FDA Panel Backs Limiting Use of Testosterone Replacement Drugs

 

Research has shown that the use of replacement drugs for testosterone should be restricted. These drugs can be used by patients who suffer from medical conditions like impairment of the testicles that interferes with their functions. The drugs should also be used when they have been prescribed by the doctor. This is a report that was concluded by the FDA advisory panel of United States of America.

Reports from FDA

The Food and drugs administration is not indebted to follow what the panel says but it does. The panel also advised the companies to do more research on cardiovascular risk of this therapy on the patients who have low testosterone levels. The symptoms that show low testosterone include reduced mass of the muscles, depression, fatigue and low libido and sexual desire. The votes of the panel were 20-1 and this shows the people who were in favor of the drugs being restricted in people who had medical condition that were related to low levels of testosterone. This report shows that when the restriction of the panel is put in effect; companies will not have the power to market or advertise their products. However, physicians and doctors were allowed to prescribe drugs that can be used for low testosterone and this included prescribing the drugs that are off label.

The treatment products for low testosterone include injections that are short acting, skin patches, and gels that can be applied topically. The market leader is AbbVie Inc’s AndroGel and this company generated approximately 1.04 billion dollars and this was through sales in the year 2013.

The advisory panel also said that it may consider supporting a product that is being developed privately by a company called Clarus Therapeutics Inc. and in case the product is approved, it will be the first treatment that can be used orally and it will challenge the other treatments that are in the market.

The Rise in Related Prescriptions

Prescriptions

The studies have indicated that there is an increase in the prescriptions of treatment for low testosterone and this was done in 2010 to 2013. The study showed that there was a rise in prescription from 1.3 million to 2.3 million. The study also showed that the men who got the prescriptions were between the ages of 40-64. The agency said that there were some issues concerning the prescriptions that were alarming. This included the fact 21% of the people who were given this prescriptions did not have their levels of testosterone checked before and during the treatment.

There is also a black box warning that was to be issued by FDA concerning the serious cardiovascular risks that are associated with taking the drugs. This was for a petition that was made by consumer watchdog public citizen but the petition was denied by FDA. This is because the FDA said that it was still assessing the cardiovascular risks that are associated with taking the drugs. In addition, most companies said that the black box warning could not be issued because there was inadequate data to prove the cardiovascular risks associated with taking these therapies.

Related Studies

More research on testosterone therapies have showed that the drugs are used by over 2 million Americans and most of them are not prescribed by the doctor or physician. The medical experts are alarmed by the fact that most people use these drugs because of symptoms that are associated with increased age. In case the recommendations of the FDA panel are adopted, the number of men who are prescribed for these drugs will reduce. It will also cut down on marketing of these products by different companies as this is one of the ways in which sales are increased. Dr Domanski, who is one of the directors of a research institute that deals with stroke voted for a change in the labeling of the drugs. The panelists said that the label should be restricted to men who have medical conditions that require the use of this drugs and this includes problems associated with the pituitary gland.

The research also indicated that one of the factors that increased the used of these drugs is the fact that they are very easy to use for example gels. The FDA has also indicated that the health benefits of using testosterone therapies cannot be proven and that people should be cautious with their use. The use of these drugs has quadrupled since the year 2000 and this is commonly in men who are above 40 years.

Conclusion

The different studies done by FDA have shown that the use of drugs for low testosterone should be reduced. This is because of the risks associated with their use and this includes heart conditions. Studies indicate the use of these drugs has increased over the years and it is more common in men who are above 40 years.