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. 

We are saddened to report that the Hon. Paul G. Rogers, NCPIE's founding 
Chairman, died Monday, October 13, 2008 in Washington, DC. He was 87. 

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.

The Food and Drug Administration (FDA) today issued two Warning Letters to 
Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic 
drugs produced by Ranbaxy's Dewas and Paonta Sahib plants in India. The 
Warning Letters identify the agency's concerns about deviations from U.S. current 
Good Manufacturing Practice (cGMP) requirements at Ranbaxy's manufacturing 
facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India.

Because of the extent and nature of the violations, FDA today issued an Import 
Alert, under which U.S. officials may detain at the U.S. border, any active 
pharmaceutical ingredients (API) (the primary therapeutic component of a finished 
drug product) and both sterile and non-sterile finished drug products 
manufactured at these Ranbaxy facilities and offered for import into the United 
States.  Today's announcement does not impact products from Ranbaxy's other 
plants which are not affected by today's actions. FDA has inspected those 
facilities and, to date, they have met U.S. cGMP requirements for drug 
manufacturing.

The FDA recommends that consumers continue taking their medications 
manufactured by Ranbaxy and not disrupt their drug therapy, which could 
jeopardize their health. Patients who are concerned about their medications should 
discuss their concerns with their health care professional. Ranbaxy manufactures 
many drugs, and only a portion of them are made at these two plants located in 
Dewas and Paonta Sahib, India. At these two facilities, Ranbaxy manufactures 
more than 30 different generic drugs (in multiple dosage forms), such as 
antibiotics, anti-virals, and others, for the U.S. market.  For products affected, 
see: Drug List

The Kaiser Family Foundation issued an updated fact sheet on Prescription Drug 
Trends. This updated fact sheet provides trend information about prescription drug 
expenditures and coverage, key factors that contribute to rising prescription 
spending, and efforts to contain certain rising drug costs.