Testosterone drugs should be scrutinized by drug manufacturers in a cooperative manner to best determine their safety and efficacy, according to the the U.S. Food and Drug Administration.
The FDA recently called for new testosterone drug safety clinical trials to be performed jointly by manufacturers. Such studies would be able to show whether testosterone drug side effects include a heightened risk of heart problems.
These testosterone drug safety trials will also indicate whether these medications provide any real benefits for men whose low testosterone levels can be attributed to their age as opposed to some other condition.
FDA officials hope that these testosterone drug safety tests will allow manufacturers to prove jointly that such testosterone drugs help male patients who do not have “classic hypogonadism” without serious side effects like heart attacks and strokes.
The FDA was prompted to call for these testosterone drug safety tests because low testosterone drugs have reportedly been connected with a heightened risk of heart attacks.
Heart attacks are already more likely in middle-aged and/or elderly men, so a medication with increased risk of heart attacks would be unacceptable unless the benefits truly outweigh the risks.
The FDA is concerned that, potentially, testosterone drugs may have no real benefits for middle-aged or elderly men, and therefore put such men at completely unnecessary risk of heart attacks and strokes.
Testosterone Drug Safety Lawsuits
Some testosterone drug safety lawsuit allege that drug companies are engaging in aggressive marketing tactics, encouraging middle-aged and elderly men alike to use the drugs despite alleged side effects like heart attacks and strokes, which can be fatal.
According to these testosterone product lawsuits, some doctors are even providing men with testosterone drugs without having any knowledge of their patients’ testosterone levels. With this in mind, it is possible that some patients who take low testosterone drugs may not have actually low testosterone levels, and may only perceive them to be low.
These lawsuits suggest that some patients are being allowed to take a medication with real, severe side effects despite having no need to do so. These testosterone drug safety lawsuit allege that this is, in large part, due to drug manufacturers’ aggressive marketing tactics.
The FDA found in recent testosterone drug research that at least 28 percent of men who were prescribed low testosterone drugs had probably not been tested for testosterone levels, and may therefore not have had any reason to take the medication in the first place.
Testosterone Drug Studies and Safety Issues
A 2014 testosterone drug safety study found that the serious side effects associated with testosterone drugs may double the risk of heart attacks in men 65 years or older. As for younger men with a prior history of heart disease, the same study showed that testosterone drugs could double their risk of heart attacks.
A 2015 testosterone drug safety study found that those who use testosterone for the first time may be about 40 percent more likely to have a heart attack compared to men who did not use the drugs.
In response to these testosterone drug safety studies, the FDA announced that testosterone drugs would include a warning label update. This update would include information about the potential link between testosterone drugs and serious heart problems.
The FDA also indicated that testosterone drugs should only be used by men actually diagnosed with hypogonadism.
Testosterone Drug Lawsuits
Testosterone drug manufacturers are facing an increasing number of testosterone drug lawsuits. These lawsuits allege that drug manufacturers failed to adequately warn about the potential risk of serious cardiovascular events associated with their testosterone drugs.
Lawsuits also allege that had they been adequately warned about these risks they would not have taken the drugs. Therefore, they would not have suffered from sometimes life-threatening side effects.
Some plaintiffs have suffered sudden heart attacks, deep vein thrombosis (DVT), stroke, or died, while either using these testosterone drugs or afterward.
Testosterone drug lawsuits have been centralized as part of a multidistrict litigation. A few bellwether Androgel cases are being prepared.
If you or someone you know has suffered a cardiovascular injury or other serious side effect after or while using a testosterone drug, you may be able to file a testosterone drug lawsuit.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The testosterone attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, testosterone product lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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Join a Free Testosterone Product Class Action Lawsuit Investigation
If you or someone you know suffered a heart attack, stroke, blood clot, or other injury as a result of using a testosterone gel or cream, legal options are available. Find out if you qualify to join a free testosterone gel class action lawsuit investigation and pursue compensation for you or your loved one’s injuries by filling out the form below.
An attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.
- First Name*
- Last Name*
- Street Address*
- Apt. #
- City*
- State*
AlabamaAlaskaArizonaArkansasCaliforniaColoradoConnecticutDelawareDistrict of ColumbiaFloridaGeorgiaHawaiiIdahoIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMissouriMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaNorth DakotaOhioOklahomaOregonPennsylvaniaRhode IslandSouth CarolinaSouth DakotaTennesseeTexasUtahVermontVirginiaWashingtonWest VirginiaWisconsinWyomingArmed Forces AmericasArmed Forces EuropeArmed Forces Pacific
- Zip Code*
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- Were you or a loved one injured after using a testosterone cream, tesosterone gel or other tesosterone therapy product?*
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- What injury did you or your loved one suffer?*
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Heart Attack/Myocardial Infarction
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Stroke
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Deep Vein Thrombosis (blood clot in the leg)
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Pulmonary Embolism (blood clot in the lung)
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Death due to any of the above
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Other (please specify in the additional information box below)
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- What year did this injury occur? For example, 2012.
- What product caused the injury?*
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AndroGel
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Androderm
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Axirom
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Delatestryl
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Depo-Testosterone
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Fortesta
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Striant
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Testim
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Testopel
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Other or Over-the-Counter (please specify in the additional information box below)
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- ¿Necesita un orador español?
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- No
- Please enter any additional information you would like the staff reviewing your submission to know. Remember, the more detailed your complaint, the more likely you will be contacted for a free case evaluation.
- I understand and agree that submitting this form does not create an attorney-client relationship and that the information I submit is not confidential or privileged and may be shared.*
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Yes
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