Risperdal Male Breasts Warning
WARNING: Breast Development in Males Caused By Risperdal
The prescribing information published for Risperdal contains only a brief Risperdal gynecomastia warning. In fact, the brevity and lack of detailed Risperdal male breast warning information included in the product literature are the subject of Risperdal boys breast development lawsuits. Researchers, doctors, consumers, and lawyers representing men who developed breasts while taking Risperdal say the Risperdal boys breast growth warning should be strengthened. “The initial Risperdal labeling downplayed the risk of adverse events resulting from increased prolactin levels, says the Citizens Commission on Human Rights. These groups have called on the FDA, Janssen, and Johnson & Johnson to warn consumers of Risperdal risks, including an unsuccessful Citizen’s Petition to issue a FDA Risperdal male breast warning.
Risperdal Risks Largely Unknown, without FDA Risperdal Male Breast Warning
Johnson & Johnson has been aware of the Risperdal male breast link since it was revealed in pre-market testing, and has paid significant civil and criminal fines as a result of its failure to adequately warn patients of the risk. Yet the FDA has never taking the step of requiring the drug giant to issue a Risperdal warning for the boys breast development risk. Stephen Sheller, lawyer for Aaron Banks in the first Risperdal gynecomastia lawsuit to settle, inferred that the absence of an FDA Risperdal breast growth warning had contributed to the lack of public awareness on the subject. Sheller said, “Risperdal should be a drug of last resort. The adverse event profile is so significant; you don’t want to use it except as a last resort. There are many alternatives to these kinds of drugs. But ‘big pharma’ and the FDA have failed to protect the public.” A Risperdal lawsuit filed in 2013 by the Kentucky attorney general pushed for a federal trial on the grounds of a missing Risperdal warning label.
Early Clinical Testing Reveals Risk but No Risperdal Boys Breast Warning
Pre-market testing conducted by Janssen, the pharmaceutical arm of Johnson & Johnson that markets Risperdal, before Risperdal was approved for teens in 2007 indicated that 2.3% of boys taking Risperdal would develop gynecomastia, or male breast growth. Medical experts suggest the percentage of men and boys who grow male breasts from Risperdal is much higher. A Duke University study from June 2006 found that Risperdal was to blame for 70% of the gynecomastia cases included in the research. Furthermore, court documents from the first Risperdal gynecomastia lawsuit indicate that Janssen representatives claim Risperdal may not be the cause of boys breast development, or that such breast development is normal for teenage boys. Dismissing the severity of Risperdal gynecomastia and failing to issue an adequate Risperdal gynecomastia warning is one source of the company’s legal problems. Another is the fact that Risperdal was widely marketed for use in teens prior to the drug’s approval for children in 2007.
The dangers of failing to issue a Risperdal male breast warning are complex. First, doctors prescribing Risperdal and patients taking Risperdal are not aware of the risk of male breast growth. Secondly, boys and men who grow breasts while taking Risperdal can feel isolated and estranged as a result of their breast growth. Gynecomastia is largely unknown, and the social stigma connected to boys breast growth makes it difficult for males suffering from this condition to seek help. In the absence of a formal Risperdal gynecomastia warning, males who develop breasts assume they are uniquely flawed. Body image, masculinity, and sexual identity come into question, and the psychological damages resulting from male breast growth are deep and prolonged.
Citizen’s Petition for FDA Risperdal Male Breast Warning Denied
In July of 2012, a group led by Risperdal lawyers submitted a petition for an FDA Risperdal Warning. The petition called on the FDA to revoke Risperdal’s indication for pediatric use until the drug could be shown to be safe for children. As a compromise, the petition suggested a Black Box FDA Risperdal Warning be added to the product’s label. Currently, Risperdal’s prescribing information for doctors makes a brief mention of gynecomastia on pages 12 and 14, noting that, “The long-term effects of Risperdal on growth and sexual maturation have not been fully explored.” The literature concedes that, “Risperidone is associated with higher risk levels of prolactin elevation than other antipsychotic agents,” but the FDA Risperdal warning request was denied.
Lack of Risperdal Warning for Boy’s and Men’s Breast Growth May Contribute to Need for Surgical Removal
Perhaps in part due to the lack of a true Risperdal boys breast growth warning, many cases of male breasts from Risperdal require surgical removal. Tamoxifen is a drug that has been used successfully to reverse moderate gynecomastia by lowering estrogen levels, but due to lack of awareness of the problem most males with Risperdal gynecomastia don’t seek medical attention until the problem is extreme. 18,500 men and boys have breast reduction surgery each year in the United States. In many cases, Risperdal gynecomastia requires ultrasound-assisted liposuction, whereby the fat and breast tissue is melted and then removed with a liposuction device. The surgery requires incisions that leave small scars near the nipples. The most extreme cases of Risperdal breast growth require a surgery similar to mastectomy, where the breast tissue is removed and the chest must be reshaped. Liposuction is an outpatient surgery, but requires that the patient wear a compression vest for at least a month while the incisions heal. The cost of the surgery, ranging from $3500 – 6000, is not covered by most health insurance policies.
The larger scars left by Risperdal boys breast development are emotional rather than physical. In an article published on salon.com entitled “Man boobs and my decade of shame”, Zachary Valenti offers a candid account of his experience of Risperdal breast development: “It took more than breast reduction surgery for me to find [peace] for myself.” Growing abnormally-large breasts can cause significant shame, self-loathing, and anxiety in men and boys. In American culture in particular, which places a strong emphasis on the differences between males and females, breasts are a potent symbol of female sexuality. Men and boys who grow breasts from Risperdal report feeling emasculated, ashamed, and ostracized because having breasts is antithetical to being a man. These feelings and the associated emotional damage can require years of therapy to repair, warn psychologists, long after a surgical procedure has removed the excess breast tissue. Warning of Risperdal side risks, experts say gynecomastia may impact a boy’s ability to participate or succeed in athletics, academics, family life, social life, and professional endeavors.
Risperdal Male Breast Warning for Teen Boys
A 2008 Wall Street Journal article cautions that a Risperdal male breast warning is most important for adolescents taking the drug. With their bodies already changing so dramatically, and issues of masculinity, self-worth and body image already at the forefront, teen boys who grow male breasts are most vulnerable for emotional damage and social trauma from gynecomastia. Unaware that their abnormal breast growth is caused by taking Risperdal, boys who grow breasts often attempt to hide the problem from the people around them. Retreating from families and friends, shying away from sports and other activities that may highlight the difference in their bodies, teen boys who grow breasts can become isolated and riddled with anxiety that someone will discover their abnormality. Showering and changing in locker rooms, going to sleep-away camp, dating, and going to the pool or beach are examples of typical teen activities that are problematic for boys with breasts. Scared of the social stigma or teasing that may result if others see their chest, boys with breasts go to great lengths to hide their bodies. Teasing from peers and the use of derogatory terms such as “moobs” (for male boobs) lead to poor self-esteem. Social distrust, self-loathing, and depression may result from Risperdal boys breast growth, conditions which may impact the future course of a young man’s life for years to come. Aware of the connection between Risperdal and male breasts that is particularly damaging to teens, Johnson & Johnson’s subsidiary Janssen has admitted in civil suits to illegally marketing the drug for off-label uses in teens prior to 2007.
The Department of Justice filed suit against Janssen and Johnson & Johnson over the companies’ failure to issue a Risperdal gynecomastia warning and promotion of the drug to children in spite of the known risks:In addition to promoting Risperdal for elderly dementia patients, from 1999 through 2005, Janssen allegedly promoted the antipsychotic drug for use in children and individuals with mental disabilities. The complaint alleges that J&J and Janssen knew that Risperdal posed certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development and milk production. Nonetheless, one of Janssen’s Key Base Business Goals was to grow and protect the drug’s market share with child/adolescent patients. Janssen instructed its sales representatives to call on child psychiatrists, as well as mental health facilities that primarily treated children, and to market Risperdal as safe and effective for symptoms of various childhood disorders, such as attention deficit hyperactivity disorder, oppositional defiant disorder, obsessive-compulsive disorder and autism. Until late 2006, Risperdal was not approved for use in children for any purpose, and the FDA repeatedly warned the company against promoting it for use in children.
Referring to the Department of Justice Risperdal lawsuit, which settled for $2.2 billion in civil and criminal fines in November of 2013, Attorney General Eric Holder said, “The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust.”
Risperdal Lawyers Help Boys, Men, and their Families
Our attorneys handling Risperdal lawsuits for boys and men with male breast growth, and the family members of such persons, offer legal expertise in the realm of representing individuals against pharmaceutical giants. They will leave no stone unturned as they prepare your case for trial, and fight to the end to assure you get the compensation you deserve. If you or a loved one developed male breasts from Risperdal, a member of our Risperdal lawyer team will be happy to provide you with a free Risperdal claim evaluation.
Risperdal Breast Lawsuits
Males who have been diagnosed with gynecomastia and have taken Risperdal may have grounds for a Risperdal lawsuit. Our firm offers legal representation for Risperdal male breasts lawsuits on contingency basis, meaning that there is no fee for our legal services unless we win compensation on your behalf.