Medicine is rigorously tested for safety and effectiveness before becoming available to the consumer.

In
the U.S., the FDA makes sure this happens. Once on the market, the FDA, along with the makers of the
drug, continue to monitor the medicine for any unforeseen problems. Should an issue develop, or the
safety of a medication come into question, a recall may be initiated.

When Is a Drug Recall Announced?

A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because
it is found to be either defective or potentially harmful. Sometimes, the makers of the drug will discover a
problem with their drug and voluntarily recall it. Other times, the FDA will request that the medicine be
recalled after receiving reports of problems from the public.

Why Are Drugs Recalled?

A number of factors can cause a drug to be recalled. A recall may be issued if a medicine:
Is a health hazard. Unfortunately, some health risks associated with certain medications are not realized
until after they become widely used. For example, in 2000, medicines containing the drug
phenylpropanolamine (PPA), such as certain decongestants and weight loss medicines, were recalled after
learning that PPA increases the risk of hemorrhagic stroke, or bleeding in the brain. Another example is the
weight loss drug Meridia (sibutramine). Meridia was recalled from the U.S. market in 2010 after it was
found to increase a person's risk of heart attack and stroke.
Is mislabeled or packaged poorly. Sometimes a medicine is recalled because of confusing dosing
instructions or a problem with the dosing tool provided with the drug.
Is potentially contaminated. During production or distribution, a medicine may become contaminated
with a harmful or non-harmful substance.
Is not what it says. For example, you may think you are taking a pain reliever based on the package
material, when in fact what is inside the box is something else.
Is poorly manufactured. Manufacturing defects related to a products quality, purity, and potency may be to blame
for a drug recall.

In a drug recall, the manufacturer of a prescription drug or over-the-counter medicine takes its product off
the market. Sometimes the U.S. Food and Drug Administration (FDA) requests the recall, while at other
times the recall is initiated by the manufacturer. Either way, the FDA plays a key role in the process.
Recent examples of drug recalls include:

McNeil Consumer Healthcare's April 2010 recall of certain batches of over-the-counter children's drugs,
including liquid Tylenol, Motrin, and Zyrtec because of possible contaminants.
The 2008 recall of Baxter Healthcare's anticoagulant drug, heparin, because the FDA found contaminants in
the drug that caused severe injury and death in some people. (For more on the heparin recall, see Nolo's
article Heparin Recall and Litigation.)

Read on to learn how the FDA approves and monitors drugs, when and how recalls occur, and how to notify
the FDA if you suspect a serious problem with a drug.

What Is the FDA's Role in Monitoring Drugs?

The FDA is responsible for making sure that products like drugs, vaccines, and medical devices are safe
and effective.
The FDA's Center for Drug Evaluation and Research evaluates new drugs to ensure they work correctly and
that their health benefits outweigh known risks. The Center for Drug Evaluation and Research does not test
the drugs itself. Instead, a new drug's manufacturer tests the product on both animals and humans, and

then sends the results to the center. Experts at the Center for Drug Evaluation and Research review the
studies and determine whether the drug is safe, effective, and of good quality.
Once a drug is approved by the FDA and on the market, the manufacturer must review and report any
problems linked to the drug. Consumers can report problems directly to the FDA through the MedWatch
program. (To learn more about how to report a drug problem, see the "Reporting Defective Drugs:
MedWatch" section below.) Sometimes, the FDA requires the manufacturer to conduct additional clinical
trials involving the drug.

When Are Drugs Recalled?

A recall occurs when a drug manufacturer or the FDA decides that a pharmaceutical drug is not safe and
should be removed from the market. Sometimes a recall is necessary because new research shows that
the drug is too dangerous for use by consumers. This could be because of any of the following:

The drug causes dangerous side effects.

The FDA has discovered a safer alternative to the drug.
Consumers use the drug improperly and that unauthorized use causes serious injury or death.

Other times, the drug is considered safe if manufactured correctly, but a manufacturing error or
contamination incident makes a particular batch of the drug unsafe.

Types of Recalls
Recalls are grouped by the severity of the danger posed by the recalled drug. Here are the different types
of recalls.

Class I recall. There is a reasonable probability that a consumer's use of or exposure to a drug will cause
serious health problems or death.
Class II recall. Use of or exposure to a drug may cause temporary or medically reversible health problems, or
there is a remote risk that the drug will cause serious health problems.
Class III recall. Use of or exposure to a drug is not likely to cause adverse health consequences.
Market withdrawal. The drug has a minor problem that the FDA would not normally monitor. For example,
the manufacturer removes a drug from the market because of after-manufacturing tampering and not because
of a problem with the drug itself.
Medical device safety alert. A medical device has an unreasonable risk of causing substantial harm. In
some case, these situations also are considered recalls.

How Does a Recall Happen?

Recalls come about in one of three ways.

The manufacturer initiates the recall. This is the most common method of recall.
The FDA requests that the manufacturer voluntarily recall the drug. In this scenario, the FDA informs
the manufacturer that its product is defective and suggests or requests that the manufacturer recall the drug.
The FDA orders the manufacturer to recall the drug. If the manufacturer refuses to recall the drug, the
FDA can go to court to force the manufacturer to recall the drug or to get legal authority to seize the drug.

When a manufacturer initiates a drug recall, it must notify the FDA, submit progress reports on the recall,
and follow up to make sure the recall was successful. If the FDA requests a recall, the manufacturer is
expected to comply. Rarely does the FDA need to seize the drug itself. The FDA publishes guidelines for
manufacturers to follow when recalling drugs. These are found in Title 21 of the Code of Federal
Regulations, Part 7. (To view the Code of Federal Regulations, visit Nolo's Legal Research Center.)

Notice of Recalls

There are several ways that the manufacturer and the FDA notify consumers about a recall.
Direct notification. The drug manufacturer must notify its direct accounts (such as wholesalers or chain
drug stores) about the recall. The notification must do all of the following:

Inform the reseller that the drug has been recalled.

Request that the reseller stop distributing the drug.
If appropriate, request that the reseller notify its customers about the recall.
Instruct the reseller on what to do with the drug.

Public notification. The FDA maintains a list of drug and medical device recalls on its website
(www.fda.gov) called Recalls, Market Withdrawals, & Safety Alerts. For the most part, this list includes
Class I safety recalls. To find out about Class II and Class III recalls, you can check the FDA's weekly
Enforcement Reports, also found on the FDA website.
Media coverage. Often, if a drug recall affects many people, or the recalled drug causes severe injury or
death, the media will report on the recall.

Reporting Defective Drugs: MedWatch

The FDA encourages consumers and healthcare professionals to report problems they suspect are caused
by drugs, vaccines, or medical devices, including:

serious adverse events (death, risk of dying, admission to the hospital, prolonged hospital stay, disability, or
other serious health consequences)
drug quality problems, and
potential or actual errors in administering the drug.

Consumers can report problems with drugs or medical devices by filling out the MedWatch Online
Voluntary Reporting Form (available on the FDA's website at www.fda.gov). Consumers can report
problems with vaccines to the Vaccine Adverse Event Reporting System (on the U.S. Department of Health
and Human Services' website at www.hhs.gov).

What to Do If You Are Injured by a Drug

If you have been harmed by use of a pharmaceutical or over-the-counter drug, you may be able to bring a
product liability claim against the drug manufacturer. To learn more about product liability law, see Nolo's
article Product Liability Claims Involving Pharmaceutical Drugs.
This article contains information from the FDA website.

In a recent University of Cincinnati study published in Neurology, subjects with Parkinsons Disease were
given shots of two supposedly similar medications. They were told that the first was more expensive, and
the second was similar in effectiveness but, because of differences in manufacturing, was much cheaper.
The overall result was that patients motor skills after the first shot were improved 28% compared to the
second shot. The one fact that the patients werent told: Both shots were actually just saline solution.
Study authors believe patients got better because they had very high expectations, which translated into
health benefits.
There has been a lot of debate about the use of generic drugs vs. brand names. Are generics really as
effective? It pays to be informed since, according to the FDA, nearly 8 in 10 prescriptions filled in the
United States are for generic drugs. The use of generic drugs is expected to grow over the next few years
as a number of popular drugs come off patent through 2015.
What is the difference between generics and brand names? Is there a time when one is preferable over the
other? We spoke with C. Michael White, Pharm.D., Professor and Head, Department of Pharmacy Practice,
University of Connecticut, to get an explanation:
Q: Why are brand names so much more expensive than generics?
A: "Unlike the generic manufacturer, the original pharmaceutical company has to pay for more than just
the actual production of that medication. The Tufts Center for the Study of Drug Development estimates
that the cost to develop and win marketing approval for a new drug is $2.6 billion. It also pays for research
and development for medications that failed in trials and cant be brought to market. According to the IMS
Institute for Healthcare Informatics, generics have saved Americans one trillion dollars in health care
savings over the past decade--a current rate of more than one billion dollars in savings every other day."
Q: What happens when a brand name goes generic?
A: "At the end of an approximately seven-year period of exclusivity, the FDA allows one specific generic to
be the first to market. That generic is given a period of time of exclusivity for about six months. At the end
of that time period, any manufacturer that can prove that it can achieve the same drug concentrations in
the blood that the brand name does can make a generic. Manufacturers of generics arent required to do
studies in people to prove safety. It is assumed that if they can achieve same blood concentration, they will
achieve same results."
Q: Do generics have to have the same recipe, effect, side effects?
A: "The generics have to have the number of milligrams of drug that is included on the label in the pills.
You can take it to the bank that that does not vary. In addition, the pill needs to get you within 10 percent
above or below the blood concentrations achieved with the brand for the FDA to approve the generic, and
in reality, they only usually vary by 3-4 percent in one direction or another. So yes, they are very similar in
terms of the active ingredient. It is possible that one generic will get you a 3 percent lower concentration
than the brand and another can get you a concentration that is 3 percent above the brand and therefore
the two generics can be 6% different from each other. Most people will never notice a difference.
"According to the FDA, generic drugs do not need to contain the same inactive ingredients as the brand
name product. Inactive ingredients are those that have nothing to do with the therapeutic action of the
drug; binding materials, dyes, preservatives, and flavoring agents. Thats why sometimes a pill you have
been taking will suddenly look different. It usually means a different manufacturer has made that pill than

the one you had before. Also, given individual variations, a person can have an allergic reaction to an
inactive ingredient in one generic and not another."
Q: Is this true for over-the-counter, as well as prescription meds?
A: "Yes. The Food and Drug Administration has very strict criteria so over-the-counter store brands must
achieve very similar blood concentrations as name brands. Most people dont notice a difference. I strongly
recommend that patients start out on generic medications or switch to generic medications if they are
available, since they almost always work as well and can save people a lot of money. Why throw away
money to get a brand name when the generic will give you what you need for a fraction of the cost?"
Q: So, will you always achieve the same effect with a generic as with a brand name?
A: "Keep in mind that there is a lot of diversity among people. When they do the blood concentration
studies, they do them in average people, but because the inactive ingredients and process of
manufacturing are different, they cant assure that everyone will achieve same blood concentrations. For
example, if you have a shorter colon or disease that makes food pass through your intestines faster or
slower, that might make a difference. Other people are just very sensitive to small changes in blood
concentrations and notice a difference."
Q: Are there other instances when you should opt for a brand name?
A: "NTI (narrow therapeutic index) drugs can be tricky because the blood concentrations you need to
achieve a therapeutic dose and the concentrations that will cause harm are very close together. Small
changes in concentrations can lead to ineffective or toxic responses. Medications for seizures, heart
arrhythmias, thyroid hormone, warfarin (blood thinner), and lithium are all NTIs. With these, you need to
talk to your physician about switching to generic, make sure you understand the risks and rewards, and
that you are more closely monitored for the first couple of weeks afterwards.
"Of these NTI drugs, patients with anti-epilepsy drugs are a unique group that do equally well when started
on brand or generic drugs but during the couple of weeks after switching from brand to generic or generic
to brand, they are more likely to go to the emergency department or their doctors office. Epileptic patients
should not be routinely changing between forms of the drug for this reason.
"Some patients will tolerate a brand name medication but when they switch medications, they simply do
not do as well. The reason may be that that while the blood concentrations of the brand name medication
are very similar, what the tablets are made out of can vary. So while the average patient does as well, not
everyone will. If you are that outlier, you are better off on the branded medication or another generic. I
usually recommend trying two generic versions before giving up and moving back to a brand name drug
because again, the costs are much cheaper.
"Theres been a lot of consolidation in the generic manufacturing industry (companies merging with other
companies, leaving less competition in the field). In very rare cases, we are left with only one generic
manufacturer, so the generic is more expensive than the brand name. Supply and demand also happens in
generic drugs and its all what the market will bear. Insurance companies may stipulate that you get a
lower co-pay with generic than with a brand name even if brand name is less expensive. Patients with very
expensive generics should ask their pharmacists if brand name medications are actually cheaper and if
they are, switch back to the brand."
Q: Is it dangerous to your health to switch back and forth?
A: "Most people taking almost all drugs would not notice a perceptible difference in efficacy or safety when
switching between brands and generics or between generics, except in the case of NTIs, which are trickier.
If you are on a NTI drug, talk with your doctors about the risks and rewards of switching. For all the other
drugs, if you switch and you have mild symptoms, there is a chance that those things will resolve and you
should stay the course. If its more than a mild inconvenience, then you need to let your doctor know right
away."