Bentyl (dicyclomine) is a drug that belongs to a class of medications called anticholinergics, which are used to treat various conditions that involve spasms or contractions of smooth muscles, such as irritable bowel syndrome (IBS), bladder problems, asthma, and Parkinson’s disease¹. Bentyl works by blocking the action of a chemical called acetylcholine, which is responsible for stimulating the smooth muscles in the digestive tract and other parts of the body.

Bentyl was approved by the U.S. Food and Drug Administration (FDA) in 1950 as a prescription drug for the treatment of IBS and other functional bowel disorders. It was available in different forms, such as tablets, capsules, syrup, and injection.

However, in 2016, the FDA announced that it had determined that Bentyl syrup and other drug products were not withdrawn from sale for reasons of safety or effectiveness. This means that the FDA did not find any evidence that Bentyl syrup and other drug products were unsafe or ineffective, but rather that they were discontinued by the manufacturers for other reasons, such as low demand, market competition, or business decisions.

Reasons for Discontinuation

According to the FDA notice, the following drug products were discontinued by their respective manufacturers:

• Bentyl (dicyclomine hydrochloride) syrup, 10 milligrams (mg)/5 milliliters (mL), NDA 011626, held by Aptalis Pharma US Inc., discontinued on or about June 30, 2014.
• Dicyclomine hydrochloride syrup, 10 mg/5 mL, ANDA 040062, held by Lannett Co., Inc., discontinued on or about December 31, 2014.
• Dicyclomine hydrochloride syrup, 10 mg/5 mL, ANDA 040063, held by Lannett Co., Inc., discontinued on or about December 31, 2014.
• Dicyclomine hydrochloride syrup, 10 mg/5 mL, ANDA 040064, held by Lannett Co., Inc., discontinued on or about December 31, 2014.
• Dicyclomine hydrochloride syrup, 10 mg/5 mL, ANDA 040065, held by Lannett Co., Inc., discontinued on or about December 31, 2014.

The FDA notice did not specify the exact reasons why these drug products were discontinued by their manufacturers. However, some possible factors that may have contributed to their discontinuation are:

• Low demand: Bentyl syrup and other drug products may have faced low demand from consumers and prescribers due to the availability of other forms of Bentyl (such as tablets and capsules) or other anticholinergic drugs (such as hyoscyamine and propantheline) that may have been preferred or more convenient to use.
• Market competition: Bentyl syrup and other drug products may have faced market competition from generic versions of Bentyl or other anticholinergic drugs that may have been cheaper or more accessible to consumers and prescribers.
• Business decisions: Bentyl syrup and other drug products may have been discontinued by their manufacturers due to business decisions that involved factors such as production costs, profitability, marketing strategies, or regulatory compliance.

Implications for Consumers and Prescribers

The discontinuation of Bentyl syrup and other drug products does not mean that they are unsafe or ineffective for the treatment of IBS and other functional bowel disorders. The FDA notice stated that the Agency will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

This means that consumers and prescribers who use or prescribe Bentyl syrup and other drug products can still access them if they are available from other sources or manufacturers. However, they should be aware that the supply and availability of these drug products may be limited or uncertain due to their discontinuation by their original manufacturers.

Therefore, consumers and prescribers who use or prescribe Bentyl syrup and other drug products should consult with their healthcare providers or pharmacists about alternative options for the treatment of IBS and other functional bowel disorders. These may include other forms of Bentyl (such as tablets and capsules), other anticholinergic drugs (such as hyoscyamine and propantheline), or other types of drugs (such as antidiarrheals, laxatives, antidepressants, or probiotics) that may be more suitable or effective for their individual needs and preferences.

Conclusion

Bentyl is a drug that is used to treat IBS and other functional bowel disorders by blocking the action of acetylcholine, which causes spasms or contractions of smooth muscles in the digestive tract and other parts of the body. Bentyl was available in different forms, such as tablets, capsules, syrup, and injection. However, in 2016, the FDA announced that Bentyl syrup and other drug products were not withdrawn from sale for reasons of safety or effectiveness, but rather that they were discontinued by their manufacturers for other reasons, such as low demand, market competition, or business decisions. The discontinuation of Bentyl syrup and other drug products does not mean that they are unsafe or ineffective, but it may affect their supply and availability. Therefore, consumers and prescribers who use or prescribe Bentyl syrup and other drug products should consult with their healthcare providers or pharmacists about alternative options for the treatment of IBS and other functional bowel disorders.