Atypical antipsychotic drugs entered the market in the late 1980s, and the first studies suggesting they caused an increased mortality risk in elderly patients with dementia appeared in the medical literature at the end of the 1990’s. In 2005, the FDA added a boxed warning to the labels of the entire class of atypical antipsychotic drugs, warning that they were associated with an absolute increase in the risk of death of 1.9% compared to placebo in that same patient population. However, between 2000-2019, pharmaceutical companies racked up $100 billion in sales for these same drugs and continued illegally marketing atypical antipsychotics to elderly populations.
Here, the Drug Pricing Lab uses attributable risk calculations to estimate the toll suffered by elderly individuals by the use of atypical antipsychotics over the last two decades. Based on indirect measures and using both sales and survey data as sources, we estimate the use of atypical antipsychotics compared to has led to between 300,000 and 1,200,000 needless deaths.
Initial FDA approvals for atypical antipsychotics:
A1: Geodon, February 2001
A2: Abilify, November 2002
A3: Risperdal Consta, October 2003
A4: Seroquel XR, May 2007
A5: Abilify Maintena, February 2013
FDA warning added to FDA label for cerebrovascular adverse events in elderly patients with dementia. Warning section includes the following language for the first time: “Risperdal is not approved for the treatment of patients with dementia-related psychosis.”
W1: Risperdal, September 2003
W2: Zyprexa, January 2004
W3: Abilify, March 2005
Boxed warning added to FDA label for increased mortality in elderly patients with dementia-related psychosis.
W4: Atypical antipsychotics, April 2005
Legal settlements related to marketing to elderly patients are notated by doted vertical lines.
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The infrastructure bill includes a drug waste provision from the Recovering Excessive Funds for Unused and Needless Drugs (REFUND) Act, which requires manufacturers to rebate the amount wasted back to CMS. An estimated $3 billion over 10 years can be recouped and invested in roads, bridges, and other infrastructure initiatives.