Articles Posted in Testosterone therapy

Manufacturing and marketing testosterone replacement therapy (TRT) drugs is a huge industry.  According to data presented by Statistica, testosterone replacement hormone products brought in over $2.4 billion in 2013. That number has risen in years, recently topping $3.8 billion.  The problem is there is not much evidence about what it really means to have a normal testosterone level, and there is even less medical evidence taking testosterone replacement hormone will actually do anything beneficial despite claims by drug companies. It has also been shown increasing testosterone levels also means higher chances of having a stroke or heart attack for men who didn’t need the drug in the first place.

The reason testosterone therapy drugs were invented in the early 1970s was to treat a developmental disorder known as hypogonadism. In reality, the clear majority of patients who take testosterone therapy drugs today do not suffer from hypogonadism. The reason they take these meds is because they have been told in countless advertisements and patient information pamphlets if they take TRT drugs, they will no longer “suffer” from the normal symptoms of the aging process.  These symptoms include what one might expect such as the following: Continue reading

Litigating a testosterone replacement therapy lawsuit in Boston can involve many complex issues. One recently litigated issues deals with the challenges in filing certain claims against generic drug manufacturers involving failure to warn of a known danger.  This is a claim that the manufacturer of a drug did not adequately include warnings about certain known dangers or adverse events (side effects) on the information given to doctors or the monograph warnings given to patients at pharmacies when they go to get their prescriptions filled.

The specific problems arise when a patient gets a generic version of a prescription drug.  The makers of generic drugs still must have their products approved by the U.S. Food and Drug Administration (FDA), but they are not applying for approval under a new drug application.  Since they are making a generic version of a brand name drug, as long as the generic is substantially similar to the brand name, the generic drug manufacturer is prohibited under federal law from changing warnings used by the brand-name drug manufacturer.   In other words, the generic manufacturer must simply copy the warnings use by the brand-name drug maker.  This was confirmed in two landmark cases entitled PLIVA Inc. v. Messing, and Wyeth v. Levin.   Continue reading

The Journal of the American Medical Association (JAMA) recently published a large series of studies that primarily involved the risks and benefits of testosterone replacement therapy.  A recent article from Star-Telegram examined the results of these and discussed what they mean to those who are considering taking testosterone replacement therapy (TRT) drugs, or have already begun taking them and are worried about possible adverse effects and complications.

The first thing to understand is that while hundreds of thousands of men are taking testosterone replacement therapy drugs every year, the medication was first developed in the 1960’s to treat a relatively rare medical condition known as hypogonadism.  This condition involved extremely low levels of testosterone in men due a glandular defect and would affect normal development.   Continue reading