Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 11 April 2014 | By Alexander Gaffney, RAC
The European Medicines Agency's (EMA) has announced it will initiate a review of testosterone-containing medicines following concerns that the drugs, used primarily to treat a condition commonly known as "Low-T," may cause an elevated risk of cardiovascular side effects.
Those concerns were first raised by the US Food and Drug Administration (FDA) in February 2014 following the publication of two separate studies in the Journal of the American Medical Association (JAMA) and the journal Public Library of Science: Medicine (PLoS: Medicine).
The JAMA study suggested a 30% increase in risk of stroke, heart attack and death in those taking products intended to treat Low-T, while the PLoS study showed that older men (ages 65 and older) exhibited a two-fold increase of heart attack and younger men with a history of heart disease had a two- to three-fold increased risk of the same.
Based on those studies, FDA said it would reassess the risks of testosterone treatment, but stopped short of asking physicians to alter their current prescribing habits.
In the US, the drugs are already subject to a number of serious safety warnings, including that accidental exposure to testosterone (such as by family members) may cause health problems. The drugs also contain warnings that patients should tell their doctors if they have prostate cancer, heart problems, kidney or liver problems or urinary problems.
Now EU regulators are beginning their own assessment after Estonia's State Agency of Medicines requested a review.
In an 11 April 2014 statement, EMA cited the same JAMA and PLoS studies cited by FDA, and said its review would seek to confirm if those risks were in fact present.
While testosterone-containing drugs are not approved at the EU-wide level, several EU member states have authorized them. The drugs are used to treat hypogonadism, a condition marked by low levels of the hormone testosterone.
EMA's review will be carried out by its Pharmacovigilance Risk Assessment Committee (PRAC), which will ultimately recommend if the drugs should continue to be marketed, if they should bear additional warnings regarding their use, or if they should be withdrawn from the market entirely by member states.
Tags: Hypogonadism, Testosterone, Low-T, PRAC, Latest News, safety, review, EU