A recent request made under the Freedom of Information Act (FOIA) has revealed that the U.S. Food and Drug Administration has received more than 100 reports of serious medical problems allegedly linked to AndroGel, a product used to treat low testosterone levels.

FOIA requests helps lawyers, reporters, and concerned citizens get information from the government. AndroGel is a drug designed to be applied to the underarms as a gel. The drug is designed to replace testosterone* This is intended to treat low T, a condition that causes older males producing less testosterone. However, concerns have surface that such drugs may be over-prescribed, the condition may be over-diagnosed, and the drugs may cause serious health problems.

In response to concerns surrounding the link between an increased risk of heart-related illness from AndroGel, a FOIA request was sent by the Levensten Law Firm to the FDA. The request sought documents involving AndroGel injuries collected between 2002 and 2013.

According to the information provided by the FDA, they have received reports of 42 heart attacks, 18 cerebral vascular incidents (stroke and related ailments), 44 pulmonary embolisms, and 12 deaths. While it is important to recognize that this is preliminary data, the ailments listed could all be traced back to blood clots forming within the body. For example, heart attacks can be caused by blood clots lodging in the tissues of the heart just as pulmonary embolisms are often caused by blood clots lodging in the blood vessels that supply the lungs.

>>Testosterone Gel Lawsuits Growing

Existing research has also found a link between androgen-replacement products such as testosterone gel or testosterone cream and blood clot related ailments. For example, a November 2013 study, published in the peer-reviewed medical journal The Journal of the American Medical Association(JAMA), found a link between androgen therapies like AndroGel and an increased risk of heart attack, stroke and death. The JAMA article said that the risk was more pronounced among older males with existing heart problems.

Other androgen-replacement products have come under increased government scrutiny. In January, the FDA announced an investigation into the safety of these treatments in response to concerns regarding the drugs’ safety records.