Zyprexa, Seroquel, Abilify and other atypical antipsychotic drugs, meant to be used sparingly for severe mental illness like schizophrenia and bi-polar disorder, are being prescribed in increasing numbers to young children and the elderly. Doctors have helped to turn atypical antipsychotics like Zyprexa into blockbusters by prescribing them for more common conditions such as dementia and aggression. Some have accused drug makers of illegally promoting off-label uses as the reason behind this surge in atypical antipsychotic drug prescriptions. Yet even as the use of atypical antipsychotic medications has grown, so have the number studies questioning some of the drugs’ benefits, especially in light of their link to serious side effects such as sedation, obesity, and diabetes.
Drugs receive US Food and Drug Administration (FDA) approval for specific purposes; however, medications are often prescribed as off-label—purposes other than that for which they were approved—on some difficult-to-treat conditions. Off-label prescribing is legal at physician discretion; however, off-label marketing by drug companies is in violation of federal law.
The first antipsychotics, like Thorazine, helped many but came with severe side effects, such as tardive dyskinesia, involuntary and debilitating movements. The second generation, dubbed atypicals, emerged in the 1990s and cause fewer involuntary movements, but weight gain and diabetes can result from their use, said Tom Clark, clinical affairs director for the American Society of Consultant Pharmacists Foundation. Atypicals include Risperdal, made by Janssen Pharmaceutica, part of Johnson & Johnson; Zyprexa from Eli Lilly & Co.; Seroquel by AstraZeneca P.L.C.; Geodon by Pfizer Inc.; and Abilify by Bristol-Myers Squibb Co.
State officials are finding atypicals have become the largest drug class in Medicaid and many question if this is due to illegal off-label marketing or true patient need. Several states are suing drug makers for off-label promotion and commissioning “ghost-written” articles to increase use of their products. Meanwhile, drug makers are obtaining new approvals from the FDA to treat more conditions. For instance, in the last two years, Risperdal received approval to treat schizophrenia in adolescents and the irritability of autism in children ages five to 16.
However, increased use of these new antipsychotics can have unforeseen results. Nicola Huff, whose son, John Aaron, took Risperdal for seven years to resolve behavioral problems said at age 14, he developed female-sized breasts that had to be surgically removed. Tammy Wandling, whose son Austin has autism, said a psychiatrist put him on Risperdal at age four. In less than nine months, Austin developed a baseball-size growth in his right breast. Research suggests Risperdal can cause an increase in the hormone prolactin, which causes breasts to enlarge and make milk.
More than 26 percent of the nation’s nursing home residents were on antipsychotics in early 2007, compared with 19.4 percent in 1999, federal surveys show. Those drugs do little to help dementia patients, said Lon S. Schneider, a California psychiatrist and lead investigator of the CATIE-AD study of outpatients with Alzheimer’s. He and his colleagues found that patients on anti-psychotics for 12 weeks had a slightly greater risk of dying sooner than those on placebo.
Zyprexa-maker Lilly set aside $1.2 billion to settle 31,000 claims and still faces 1,200 cases and a federal probe. Bristol-Myers Squibb, maker of Abilify, agreed to pay $515 million last year, in part to settle off-label marketing allegations; the firms also face thousands of additional claims. AstraZeneca has 8,000 suits pending for Seroquel.