How Safe is Your Children's Cold and Cough Medicine?

As concerns about the safety of children's cough and cold products mount, the FDA has announced its intention to review the medications. Health officials say the drugs have been blamed for a whole slew of side effects and even death. Because of the growing concerns, the FDA has agreed to meet on October 18 to reevaluate the safety and effectiveness of cough and cold medicine used by children, particularly those under the age of two.

Since 2004, there have been numerous reports of adverse side effects of the drugs. More than fifteen-hundred children under the age of two have been hospitalized as a result of the medicine and the CDC has verified at least three deaths. There are believed to be more, but they have yet to be confirmed. Most researchers and healthcare professionals believe the adverse effects are likely due to children being given too much of the drugs. When children receive too much of the medication, too often, or if more than one drug with the same active ingredient is used, it can be harmful. Some doctors are attributing the deaths to dextromethorphan, a cough suppressant. They believe that when the first dose fails to work, parents give the children more medicine resulting in an overdose. When a child receives too much of the medication, it can affect the heart and blood vessels leading to things such arrhythmias and stroke.

In order to prepare for the meeting, the FDA's Nonprescription Drug Advisory Committee is reviewing data on the drugs and their dosages. When the drugs were initially approved several years ago, the guidelines were set using the information from studies done on adults. There was no mandate on the effectiveness or safety of the drugs for use with children. In fact, there is no guideline for dosage of the medication for children under the age of two. After meeting, the FDA is wanting to address these recommendations and evaluate whether the benefits of the drugs outweigh the risks.

In the meantime, the FDA is offering recommendations on the drugs and how to avoid giving children too high of a dose. These recommendations include:

Carefully follow all directions for use of the drug that are included with the medication.

If your child is under two years of age, consult his/her doctor before giving him/her any cold medication. Do not do so until the doctor has given you specific directions including the proper dosage.

Do not use medicine made for adults on children. If it is made for children it will say either babies, infant, children, or pediatric somewhere on the package.

Consult your child's doctor about dosage and before combining any medications.

The take-away is for parents to understand that it is important to not give too much of the medicine to their children. Caution should be exercised when giving children cough and cold medicine, especially if they are under the age of two. If you have a question, call the child's doctor. While the drugs have not been proven to be unsafe, serious questions have been raised about the safety of the drugs.

Source

HealthDay