Medications for Kids

September 23, 2012

When adults are advised by their health care professional to use a medication, they expect to receive information—backed up by data from studies—on the correct and safe dose to take. For drugs used in children, this information may not be available because historically not all products are studied in children.

To fix this situation, Congress passed legislation to increase pediatric studies and incorporate the resulting information in labeling. This is a key point because medicines often affect children differently from the way they work in adults.

The Food and Drug Administration (FDA) has been working hard on this project. To make it easier for parents and health care professionals to find information on pediatric medications, the FDA created a database that covers medical products studied in children under recent pediatric legislation.

A Label for Kids

Parents should always read medicine labeling carefully. For prescription medications and vaccines, there is a Pediatric Use section in the labeling that says if the medication has been studied for its effects on children. The labeling will also tell you what ages have been studied. (This labeling is the package insert with details about a prescription medication.)

Congress’ efforts to increase the number of studies of prescription drugs used in children have allowed FDA to build a foundation for pediatric research and discover new things. For example, researchers have found that certain drugs produce more side effects for the nervous system in children than adults, says Dianne Murphy, M.D., OPT’s director.

FDA is able to use information gathered from pediatric studies to make labeling changes specific to kids, and to share that news with the public. The database, which is updated regularly, currently contains more than 440 entries of pediatric information from the studies submitted in response to pediatric legislative initiatives. The labeling changes include:

  • 84 drugs with new or enhanced pediatric safety data that hadn’t been known before;
  • 36 drugs with new dosing or dosing changes;
  • 80 drugs with information stating that they were not found to be effective in children; and
  • 339 drugs for which the approved use has been expanded to cover a new age group based on studies.

The easiest way for parents to use the database is to search by their child’s condition to find all mentions of that condition in all of the labeling information within the database. If you know the name of the drug you want to find, sort the database’s information by trade name.

Avant says parents should note that the database contains the version of the label at the time of the labeling change. It may not be updated with later changes if they don’t affect children.

Immune System

September 19, 2012

Winter season is approaching, it’s time to take care of your health and improve your immune system in order to prevent all those colds.

Your immune cells can lose some of their protective effects when your body is constantly battling negative health habits such as a poor diet, little sleep, and too much stress. As such, it’s not surprising that doctors frequently recommend certain lifestyle changes as a way to optimize the function of your immune system.

According to the Harvard University, your first line of defense is to choose a healthy lifestyle. Following general good-health guidelines is the single best step you can take toward keeping your immune system strong and healthy. Every part of your body, including your immune system, functions better when protected from environmental assaults and bolstered by healthy-living strategies such as these:

  • Don’t smoke.
  • Eat a diet high in fruits, vegetables, and whole grains, and low in saturated fat.
  • Exercise regularly.
  • Maintain a healthy weight.
  • Control your blood pressure.
  • If you drink alcohol, drink only in moderation.
  • Get adequate sleep.
  • Take steps to avoid infection, such as washing your hands frequently and cooking meats thoroughly.
  • Get regular medical screening tests for people in your age group and risk category.

X-Rock for Men

September 11, 2012

FDA tests found that X-Rock, marketed as a dietary supplement for men, contains the active ingredient sildenafil found in an FDA-approved prescription drug product used to treat erectile dysfunction.

X-Rock for Men, sold in one-capsule blister cards, was distributed nationwide to wholesalers and to consumers through the Internet.

Risk: The active ingredient sildenafil may interact with prescription drugs containing nitrates (such as nitroglycerin) and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed drugs containing nitrates. Another similar active ingredient found in X-Rock may also interact with nitrates and cause side effects, such as headaches and flushing.

Recommendations

  • Contact your health care provider if you have experienced any problems that may be related to taking this product.
  • Stop using the product and return it to the place of purchase or directly to the company, XRock Industries LLC, if you bought it as part of its Direct Response Program. Call 877-976-2563 Monday through Saturday 9 a.m. to 9 p.m. EST for instructions on returning the product.