Zantac (ranitidine) Recall

The U.S. Food and Drug Administration is alerting health care professionals and patients to a voluntary recall of over-the-counter (OTC) ranitidine tablets (75 mg and 150 mg), labeled by Walgreens, Walmart, and Rite-Aid and manufactured by Apotex Corp. This medication is being recalled due to low levels of a nitrosamine impurity. The agency encourages patients and health care professionals to report any adverse reaction to the FDA’s MedWatch program.

Why is it being recalled?

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

What products are recalled?

The affected Ranitidine Hydrochloride Capsule can be identified by NDC numbers stated on the product label. The affected Sandoz Ranitidine includes 30 count, 60 count and 500 count bottles in the following lots. The product can be identified by the NDC number and lot number provided above. Sandoz Ranitidine Hydrochloride Capsules were distributed nationwide to wholesalers.

Patient Information

  • FDA is not recommending individuals stop taking all ranitidine medicines at this time.
  • Consumers taking OTC ranitidine could consider using other OTC products approved for their condition.
  • Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. Multiple drugs are approved for the same or similar uses as ranitidine.

Need help?

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

Sources:

  1. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-zantac-ranitidine
  2. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-voluntary-recall-ranitidine-hydrochloride-capsules-150mg-and-300mg-due-elevate

Interested in CBD Oil? Talk to Your Pharmacist First

Bottle of CBD Oil
Image Source: Caleb Simpson/Unsplash

The CBD industry has been booming as of late and you might be wondering if CBD oil is right for you. Unfortunately, the popularity of CBD products is growing faster than researchers can keep up, and there are a lot of unknowns when it comes to the benefits and drawbacks.1 Currently, the FDA has not approved CBD oil as a standalone medication. While doctors can still recommend it, they cannot currently write a prescription. Before purchasing CBD oil, it’s important to talk with a pharmacist to avoid any negative medication interactions.

What is CBD Oil?

Cannabidiol is extracted from the flowers and buds of marijuana or hemp plants. It does not produce intoxication; marijuana’s “high” is caused by the chemical tetrahydrocannabinol (THC). The non-intoxicating marijuana extract is being credited with helping treat a host of medical problems — everything from epileptic seizures to anxiety to inflammation to sleeplessness.2

Is CBD Oil Safe?

Last year, a U.S. Food and Drug Administration advisory panel unanimously recommended approval of the CBD medication Epidolex to treat two rare forms of childhood epilepsy.3 As for CBD’s usefulness in treating other conditions, the consensus is still unclear. One current concern regarding the efficacy of CBD oil is the lack of regulation. The FDA does not currently regulate products like CBD oil which can lead to a variation in ingredients product-to-product.

CBD Oil and Medication Interactions

It’s very important to talk to a pharmacist before starting CBD oil, because it can interact with a lot of common and daily medications. CBD oil is broken down by enzymes in your liver and during that process, it can block those same enzymes from breaking down other medications. Drugs for anxiety, cholesterol, seizures, blood thinners and heart medicines can all interact negatively with CBD oil.1 While we’re not saying that you should avoid CBD oil all together, you should always speak with a doctor or pharmacist before purchasing.

Tria Health Can Answer Your Medication Questions

If Tria Health is offered through your benefits plan, you have the option of receiving a one-on-one, private consultation with one of Tria Health’s pharmacists over the phone. During your consultation, your pharmacist will review all your current medications, including vitamins and supplements. If you’re interested in exploring CBD Oil, Tria’s pharmacist will be able to provide you with recommendations.

Sources:

  1. https://www.wbir.com/article/news/health/pharmacists-cbd-may-interfere-with-some-daily-medications/51-142c8c3e-0fd7-43c8-b6e8-6fb68a3d5e97
  2. https://www.webmd.com/pain-management/news/20180507/cbd-oil-all-the-rage-but-is-it-safe-effective#1
  3. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm

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