WASHINGTON, DC — An advisory panel to the Food and Drug Administration (FDA) has expressed concerns about oral testosterone pills, specifically from the drug developer Lipocine, according to Forbes.
The panel overwhelmingly voted against the approval of the company’s drug Tlando, which is an oral testosterone treatment meant to treat “Low T,” a disorder that has commonly been treated with topical gels and creams such as AndroGel.
AbbVie, the makers of AndroGel, are facing lawsuits alleging the company downplayed the cardiovascular risks of testosterone drugs, as many patients have suffered heart attacks, strokes, and other problems due to the drug.
Similar to AndroGel, the advisory panel was concerned with the cardiovascular safety issues with Tlando. This was not the first time concerns were raised.
Back in 2015, the FDA denied their approval of the drug due to issues in its clinical trials. In the studies, one dosage of the drug found in Tlando caused an increase in systolic blood pressure.
“We continue to believe that efficacy and safety results from numerous clinical studies with Tlando are consistent with other FDA approved TRT products,” Mahesh Patel, chief executive officer of Lipocine, said in a statement. “We look forward to continuing to work with the FDA through the remainder of the review process.”
The FDA will make its final decision by May 8, 2018, according to Forbes.
As far as lawsuits go for Abbvie, they were ordered to pay $140 million in damages to one man and $150 million to another. Both men cited that they suffered heart attacks as a result of the product.
These testosterone drug cases may continue to be battled in court as patients present the dangers of the drugs, while the pharmaceutical companies claim the patient is liable for having used the drug.
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