ADHD Drugs Send Thousands of Children to Hospitals
In 2004, more than 2,500 children taking drugs to treat attention deficit hyperactivity disorder (ADHD) had to go to U.S. hospital emergency departments and most of the cases involved accidental overdoses, says a federal Centers for Disease Control and Prevention study released Thursday.
The study said about 25 percent of the children seen at the emergency departments had serious heart or blood pressure events, including chest pain, fainting, or palpitations, Bloomberg news reported. Many other cases involved children who accidentally took someone else's medication.
The findings were released as U.S. regulators are considering whether to require the drugs to carry stronger warnings about a possible link to sudden death and heart risks.
"Clinicians should recognize that unintentional overdoses of stimulant medications are an important cause of injury to patients," said Adam Cohen, of the CDC. He said it was the first time the CDC had analyzed this kind of data, so it's not possible to say whether such problems are new or how common they may have been in previous years, Bloomberg reported.
An estimated 3.3 million children and 1.5 million adults take ADHD drugs, and 25 deaths linked to the drugs -- 19 involving children -- were reported to the U.S. Food and Drug Administration from 1999 through 2003. There were also 54 reported cases of serious heart problems, including heart attacks and strokes.
Ex-FDA Head Said to Seize Control of Plan B Approval Process
Former U.S. Food and Drug Commissioner Lester M. Crawford bypassed normal procedure when he took control of the request to approve over-the-counter (OTC) sales of the Plan B "morning-after" birth control pill and delayed that approval, say two senior FDA officials.
The officials, Dr. Steven Galson and Dr. Janet B. Woodcock, were interviewed by lawyers for the New York-based Center for Reproductive Rights, which has launched a lawsuit against the FDA over its handling of the application for OTC sales of Plan B.
Woodcock and Galson said Crawford intervened in early 2005 as FDA staffers were preparing to authorize OTC sales of Plan B to women 17 years of age and older, the Baltimore Sun reported.
The two officials said Crawford cut them out of the process, which they normally take part in, and handled the issue by himself. In his deposition Wednesday, Crawford confirmed that Plan B "was his decision," his lawyer said.
Plan B is designed to prevent pregnancy if taken within 72 hours after sex. Pro-choice groups say the FDA's delay in approving OTC sales of Plan B is based on politics, not medical science, the Sun reported.
The nomination of Dr. Andrew C. von Eschenbach, President Bush's pick to succeed Crawford, is being blocked by Democratic senators until the FDA takes action on Plan B.
No Pharmacy Logos on Medicare Drug Cards: U.S. Officials
The U.S. government said Wednesday that insurers participating in the Medicare prescription-drug benefit can't feature logos of big pharmacies on the identification cards they issue next year.
The Centers for Medicare and Medicaid Services also told insurers that when they market their drug plans to consumers next year and list a particular company as a partner, they also need to note that "other pharmacies/physicians/providers are available in our network," the Associated Press reported.
Medicare officials had received many complaints from owners of small pharmacies that insurers participating in the new drug benefit tried to direct consumers to large companies. For example, cards issued by Humana Inc. displayed logos from Wal-Mart or CVS.
"It's terribly confusing for seniors. I had seniors who we helped sign up for a program, but once they got their card, they would say, 'Sorry, I can't come in because my card uses another pharmacy,' " John T. Sherrer, a pharmacist from Marietta, Ga., told the AP.
He believes the logos on the cards cost him many customers.
Sherrer and other owners of independent pharmacies were in Washington, D.C., this week to talk with lawmakers about the co-branding issue and other concerns with the drug benefit.
U.S. Kids Linked to TVs, Video Games, Computers: Report
One-third of American children age 6 and younger live in homes where the television is on nearly all the time, and almost 20 percent of children under age 2 have a TV in their bedroom, says a Kaiser Family Foundation study released Wednesday.
The study, which included focus groups and a national survey of 1,051 parents of children 6 months to 6 years old, also found that 83 percent of children under age 6 watch TV, play video games, or use the computer on a typical day. They get about two hours per day of screen time, compared to 48 minutes a day listening to a story being read to them, The New York Times reported.
The study also concluded that many parents encourage the use of TV, video games and computers by their children, often starting in infancy. These parents cite a number of reasons: it helps their children learn; it give the parents time to cook or shower; the parents use screen time as a reward or to help their children wind down at bedtime.
"I had this sense of kids clamoring to use media and parents trying to keep their finger in the dam. I found that not to be a very accurate picture in most cases," lead researcher Victoria Rideout told The Times.
Media use increases as children grow older. The study found that 61 percent of children 1 year or younger watch TV, while 90 percent of children ages 4 to 6 have daily screen time.
Groups Demand Direct-to-Consumer Rx Drug Ads Stop
The U.S. Congress should put a stop to all prescription drug advertising aimed at consumers, says a coalition of 39 medical, health and seniors' groups.
"Prescription drug ads are dishonest and dangerous. They hype the benefits and cloak the risks of prescription drugs," Gary Ruskin, executive director of Commercial Alert, said in a prepared statement.
He noted the following comment made more than two decades ago by Robert A. Schoellhorn, former chairman of Abbott Laboratories: "We believe direct advertising to the consumer introduces a very real possibility of causing harm to patients who may respond to advertising by pressuring physicians to prescribe medications that may not be required."
"We agree," Ruskin said. "We would add that the possibility of creating another Vioxx catastrophe has only grown since then."
Regulation of direct-to-consumer prescription drug advertising is inadequate, said Amy Allina, program director of the National Women's Health Network.
"The ad campaigns promoting hormone therapy to women at menopause were a triumph of marketing over science. Drug companies ducked and weaved around the regulations for truth in advertising, touting unproven benefits for their menopause drugs, which exposed millions of women to breast cancer and heart disease risks with little or no benefit to many," Allina said in a prepared statement.
The groups want legislation to stop direct-to-consumer prescription drug ads.