Market Withdrawal of Drugs

Why is the distribution of medicines discontinued?

Drugs are subject to a product life cycle. They are discovered, patented, developed, approved, marketed and, in some circumstances, withdrawn from the market years to decades later. Often, distribution is discontinued due to commercial considerations. For example, the cost of approval and production exceeds the revenue from sales. Because the prices of reimbursable drugs are regulated by the government, it is not possible to raise prices at will. Some drugs become obsolete over time – new products are developed with better efficacy, beneficial pharmacokinetics or fewer side effects. Difficulties with raw materials, synthesis, or production, as well as quality deficiencies or research fraud, can lead to discontinuation. New scientific evidence may make it clear that the risks exceed the benefits of the drug or that clinical efficacy is insufficient. Then companies or drug regulators may conclude that a drug must be withdrawn from the market. Withdrawal from the market may be voluntary or involuntary (forced by the authorities).

What are the options for affected patients?

  • Often, other medications – generics or originals – are available that contain the same active ingredient.
  • Often, the drugs or corresponding generics are still available abroad. They can be imported under consideration of the legal requirements of pharmacies.
  • The drug can be replaced by another with the same effect or from the same drug group.
  • In pharmacies, medicines – including capsules, tablets, eye drops, ointments, suppositories or solutions – can be prepared individually as a magistral prescription.
  • It is possible that the drug will be reintroduced at a later date, from the same or another manufacturer.
  • Before the end of distribution, remaining stocks are still available from distributors – you can stock up.
  • Seek dialogue with medical people, the authorities and the companies. Possibly another company or a generic company is ready to jump into the breach.

A market withdrawal may be justified. Drugs exist that are ineffective, toxic or may cause adverse effects. They should no longer be used or manufactured.

Is there no obligation on industry?

Market withdrawal can be troublesome, frustrating, burdensome, and costly for patients and professionals, and it can put health at risk. In the free market, companies can stop manufacturing and distributing a drug at any time without consultation. In some cases, however, the question arises whether they would not have a moral, cultural, or even historical obligation to the products and to society.

Examples

A small selection of drugs that are no longer available in many countries: Acomplia – Astho Med – Batrafen – Bisolapid – Codipront – Contac – Dramamine – EmodellaExubera – Fansidar – Gastrosil – Hismanal – Irgamid – Jacutin – Limptar – Lipobay- Marzine – Mosegor – Nemexin. Premarin – Premella – Quadriderm – Rhinathiol Promethazin – Scopoderm TTS – Semap – Semprex – Teldane – Tetragynon – Tilarin – Tofranil – Uprima – Virudermin – Visaline – Vioxx – Zaroxolyn – Zorac