News - Press releases

FDA News Alert: OTC Nicotine Replacement Therapy (NRT) Labels May Change

2013-04-02T21:00:00Z

FDA News Alert: OTC Nicotine Replacement Therapy (NRT) Labels May Change

FDA News Alert: Know the Active Ingredients in Your Children’s Medicines

2013-03-14T21:19:23Z

FDA News Alert: Know the Active Ingredients in Your Children’s Medicines

FDA News Alert: What Consumers Should Know About Triclosan

2013-03-07T23:40:36Z

FDA News Alert: What Consumers Should Know About Triclosan

FDA News Alert: People Seek Information about Hemorrhoids

2013-02-12T20:26:17Z

FDA News Alert: People Seek Information about Hemorrhoids

FDA News Alert: Don’t Double Up on Acetaminophen This Flu Season

2013-01-24T21:21:26Z

The FDA’s latest Consumer Update reminds us to never take more than one medicine containing acetaminophen at a time.

New Research Shows Negative Interactions Between Grapefruit and Certain Medicines

2012-11-27T21:37:48Z

Researchers have updated a list of medicines that may have negative interactions with grapefruit, if taken together.

FDA Warns Parents to Safely Store OTC Eye Drops and Nasal Sprays Out of Children’s Reach

2012-10-25T21:22:54Z

The FDA has issued a warning to safely store over-the-counter eye drops and nasal decongestant sprays out of the reach of children. You can visit the Up and Away site for more tips on keeping medicines out of sight of small children. If your child accidentally swallows these medicines, call the National Capital Poison Center (1-800-222-1222) and seek emergency medical attention immediately.

FDA Consumer Updates on Topical Pain Relievers

2012-09-13T21:34:33Z

The FDA has released a new warning stating that some consumers have reported serious skin injuries from using certain over-the-counter (OTC) topical pain relievers containing menthol, methyl salicylate, and capsaicin to relieve mild muscle and joint pain. Although rare, these injuries have ranged from mild to severe chemical burns. The FDA has posted guidelines for patients to avoid these injuries, as well as information on reporting any unexpected side effects from topical pain relievers to the FDA MedWatch Program.

News Regarding OTC Products Containing Benzocaine

2012-05-31T19:37:06Z

The U.S. Food and Drug Administration has issued a communication regarding a rare adverse effect in professional and OTC products containing benzocaine. OTC gel and liquid medications containing benzocaine provide relief for children and adults who experience mouth pain. While FDA’s announcement notes very rare but serious instances of methemoglobinemia, a condition in which the amount of oxygen carried through the blood stream is reduced, associated with these benzocaine medications, these products are safe when used as directed for the large majority of consumers.

Due to these rare instances, FDA has recommended that the products not be used in children under two years of age except under the advice of a healthcare professional.

FDA Drug Safety Communication: Infants’ Liquid Acetaminophen

2011-12-27T15:50:51Z

The U.S. Food and Drug Administration (FDA) is informing the public that an additional concentration of liquid acetaminophen marketed for "infants" (160 mg/5 mL) is now available at local stores. Until now, liquid acetaminophen marketed for infants was only available in 80 mg/0.8 mL or 80 mg/mL concentrations. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

To avoid confusion and the potential for dosing errors, consumers, parents, and caregivers should carefully read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use. Do not depend on banners stating it is a new product to identify different concentrations of liquid acetaminophen. Many products have similar banners.

It is also important to use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Patients and caregivers should contact their healthcare professional if they find the measuring device confusing or are unsure how to measure a dose for a child using the device provided.

Healthcare professionals should make sure to provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

Changes in Labeling for Children’s Pain Reliever (via Parenting Squad)

2011-11-17T19:56:09Z

When your child wakes up in the middle of the night crying with a fever, you need to have the right kind of medication on hand and know the correct dosage that your child requires to start feeling better. In the past, it could be quite confusing because infants' (under age 2) liquid acetaminophen was made in a concentrated form that required a smaller dose, while children's (ages 2 and up) liquid medication was not concentrated and required a whole different level of dosing. If you made a mistake and mixed up the two bottles (so easy to do at 2 a.m. when you are exhausted and not seeing straight), you could easily give too much or too little medication — a potentially dangerous situation. Fortunately, manufacturers of these children's medications realized that this situation was confusing and potentially harmful, and have made voluntary and self-initiated changes to make all of this a lot simpler for parents.

What Parents Need to Know About Infant and Children’s Acetaminophen (via Kiddie Corner Deals)

2011-10-31T14:33:24Z

Changes have been made to all single-ingredient liquid infant’s and children’s acetaminophen only and do not apply to solid, single-ingredient acetaminophen or multi-symptom treatments that contain acetaminophen. But why have they made these changes? To make it easier for parents and caregivers to use the medicines and to reduce medical errors including overdosing. They have also included a better safety feature on the new infant and children’s acetaminophen bottles. They are now equipped with flow restrictors so if a child were to accidentally get a hold of a bottle of the medicine a minimal amount will leave the bottle.

We Need to go Metric to Prevent Errors with Oral Liquids

2011-10-27T13:53:28Z

Michael Cohen, president of the Institute for Safe Medication Practices (ISMP), recently wrote an opinion piece for the Philadelphia Inquirer on the importance of standardized units of measurement in oral liquid medicines. In the article, Cohen advocates for moving to the metric system in order to prevent accidental overdoses as a result of incorrect dosing. For more information, read the full article.

Accidental Drug Poisonings among Young Children on the Rise

2011-09-19T16:00:40Z

A new study published in the September 2011 issue of the Journal of Pediatrics found that the number of accidental drug poisonings among young children surged 22 percent from 2001 to 2008. Researchers name increased quantities of medicines in the home as the primary cause. In 95 percent of the cases, the poisoning occurred because the unsupervised child ingested the drug, not because of a labeling or dosage error by a parent or health care worker.

FDA Takes Steps to Help Protect Consumers from Skin Damage from the Sun

2011-06-14T19:57:53Z

The U.S. Food and Drug Administration (FDA) issued a recent Consumer Update announcing steps the agency is taking to help protect consumers from skin damage caused by excessive sun exposure.