Tag Archives: FDA

FDA Issues Draft Guidance For Investigator Conflicts

In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years.

Cause for alarm: Antipsychotic drugs for nursing home patients

When a loved one moves into a nursing home, the support of family and friends is particularly important. This is especially true when the nursing home patient has dementia and can’t adequately advocate on his or her own behalf.

A newly released report from my office — the Office of the Inspector General for the Department of Health and Human Services — makes clear just how crucial it is for families to monitor and ask questions about medications that such patients receive. The report found that too often, elderly residents are prescribed antipsychotic drugs in ways that violate government standards for unnecessary drug use.

Creating juvenile zombies, Florida-style

They’re children of the new Florida ethic. Zombie kids warehoused on the cheap in the state’s juvenile lock-ups. Kept quiet, manageable and addled senseless by great dollops of anti-psychotic drugs.

A relatively small percentage of young inmates pumped full of pills actually suffer from the serious psychiatric disorders that the FDA allows to be treated by these powerful drugs. But adult doses of anti-psychotic drugs have a tranquilizing effect on teenage prisoners. Prescribing anti-psychotics for so many rowdy kids may be a reckless medical practice, but in an era of budget cuts and staffing shortages, it makes for smart economics.

How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

In 2008, the FDA declared that powerful antipsychotics such as AstraZeneca (AZN)’s Seroquel were being over-prescribed and started a monitoring initiative to curb their use. It hasn’t worked, judging by an analysis of the FDA’s adverse event database by the Institute for Safe Medication Practices.

Seroquel is only approved for schizophrenia, mania and bipolar disorders. It’s a powerful drug that has serious side effects if taken for a long time: It’s associated with weight gain and diabetes, among other problems.