Discontinuation of specific branded products
The perception that mesalamine is being discontinued stems from the withdrawal of specific brand-name formulations, not the entire class of medication. The most notable example is the branded product Asacol. The manufacturer, Allergan, voluntarily withdrew the original Asacol (400mg) from the market in 2020 following a notice from the Food and Drug Administration (FDA). The FDA had flagged an inactive ingredient, dibutyl phthalate (DBP), as a potential concern, prompting the manufacturer's decision.
Following the discontinuation of Asacol 400mg, Allergan later also discontinued Asacol HD (800mg). However, in this case, the FDA investigated and determined that Asacol HD was not withdrawn for safety or efficacy reasons. Instead, this discontinuation was based on the manufacturer's own business decisions. The practice of discontinuing older, branded products to introduce newer, often more expensive, formulations is a common strategy in the pharmaceutical industry. When the patent for the original Asacol was about to expire, the company introduced the new formulation, Delzicol, and later discontinued Asacol HD, shifting patients toward the newer product. This market-driven decision, rather than a safety issue, is the primary reason behind many mesalamine brand withdrawals.
The role of generic competition and manufacturing challenges
Patent expirations have been a major driver behind the pharmaceutical market's shift toward generic products. The mesalamine market is no exception. As patents on branded drugs expire, generic versions become available, leading to increased competition and often lower prices for patients. However, the path to generic availability is not always smooth. Some generic manufacturers have faced their own challenges, contributing to short-term supply disruptions and recalls.
- Manufacturing and Quality Issues: Supply chain disruptions, manufacturing quality problems, and other logistical hurdles can lead to temporary or permanent shortages of specific generic products. For example, Sun Pharmaceutical recalled nearly 55,000 bottles of mesalamine capsules after samples failed to meet dissolution specifications during routine testing. Such recalls, while necessary for patient safety, can create anxiety and confusion among users.
- Formulation Complexity: The specialized delayed-release and extended-release formulations of mesalamine are complex to replicate. These intricate delivery mechanisms ensure the drug is released at the correct location within the intestine, where it can act on the inflammation. This complexity can pose significant challenges for generic manufacturers seeking FDA approval, as evidenced by the lack of timely generic versions for some formulations, like Pentasa.
- Market Consolidation: Over time, market forces may lead to fewer manufacturers producing a specific formulation, increasing the risk of shortage if one manufacturer encounters issues. Regulatory filings, such as those related to Asacol HD, demonstrate the constant interplay between market dynamics and regulatory oversight.
What this means for patients
Patients taking a discontinued mesalamine brand have several options, but it is crucial to consult with a healthcare provider before making any changes. The following steps can help navigate the transition:
- Consult Your Doctor: Do not abruptly stop taking your medication. Your gastroenterologist can assess your condition and recommend an appropriate alternative mesalamine formulation or a different type of medication.
- Generic Substitution: In many cases, a therapeutically equivalent generic mesalamine is available. While formulations may differ, their effectiveness is generally comparable.
- Alternative 5-ASA Formulations: Other 5-aminosalicylic acid (5-ASA) products are available, including different oral formulations (e.g., Lialda, Pentasa, Delzicol) and rectal preparations (e.g., enemas, suppositories).
- Explore Different Drug Classes: For more severe disease or if 5-ASAs are not tolerated, alternative drug classes such as corticosteroids, immunomodulators, or biologics may be necessary.
Comparison of mesalamine and alternative treatments
| Feature | Mesalamine (Oral) | Mesalamine (Rectal) | Balsalazide (Colazal) | Corticosteroids (e.g., Budesonide) | Biologics (e.g., Adalimumab) |
|---|---|---|---|---|---|
| Drug Class | 5-Aminosalicylate (5-ASA) | 5-Aminosalicylate (5-ASA) | 5-Aminosalicylate (5-ASA) Prodrug | Steroid | Immunosuppressant |
| Administration | Oral tablets or capsules | Enemas or suppositories | Oral capsules | Oral or Rectal foam | Injection or infusion |
| Targeted Use | Mild to moderate ulcerative colitis (UC); maintenance of remission | Distal UC, proctosigmoiditis, and proctitis | Mild to moderate UC | Moderate to severe UC; short-term use | Moderate to severe IBD |
| Key Considerations | Different delivery systems for targeted release in the colon or small intestine | Topical treatment, better for distal disease, can be less comfortable | Converted to mesalamine in the colon by bacteria | Potent anti-inflammatory, but carries risk of significant side effects with long-term use | Targets specific inflammatory proteins, for more advanced disease management |
| Discontinuation | Specific branded products have been withdrawn for commercial or regulatory reasons | Rare for generics, some temporary shortages reported | Generally available | Various formulations available | Generally available |
Conclusion: Moving forward after discontinuation
While the news that a specific branded medication is being discontinued can be unsettling for patients, it is important to remember that mesalamine as a therapeutic agent is not being eliminated. The withdrawals of products like Asacol and Asacol HD were primarily driven by strategic business decisions and, in one instance, a regulatory concern about an inactive ingredient. The FDA explicitly stated that the Asacol HD withdrawal was not due to safety or efficacy issues, a crucial point for patients to understand. For those affected, therapeutically equivalent generic versions and newer branded formulations remain widely available. For patients who require a switch, open communication with a healthcare provider is essential to determine the most suitable alternative treatment, ensuring that the management of inflammatory bowel disease remains consistent and effective.
