A banned drug is one that is taken off the market because a regulatory body decides that it is no longer safe for consumers to have. In the United States, the Food and Drug Administration makes the call on which drugs can be sold (on the basis of safety and effectiveness) and which drugs should be recalled (on the basis of health risks being discovered after the drugs make it to market).
Banning a Drug
The legal act of banning a drug is an example of how the safety of medical drugs is ensured an ongoing process. Even after the FDA approves a drug for production and distribution, the agency continues to keep an eye on test results and clinical trials. At one end of the spectrum, the FDA merely updates drug labels, so that patients are kept informed about newly discovered side effects, interactions, and any health risks. The agency has its own online reporting system, into which manufacturers report any problems that arise that implicate certain drugs. Doctors and researchers are part of this conversation, and their combined efforts usually address most problems with prescription drugs, without the drastic need for a recall.
On occasion, the reporting and review process reveals that a drug poses a health risk to patients that is too great for a simple update to remedy. When this happens, pharmaceutical manufacturers and the FDA get together to make a case-by-case decision on whether to halt production of the drug, and send the order to doctors, distributors, and pharmacies around the country to not prescribe or sell the drug to patients.
Some common reasons for a recall might include:
- Health problems: If a study or clinical trial discovers that there is a connection between consuming the drug (even as directed) and a health problem, the drug may be recalled. A drug that is linked to a greater chance of causing a heart attack, stroke, kidney failure, or some other serious complication would likely be taken off the market.
- Drug interactions: Sometimes, it is only after the drug has been approved for the market, that researchers learn that taking another drug simultaneously causes severe health problem. Even consuming certain foods might be so problematic with the particular drug that the FDA decides the drug is too risky to be prescribed or sold.
- Manufacturing errors: Even things like packaging mistakes that might unseal a bottle before it reaches a patient are grounds for a recall. Bigger problems, like the possibility of contamination, will obviously be a red flag.
Recalling a Drug
More often than not, pharmaceutical manufacturers issue a voluntary recall for a drug deemed unsafe, but the FDA has been known to request a recall. This takes place if a large number of patients and doctors report problems with the drug to the manufacturer, and research studies and clinical trials conclude that the drug poses a risk to patients.
In an ideal scenario, the FDA and the manufacturer work closely together to track the drug’s recall and ensure that the drug is no longer on the market. In a worst-case scenario, the FDA has the power to issue a mandatory recall order for a pharmaceutical drug if it deems that the manufacturer is not complying with federal standards. Mandatory recalls are not commonly used, but the mere threat of one – and the damage that such an issuance would do to a company – is enough to get manufacturers to work with the FDA on taking a drug off the market.
On the other end of the spectrum are the much simpler “market withdrawals,” also known as “product withdrawals,” which take place when a manufacturer makes the decision to stop distributing a drug but otherwise leaves current and pre-existing prescriptions untouched. Patients do not have to return their drugs, but the drug itself is gradually removed from the market through the termination of its supply (as opposed to a recall, which is much more immediate).
While a recall is akin to a decision made in the interests of public health, market withdrawals are made on business lines. They usually happen when a manufacturer decides that a drug is unprofitable, perhaps due to declining sales revenues or negative publicity that damages the company’s public image, and quietly closes down the drug’s production as a form of damage control. A market withdrawal draws much less attention and scrutiny than an outright recall.
The FDA either requests or initiates a drug removal when it determines that the drug’s risks are too numerous compared to its benefits.
One example is the drug Accutane, the brand name of isotretinoin. Accutane was on the market for 27 years, produced by Hoffman-La Roche for the treatment of severe acne. Isotretinoin was originally developed as a treatment for cancer. While tests showed it was ineffective in that regard, it had the surprising side effect of treating acne. Those same tests also showed that the drug was likely to cause birth effects, so the manufacturer abandoned development on the project.
However, in 1975, two researchers independently stumbled upon isotretinoin’s acne-treating properties and published a paper about their work. Hoffman-La Roche resumed working on the drug, but clinical trials were set up to carefully filter out women who were pregnant or likely to become pregnant. Hoffman-La Roche’s application for isotretinoin for the treatment of acne was approved by the FDA in 1982 even though scientists published articles that warned of the potential birth defects by the prescription of Accutane. However, the drug was immensely popular among dermatologists and general practitioners.
Within the first year of distribution, cases of birth defects were reported, which prompted Hoffman La-Roche to send warning letters to doctors, and update and print more labels on drug bottles. When the manufacturer was hit with lawsuits, the FDA’s advisory committee recommended that the agency take strong measures, which the FDA did. In an unprecedented step, the agency told blood banks not to accept blood from people on Accutane and added to Accutane’s label that that women should take contraceptives for one month before taking Accutane.
Birth Defects and Miscarriages
Nonetheless, people kept taking Accutane, and the number of babies born with birth defects also increased. In 1985, the drug bottle’s label was updated again; three years later, another FDA advisory committee was convened, which resulted in an internal agency memo that estimated that as many as 1,000 babies had been born with birth defects, 1,000 miscarriages had been caused, and as many as 7,000 women had to receive abortions, all due to isotretinoin. The memo was leaked to The New York Times, which swung the pendulum of popular opinion against Accutane and Hoffman-La Roche.
Within the FDA, dermatologists and La Roche representatives argued in favor of keeping the drug in production and on the market but increasing educational outreach about the risks of consumption. Pediatricians and the Centers for Disease Control called for the FDA to pull Accutane off pharmacy shelves. The FDA committee eventually decided to limit the number of physicians who were in a position to prescribe the drug and required a second medical opinion before Accutane could be prescribed.
The FDA itself claimed that it did not have the legal authority to restrict who had the right to prescribe Accutane but took another unprecedented stop: It told La Roche to make their warnings even more visible and graphic, to create informed consent forms that had to be used when doctors prescribed the drug, and to conduct follow-up studies to determine whether these measures were successful in ensuring that pregnant women were no longer subject to the drug.
La Roche implemented the measures, even offering to pay for contraception counseling and pregnancy testing for women who were prescribed Accutane, but a 2000 report from the CDC found problems with La Roche’s plan. The report also found that off-label use of Accutane led to an increase in the number of prescriptions, which caused La Roche to revamp its efforts, requiring two pregnancy tests, two kinds of contraception, requiring doctors to send prescriptions to pharmacies directly, increasing the number of educational resources, and providing free pregnancy tests.
Low Market Share and Dangerous Drug Recalls
A blog on Social Justice Solutionslisted Accutane as the first on a list of “the FDA’s most dangerous drug recalls.”
Another FDA advisory committee meeting in 2000 saw dermatologists demand autonomy to prescribe Accutane on their own, defending the drug for its notable effectiveness in treating severe acne. There were still calls for La Roche to adopt even stricter measures for how Accutane was prescribed or to drop the drug entirely.
The committee meeting resulted in the FDA coming up with a new regulatory scheme, which required La Roche and prescribing doctors to communicate very closely on training and prescribing practices with pregnant patients.
In 2009, La Roche discontinued Accutane from its manufacturing and distribution lines due to a low market share of 5 percent, and the prohibitive cost of personal injury lawsuits initiated by patients who had been prescribed the drug. In 2010, for example,, a jury decided that La Roche had to pay $25 million to a man who developed Crohn’s disease after taking Accutane for his acne. Six years later, the case is still being argued.
Generic, cheaper isotretinoin is still available throughout the United States, sold through other companies. La Roche continues to defend its use of Accutane, claiming that over 13 million patients have been treated for severe acne since the drug was introduced in 1982. The company, based in Switzerland, continues to manufacture and distribute a new formulation of Accutane internationally.
Perhaps one of the most infamous of banned drugs is methaqualone, which is much better known by its trade name of Quaalude. Quaalude is a central nervous system depressant, with the properties of a sedative and hypnotic that induce sleep in people who suffer from insomnia or anxiety.
It became popular in the 1970s, primarily for its intended use – an author told the BBC that “doctors were essentially giving [Quaaludes] out like candy” – but also as a recreational drug; people would take Quaaludes for their quick and powerful effects (which took only 30 minutes to kick in and could last for as long as six hours) or to counter the highs of stimulants (like cocaine or methamphetamines) that they were consuming at the same time.
The problem was compounded because of so-called “stress clinics,” what today we would call “pill mills” – drug rings using pharmacies as a front office to sell controlled and prescription medication in large quantities, where customers didn’t need to show a doctor’s prescription in order to pick up their drugs. For Quaaludes, people could merely check off boxes on a form before receiving their pills.
This led to what a history professor at the University of Buffalo called “a sedative boom.” The barbiturates of the 1950s fell from popularity, and the wave of newer sedatives that made Valium a household name throughout the next two decades also ushered in Quaaludes. It’s no coincidence that Quaaludes enjoyed the height of their popularity during the “free love” movement of the 1970s; users became so relaxed and comfortable that they felt compelled to engage in sexually promiscuous and risky behavior. Across college campuses, Quaaludes and alcohol became a popular combination.
A Losing Business
The drowsiness induced by methaqualone may have been desired, but with it came reduced respiration and heart rate, as well as kidney or liver damage and delirium. Quaaludes are highly addictive, and unintentionally consuming too much – especially if another substance was taken at the same time – could easily shut the body down, putting a person into a coma that could eventually lead to their death. The drug was also implicated in suicide attempts and car crashes, as a result of people attempting to drive while under its effects.
As more and more stories of Quaaludes being connected to fatalities and sex crimes started circulating, regulators and Lemmon Company, the drug’s manufacturer, took notice. A lawyer for the company told the Associated Press in 1981 that there was “no doubt” his company “lost a considerable amount of business” because of the negative public image people started to have of Quaaludes. That same year, says PBS, the US Drug Enforcement Administration reported that Quaalude consumption came only behind that of marijuana, and further estimated that anywhere from 80 percent to 90 percent of methaqualone’s production was hijacked by the illegal drug trade. The DEA warned that Quaalude was on track to match heroin’s popularity as the most dangerous drug in America.
Such was the fear of what Quaaludes could do that Gene Haislip, the Deputy Assistant Administrator of the Office of Diversion Control for the DEA – the third most powerful man in the agency – personally traveled around the world, talking to government officials in every country that owned a factory that produced methaqualone (West Germany, Austria, Hungary, and China) and convinced them to cease those operations. “In the end,” Haislip told PBS, “the Colombian [drug cartels] could no longer get their drug powder.” Starved of the key ingredient in the creation of Quaaludes, they gave up.
From Free Love to Schedule I
This effectively took Quaaludes off the American market, even for their original use as a sleeping aid. Doctors were reluctant to prescribe methaqualone to their patients because the stigma of a drug used in sexual assaults far outweighed any popularity it once enjoyed. All that was left were the formalities. In 1984, Congress banned the production and distribution of the drug, and President Ronald Reagan signed legislation that rendered Quaalude a Schedule I drug in the United States, stripping it of any legal or medical legitimacy. Also in 1984, the government of the United Kingdom declared Quaalude a Class B drug, which criminalized its manufacturing and sale in that country.
Methaqualone still exists, albeit illegally. Drug rings that run illegal laboratories in Mexico continue to manufacture drugs that resemble methaqualone and then pass the products off as authentic Quaaludes. Other countries, such as India and South Africa, still permit the use of methaqualone, but the name Quaaludes is rarely seen in marketing or promotion.
Few drugs have enjoyed a meteoric rise and fall like terfenadine, sold under the brand name Seldane. The FDA approved Seldane in 1985 for the treatment of allergies. It was hailed for how, unlike other antihistamines, it did not induce drowsiness and fatigue in users.
This property made Seldane an immensely popular drug, making $440 million for its manufacturer Hoechst Marion Roussel in in 1996. Doctors wrote 4.3 million prescriptions for the drug, and a further 2.3 million for Seldane-D, a variation.
But the lack of drowsiness was a double-edged sword; because the dosing was no longer limited by sedation, doctors (and patients) would often increase the dosage above safety limits in order to treat allergies sooner. This inevitably led to cases of overdoses, which spelled trouble for Seldane. Additionally, patients taking Seldane while also consuming antibiotics or antifungal drugs were in danger of developing abnormal heart rhythms.
In the years it was on the market, the FDA received up to 40 reports of “serious heart rhythm abnormalities,” resulting in eight deaths, and Seldane was implicated in each of them. However, the FDA resisted calls to remove Seldane from shelves, claiming that it was the only drug available that could cure allergies without sedative effects. Essentially, the agency argued that the benefits of Seldane outweighed its risks.
That said, the FDA did issue warnings to doctors about the possible side effects of prescribing Seldane when patients were taking other drugs. Hoechst Marion Roussel sent their own warnings. In a 1997 op-ed on “The Hazards of Seldane,” The New York Times warns that “dangerous incidents [related to Seldane consumption] have decreased, [but] they have not been eliminated.”
In 1992, the FDA issued a statement that warned of Seldane’s danger to patients with liver problems, which halted Hoechst Marion Roussel’s plan to apply for Seldane to be sold over the counter. The manufacturer agreed to update their label and to send out a new series of warnings to patients and physicians.
Four years later, the FDA approved another antihistamine produced by Hoechst Marion Roussel, named Allegra. Allegra had the same active compound as Seldane, so it still offered sedation-free allergy treatment, but it did not cause the same heart rhythm abnormalities that plagued Seldane.
With this, the FDA felt that Seldane had no more lifelines and made plans to request that production of the drug be discontinued. In 1997, Hoechst Marion Roussel made the decision to shut the door on “one of the most popular allergy drugs ever sold,” in the words of the Los Angeles Times. At its peak, it was one of the most widely used drugs in the world and the third-best selling allergy medication in the country.
Pharmaceutical companies can sink millions of dollars and decades’ worth of research into producing a drug, but there’s no way of knowing what will happen once the pills are actually prescribed to potentially hundreds of thousands of people, all with their own medical histories, lifestyles, and other drug therapies that they are currently on. Some drug creators find this out the hard way.
Mibefradil, manufactured and distributed by Roche Laboratories as Posicor, was approved by the FDA in June 1997 to treat high blood pressure and chest pain. Less than a year later, it was recalled. Posicor had problems from the outset; from the moment it hit the shelves, it came with a disclaimer that it could not be taken in conjunction with a number of other drugs (including, somewhat ironically, Seldane). Research discovered that Posicor had the unexpected effect of reducing the specific liver function that helps the body purge medications, resulting in the drug contents staying in the blood for too long, which could lead to potentially fatal side effects as well as irregular heartbeats.
Within six months of approval, the FDA announced that it had received reports of heart arrhythmias in approximately 20 patients. Roche Laboratories had to update its label with even more drugs that could react badly with Posicor.
The final tally of drugs too dangerous to take with Posicor was 25. The FDA warned that the scope of the risk could not be appropriately covered by standard label warnings.
By the time Roche voluntarily (and “abruptly,” in the words of Circulation) took Posicor off the market in 1998, the drug had been implicated in the deaths of as many as 143 people. Two FDA researchers wrote in a medical journal a year after Posicor was recalled that the problems that led to the removal of the drug were “unexpected.” However, one of those researchers later said that the serious adverse reactions “perhaps could have been anticipated.”