Tag Archives: FDA

Are You Taking Pills You Don’t Need? Here Are Some Reasons Why

Most people blame direct-to-consumer advertising, especially on TV, for elevating everyday anxiety to depression, depression to bipolar disorder, childhood behavior problems to psychiatric illnesses, lack of sleep to excessive sleepiness, migraines to epilepsy drug deficiencies and old age to hormone deficiency

But ghostwriting also helps the national malaise of people suffering from and treating diseases that didn’t even exist before and ballooning government and private health plans costs.

Heart Warning Added to Label on Popular Antipsychotic Drug Seroquel

Today the New York Times has reported, “AstraZeneca is adding a new heart warning to the labels of Seroquel, its blockbuster antipsychotic drug, at the request of the Food and Drug Administration, company and agency officials said on Monday.” And that “Seroquel is one of the top-selling drugs in the world, at $5.3 billion last year, including $3.7 billion in the United States. Introduced in 1997, it has been approved for schizophrenia, bipolar disorrder and severe depression. Seroquel has caused legal problems for AstraZeneca, including a $520 million payment in 2009 to settle government charges of illegal marketing. Thousands of lawsuits are pending over side effects like diabetes.”

While this is seemingly good news, look a little deeper in today’s article from Paul Thacker, an investigator for Project on Government Oversight…

1 out of every 7 Elderly Nursing Home Residents on Antipsychotics—Despite Risk of Death

Long-term-care (LTC) facilities are overusing antipsychotic drugs. One of every 7 elderly nursing home residents is receiving at least 1 atypical antipsychotic; in 83% of these cases, the drug is associated with a dementia diagnosis, yet the use of atypical antipsychotics in dementia increases the risk of death and is not approved by FDA, according to a report from the Office of the Inspector General (OIG).

Bad Side-Effects Ahead For Pharma?

In 2006, The New York Review of Books reported that four-year-old Rebecca Riley died of the effects of two prescription drugs—Clonidine and Depakote.

These medications, along with Seroquel, were prescribed for Rebecca after she was diagnosed, at the age of two, with attention deficit hyperactivity disorder (ADHD) and bipolar disorder. The three drugs are not approved by the Food and Drug Administration (FDA) for treatment of ADHD or long-term treatment of bipolar disorder, nor are they approved for children as young as Rebecca.

The New York Review of Books‘ recent two-part article (1) by Marcia Angell on the treatment of mental illness with psychoactive drugs (those that affect the mental state) addresses an issue that may one day prove very important to investors in pharmaceutical stocks. (All statistics and quotations herein are drawn from Dr. Angell’s article.) It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so. The profits in psychoactive drugs, however, make it tempting to flout the law. In the past four years, AstraZeneca (AZN), Pfizer (PFE), Eli Lilly (LLY), Bristol-Myers Squibb (BMY) and Forest Labs (FRX) have all settled federal charges of marketing psychoactive drugs off-label, at a cost running into hundreds of millions.

Paxil and Prozac Linked to Risk of Heart Birth Defects

According to Finnish researchers, doctors should avoid prescribing Paxil or Prozac to pregnant women, due to the potential risk of heart birth defects.

In a study published in Obstetrics & Gynecology medical journal, researchers found that side effects of Prozac and Paxil use during pregnancy may increase the risk of women giving birth to children with congenital heart defects. Both drugs belong to a class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs).