There are many reasons why drugs that are available for patient treatment could be removed from the market. Several regulatory agencies, medical societies, and watchdog groups are permanently monitoring and recording any possible side effects or adverse reaction to the thousands of currently approved medical treatments. After any drug ingestion has reported an unfavorable outcome, an investigation file is opened, and new evidence is added to it as soon as it is found.

Each country has its policies for drugs approval or withdrawal. Hospitals and medical doctors from around the world report any new finding to the respective regulatory agency. If there is, a real danger to public safety, or the side effects frequency and severity of them are higher than expected, the reported drug entered in alert state or warning. Afterwards, if the evidence found shows a clear link between the drug and the adverse health effects, the drug might be withdrawn. Concisely, if the risk from using the drug outweighs its potential benefits, the drug might be withdrawn or removed from public use.

Notice the difference between a drug recall and a drug withdrawal. A drug recall is the temporary market removal of a specific lot or a drug produced for a limited period. Additionally, drug recalls can be observed when the final product contains any unreported chemical, or the final product has an undisclosed substance or a contaminated material. Once, the corrections are made it can be returned to the market.

On the other hand, a drug withdrawn means that the safety, real benefits, efficacy, or functions of the drugs cannot be proven in several clinical studies. Therefore, the drug is labeled as unsafe, dangerous, or inefficient for medical treatments and it is removed from the market. However, the excluded medication can be modified, and its therapeutic indication can be changed, to be reintroduced as a new medicine with new label indications.

The drugs included in this article are from the United States Food and Drugs regulatory agency the FDA and the European Medicines Agency (EMA). Because of the permanent pharmaceutical industry supervision, few drugs are withdrawn since most of the time the pharmaceutical company makes a voluntary recall when a grave doubt arise about a particular drug to avoid the legal implications, monetary losses, and public scrutiny.

1 Tetrazepam (Trade name: Myolastan, Clinoxan, Epsipam)

Withdrawn on 2013

Indicated for Treatment of severe muscle spasms, anxiety disorder

How it supposed to work: as muscle relaxant

Withdrawal reasons: severe skin problems, there is a considerable controversy about the reason for the drug withdrawal, some in favor said it caused severe problems on the patient skin with some life-threatening conditions. On the other hand, those against it said there is not enough evidence.


2 Drotrecogin alfa (Trade name: Xigris)

Withdrawn on 2012

Indicated for Treatment of Sepsis

How it supposed to work: It produces a decrease in the inflammatory response and makes thinner the blood eliminating some clots.

Withdrawal reasons: The drug fails to prove any survival benefits. On the contrary, it produced severe bleeding.


3 Dextropropoxyphene (trade name: Darvocet, Darvon)

Withdrawn on 2010

Indicated for Treatment of moderate to severe pain

How it supposed to work: It is a painkiller from the opioid group. It reduces the pain; additionally, it can be used as anti-cough medication.

Withdrawal reasons: The drug can produce heart alteration such as arrhythmias and heart attacks; additionally, it can be fatal in overdose.


4 Gemtuzumab Ozogamicin (trade name: Mylotarg)

Withdrawn on 2010

Indicated for Treatment of some types of cancer of the blood called acute myeloid leukemia

How it supposed to work: It is a monoclonal antibody, which might reduce the bad cells count. 

Withdrawal reasons: The drug failed to prove any benefits, and its used was linked to increasing the number of patient’s deaths and overall risk of death.


5 Rosiglitazone (trade name Avandia)

Withdrawn on 2010 in Europe, Available in the USA

Indicated for Treatment of high blood sugar levels, Diabetes Mellitus

How it supposed to work: The drug should make the body cells more sensitive to the hormone insulin.

Withdrawal reasons: Drug was linked in 2010 to several heart attacks and patients deaths, EMA withdrawn it from the market in 2010. In the USA the FDA allows its prescription, under a signed patient risk acknowledgment


6 Sibutramine (trade name: Reductil, Meridia)

Withdrawn on 2010

Indicated for Treatment of obesity, weight control

How it supposed to work: The drug reduces the patient hunger, it is an appetite suppressor.

Withdrawal reasons: Drug was linked in 2010 to several heart attacks, strokes, and patients’ deaths. In some countries the drug still being available.


7 Sitaxentan (trade name: Thelin)

Withdrawn on 2010

Indicated for Treatment of: Pulmonary artery high blood pressure

How it supposed to work: It reduces the pulmonary artery blood pressure.

Withdrawal reasons: Drug was linked alteration of the liver function and liver damage.


8 Efalizumab (trade name Raptiva)

Withdrawn on 2010

Indicated for Treatment of: Psoriasis, Rheumatoid arthritis, and other autoimmune diseases

How it supposed to work: It reduces local inflammation and the immune system response.

Withdrawal reasons: Drug was linked to brain damage among the patients.

The number of drugs withdrawn is reducing overtime. The pharmaceutical industry follows the highest safety guidelines to avoid exposing the patient to unknown risk. The legal settlements obtained over the years have increased the safety measurements and the speed answer of this industry to recall voluntarily any high risk or harmful medicine.

Unfortunately, there are some side effects or negative association which are discovered only after several years of patients’ exposure. Thanks to the information, exchange across diverse medical societies, regulatory agencies and watchdog groups any potential detrimental effects caused by a particular medicine is rapidly addressed to safeguard consumer safety. The fast response is either by the public pressure on the regulatory agencies or by the voluntary recall of the pharmaceutical companies.