Axiron testosterone solution linked to possible health risks for men.
More troublesome were reports of accidental exposure to women and children. Included in the press release from the manufacturer we found this statement: “Stop using AXIRON and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to AXIRON. Signs and symptoms in children may include enlarged penis or clitoris; early development of pubic hair; increased erections or sex drive; aggressive behavior. Signs and symptoms in women may include changes in body hair and a large increase in acne. ”
What is Axiron?
Axiron is a topical solution testosterone treatment from Acrux Pharma Pty Ltd. It was first approved by the F.D.A. in November of 2010 as a prescription medicine used to treat adult males that have low or no testosterone. It was widely sold in the U.S. from its approval period up until recently when it was discontinued from the manufacture. As noted on the F.D.A. website “This discontinuation is not related to safety or efficacy of drug.”
If you or someone you love was harmed as a result of Axiron solution, you may be entitled to financial compensation. There may be substantial cash awards from claims and settlements from an Axiron class action lawsuit or multidistrict litigation (MDL). Call the lawyers and attorneys at National Injury Help today to see if you qualify for an Axiron testosterone lawsuit.
Call 1-800-214-1010 for a free case evaluation or use the form on the bottom of your screen.
Whatever the problems with the drug may be, they are apparently exacerbated by doctors who prescribe it for a host of ailments, prescriptions that ignore the limited extent of the drug’s approval by the U.S. Food and Drug Administration (FDA). This is called “off-label use” and this is not recommended by the FDA.
What are the Axiron Lawsuits about? – Possible Misrepresentation of Risks
The starting point for this issue is to understand that the FDA approved the drug only for hypogonadism, that is, when the testicles do not produce enough testosterone. Low T therapy has not been approved for a myriad of other conditions, including age-related decline in testosterone levels, low sex drive, muscle loss, irritability or fatigue. When manufacturers don’t mention the possible side effects, then they open themselves up for litigation.
FDA on Axiron – Gets labeling change applied.
Following an Advisory Committee meeting in 2014, the US Food and Drug Administration required holders of new drug applications for approved testosterone products to conduct a well-designed Postmarketing Requirement (PMR) clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of testosterone products. The F.D.A. in March 2015 reviewed research on Axiron and other low-T testosterone treatments and demanded a label change to the package that reflects new data on increased risks of heart attacks, strokes and blood clots.
Do I Qualify for an Axiron lawsuit? How do I file a claim?
The best answer to see if you qualify for an Axiron lawsuit claim is to simply call us at 1-800-214-1010 and speak directly to our intake staff; they will ask you a number of questions about your use of Axiron. The attorneys and lawyers at National Injury Help can help you if you’ve been harmed by taking Axiron.
Four common questions about the Axiron lawsuit.
- How much can you get from an Axiron lawsuit?
- I got blood clots or heart attack from Axiron , can I sue?
- How much compensation would I get from an Axiron solution lawsuit?
- How much are the settlement amounts in the Axiron lawsuit?
The answer to these questions can be difficult to predict, as the class action or MDL for this hasn’t started yet. There is still time for join in this Axiron lawsuit, but there are statutes of limitations that apply.
Some of the past defective drug lawsuits have had millions of dollars in a compensation fund, and then that is divided up between all who have joined the lawsuit. Example: $50,000,000 in a settlement fund that would serve 1,000 victims would be $50,000 per person. This is only an example and does not represent what may happen for Axiron.
Axiron testosterone Lawsuit Claims & Settlements, risks of blood clots heart attack stroke page updated on April 10, 2019.