FDA Rejects Another Weight Loss Drug

It is becoming common practice for the Food and Drug Administration (FDA) to reject applications for new weight loss drugs. Over the past year,  the FDA rejected applications for three anti-obesity medications. This week, the FDA rejected the application for Contrave. Contrave is a combination of an antidepressant and an anti-addiction drug to curb appetite. Early studies demonstrate  modest weight-loss benefits (i.e., approximately 4.5% weight loss). 

However,  FDA scientists and safety advocates were critical of the data indicating Orexigen, Contrave's manufacturer, enrolled a limited number of elderly patients or patients with a history of heart disease in its trials, making it difficult to determine the drug’s safety in patients who are likely to need it most.

The FDA has not approved a weight loss medication since the 1990's. We all remember the combination drug fenfluramine and phentermine (i.e., Fen-Phen) and its risk for heart valve issues and pulmonary hypertension. If you were not aware, the FDA was instrumental in removing a weight loss drug from the market last year. Meriida was a good weight loss drug but long-term results demonstrated concerns of increased risk for strokes and heart attacks. 

It is apparent that the FDA is very cautious when approving future weight loss drugs. However, we must recognize obesity is global epidemic and is one factor leading to increased healthcare cost. Under the proper guidance and physician supervision, weight loss medications do offer advantages and positive results. 

As of today, there are two approved drugs for weight loss; phentermine and xenical. Phentermine is an appetite suppressant and xenical is a fat-blocking agent. Both have benefits in weight loss but should only be used in combination with a proper lifestyle program encompassing calorie restriction and physical activity.

There are risks with prescription weight loss drugs

 

When considering long-term weight loss medications, you should address the following with your physician.

• Addiction. Currently, all prescription weight loss drugs, excluding xenical, are considered "controlled substances." There are prescription requirements your physician should follow to limit the risk of developing an addiction.

• Tolerance. Most individuals experience a weight loss plateau following 3 to 6 months of weight loss.  There is a concern that individuals develop a tolerance for the medication. However, it is unclear whether this leveling off is the result of  drug tolerance or if the drug has reached its limit in effectiveness. Moreover, there are other mediating factors related to metabolic changes from weight loss. Therefore, metabolic changes and/or tolerance to the drug are questionable.

• Side effects. Most side effects from weight loss drugs are mild and usually improve as the body adjusts to the medication. It is uncommon for serious or even fatal outcomes to occur with these medications. There are still risks involved and with phentermine the risk is an increase in  blood pressure. 

There are side effects with prescription weight loss drugs

 

Most appetite suppressants are used as a short-term treatment for obese people. Not only do the drugs' effects tend to wear off after a few weeks, but they can also have some unpleasant side effects, such as

• Increased heart rate
• Increased blood pressure
• Sweating
• Constipation
• Insomnia 
• Excessive thirst
• Lightheadedness
• Drowsiness
• Headache
• Anxiety
• Dry mouth

Noted side effects with Xenical include 

• Abdominal cramping, 
• Flatulence (i.e., passing gas) 
• Increased number of bowel movements, 
• The inability to control bowel movements. 
• Leakge of oily stool. 

These side effects are generally mild and temporary, but typically are  worsened by eating foods that are high in fat. Therfore, you should limit your daily intake of fat to less than 30% of your overall caloires. 

Another important factor is taking a good multivitamin. If you consume fewer than 1200 calories per day you typically are unable to obtain the needed requirements for vitamins and minerals. Moreover, since vitamins are fat soluble xenical could prevent the absorption of these vital nutrients. Therefore, one should consider taking a multivitamin at least two hours before or after taking the medication.

Since these drugs are not recommended for long-term use, it is important  to learn new eating habits and to exercise while the drug is still effective. Once healthy eating and regular exercise have been learned and established, it is important to continue a low calorie diet and to exercise in order to lose and maintain the goal weight.

The Bottom Line!

Weight loss medications have their place in treatment. They should be considered secondary to initial treatment options. According to the national guidelines for weight management, you should focus on behavioral counseling, calorie restriction, and physical activity as your primary option. Only under situations determined by you and your healthcare provider should weight loss medications be used. They do offer advantages but there are always risks. 

Thanks for reading my blog and I welcome your thoughts and opinions.

Best, Dr. Scott

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