FDA approves and cautions about Diet Pills

New Diet Pills Offer Option to Off-Label Obesity Drugs

These drugs offer an additional tool for the physicians specializing in Weight Loss.  Physicians need to counsel their patients  about the drug’s side effects and risks, and determine a personalized approach for the patient’s wellness. We counsel the patients to make sure that the risks from taking the drugs are mitigated.

The FDA’s press release about Qysmia cautions –

FDA approves weight-management drug Qsymia

Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate; this drug’s effect on heart rate in patients at high risk for heart attack or stroke is not known. Therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose.

The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. The purpose of the REMS is to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia will only be dispensed through specially certified pharmacies.

About Xenical and Alli, Orlistat – the FDA released this consumer report on May 26, 2010.

FDA Consumer Update Weight-Loss Drugs and Risk of Liver Failure

FDA has identified and reviewed 12 cases of severe liver injury reported in people taking Xenical and one case reported with the use of Alli. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury.

A cause-and-effect relationship of severe liver injury with orlistat use has not been established; however, because of the seriousness of this possible side effect, FDA has revised the drug labels for Xenical and Alli to include new safety information about the rare occurrence of severe liver injury.

Results of a retrospective chart study of more than 100 patients over an average duration of 6 months. Ninety eight percent of patients lost an average of more than 20 lbs,. BMI decreased an average of about 10%.  The body’s lean mass composition improved by 10%.

The Inspire program is effective in achieving a level of weight reduction that preserves lean mass and is correlated with a significant decrease in the incidence of type 2 diabetes, cardiovascular disease and other obesity-related co morbidities. The success of the program is likely related to its unique multidisciplinary approach that incorporates proven evidence-based strategies into practical medical management.