When your child next has ear pain the FDA wants to ensure they get only FDA approved prescription drugs that are effective and safe for your child.

The FDA is telling companies to cease marketing sixteen unapproved prescription drugs which have labels indicating they relieve swelling and ear pain. These drops contain active ingredients like hydrocortisone and benzocaine, but the FDA has not evaluated them for safety, quality, and effectiveness.

Pharmacies as well as health care providers have sold drugs that had labels which didn’t disclose that the product wasn’t approved by the FDA. Charles E. Lee, M.D of the FDA says that we don’t know if the drugs have any benefits and we can’t accept the chances that they may have risks.

Why FDA Is Taking Action at this Time

The FDA has its Unapproved Drugs Initiative, so it’s taking action. The FDA seeks to protect consumers from drugs that aren’t proven to be safe, of high quality, or effective.

It’s a risk to public health when a drug isn’t shown to be effective, especially if it has some safety concerns. The FDA has received reports that state the products can cause mouth, face, neck, eye, and ear local allergic reactions. Other symptoms can include burning, stinging, itching and irritation of the ear.

Unapproved ear drug products which require a prescription containing these ingredients are covered by the action of the FDA:

  • benzocaine and antipyrine
  • benzocaine, antipyrine and zinc acetate
  • benzocaine, chloroxylenol and hydrocortisone
  • chloroxylenol, pramoxine and hydrocortisone
  • benzocaine
  • chloroxylenol and pramoxine

The quality of the drugs isn’t known for certain. When a drug is approved by the FDA, the drug manufacturing process is reviewed which ensure that the drug is of purity ad well as consistent quality. These unapproved ear drops have not been examines in this way. The products are prescribed for infants and small children so this is troubling. Drugs that are intended to be used on children should be tested in children. The drugs mentioned haven’t bene shown to be effective in anyone so there’s no proof that the products actually work.

Alternatives Approved by the FDA Available

There are other treatment options available for children with ear problems. The FDAs action only impacts a small percentage of drugs prescribed to treat otitis externa (outer ear infections), excess buildup of earwax, and otitis media (middle ear infections). There’s also F many OTC products available that can be used for earwax buildup or swimmers ear.

There are other solutions for ear problems and choices for consumer sot make. You need to use the products that are known to be safe and avoid the ones that haven’t been test fully for safety and effectiveness.

When you take OTC (over the counter) or prescription medications you may also take a regular vitamin too or some other type of dietary supplement. There may be a danger in mixing dietary supplements with regular medications you’re taking.

Medical officer Robert Mozersky who works at the FDA says that some dietary supplements impact the metabolism and increase it while some other dietary supplements decrease the metabolism.

The metabolism, absorption, or excretion of a medication can be impacted so the potency is changed. You may be getting too much or too little of the medication you’re taking now.

Medications and dietary supplements combined together may have dangerous or even life-threatening consequences. Drugs used for heart disease, HIV/AIDS, depression, birth control pills, and drugs for organ transplant treatment are made less effective when taking with the herbal supplement St. John’s Wort. It depends on the medication being taken, but the results may be serious.

Prescription blood thinner warfarin, herbal supplement ginkgo biloba, aspirin, and vitamin E supplements can thin the blood. If these are taken together there could be a stroke or internal bleeding.

Dietary supplements are commonly used and include minerals and vitamins as well as other less common substances such as, amino acids, botanicals, herbals, as well as enzymes. The (NHANES) or National Health and Nutrition Examination Study from 2005-2008 of the Centers for Disease Control and Prevention (CDC) said that 72 million people or 34% of participants in the United States took some type of dietary supplement with prescription medication. Many take supplements to ensure they get the right essential nutrients, but dietary supplements shouldn’t be used as a replacement for eating a wide variety of foods we need for a healthy diet.

Consumers are under the false impression that “natural products such as an herbal supplement or fish oil won’s hurt them, but natural doesn’t mean that it’s safe to take. A weight loss product might be herbal or “natural,” but might be unsafe for people to take that have certain medical conditions.

Children can be harmed by taking both medications and supplements. The metabolism of a child is unique and when they are at different ages, the metabolism works at different rates. For children ingesting dietary supplements with medication can increase the chances of adverse events taking place.

If you plan to have some type of surgery, dietary supplements can harm you as you may have medication you take before, after, or during the surgery procedure. Your doctor may have you stop using supplements about 2-3 weeks before you medical procedure is to take place. You may have blood pressure, heart rate, or bleeding risks if you continue take supplements before the procedure date.

If you’re breastfeeding or pregnant you need to discuss dietary supplements with your doctor to understand your risks.

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.

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.