More and more U.S. children are being given drugs to fight chronic conditions such 
as asthma and hyperactivity, according to a study published on Monday.  From 
2002 to 2005 prescriptions for medicines to treat type-2 diabetes doubled, asthma 
medications rose by more than 46 percent, medicines for attention-deficit 
hyperactivity disorder increased by more than 40 percent and prescriptions for 
cholesterol-lowering drugs were up by 15 percent. The study was conducted by 
Emily Cox of Express Scripts Inc. in St. Louis, a manager of pharmacy insurance 
benefit plans, Dr. Donna Halloran of the Pediatric Research Institute in St. Louis, 
and Douglas Mager of the Kansas Health Institute in Topeka.

In a report published in the November issue of Pediatrics, they said the increases 
could mean that chronic conditions are on the rise.  But they said the trend could 
also reflect other factors such as changes in the way doctors prescribe drugs and 
better screening that identifies more chronic conditions.

In addition, the team said federal programs that encouraged research on pediatric 
drugs resulted in "increased data on safety and efficacy in children (that) likely 
provided physicians with a greater degree of confidence to prescribe (such drugs)."

Half of U.S. doctors report using placebos several times a month, according to a 
study published in the British Medical Journal (BMJ).  However, nearly 70% of 
those that use placebos described the treatment to their patients as "a potentially 
beneficial medicine not typically used for your condition." Only 5% of doctors 
explicitly called it a placebo treatment. Most doctors used actual medicines as a 
placebo treatment: 41% used painkillers, 38% used vitamins, 13% used 
antibiotics, 13% used sedatives, 3% used saline injections and 2% used sugar pills.

A record number of deaths and serious injuries associated with drug therapy were
reported to the U.S. Food and Drug Administration (FDA) in the first quarter of 
2008. Serious injuries associated with drug therapy reached a total of 20,745 new 
cases; reported deaths totaled 4824 cases, a 2.6 fold increase from the previous 
quarter.

In addition, varenicline (Chantix, Champix), an aid to stopping smoking, accounted
for more reported serious injuries than any other prescription drug for a second 
quarter, a total of 1001 new cases, including 50 additional deaths. Varenicline was 
the subject of a previous Quarter Watch special report1 and a separate FDA Public 
Health Alert about psychiatric side effects. Ranked second in reported serious 
injuries was heparin, a drug that helps prevent injury from blood clots. Heparin was 
the subject of a major product recall after a potentially lethal contaminant was 
identified and traced to suppliers in China. In the first quarter of 2008, the FDA 
received reports of 779 cases of serious injury in which heparin was the principal 
suspect drug.

 These findings come from a program being developed by the Institute for Safe
Medication Practices (ISMP) to improve patient safety through increasing our
understanding of how and why drug-related injuries and medication errors occur. 
The results come from analyzing new adverse drug events reports submitted to 
the FDA. The agency releases computer excerpts of these reports for research 
use after personalidentifying information has been removed.

Consumers and health care professionals can now go to a single page on the U.S. 
Food and Drug Administration's Web site to find a wide variety of safety 
information about prescription drugs. The Web page,www.fda.gov/cder/drugSafety.htm, 
provides links to information in these categories:

Drug labeling, including patient labeling, professional labeling, and patient 
package inserts;
  
Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure 
that their benefits outweigh their risks;
A searchable database of postmarket studies that are required from, or agreed 
to by, drug companies to provide the FDA with additional information about a 
drug's safety, efficacy, or optimal use;
 
Clinicaltrials.gov, a searchable database of clinical trials, including information 
about each trial's purpose, who may participate, and useful phone numbers;
 
Drug-specific safety information, including safety sheets with the latest 
information about the drug and  FDA press announcements, fact sheets, and drug 
safety podcasts;
Quarterly reports that list certain drugs that are being evaluated for potential 
safety issues, based on a review of information in the FDA's Adverse Event 
Reporting System (AERS);
 
Warning Letters, Import Alerts, Recalls, Market Withdrawals, and Safety 
Alerts;
Regulations and guidance documents;
   
Consumer information about using medications safely and disposing of unused 
medicines;
 
Instructions how to report problems to the FDA through its MedWatch 
program;
 
Consumer articles on drug safety.
 

Establishing such a Web page is one of the requirements of the Food and Drug 
Administration Amendments Act of 2007. 

Background: The Consumer Healthcare Products Association (CHPA), an 
association that represents most of the makers of nonprescription over-the-
counter (OTC) cough and cold medicines in children, recently announced that its 
members are voluntarily modifying the product labels for consumers of OTC cough 
and cold medicines to state "do not use" in children under 4 
years of age. Additionally, the manufacturers are introducing new child-resistant 
packaging and new measuring devices for use with the products.

The U.S. Food and Drug Administration supports the voluntary actions by CHPA 
members to help prevent and reduce misuse and to better inform consumers about 
the safe and effective use of these products for children. The FDA continues to 
assess the safety and efficacy of these products and to revise its OTC monograph 
(list of approved ingredients and amounts) for these medicines. Although this new 
labeling is inconsistent with the current monograph, FDA will not object, under the 
circumstances presented here, to the new label modification stating "do not use in 
children under 4," which reflects a more restrictive use of the drugs in children.

The steps that are being taken by CHPA will not affect the availability of the 
medicines, but this voluntary action will result in a transition period where the 
instructions for use of some OTC cough and cold medicines in children will be 
different from others. FDA does not typically request removal of OTC products 
with previous labeling from the shelves during a voluntary label change such as 
this one. Therefore, some medicines will have the new recommendation "do not 
use" for children under 4 years of age, while others will instruct that they not be 
used for children under 2 years of age. If parents or caregivers have or purchase a 
product that does not have the voluntarily-modified labeling, FDA recommends 
that they should adhere to the dosage instructions and warnings on the label that 
accompanies the medication. They should not, under any circumstances, give 
adult medications to children. If parents or caregivers have questions or are just 
not sure about how to use a product, they should consult with their doctor or 
pharmacist.

FDA is proceeding with its rulemaking process to update the existing OTC 
monograph for cough and cold products for children, and will consider input from 
the recent hearing of Oct. 2. The rulemaking process affords additional 
opportunity for the submission of data and public comment. Until all these issues 
are resolved, FDA continues to recommend to parents and caregivers the following:
Do not give children medications labeled only for 
adults.
Talk to your healthcare professional if you have any 
questions about using cough or cold medicines in children.
Choose OTC cough and cold medicines with child-resistant 
safety caps, when available. After each use, make sure to close the cap 
tightly and store the medicines out of the sight and reach of children.
Check the "active ingredients" section of the DRUG FACTS 
label of the medicines that you choose. This will help you understand 
what symptoms the "active ingredients" in the medicine are intended to treat. 
Cough and cold medicines often have more than one active ingredient (such as an 
antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain 
reliever/fever reducer).
Be very careful if you are giving more than one medicine to 
a child. If you are giving more than one medicine to a child make sure 
that they do not have the same type of "active ingredients." If you use two 
medicines that have the same or similar active ingredients, a child could get too 
much of an ingredient and that may hurt your child. For example, do not give a 
child more than one medicine that has a decongestant.
Carefully follow the directions for how to use the medicine in 
the DRUG FACTS part of the label. These directions tell you how much 
medicine to give and how often you can give it. If you have a question about how 
to use the medicine, ask your pharmacist or your doctor. Overuse or misuse of 
these products can lead to serious and potentially life threatening side effects 
such as rapid heartbeat, drowsiness, suppression of the respiratory system, 
seizures and other adverse events.
Only use measuring devices that come with the medicine or 
those specially made for measuring drugs. Do not use common household 
spoons to measure medicines for children because household spoons come in 
different sizes and are not meant for measuring medicines.
Understand that using OTC cough and cold medicines does 
not cure the cold or cough. These medicines only treat your child’s 
symptom(s) such as runny nose, congestion, fever and aches and do not shorten 
the length of time your child is sick.