As an Androgel injury lawyer in Miami, I am concerned about the recent reports that men who take Androgel, Axiron, Testim, Foresta, and other low testosterone replacement drugs are at a higher risk for heart attacks and strokes.
Our lawyers in Miami for people who want to sue a drug company believe the FDA should now require low T drugs to come with a “Black Box” warning. Black Box warnings issued by the FDA are reserved for drugs that can cause problems leading to death or serious injury.
Drugs with the Black box, or “box warning,” carry warnings on the sides of their boxes, and those drugs are not permitted to use reminder ads. The drug warning labels are designed by the pharmaceutical company that actually makes the drug and must be approved by the FDA.
BLACK BOX WARNING NEEDED ON LOW T DRUGS
We believe there should be a Black Box warning on testosterone boosters after our review of recent reports of patients who have taken low T drugs and then suffered heart attacks and strokes. This should be a serious health concern for the over five million men in America who last year received prescriptions for testosterone products made by Androgel, Axiron, Testim, and Fortesta. Currently almost 13,000 prescriptions are filled for testosterone replacement drugs each day.
Some recently published reports and studies show an increased risk of heart attacks and strokes. Ironically, studies funded by the drug industry showed no increased risk, collectively, compared to 14 independent studies which collectively showed a highly significant increase in cardiovascular risk. Yet currently, the FDA-approved labels on the drugs in question include no mention of testosterone-induced cardiovascular risk.
FDA INVESTIGATING LOW TESTOSTERONE DRUG RISKS
In January, the FDA announced that it was investigating claims, in large part based upon the aforementioned studies, but as of today, the FDA has not required the drug makers to change the labels.
In its “Safety Announcement,” the FDA warned that it has been “. . . monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy.” You can read the FDA’s Testosterone Safety Announcement here.
What Are Low Testosterone Boosters?
Testosterone drugs should be used only by men who have a documented condition known as Low T, NOT simply as the anti-aging, sex-drive- increasing panacea depicted in hundreds of advertisements in magazines, on TV, and over the internet.
Low testosterone can be diagnosed only by a series of blood tests. This condition can occur when the testicles fail to produce testosterone because of genetic problems or chemotherapy.
WHY IS THE FDA NOT PROTECTING US?
As a lawyer who sues drug companies, I believe that as long as there is a risk, there should be a warning. In my opinion, consumers have the right to be protected by the FDA, even at the risk of being over-protected. The FDA should play the role of the Jewish mother, and warn of us every known risk.
Then, with all the available information in hand, if we as adults knowingly assume a risk, such as taking a dangerous drug–or staying up too late on a school night–we can suffer the consequences.
For the FDA to know of a danger and not force drug makers to share it is wrong. It is not in our best interest to allow the FDA to rely on a multi-billion-dollar pharmaceutical industry–with a documented history of hiding the truth, and falsifying reports that have destroyed lives–to police itself.
The FDA’s refusal to require a Black Box warning simply renders the FDA an irrelevant spectator rather than the guardian of our well-being that we need. Americans need a Marine to protect us from drug companies, not just a school crossing guard.
CLAIMS AGAINST ANDROGEL, AXIRON, TESTIM, AND FORESTA
For more than 20 years, I have helped people and their families who have been hurt by drug companies that put their profits ahead of people. My law firm that sues drug companies is located in South Florida, and we represent people from across the country.
We proudly provide free initial no-fee/no-cost consultations via SKYPE, email, or Toll-Free at 1-866-597-4529. Call us today.
We are currently investigating claims for men across the country, and we are ready to help you.