Is Azohel Legal in Taiwan? Safety Concerns for Oral Ulcer Treatment - Pharmacology

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Regarding the medication Azohel?


I would like to ask if the drug Azohel is legal in Taiwan? Are there any adverse effects on the body after using it (for oral ulcers)? Thank you.

tyuu, 20~29 year old female. Ask Date: 2004/10/19

Dr. Zheng Shuwen reply Pharmacology


The Azohel® medication's registration certificate with the Taiwan Department of Health has expired, and the distributor has not applied for an extension, thus it is not considered a legal medication.
Azohel® was previously commonly used to treat bacterial infections such as stomatitis, erysipelas, cystitis, urethritis, and pyelonephritis.
There have been reports of bladder cancer cases associated with the use of this product abroad.

Reply Date: 2004/10/19

More Info


Azohel, a medication previously used for various bacterial infections, is no longer legally available in Taiwan. The drug's registration with the Taiwanese health authorities has expired, and the distributor has not sought to renew its license. This means that Azohel is not considered a legal medication in Taiwan, and its use is not sanctioned by health authorities.
The safety concerns surrounding Azohel are significant, particularly given its history of use. While it was initially prescribed for conditions such as oral ulcers, its association with serious adverse effects, including reports of bladder cancer in some patients, raises red flags about its safety profile. The lack of current regulatory approval means that there is no oversight regarding its manufacturing, distribution, or usage, which further complicates any potential benefits it might have had for treating oral ulcers.

When considering the treatment of oral ulcers, it is crucial to explore safer and legally approved alternatives. Oral ulcers can be caused by various factors, including viral infections, stress, certain medications, and nutritional deficiencies. Common treatments for oral ulcers include topical anesthetics, corticosteroids, and antiseptic mouthwashes, which are generally considered safe and effective. For example, medications like benzocaine or triamcinolone acetonide can provide relief from pain and inflammation associated with oral ulcers.

The use of unapproved medications like Azohel poses several risks. First, without regulatory oversight, there is no guarantee of the drug's quality, efficacy, or safety. Patients using such medications may expose themselves to unknown side effects or interactions with other medications they may be taking. Furthermore, the psychological impact of using a drug that has been linked to severe health risks, such as cancer, can also contribute to anxiety and stress.

In summary, Azohel is not legal in Taiwan, and its use for treating oral ulcers is fraught with potential health risks. Patients experiencing oral ulcers should consult healthcare professionals for appropriate diagnosis and treatment options. It is essential to prioritize safety and efficacy when selecting medications, especially for conditions that can significantly impact quality of life. Always discuss with a healthcare provider before starting any new treatment, particularly if it involves unapproved or expired medications.

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