If You Use This Medication at Night, Stop Immediately, FDA Warns


Many of us rely on daily medications, whether that's a prescription for high blood pressure or over-the-counter meds for your allergies. For those of us who have trouble hitting the hay, taking sleep aids is often the last thing we do before getting into bed. If you fall into that category, it's important to know that the U.S. Food and Drug Administration (FDA) just issued a new warning about one nighttime medication that could do more harm than good. Read on to find out what the agency says you need to stop taking immediately.

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Sleep conditions are prevalent in the U.S.

According to the Centers for Disease Control and Prevention (CDC), approximately 70 million Americans have chronic sleep problems, ranging from not being able to sleep at all (insomnia), to not being able to stay awake (narcolepsy).

Snoring is one of the most common sleep habits, with Johns Hopkins Medicine estimating that up to 45 percent of adults snore on occasion, while 25 percent snore regularly. This can be a sign of a serious condition called obstructive sleep apnea, but it can also be particularly troublesome if you have a bed partner.

You could be keeping the person next to you awake throughout the night, whether you're letting out little rasps or full-blown snorts. That's why so many of us reach for a solution before we head to bed. But if this particular product is in your medicine cabinet, you'll want to reconsider using it tonight.

This homeopathic remedy has been recalled.

According to a June 9 announcement from the FDA, Green Pharmaceuticals Inc. is voluntarily recalling certain SnoreStop NasoSpray products, as FDA testing identified microbial contamination.

SnoreStop NasoSpray is used to help keep non-apneic snoring symptoms—meaning those not due to sleep apnea—at bay. Customers use a nasal pump to deliver the medication. The recalled nasal spray was sold at health food stores across the U.S., as well as online.

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The contaminated products pose significant risk to immunocompromised people.

One specific lot is being recalled, which was contaminated with Providencia rettgeri bacteria, the FDA said. This bacteria is not typically associated with illness in humans, but dangers are higher for those that are immunocompromised, as use of the contaminated nasal spray could lead to serious adverse effects, including bacteremia/sepsis, pneumonia, invasive fungal rhinosinusitis, and disseminated fungal infection.

Those who are not immunocompromised could still get an infection, but it would be responsive to treatment and not as severe.

While there have not been any reports of adverse events in relation to the recall, consumers who purchased recalled nasal spray are instructed to stop use right away and return it to the place of purchase.

Additionally, if you experience any issues resulting from the use of the SnoreStop spray, contact your doctor or health provider, the FDA warned. You can also report adverse reactions to the FDA's MedWatch Adverse Event Reporting program online or via mail or fax.

Check your nasal spray to see if it is part of the recall.
David Smart / Shutterstock

Green Pharmaceuticals is notifying both customers and retailers via email to coordinate the return and replacement of the recalled nasal spray, but you might want to check your product yourself.

The nasal spray was sold in 0.3 fluid ounce bottles and packaged in clear transparent plastic boxes. The product itself is tri-colored, with a black container and a red and yellow cap. The affected lot has a sticker on the bottom of the bottle with 2373 printed on it. On the outer packaging, check for 21222 printed on a sticker.

If you have recall-related questions or concerns, the FDA advises contacting Green Pharmaceuticals directly. You can reach the company by phone at 805-388-0600 or by email at [email protected], Monday through Friday between 8 a.m. and 5 p.m., Pacific Standard Time.

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