Infant Ibuprofen Recall

Tris Pharma, Inc. has issued a voluntary nationwide recall of infant ibuprofen amid concerns the medication, which was destined to be sold at several major retailers, may contain a higher concentration of ibuprofen than labeled. The lots were sold under Walmart, CVS Pharmacy and Family Dollar. As of now, the company has not received any reports of serious adverse events related to the recall.

Why is it being recalled?

Per Tris Pharma, “The reason for the recall was a potential higher concentration of Ibuprofen of less than 10% above the specified limit in some bottles from these three batches. Safety issues or toxicity is generally accepted to be a concern in infants at doses more than 700% of the recommended dose.” If Ibuprofen is taken in excess, a side effect could be permanent kidney injury, nausea, vomiting, stomach pain, diarrhea, tinnitus, headaches or possible stomach bleeding.

What products are recalled?

Affected products are labeled “Infants’ Ibuprofen Concentrated Oral Suspension” and were labeled to contain 50 mg. of ibuprofen per 1.25 mL. 

NDC; LOT; EXPIRATION; DESCRIPTION ; COMPANY;
49035-125-23 00717009A
00717015A
00717024A
02/19
04/19
08/19
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Wal-Mart Stores Inc
59779-925-23 00717024A 08/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle CVS Pharmacy
55319-250-23 00717024A 08/19 Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle Family Dollar Services Inc.

Next steps you should take

  • To determine whether a specific product has been recalled, patients should look at the drug name and see if the NDC, Lot, and expiration dates matches those listed above.
  • If you have one of the recalled medicines, follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. 

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

Source: https://www.fda.gov/Safety/Recalls/ucm627780.htm

Genetic Testing & Medication Effectiveness – It’s Cool, But Does It Work?

Row of Microscopes on a Table
Image Source: Ousa Chea/Unsplash

In October, the FDA cleared the first DNA test meant to be marketed directly to consumers to help them determine how well certain drugs may work for them.1 The DNA test, conducted by 23andME, provides information on 33 genetic variants that the company say are associated with how patients respond to more than 50 commonly prescribed prescription and over-the-counter medications. While this test is the first consumer directed to be cleared by the FDA, expect to see more in the coming years as pharmacogenetics becomes more mainstream. But the big question is…does it really work?

Background:  What is Pharmacogenetics?

Pharmacogenetics or pharmacogenomics is the study of how genetics impact pharmacology. Pharmacogenetic (PGx) testing is used for determining how an individual will respond to a particular medicine.2 With this type of testing, clinicians would be able to provide a personalized medication plan, rather that prescribing based off the average population. This helps avoid trial and error in finding optimal dosages.

What are the caveats?

The FDA’s marketing authorization came with crucial caveats. The agency cautioned that the test cannot assess whether a drug is appropriate, or gauge a patient’s ability to respond to any specific medication.3 This essentially means that a patient still needs a clinician’s insight in finding the correct medication, but utilizing the results of a DNA test can assist in the dosing process. Pricing can also vary with DNA testing. In many cases, the costs may not outweigh the benefits.

Questions?

If your health plan includes Tria Health, you can talk with a clinically trained pharmacist and review all your current medications (prescription, over the counter and supplements). Tria Health’s pharmacists will help make sure your medications are effectively treating your condition(s) and identify any cost savings opportunities.

Sources:

  1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624753.htm  
  2. http://www.rxeconsult.com/healthcare-articles/Overview-Of-Pharmacogenetic-PGx-Testing-Benefits-Costs-And-Role-In-Personalized-Medicine-853/
  3. https://www.statnews.com/2018/10/31/fda-clears-23-and-me-genetics-test-drug-effectiveness/

Losartan Recall

Recall

Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan. The FDA will continue to investigate this issue and provide additional information when it becomes available. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

Why is it being recalled?

N-Nitrosodiethylamine, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

What products are recalled?

The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. It is important to note that this recall encompasses less than 1% of the national Losartan drug products. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

Next steps you should take

  • Because Losartan is used in medicines to treat serious medical conditions, patients taking the recalled Losartan should continue taking their medicine until they have a replacement product.
  • To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.
  • If a patient is taking one of the recalled medicines, they should follow the recall instructions provided by the specific company. This information will be posted to the FDA’s website.
  • Patients should also contact their health care professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another product not affected by this recall or an alternative treatment option.

 

Need help?

Contact your Tria Health pharmacist today for additional assistance with the recall process: 1.888.799.8742

 

Source: https://www.fda.gov/Safety/Recalls/ucm625492.htm

New Study Finds Tainted Supplements

Pills on a silver tray
Image Source: rawpixel/Unsplash

A new study published in early October revealed unapproved and sometimes dangerous drugs in 746 dietary supplements, almost all of them marketed for weight loss, muscle growth or sexual enhancement.1

Supplement Contaminations

About 80 percent of supplements were contaminated by one pharmaceutical that should not have been in the product. Twenty percent contained at least two such drugs, and two of the supplements contained six unapproved drugs. Despite these contaminants, fewer than half the products were recalled.2 In the United States, more than 50% of adults consume dietary supplements, fueling a $35 billion industry.3,4 As the dietary supplement industry continues to grow in the United States, it is essential to further address this significant public health issue.

What Does This Mean for You?

The presence of pharmaceutically active ingredients in dietary supplements makes them unapproved drugs and represents an important public health concern. The study found indications that a large percentage of products continue to be sold and are potentially dangerous even after FDA warnings. This is alarming, especially considering that the FDA is only able to test a portion of products available on the market. Taking a combination of herbal supplements or using supplements together with prescribed medications could lead to harmful, even life-threatening results.

Supplement Safety Tips

  • If you’re currently taking prescription medications and thinking about starting an herbal supplement, always talk to your doctor or pharmacist first about possible drug interactions.
  • Stick to brands that have been tested by independent sources
    • Check ConsumerLab.com or U.S. Pharmacopeia Convention (USP)

Do you have any questions regarding your supplements or medications?

Tria Health provides one-on-one confidential counseling with a pharmacist for any of your medication related questions. If Tria Health is currently a part of your healthcare plan, call the Tria Health Help desk today for any of your questions.

Tria Help Desk: 1.888.799.8742

 

Sources:

  1. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706496
  2. https://www.washingtonpost.com/national/health-science/diet-weight-loss-and-sex-supplements-are-tainted-with-unapproved-drugs/2018/10/12/b3e93bfc-cd7c-11e8-a360-85875bac0b1f_story.html?noredirect=on&utm_term=.398811a1e823
  3. Bailey RL, Gahche  JJ, Lentino  CV,  et al.  Dietary supplement use in the United States, 2003-2006.  J Nutr. 2011;141(2):261-266. doi:10.3945/jn.110.133025
  4. US Food and Drug Administration. Constituent updates—FDA creates the Office of Dietary Supplement programs and announces new nutrition office leadership. http://wayback.archive-it.org/7993/20171114120120/https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm478303.htm. Published December 21, 2015. Accessed June 2017.

Children’s Medicine Recall

Recall

The FDA has recently released a statement regarding more than 30 King Bio medicines for children and infants. A “small percentage” of the medicines tested positive for microbial contamination. King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should discontinue use/distribution and contact King Bio at recall@kingbio.com to make arrangements to return product. These products were distributed Nationwide to distributors and retail stores August 2017 – July 2018.1

What is a Microbial Contamination?

Microbial contamination is the unintended introduction of bacteria into a controlled area (petri dish, stock media, work station). Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness to date.

What Products are Recalled?

You can find a list of the products affected on the FDA’s website.

Have any Questions for us?

Contact the Tria Health Help Desk at 1.888.799.8742

 

Source:

  1. https://www.fda.gov/Safety/Recalls/ucm617945.htm