Drug Enquirer

NEWS AND FACTS ABOUT MEDICINES YOU TAKE

Strattera

FDA: Strattera May Prompt Suicidal Thoughts in Children & Teens

Strattera, a drug used to treat attention deficit hyperactivity disorder (ADHD), now carries a “black box” warning—the strongest the FDA can require—following an analysis of a dozen clinical trials in which about five patients reported suicidal thoughts. One participant attempted suicide.

Emergency  Hospital

ADHD Drugs Send Thousands to the ER

ADHD medicines are linked to cause of death in 25 people, 19 were children, reported to the FDA from 1999 to 2003.

One-in-Five Teens Abuses Medications

Easy to get. Easy to use. Nearly one in five teenagers reported abusing prescription and over-the-counter medications, according to a 2006 national study funded by the National Institute on Drug Abuse, part of the National Institutes of Health.

Over-the-Counter Drugs: Safe?

If over-the-counter drugs were dangerous, the FDA would never allow them to be sold without a prescription, right? Not exactly. Almost all OTC medications were at one time prescription drugs and have inherent risks of adverse reactions like any prescription.

What is a “Black Box” Warning?

A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. It is the strongest alert the FDA can require.

Even though the bold warning label is always printed on the manufacturer's wholesale packaging, patients may never see the “black box” risks.

FDA: Antidepressants Increase Risk of Suicidal Behavior in Users Under 25

Strong “black box” warning labels about the suicide risk associated with antidepressants are updated to add young adults ages 18 to 24.

Antidepressants since 2004 have carried the strongest warning about an increased risk of suicidal thoughts and actions in children and adolescents. The FDA says users of all ages should be closely monitored.

Skyrocketing Abuse of Prescription Meds

Prescription drug abuse is now the nation's fastest-growing drug problem, according to the director of the White House Office of Drug Control Policy, as reported by Associated Press.

A 400 percent increase in substance-abuse was found in children and adults (ages 12 and up) during the ten-year period of 1998 to 2008, according to the same government study. The rise in illicit use of pharmaceuticals spans every gender, race, ethnicity, education and employment level, and all regions of the country.

More Americans Taking Prescription Drugs

For the first time, more than half of all insured Americans are taking prescription medicines regularly for chronic health problems, according to data compiled by Medco Health Solutions, reports Associated Press.

Medication use: Number of Americans taking prescription drugs on a regular basis. Children and teenagers: one-in-four. Women: almost two-thirds. Men: more than half. Seniors 65 and older: three-out-of-four.
ABOVE: “Study shows more Americans taking prescription drugs.” Associated Press, USA Today, May 14, 2008.
Related News

Too Much of a Good Thing?

For one-in-five drugs, dosages are ultimately lowered years after FDA approval—after millions of people have received the higher doses.

Women May Need Different Doses

Doses are not adequately tailored for the differing needs of women and the elderly, even though it's well recognized that these groups suffer more frequently from side effects.

Supreme Court: Generic Drugmakers Not Required to Warn of Dangers

Generics are now buy-at-your-own-risk drugs.

(June 23, 2011) U.S. Supreme Court Justice Sotomayor, expressing frustration, said: “As a result of today's decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The court gets one thing right: This outcome makes little sense.”

Even the representing trial attorneys (American Association of Justice) said the ruling was “disastrous” for consumers.

In the News

Marketing Myth: One-Dose-Fits-All

“It's the holy grail that every drug company tries to achieve,” according to a former director of the Center for Drug Evaluation and Research at the Federal drug agency who said: “One-dose-fits-all is a marketing myth.”

DEA: Explosive Rise in Childhood ADHD and Medication Use

The number of kids taking psychotropic medication has exploded in recent years, according to the Drug Enforcement Administration (DEA).

Methylphenidate (Concerta, Focalin, Metadate, Ritalin) and amphetamine (Adderall, Dexedrine, Vyvanse) are Schedule II drugs, considered potential drugs for abuse under the Controlled Substances Act and production levels are therefore regulated by the federal government.

Prescription Deaths

Reaction to medications is the third leading cause of death in America; dwarfing deaths caused by automobile accidents, AIDS, alcohol and illicit drug abuse, infectious disease, diabetes, and murder.

Chart: Leading Causes of Death in U.S. 100,000 by properly prescribed drugs, plus 80,000 by improperly prescribed drugs equals 180,000 deaths by prescription drugs.

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