Why was Dimetapp taken off the market?

Dimetapp, the popular over-the-counter children’s cold and allergy medicine, was voluntarily withdrawn from the market in 2008 by its manufacturer due to concerns over misuse of the medicine. While Dimetapp is an effective decongestant and antihistamine, it contains ingredients that can be misused if taken in very large quantities.

What is Dimetapp?

Dimetapp is an over-the-counter medication that has been commonly used since the 1960s to relieve symptoms associated with the common cold, hayfever, sinusitis and other respiratory allergies. It contains two active ingredients:

  • Brompheniramine maleate – an antihistamine that reduces watery eyes, itchy throat/nose/eyes and sneezing
  • Phenylephrine hydrochloride – a decongestant that dries up nasal secretions and opens nasal passages

By combining an antihistamine and a decongestant, Dimetapp effectively controls a wide range of cold and allergy symptoms. The medicine comes in liquid and tablet forms and is suitable for both adults and children over 6 years old.

Why was Dimetapp discontinued?

In 2008, Dimetapp was voluntarily withdrawn from the market by its manufacturer, Schering-Plough Healthcare Products. This decision was made due to concerns over the misuse of the medicine, particularly by teenagers and young adults engaging in recreational drug use.

The active ingredients in Dimetapp – brompheniramine and phenylephrine – have the potential to be misused when taken in very high quantities. This deliberate misuse can induce a mild stimulant and dissociative effect due to the way the ingredients interact with receptors in the brain.

While unintentional overdose of Dimetapp is very rare, there were increasing reports of teenagers and young adults intentionally misusing it by taking dozens of times the recommended dose to get high. This misuse resulted in instances of seizure, irregular heartbeat, and other dangerous side effects.

Key events leading to the discontinuation of Dimetapp

  • 1960s – Dimetapp first enters the market and quickly becomes a popular OTC cold and allergy medicine.
  • 1980s – Isolated reports of Dimetapp misuse begin to emerge.
  • Early 2000s – Discussions begin around reformulating Dimetapp to make misuse more difficult.
  • Mid 2000s – Reports of recreational Dimetapp misuse continue to increase, especially among teenagers.
  • 2006 – The issue gains more mainstream attention when highlighted by national media outlets.
  • 2008 – Due to continued concerns, Schering-Plough voluntarily discontinues Dimetapp in April 2008.

While Dimetapp had been on the market for nearly 50 years, growing awareness of its potential for abuse eventually prompted the manufacturer to withdraw it completely in 2008.

Which ingredients were involved in the misuse?

The misuse of Dimetapp largely involved recreational users taking extremely high doses of the medicine to induce stimulant and dissociative effects. The key ingredients involved were:

  • Brompheniramine – An antihistamine that in very high doses can cause mild stimulant effects due to anticholinergic properties.
  • Phenylephrine – A decongestant that in high doses acts as a stimulant by elevating blood pressure and heart rate.

Combined together in dozens of times the recommended dose, these two ingredients could produce a euphoric high, as well as potential dangerous side effects such as arrhythmia and seizures.

What were the effects of misusing Dimetapp?

The misuse of Dimetapp involved taking anywhere from 10 to even 100 times the recommended therapeutic dose. This could result in a range of effects and side effects, including:

  • Euphoria
  • Dissociation/delirium
  • Hallucinations
  • Increased heart rate and blood pressure
  • Dry mouth
  • Blurred vision
  • Drowsiness
  • Seizures
  • Arrhythmia
  • Respiratory depression

The stimulant and anticholinergic effects could provide recreational users with an intoxicated, dissociative high. However, the enormous overdoses led to dangerous elevations in heart rate/blood pressure and toxicity, resulting in life-threatening side effects.

What other OTC cold medicines have been misused?

Along with Dimetapp, other common over-the-counter cold and allergy medicines have also faced issues with misuse due to their ingredients:

  • Coricidin HBP – Contains dextromethorphan (DXM) which in high doses causes dissociative, hallucinogenic effects.
  • Benadryl – Contains diphenhydramine which in high doses has anticholinergic effects.
  • Robitussin cough syrup – Also contains DXM like Coricidin.
  • Sudafed – Contains pseudoephedrine which is used to illegally manufacture methamphetamine.

In response to misuse issues, many of these products have been reformulated to reduce abuse potential. For example, replacing DXM with alternative antitussives like guaifenesin.

What measures were taken to prevent Dimetapp misuse?

Prior to withdrawing Dimetapp in 2008, several measures were taken to try and reduce misuse of the medicine while keeping it available for legitimate use:

  • Dosage limits – Restrictions on purchase quantity to prevent users buying large amounts.
  • Prescription status – Requiring a prescription for purchase.
  • Formulation changes – Altering formulations to achieve similar efficacy but with less misuse potential.
  • Active ingredient changes – Replacing brompheniramine and/or phenylephrine with other actives less prone to misuse.
  • Warning labels – Clear warning labels advising against use except as directed.

However, these measures ultimately did not adequately resolve the misuse issues, leading the manufacturer to make the voluntary decision to discontinue Dimetapp in 2008.

Why did the manufacturer voluntarily discontinue it?

There were several key reasons why Schering-Plough decided to voluntarily withdraw Dimetapp from the market in 2008, rather than be compelled by regulators to do so:

  • Preserve the Dimetapp brand reputation – Continuing misuse reports could damage the trusted brand name.
  • Avoid stricter regulatory action – Get ahead of the issue before regulators imposed harsher restrictions.
  • Reduce liability – Removing the product helped limit legal liability risks.
  • Be socially responsible – Discontinuation demonstrated the company’s responsibility to public health.
  • Pressure from retailers – Major retailers like CVS had begun restricting access due to misuse concerns.
  • Inability to prevent misuse – Formulation and other changes failed to adequately prevent misuse.

With misuse increasing and other mitigation strategies ineffective, Schering-Plough determined voluntarily discontinuing production was the most responsible choice.

Has Dimetapp become available again since 2008?

No, Dimetapp has not returned to the market since being voluntarily discontinued by the manufacturer in 2008. The Dimetapp brand name is still owned by the pharmaceutical company Merck, who merged with Schering-Plough in 2009.

However, Merck has not reintroduced Dimetapp or sold the rights to another company. This is likely because the same concerns around misuse of the medicine that caused it to be withdrawn originally would still remain today if it returned.

While Merck could potentially reformulate Dimetapp to reduce misuse potential, the company has focused its efforts on other products instead. Developing a new version of Dimetapp is likely not seen as a worthwhile commercial opportunity due to past misuse issues.

Unless Merck decides to bring back Dimetapp in the future, possibly with a new formulation less susceptible to abuse, the old formulation of the medicine appears to be discontinued for good.

What alternatives exist now for treating colds and allergies?

While Dimetapp was voluntarily discontinued and hasn’t returned, there are still many alternative OTC medication options for relieving cold, flu, sinusitis and allergy symptoms today. Some examples include:

Medicine Active Ingredients Uses
Claritin Loratadine Allergy symptom relief
Zyrtec Cetirizine Allergy symptom relief
Benadryl Diphenhydramine Allergy & cold symptom relief
Sudafed Pseudoephedrine Nasal decongestant
Mucinex Guaifenesin Cough & chest congestion

In addition to oral medications, other options like nasal sprays and eye drops can also effectively treat specific allergy and cold symptoms.

Could Dimetapp make a comeback in the future?

While unlikely in the near future, Dimetapp could potentially make a comeback at some point down the road if certain conditions aligned:

  • New ownership – The rights could be sold to a company interested in reviving the brand.
  • Reformulation – Creating a new formula that maintains efficacy while reducing potential for recreational misuse.
  • OTC restrictions eased – Regulatory environment may eventually be more permissive of medicines with misuse potential.
  • Market demand – Enough consumer demand to make reintroduction commercially viable.

However, the original formulation of Dimetapp is unlikely to return. Any potential comeback would depend on a new owner and new formulation that resolves the issues which led to the original discontinuation. But with other alternatives available, this scenario currently seems improbable.

Could Dimetapp be obtained from other countries?

It’s unlikely Dimetapp is still available in its original formulation in any other countries currently. Some key points:

  • Dimetapp was sold in many international markets prior to 2008. Concerns over misuse led most countries to also discontinue it around the same time as the U.S.
  • Some remaining stock may have been sold in certain countries after 2008, but new production would have stopped globally.
  • Importing Dimetapp from abroad would still be illegal in the U.S., as the FDA has not approved it for sale domestically since 2008.
  • Counterfeit or illegally imported foreign medicines also pose safety risks due to lack of regulation.

In summary, while limited supplies may have persisted for a short time after 2008, Dimetapp has almost certainly been discontinued globally at this point. Any supplies from international sellers would be outdated, unsafe and illegal.

Conclusion

Dimetapp had been a popular and trusted OTC medicine for cold and allergy relief for nearly 50 years before concerns over deliberate misuse led the manufacturer to voluntarily discontinue it in 2008. The medicine has remained off the U.S. market since then, with alternative products filling the void. While a potential comeback can’t be ruled out, the original formulation is unlikely to return given the misuse liability concerns unless major changes were made. For the foreseeable future, consumers have access to various other safe and effective OTC options for treating cold, cough and allergy symptoms.

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