Concerning strokes & death among the elderly:
(the first class-action lawsuit)
[The Warning Letter to Canada, October 2002 // hc-sc.gc.ca]
[Warning Letter to America, April 2003 // fda.gov]
[Latest Label with recent changes high-lighted // fda.gov]
[probably the best source // adrugrecall.com]
[another source // mentions link to diabetes // yourlawyer.com]
[another source // lists other harmful effects as well // injuryboard.com]
[Company To Warn of Possible Risperdal Stroke Risk // April 14, 2003]
[ahrp.org // apr. 11, 2003] - demands "why the delay?" in warning the U.S. about potentially fatal risks
[Britain Warns of Stroke Risk... // yourlawyer.com]
[Stroke Risk Cited In Widely Used Drug // April 11, 2003] - J&J to send warning letter to U.S.
[injuryboard.com] - "In March 2004, Britain's Committee on Safety of Medicines warned physicians that elderly patients taking Risperdal to treat dementia, an off-label use, face three times the risk of suffering a stroke."
July 2004: Minimizing Potentially Fatal Safety Risks, including DIABETES:
(the second class-action lawsuit)
In a letter to doctors, Janssen [producer of Risperdal] admits that it had "minimized potentially fatal safety risks [such as heart attack, stroke, and death] and had made misleading claims about the drug [Risperdal] in promotional materials."[Washington Post]. Furthermore, as late as November 10, 2003, Janssen claimed that Risperdal did not increase the risk of diabetes, though the opposite was true. In April 2004 Janssen received a letter from the U.S. Dept of Health & Human Services warning them that Risperdal did indeed increase the risk of hyperglycemia-related and diabetic adverse effects. Lastly, the same week of Janssen's confession, the Miami Herald had run an article about Risperdal's causing a handful of boys to develop lactating breasts. [namiscc.org, and various other sources].
The full story about Janssen's confession: "[In 2003], the [FDA] instructed Janssen ... to change their product labeling to include warnings about the risk of diabetic-related adverse events, including the possibility of coma and death." Janssen changed complied, and then the FDA asked it to send out a letter to alert physicians to the label changes, and to make doctors aware of the fact that Janssen had previously minimized the risks of Risperdal. Janssen wrote the letter to physicians, but the FDA claims that the letter itself "omits material information about Risperdal, minimizes the potentially fatal risks associated with the drug and claims superior safety without adequate substantiation." Janssen now no longer denies this misrepresentation on their part. [source]
[Maker of Schizophrenia Medicine Clarifies Risks // July 25, 2004]
[FDA Miffed Over Letter... // April 28th] - this is an article from BEFORE Janssen's admission, and it explains the whole situation very well.
[FDA: Antipsychotic Drugs, Diabetes Linked // Sep. 18, 2003 // yourlawyer.com] - "Federal regulators have asked the makers of a widely used class of six antipsychotic drugs [including Risperdal] to include labeling language about a possible link with diabetes."
[FDA Seeks Diabetes Warning On Anti-Psychotic Drugs // Sep 17, 2003 // yourlawyer.com]
[namissc.org // many articles on one page]
[ahrp.org // July 24, '03 // Janssen confesses]
[Miami Herald // July 24, 2004 // Janssen confesses]
[second article on page // namiscc.org]- "As late as Nov. 10, 2003, Janssen claimed Risperdal did not increase the risk of diabetes among consumers--when the company knew the opposite was true"
[class action lawsuit // your lawyer.com] - Risperdal has been linked to diabetes, as already mentioned, and Janssen's above-mentioned dishonesty involving the issue has prompted a class action lawsuit. One article states: "Risperdal has been linked to Diabetes prompting the FDA to request that Johnson and Johnson issue a warning to patients and prospective patients. In a recent study Risperdal increased a patient's chances of developing diabetes by about 50 percent compared with older
Miscellaneous:
[Journal of the American Geriatrics Society; Vol 47(3) Mar 1999, US: Lippincott Wiliams & Wilkins: 1999, 377] - Some say an ad Risperdal placed in the Journal of the Geriatric Society misleadingly implied that Risperdal should be used to treat aggressive behaviors in older adults. (Such usage is not FDA approved.) Janssen denied the misrepresentation.
[forbes.com] - mentions Risperdal removing many of its warnings about heart problems, including "life threatening abnormal heart rhythm," though the drug itself is unchanged.
[Miami Herald // July 24, 2004] - (read last half of article) - about Florida foster children - even infants and toddlers - being routinely placed on mood-altering drugs, often drug "cocktails" (untested combinations). Mentions a fifteen year old girl begging a judge to prevent child welfare from forcing her to take Risperdal, which was making her gain weight and suffer dramatic mood swings. Other interesting things as well...
[Risperdal Associated with Cerebrovascular Adverse Events] - such as stroke and fatalities...
July 2004: Risperdal "cited in a federal lawsuit filed ... by a doctor who claims children have been harmed and even killed by the misuse of drugs he blames on aggressive marketing by drug manufacturers." [article // wavy.com]