The FDA Is Cracking Down On The Misuse Of An OTC Decongestant

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The FDA Is Cracking Down On The Misuse Of An OTC Decongestant

According to the United States, Food and Drug Control, manufacturers of inhalers containing the nasal rinse propylhexedrine must undertake design improvements to avoid abuse. Propylhexedrine is an under nasal decongestant that is actually “only sold through the product name Benzedrex,” according to the FDA.

The FDA Is Cracking Down On The Misuse Of An OTC Decongestant


According to the FDA, propylhexedrine is active and secure when utilized as prescribed for the short term to relieve inflammation caused by the common cold, seasonal allergies, or other respiratory allergies. Misuse, on the other hand, can be dangerous.
As per the National Capital Toxin Source, “Benzedrex inhalers are safe to buy, however, propylhexedrine misuse happens when people look for legitimate methods to get high or improve efficiency and intensity, and there have been several cases of toxicity linked to propylhexedrine obtained from an inhaler and ingested the products of one propylhexedrine inhaler has triggered heart attacks and lung damage in adults and infants” (NCPC).

The FDA Is Cracking Down On The Misuse Of An OTC Decongestant


The FDA notes that incidents of propylhexedrine misuse and abuse are on the rise. The medication can cause severe side effects such as a rapid or irregular heartbeat, hypertension, and paranoia, leading to hospitalization, injury, or death.
The FDA stated that “We are recommending that all producers of [over-the-counter] propylhexedrine nasal decongestant inhalers make brand development modifications that promote its healthy use, and e.g., changing the material to build an external shield that could make interfering with the system and exploiting the propylhexedrine within more challenging.”
According to the FDA, we need to examine this security problem and decide whether further FDA measures are required. Decreasing the volume of propylhexedrine in inhalers may also reduce the risk of severe side effects. As per the NCPC, propylhexedrine was established over 60 decades earlier as a replacement for amphetamine, which was previously the main component in Benzedrex inhalers.
According to the center, the move was introduced in reaction to violence and deaths caused by amphetamine obtained from inhalers. Propylhexedrine decreases nasal surface inflammation and swelling. Two sips in each nostril, no less than once per 2 hours, is the prescribed dosage for children and adults under the age of six. It’s not recommended to use it for longer than three days at a period.
Congestion can recur or improve if used for an extended period. If anyone taking propylhexedrine develops extreme anxiety or anger, uncertainty, irregular heart rhythm, abdominal pain, or stiffness, the FDA recommends calling 911 or drug prevention at 800-222-1222. Speak to a pharmacist or your medical care professional if you have any concerns about the medication, like how you should use it or if it might interfere with other drugs you’re taking, the FDA recommended.
However, the University of California (San Francisco) researchers suggest that the FDA establish safe-dosing guidelines and require adequate labeling. Their latest research looked at 140 adverse-event records and found that 31% of those who used ephedrine to lose weight “definitely” or “possibly” reported an adverse effect.
Three of them died, seven were permanently wounded, and four needed continuing medical care. Several healthy young people have reported adverse effects linked to ephedra, according to leading author Christine Haller, an assistant adjunct professor of clinical pharmacology and medicine, who told CMAJ that “we need more knowledge of why some people have problems. Perhaps we should ban it until then.”

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