RisperdalRisperidone
Manufacturer: Johnson & Johnson/Janssen
Labeled Indications: RISPERDAL® is an atypical antipsychotic agent indicated for: Treatment of schizophrenia in adults and adolescents aged 13–17 years. Alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed epi[...]show moresodes associated with Bipolar I Disorder in adults, and alone in children and adolescents aged 10–17 years. Treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years. Schizophrenia (Adults): RISPERDAL® (risperidone) is indicated for the acute and maintenance treatment of schizophrenia. Adolescents: RISPERDAL® is indicated for the treatment of schizophrenia in adolescents aged 13–17 years. Bipolar Mania Monotherapy (Adults and Pediatrics): RISPERDAL® is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10–17 years. Combination Therapy – Adults: The combination of RISPERDAL® with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Irritability Associated with Autistic Disorder Pediatrics: RISPERDAL® is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
Active Ingredient(s): Risperidone
Contraindications: Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone. Therefore, RISPERDAL® is contraindicated in patients with a known hypersensitivity to the product.
Drug Description: RISPERDAL® contains risperidone, a psychotropic agent belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is C23H27FN4O2 and its molecular weight is 410.49. The structural formula is: Risperidone is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl. RISPERDAL® Tablets are available in 0.25 mg (dark yellow), 0.5 mg (red-brown), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (green) strengths. RISPERDAL® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 0.25 mg, 0.5 mg, 2 mg, 3 mg, and 4 mg tablets also contain talc and titanium dioxide. The 0.25 mg tablets contain yellow iron oxide; the 0.5 mg tablets contain red iron oxide; the 2 mg tablets contain FD&C Yellow No. 6 Aluminum Lake; the 3 mg and 4 mg tablets contain D&C Yellow No. 10; the 4 mg tablets contain FD&C Blue No. 2 Aluminum Lake. RISPERDAL® is also available as a 1 mg/mL oral solution. RISPERDAL® Oral Solution contains the following inactive ingredients: tartaric acid, benzoic acid, sodium hydroxide, and purified water. RISPERDAL® M-TAB® Orally Disintegrating Tablets are available in 0.5 mg (light coral), 1 mg (light coral), 2 mg (coral), 3 mg (coral), and 4 mg (coral) strengths. RISPERDAL® M-TAB® Orally Disintegrating Tablets contain the following inactive ingredients: Amberlite® resin, gelatin, mannitol, glycine, simethicone, carbomer, sodium hydroxide, aspartame, red ferric oxide, and peppermint oil. In addition, the 2 mg, 3 mg, and 4 mg RISPERDAL® M-TAB® Orally Disintegrating Tablets contain xanthan gum.
Risperdal (risperidone) is an antipsychotic drug designed to treat schizophrenia, bipolar disorder, and symptoms of autism. It received U.S. Food and Drug Administration (FDA) approval for the treatment of schizophrenia in 1994, under a Johnson & Johnson/Janssen Pharmaceuticals patent that would not expire until 2003 (at which point, generic versions of the drug hit the market).Lawsuits allege that Johnson & Johnson never adequately warned of Risperdal’s gynecomastia risks, despite calls from doctors to do so.Unfortunately, Risperdal can cause young boys to develop female breast tissue—a condition known as gynecomastia. Drug maker Johnson & Johnson never strengthened Risperdal labels to warn of gynecomastia risks, despite calls from doctors to do so. Even worse, J&J allegedly knew of the risks but manipulated its data and withheld key evidence from the FDA in order to (eventually) obtain approval to market the drug to children.
Thousands of patients nationwide have filed lawsuits against J&J, alleging that the company understood the gynecomastia risks but did not warn consumers of them.
If you or a loved one took Risperdal and developed gynecomastia, contact us for a free legal consultation. You could be owed money.
Johnson & Johnson: A History of Deceit
The FDA approved Risperdal for use by schizophrenics in 1994. From that point until December 2003, Johnson & Johnson/Janssen held the patent on the drug and didn’t face any competition from generic versions (which debuted in 2004).But even with this edge, J&J wanted to widen the drug’s appeal to maximize its profits—despite research showing adverse effects in children and the elderly. Over the next 12 years, the company engaged in myriad deceptive tactics, as covered in great detail by Steven Brill. The following is just the tip of the iceberg.
In 1995, Johnson & Johnson cofounded the Texas Medical Algorithm Project (TMAP), which aimed to sway doctors to prescribe Risperdal to off-label Medicaid patients like kids and senior citizens.
At the same time, the company petitioned the FDA to approve the drug for use by the elderly, but the FDA refused. In 1996, Janssen petitioned the FDA again, this time for use by children. Again, the FDA denied them.
By 1996, Risperdal sales had already reached $589 million a year—nearly three and a half times that of 1994 ($172 million). In January 1999, the FDA again denied a Janssen request to expand approval to the elderly, stating that the drug maker had “failed to fully explore and explain what appeared to be an excess number of deaths” among elderly Risperdal users.
The following year, the FDA specified that the Risperdal label state it should be used only for schizophrenia, not for the much more general “psychotic disorders.”
Meanwhile, Johnson & Johnson continued to promote the drug for children, offering kickbacks to doctors, creating “back to school” marketing efforts, and even handing out candy and toys with “Risperdal” printed on them.
In 2000, Johnson & Johnson learned that 5.5% of boys taking Risperdal long-term eventually developed breasts. The Risperdal label said that this occurred in 0.1% of boys. By this point, more than a fifth of Risperdal users were children and adolescents.
In 2016, Making a Murderer filmmakers Laura Ricciardi and Moira Demos announced that their next documentary would be an adaptation of Steven Brill’s story about Johnson & Johnson, “America’s Most Admired Lawbreaker.”
Johnson & Johnson Hit with $2.2 Billion Fine
From 1999 to 2005, the FDA repeatedly warned J&J about promoting Risperdal for use by young people. During this time, the Justice Department says that Janssen promoted Risperdal for use in children and individuals with mental disabilities, despite the company knowing that Risperdal posed “certain health risks to children, including the risk of elevated levels of prolactin, a hormone that can stimulate breast development.” (In 2006, the FDA finally approved Risperdal for use by children and adolescents, specifically those suffering from autism.)In 2012, Johnson & Johnson settled a Justice Department investigation into its promotion and marketing of Risperdal (and related state investigations, lawsuits, and probes) by paying a $2.2 billion fine, one of the largest in American pharmaceutical history.
But by then, the company had made nearly $30 billion (20 domestic, ten abroad) off the drug. Two billion dollars represented a tiny fraction of this profit—a slap on the wrist given all the kickbacks, unlawful marketing tactics, and data manipulation in which Johnson & Johnson engaged, to the detriment of consumers.
Hundreds if not thousands of boys have allegedly grown breasts from taking Risperdal, and many elderly people have suffered strokes and even died.
Meanwhile, Alex Gorsky, the man responsible for Johnson & Johnson’s Risperdal marketing efforts during this time, was never punished for peddling the drug to children and the elderly. On the contrary, Mr. Gorsky was promoted to CEO of Johnson & Johnson in April 2012. He made $25 million in 2014.
Studies Link Risperdal to Gynecomastia
Gynecomastia stems from a hormone imbalance and can lead to the growth of male breasts and significant weight gain. It is believed that Risperdal may cause gynecomastia in young male users because it increases levels of the hormone prolactin, which stimulates female breast development and lactation.Children and adolescent risperidone users were found to have a gynecomastia risk that was five times higher.The Risperdal-gynecomastia link gained attention from a 2006 study by a Duke psychiatrist that found a strong association between Risperdal and gynecomastia in children and adolescents. The study concluded that when risperidone is administered to adolescents for psychotic symptoms, the drug can increase prolactin levels and lead to gynecomastia.
Another 2006 study on risperidone and gynecomastia drew a similar conclusion, noting that risperidone should be administered to young patients with caution.
A more recent study published in the Journal of Child and Adolescent Psychopharmacology concludes that there is a strong association between risperidone use and gynecomastia in young adult males. Compared to non-users, children and adolescent risperidone users were found to have a gynecomastia risk that was five times higher.
The study explicitly notes the “high psychological burden” of gynecomastia.
Traumatic Side Effects Spawn Thousands of Lawsuits
Many young men who have suffered severe and lasting personal injury from Risperdal have filed lawsuits against Johnson & Johnson to seek compensation for physical injury, financial losses, and pain and suffering.In November 2015, more than 1,500 Risperdal gynecomastia cases were consolidated as part of a mass tort in the Philadelphia Court of Common Pleas. All cases similarly allege that Risperdal caused gynecomastia in young men, and that Janssen did not warn users about this potential side effect.
Early settlements indicate that some Risperdal gynecomastia victims may be in line for significant compensation:
- In April 2015, a jury awarded a young man who developed size 44D breasts from taking Risperdal $2.5 million in damages. The jury found that Janssen failed to properly warn about the ability of Risperdal to cause gynecomastia.
- In November 2015, a jury awarded $1.75 million to a man who began taking Risperdal in 2003 for schizophrenia, who also developed gynecomastia.
- In July 2016, a jury awarded Andrew Yount of Tennessee $70 million in damages. Mr. Yount developed breasts after taking Risperdal as a five-year-old.
Johnson & Johnson also faces hundreds of lawsuits over its talc-based powders, which have been linked to an increased risk of ovarian cancer.
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