Tag Archives: off-label

Texas Doctors Prescribe $47 Million Worth of Antipsychotic & Anti-Anixety Drugs, Primarily for Kids—One Child Psychiatrist Alone Wrote 27,000 Prescriptions For Xanax

With little oversight and apparent carte blanche, a relative handful of Texas physicians wrote $47 million worth of Medicaid prescriptions for powerful antipsychotic and anti-anxiety drugs over the past two years, according to a Star-Telegram analysis. The top five doctors alone wrote $18 million worth. Grassley asked Texas and other states for the top 10 prescribers who billed Medicaid for certain drugs. The Star-Telegram used prescriber numbers to identify the doctors, then sorted and tallied the drugs they were prescribing. Also reviewed was information on other mental-health drugs that have cost taxpayers about $1.3 billion during the past five years.

Most of the drugs have gone to children and adolescents, although prescribing the drugs to children, such as a toddler, is considered “off-label” — uses not approved by the federal Food and Drug Administration. Now the state’s Medicaid program is among others under scrutiny, after Sen. Charles Grassley, R-Iowa, began investigating the use of mental-health drugs this year.

Nursing homes are seeking to end the psychiatric drug stupor

The dangers of [psychiatric ] drugs: The drugs are especially hazardous to older people, raising the risk of strokes, pneumonia, confusion, falls, diabetes and hospitalization. “There’s a bunch of problems, not least of which is those drugs can kill you,” said Dr. Mark Kunik at Baylor College of Medicine in Houston who spoke last month at the Gerontological Society of America’s annual meeting in New Orleans. Instead of looking for causes of disruptive behavior among dementia patients, doctors typically prescribe drugs to mask the symptoms, he said, because “It’s the easy thing to do. … That’s true in hospitals, in clinics and in nursing homes.” Federal regulators are cracking down on homes that don’t routinely reassess residents on psychotropic drugs. But use remains widespread.

Justice to Pharma: “Do the Perp Walk!”

Former GSK counsel is the first target in government’s executive-liability crackdown. Could J&J be next? The US Department of Justice filed criminal charges last week against Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. Going after pharma execs marks a seismic shift in the government’s efforts to stem the tide of fraud and other illegal pharma marketing practices, which a raft of billion-dollar settlements have so far failed to end. Stevens is charged with obstruction of an investigation, concealment and falsification of documents, and making false statements to the FDA in its 2002 investigation of off-label promotion of the antidepressant Wellbutrin for weight loss, an indication for which it has never been approved but has shown some clinical benefit. The DoJ says that it has evidence, in the vast paper and electronic documentation turned over by GSK, showing that Stevens hid and otherwise misled the agency about some 1,000 instances of GSK-paid doctors promoting Wellbutrin for weight loss to other doctors.

Antipsychotic Drug Seroquel— Diabetes Lawsuits Hurt AstraZeneca Profits

Among Seroquel side effects is a reported increased risk of Seroquel diabetes. According to the UK Press Association, AstraZeneca set aside $203 million to resolve approximately 18,000 claims in the US that Seroquel, a schizophrenia treatment, caused diabetes and other serious Seroquel side effects. A further $270 million was reportedly put aside for other claims and to cover AstraZeneca’s legal costs. In August 2010, AstraZeneca said it settled approximately 17,500 lawsuits alleging Seroquel caused diabetes and other injuries for approximately $200 million. The lawsuits alleged the drug maker failed to adequately warn patients about the drugs’ risks.