of the original Qsymia and its ingredients
  • Company staff has the necessary level of specialized training and skills to develop and produce Qsymia
  • Vivus has all necessary equipment, appropriate materials, containers and labels for manufacturing and packaging of Qsymia extended-release capsules
  • All instructions and techniques approved by the WHO in 1963 are observed when manufacturing this drug for obesity treatment

REMS procedure and availability of GMP certificate proves that Qsymia is a high quality, the most effective and safe drug for obesity treatment. In addition, potential benefits of Qsymia significantly exceed any possible risks.

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