FDA: Make Sure Epi-Pens Don’t Get Stuck in Tube

According to manufacturer Pfizer Inc. and distributor Mylan, due to a defective label, a small number of EpiPen 0.3 mg and EpiPen Jr 0.15 mg auto-injectors and their authorized generics do not slide out of the tube easily. There are no issues with the device or the epinephrine inside.

People with an EpiPen should check to make sure it is not stuck in the carrier tube, according to a new warning from the manufacturer and federal health officials.

“It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product,” the Food and Drug Administration said in a safety alert.

Anyone with an auto-injector that does not easily slide out or one that has a label that only is partially adhered to the auto-injector should contact MylanCustomer Relations at 800-796-9526.

 

http://www.aappublications.org/news/2018/11/07/epipens110718

New Concerns About Sesame Allergies

Sesame could become the newest allergen added to the list of foods required to be named on labels, US Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb announced Monday. There are currently eight major food allergens that must be declared on US labeling using their common names: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat and soybeans. These eight foods have accounted for over 90% of documented serious food allergies in the country when the Food Allergen Labeling and Consumer Protection Act was passed in 2004, which requires the clear labeling of ingredients.  Now the FDA is launching a formal request for information as it considers making sesame the ninth on the list.

“Unfortunately, we’re beginning to see evidence that sesame allergies may be a growing concern in the US,” Gottlieb said. “A handful of studies, for example, suggest that the prevalence of sesame allergies in the US is more than 0.1 percent, on par with allergies to soy and fish.” Over 300,000 Americans are currently affected by sesame allergies.

Sesame reactions vary from person to person and can be caused by as little as one or two sesame seeds.  Symptoms may vary but can include hives, dizziness, itching, stomach pain, nausea/vomiting, wheezing and breathing problems.  In severe cases, there is a risk of anaphylaxis or even death.  The possibility of such severe reactions is why the FDA believes that the labeling requirements for sesame need to change.

Currently, there are no food labeling requirements for sesame.  The issue for consumers is that sesame could be in an ingredient list under a word like tahini or a generic term like ‘natural flavor’.  Even the most careful consumer would have difficulty spotting the allergen under current labeling requirements.

The FDA is asking for information, specifically from epidemiologists, nutritionists, allergy researchers and physicians, “so we can learn more about the prevalence and severity of sesame allergies in the US, as well as the prevalence of sesame-containing foods sold in this country. These include foods that, under current regulations, may not be required to disclose sesame as an ingredient.”  The FDA is accepting comments from October 30 – December 31, 2018.

Label Mix-Up Prompts Montelukast Recall

Camber Pharmaceuticals is recalling one lot of montelukast sodium tablets because the bottles are labeled “montelukast sodium tablets, 10-mg, 30-count” but actually contain 90 tablets of losartan potassium, 50 mg.

“This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure,” the US Food and Drug Administration (FDA) warns in a news release.

“This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus,” the FDA says.

The lot number for the recalled product is MON17384, the expiration date is 12/31/2019, and the national drug code is 31722-726-30.

“We want to ensure that patients who take montelukast are aware of this recall due to the serious risks associated with taking losartan in its place,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

The FDA is asking patients to contact their healthcare provider or pharmacist to determine whether their montelukast medication has been recalled.

To date, Camber has not received adverse event reports associated with this recall. The FDA encourages healthcare professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting Program.

 

https://www.medscape.com/viewarticle/901490?nlid=124774_3901&src=wnl_newsalrt_180831_MSCPEDIT&uac=63260ER&impID=1727667&faf=1