Facts and Myths about Generic Drugs

October 25, 2009 · Filed Under Side Effect Facts · Comment

Today, 7 in 10 prescriptions filled in the United States are for generic drugs. This fact sheet explains how generic drugs are made and approved and debunks some common myths about these products.

FACT: FDA requires generic drugs to have the same quality and performance as the brand name drugs.

When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency. Some variability can and does occur during manufacturing, for both brand name and generic drugs. When a drug, generic or brand name, is mass produced, very small variations in purity, size, strength and other parameters are permitted. FDA puts limits on how much variability in composition or performance of a drug is acceptable.
Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name (or reference) product. Generic drugs do not need to contain the same inactive ingredients as the brand product.
Through review of bioequivalence data, FDA assures that the generic product will perform the same as its respective brand name (or reference) product. This standard applies to all generic drugs, whether immediate or controlled release.
A generic drug must be shown to be bioequivalent to the reference drug; that is, it must be shown to give blood levels that are very similar to those of the reference product. If blood levels are the same, the therapeutic effect will be the same. In that case, there is no need to carry out a clinical effectiveness study and they are not required.
All generic manufacturing, packaging and testing sites must pass the same quality standards as those of brand name drugs and the generic products must meet the same exacting specifications as any innovator brand name product. In fact, many generic drugs are made in the same plants as innovator brand name drug products.
If an innovator of a brand name drug switches drug production to an alternative manufacturing site, or they change formulation of their brand name drug, these companies are held to the same rigorous manufacturing requirements as those that apply to generic drug companies.

FACT: Research shows that generics work just as well as brand name drugs.

A recent study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. [Kesselheim et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526].

FACT: When it comes to price, there is a big difference between generic and brand name drugs. On average, the cost of a generic drug is 80 to 85% lower than the brand name product.

An IMS National Prescription Audit shows that a typical formulary now charges $6 for generic medications, $29 for preferred branded drugs, and $40 or more for non-preferred branded drugs. [Aitken et al. Prescription drug spending trends in the United States: looking beyond the turning point. Health Aff (Millwood). 2009;28(1):w151-60].
Independent research has shown that total prescription drug expenditures in the United States only increased by 4.0% from 2006 to 2007, with total spending rising from $276 billion to $287 billion. This is a sharp decrease from the 8.9% growth rate observed in prescription drug expenditures in 2006. One factor cited as a reason for the slowdown is an increase in availability and use of generic drugs [Hoffman et al. Projecting future drug expenditures--2009. Am J Health Syst Pharm. 2009;66(3):237-57].

Recently, some misinformation has raised concerns over generic drugs. Below are some common myths in circulation.

MYTH: FDA lets generic drugs differ from the brand name counterpart by up to 45 percent.

FACT: This claim is false. Anyone who repeats this myth does not understand how FDA reviews and approves generic drugs.

FDA recently evaluated 2,070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was only 3.5 percent [Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97]. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name. In fact, there have been studies in which branded drugs were compared with themselves as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.
Any generic drug modeled after a single, brand name drug (the reference) must perform approximately the same in the body as the brand name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug to the next.

MYTH: People who are switched to a generic drug are risking treatment failure.

FACT: There is no evidence for this claim. Treatment failures can and do occur when taking generic or brand name drugs. If someone is switched to a generic drug around the time they are relapsing, they may attribute the problem to the switch.

Many people who have recovered from major depression have a relapse despite continued treatment. These relapses have been shown in trials of long-term therapy. [Byrne and Rothschild. Loss of antidepressant efficacy during maintenance therapy: possible mechanisms and treatments. J Clin Psychiatry. 1998;59(6):279-88].
Many people who are on a seizure medications will re-experience a seizure despite continued treatment. [Randomised study of antiepileptic drug withdrawal in patients in remission. Medical Research Council Antiepileptic Drug Withdrawal Study Group. Lancet. 1991;337(8751):1175-80].
A percentage of people will re-experience gastric ulcers, despite an initial, positive response to and continued treatment with prescription strength antacids (cimetidine tablets; http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=8131#nlm34067-9).

MYTH: Generic drugs cost less because they are inferior to brand name drugs.

FACT: Generic manufacturers are able to sell their products for lower prices, not because the products are of lesser quality, but because generic manufacturers generally do not engage in costly advertising, marketing and promotion, or significant research and development.

When a brand name drug comes off patent and generic drugs are permitted to compete with the brand name drug, the generic products compete by offering lower prices. Unlike the manufacturers of brand name drugs, generic drug companies do not have significant expenses to recoup for advertising, marketing and promotion, or research and development activities.

MYTH: There are quality problems with generic drug manufacturing. A recent recall of generic digoxin (called Digitek) shows that generic drugs put patients at risk.

FACT: FDA’s aggressive action in this case demonstrates the high standards to which all prescription drugs – generic and brand name – are held.

In March 2008, FDA performed a scheduled inspection of the Actavis production facility and identified products that were not manufactured to required specifications over a period of time extending back to the year 2006. Included in this list of products was one particular lot of Digitek.
Actavis detected a very small number of oversized tablets in this lot (specifically, 20 double-sized tablets in a sample of approximately 4.8 million tablets).
Although Actavis attempted to remove the affected Digitek tablets through visual inspection, FDA determined that this method of removal was inadequate to assure the product’s quality and consistency in accordance with the current Good Manufacturing Practice (cGMP) regulations.
Since the detection of the manufacturing problem, FDA has been actively engaged with this company to ensure that ALL potentially affected lots of Digitek tablets have been recalled. In our best judgment, given the very small number of defective tablets that may have reached the market and the lack of reported adverse events before the recall, harm to patients was very unlikely.
FDA takes action whenever we find that a drug manufacturer is not following cGMPs. Over the last ten years, FDA has taken enforcement action against many brand name and generic firms for failing to meet FDA manufacturing quality standards.

MYTH: FDA’s enforcement action against the generic drug company Ranbaxy demonstrates quality problems with imported generic drugs.

FACT: FDA’s action demonstrates FDA’s commitment to safe generic drugs.

FDA has taken several regulatory actions against the generic drug manufacturer Ranbaxy, on the basis of problems at two of Ranbaxy’s manufacturing facilities. Ranbaxy is one of many non-U.S. based generic and brand drug manufacturers.
On Sept. 2008, the FDA issued two warning letters and instituted an Import Alert barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy’s Dewas, Paonta Sahib and Batamandi Unit facilities due to violations of U.S. cGMP requirements. That action barred the commercial importation of 30 different generic drugs into the United States and remains in effect today (http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149532.htm).
Subsequent FDA investigations also revealed a pattern of questionable data raising significant questions regarding the reliability of certain generic drug applications from Ranbaxy.
To address the allegedly falsified data, the FDA has invoked its Application Integrity Policy (AIP) against the Paonta Sahib facility. When the AIP is implemented, the FDA stops all substantive scientific review of any new or pending drug approval applications that contain data generated by the Paonta Sahib facility. This AIP covers applications that rely on data generated by the Paonta Sahib facility only.
In the fiscal year 2008, FDA performed 2,221 drug-related inspections. FDA takes many different enforcement actions, not just against generic drug manufacturers. For a list of enforcement actions in the fiscal year 2008, see http://www.fda.gov/downloads/ICECI/EnforcementActions/EnforcementStory/UCM129812.pdf. It is FDA’s responsibility to ensure that the drugs people use, generic or brand name, are safe and effective.

MYTH: Brand name drugs are safer than generic drugs.

FACT: FDA receives very few reports of adverse events about specific generic drugs. Most reports of adverse events are related to side effects of the drug ingredient itself.

The monitoring of postmarket adverse events for all drug products, including generic drugs, is one aspect of the overall FDA effort to evaluate the safety of drugs after approval. In most cases, reports of adverse events generally describe a known reaction to the active drug ingredient.

MYTH: FDA does not care about concerns over generic drugs.

FACT: FDA is actively engaged in making all regulated products – including generic drugs – safer.

We are aware that there are reports noting that some people may experience an undesired effect when switching from brand name drug to a generic formulation or from one generic drug to another generic drug. Evidence indicates that if problems with interchangeability of drug formulations occur, they occur only for a very small subset of people.
FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur. The Agency does not have the resources to perform independent clinical studies, and lacks the regulatory authority to require industry to conduct such studies. FDA will continue to investigate these reports to ensure that it has all the facts about these treatment failures and will make recommendations to healthcare professionals and the public if the need arises.

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Swine Flu

October 13, 2009 · Filed Under Side Effect Facts · Comment

H1N1 (Swine Flu)

H1N1 (Swine) flu is a contagious new influenza virus. Illness with the new H1N1 (Swine) flu virus has ranged from mild to severe. More…
The symptoms of H1N1 (Swine) flu include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, fatigue, and possibly vomiting or diarrhea. More…
H1N1 (Swine) flu is spread mainly from person to person through coughing or sneezing by infected persons. Get vaccinated to protect yourself from the H1N1 (Swine) flu. More…
If you are infected with H1N1 (Swine) flu, you should avoid close contact with others, especially those who might easily get the flu More…

What is H1N1 (Swine) Flu?

H1N1 (Swine) flu is a new influenza virus causing illness in people. It has two genes from flu viruses that normally circulate in pigs in Europe and Asia, plus avian genes and human genes. Scientists call this a “quadruple reassortant” virus.
H1N1 (Swine) flu is contagious. This new virus was first detected in people in the United States in April 2009. The virus is spreading from person-to-person, in the same way that regular seasonal influenza viruses spread.
H1N1 (Swine) flu is NOT caused by eating pork or pork products. H1N1 flu is not a foodborne disease, it is a respiratory disease. The USDA continues to remind consumers that all meat and poultry products are safe to eat when properly prepared and cooked.
Illness with the new H1N1 (Swine) flu virus has ranged from mild to severe. While the vast majority of people who have contracted H1N1 (Swine) flu have recovered without needing medical treatment, hospitalizations and deaths have occurred.
About 70 percent of people who have been hospitalized with H1N1 (Swine) flu have had one or more medical conditions that placed them in the “high risk” category for serious seasonal flu-related complications. These include pregnancy, diabetes, heart disease, asthma and kidney disease.
Unlike the seasonal flu virus, adults older than 64 do not yet appear to be at increased risk of H1N1 (Swine) flu-related complications. CDC laboratory studies have shown that about one-third of adults older than 60 may have antibodies against this virus. It is unknown how much protection may be afforded against H1N1 (Swine) flu by an existing antibody.

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Symptoms of H1N1 (Swine) Flu

The symptoms of H1N1 (Swine) flu are similar to seasonal flu, but may include additional symptoms such as vomiting and diarrhea.

Symptoms of Season and H1N1 (Swine) Flu:

Seasonal Flu

H1N1 (Swine) Flu

All types of flu can cause:

Fever
Coughing and/or sore throat
Runny or stuffy nose
Headaches and/or body aches
Chills
Fatigue

Similar to seasonal flu, but symptoms may be more severe.

There may be additional symptoms. A significant number of H1N1 (Swine) flu cases:

Vomiting
Diarrhea

Emergency Warning Signs – If you become ill and experience any of the following warning signs, seek emergency medical care.

Emergency warning signs in children:	Emergency warning signs in adults:
Fast breathing or trouble breathing Bluish or gray skin color Not drinking enough fluids Severe or persistent vomiting Not waking up or not interacting Being so irritable that the child does not want to be held Flu-like symptoms improve but then return with fever and worse cough	Difficulty breathing or shortness of breath Pain or pressure in the chest or abdomen Sudden dizziness Confusion Severe or persistent vomiting Flu-like symptoms improve but then return with fever and worse cough

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How to Prevent Contracting H1N1 (Swine) Flu

Get Vaccinated! Vaccine makers began shipping the H1N1 (Swine) flu nasal spray on Wednesday, September 30th. Several hundred thousand doses are expected to arrive at state locations on Tuesday, October 6th.
As of October 1, 2009, 47 United States jurisdictions have ordered a cumulative total of 1,378,200 doses of the nasal-spray Live Attenuated Influenza Vaccine (LAIV) for H1N1 (Swine) flu.
During the first two weeks of October 2009, states will be able to place orders for 15 microgram pre-filled syringes licensed for use in children age 4 and older, multidose vials, as well as additional LAIV. More information

Materials for distribution:

“What You Need to Know” PDF (2009 H1N1 “Flu Shot” Vaccine Information Sheet)

“What You Need to Know” PDF (2009 H1N1 LAIV “Nasal Spray Vaccine” Vaccine Information Sheet)

Use our Use our Flu Shot Locator to find vaccination sites where you live.

H1N1 (Swine) flu is spread in the same way that seasonal flu spreads.Flu viruses are spread mainly from person to person through coughing or sneezing by infected persons. Sometimes people may become infected by touching something – such as a surface or object – with flu viruses on it and then touching their mouth or nose.
People infected with the seasonal or H1N1 (Swine) flu shed virus may be able to infect others from 1 day before getting sick to 5 to 7 days after. This can be longer in some people, especially children or people with weakened immune systems.

Take these everyday steps to protect your health:

Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.

Wash your hands often with soap and water, especially after you cough or sneeze. Alcohol-based hand cleaners are also effective.

Avoid touching your eyes, nose or mouth. Germs spread this way.

Try to avoid close contact with sick people.

Stay home if you are sick until at least 24 hours after you no longer have a fever (100°F or 37.8°C) or signs of a fever (without the use of a fever-reducing medicine, such as Tylenol®). Read detailed information about how long to stay away from others.

Follow public health advice regarding school closures, avoiding crowds and other social distancing measures.

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Guidelines for Taking Care of Yourself and Others

If you have been diagnosed with H1N1 (Swine) flu, you should:

Stay home, follow your doctor’s orders, and watch for signs that you need immediate medical attention.

Remain at home for 7 days after your symptoms begin or until you have been symptom-free for 24 hours, whichever is longer.

Avoid close contact with others, especially those who might easily get the flu, such as people of any age with chronic medical conditions (such as asthma, diabetes, or heart disease), pregnant women, young children, and infants.

Wear a facemask – if available and tolerable – when sharing common spaces with other household members to help prevent spreading the virus to others. This is especially important if other household members are at high risk for complications from influenza.

Get plenty of rest.

Drink clear fluids such as water, broth, sports drinks, or electrolyte beverages made for infants to prevent becoming dehydrated.

Cover coughs and sneezes.

Clean hands with soap and water or an alcohol-based hand rub often, especially after using tissues and after coughing or sneezing into your hands.

If you are taking care of someone who has contracted H1N1 (Swine) flu, you should:

Avoid being face-to-face with the sick person. When holding a small child who is sick, place his/her chin on your shoulder so that he/she will not cough in your face.

Make sure everyone in the household cleans their hands often, using soap and water or an alcohol-based hand rub.

Remind the patient to cover coughs, and clean his/her hands with soap and water or an alcohol-based hand rub often, especially after coughing and/or sneezing.

Speak with the person’s health care provider about any special care that might be needed, especially if the person is pregnant or has a health condition such as diabetes, heart disease, asthma, or emphysema.

Talk to your health care provider about taking antiviral medication, such as oseltamivir (Tamiflu®) or zanamivir (Relenza®), to prevent getting the flu.

Ask the patient’s health care provider whether the patient should take antiviral medications.

Consider wearing a facemask or respirator, when close contact is unavoidable.

Monitor yourself and household members for flu symptoms and contact a telephone hotline or health care provider if symptoms occur.

Get medical care right away if the patient exhibits emergency warning signs

Additional Resources

Learn more About the H1N1 (Swine) flu vaccine

Learn more about Medications and Antivirals

Learn more abut H1N1 (Swine) flu treatment for people with health conditions

Learn more about Seasonal Flu

Tags: h1n1, swine flu

Seasonal Flu

October 13, 2009 · Filed Under Side Effect Facts · Comment

Seasonal Flu

The seasonal flu is contagious and can cause mild to severe illness; and in some cases can lead to death. More…
The timing and severity of this year’s flu season is uncertain. More…
Type A and B flu viruses cause epidemics in the United States every year. More…
The symptoms for the common cold and the seasonal flu are similar. More…
Get vaccinated to protect yourself from the flu. If you do get sick, follow our treatment advice. More…

Seasonal Flu Basics

Influenza (the flu) is a contagious respiratory illness caused by influenza viruses. It spreads from person-to-person and can cause mild to severe illness; and in some cases, can lead to death.

In the United States, yearly outbreaks of seasonal flu usually happen during the fall through early spring.
The best way to prevent the flu is by getting a flu vaccination each year.
Flu viruses can cause illness in people of any age group. Children are most likely to get sick because their immune systems aren’t strong enough to fight off the infection.
Some groups are more likely to have complications from the seasonal flu. These include:
- those age 65 and older
- children younger than 2 years old
- people of any age who have chronic medical conditions (e.g. diabetes, asthma, congestive heart failure, lung disease)
Complications from the flu can include:
- bacterial pneumonia
- ear or sinus infections
- dehydration
- worsening of chronic medical conditions

Every year in the United States, on average:

5 to 20 percent of the population get the flu
More than 200,000 people are hospitalized from flu-related complications
About 36,000 people die from flu-related causes

Download free flu materials from CDC

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The 2009-2010 Flu Season

Flu seasons are unpredictable in a number of ways, including the timing of the beginning, severity, and length of the flu season.

This flu season (2009-2010), there are more uncertainties than usual because of the emergence of a new 2009 H1N1 (Swine) flu virus.

Severity is uncertain. The 2009 H1N1 (Swine) flu virus – along with regular seasonal viruses – will cause illness, hospital stays, and deaths this flu season in the United States. Scientists are concerned that the 2009 H1N1 virus may cause the season to be worse than a regular flu season – with a lot more people getting sick, being hospitalized and dying than during a regular flu season.

Timing is uncertain. In past years, seasonal flu activity typically did not reach its peak in the U.S. until January or February, but flu activity has occurred as late as May. However, the 2009 H1N1 (Swine) flu virus caused illness, hospitalizations, and deaths in the U.S. during the summer months when influenza is very uncommon. So it is not known when flu activity will increase, when it will be most intense (peak), what viruses will circulate, or how long the season might last.

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Flu Viruses

There are three types of flu viruses: A, B and C. The A and B viruses cause epidemics (widespread outbreaks in a country) of infection in people every year in the United States.

Type C infections cause mild respiratory illness and are not thought to cause epidemics.
Type A viruses are divided into subtypes. Subtypes of type A that have been found in people worldwide include H1N1, H1N2, and H3N2 viruses.
Flu viruses are constantly changing. A global flu pandemic (worldwide outbreak) can happen if three conditions are met:
- A new subtype of type A virus is introduced into the human population.
- The virus causes serious illness in humans.
- The virus can spread easily from person-to-person in a sustained manner.
The H1N1 (Swine) Flu met all three conditions and caused a worldwide outbreak. In late spring, the WHO declared that a H1N1 (Swine) flu pandemic is underway.

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Flu Symptoms and Cold vs. Flu

Common Symptoms

Possible Symptoms

fever (usually high)
tiredness (can be extreme)
headache
dry cough
sore throat
runny or stuffy nose
muscle aches

These symptoms may occur, but are more likely in children than adults:

nausea
vomiting
diarrhea

Note that these additional symptoms may also be a sign of the H1N1 (Swine) flu.

Is it a Cold or the Flu?

Flu and the common cold are both respiratory illnesses, but they are caused by different viruses.

Flu and the common cold have similar symptoms (e.g. fever, sore throat). It can be difficult to tell the difference between them.
Your doctor can give you a flu test within the first few days of your illness to determine whether you have the flu.
In general, the flu is worse than the common cold.
Symptoms such as fever, body aches, extreme tiredness, and dry cough are more common and intense with the flu.
Colds are usually milder than the flu. People with colds are more likely to have a runny or stuffy nose.
Colds generally do not result in serious health problems, such as pneumonia, bacterial infections, or hospitalizations.

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Seasonal Flu – Vaccination, Prevention and Treatment

Vaccination is the best protection against contracting the flu. You need two vaccines to be fully protected this year. The seasonal flu vaccine is different from the H1N1 (Swine) flu vaccine. The CDC is encouraging people to get both vaccinations.More information on Vaccination
Find a Flu Clinic Near You and Get Vaccinated. Visit the Flu Shot Locator on this site.
For more prevention information, and to find out what to do if you get the flu, follow our advice for Prevention and Treatment

Flu-like syndrome

Tags: flu, flu symptoms

People at High Risk of Developing Flu-Related Complications

October 13, 2009 · Filed Under Side Effect Facts · Comment

People at High Risk of Developing Flu-Related Complications

October 8, 2009, 12:45 AM ET

Most people who get the flu (either seasonal or 2009 H1N1) will have mild illness, will not need medical care or antiviral drugs, and will recover in less than two weeks. Some people, however, are more likely to get flu complications that result in being hospitalized and occasionally result in death. Pneumonia, bronchitis, sinus infections and ear infections are examples of flu-related complications. The flu can also make chronic health problems worse. For example, people with asthma may experience asthma attacks while they have the flu, and people with chronic congestive heart failure may have worsening of this condition that is triggered by the flu. The list below includes the groups of people more likely to get flu-related complications if they get sick from influenza.
People at High Risk for Flu Complications:

* Children younger than 5, but especially children younger than 2 years old
* Adults 65 years of age and older
* Pregnant women
* People who have:
o Cancer
o Blood disorders (including sickle cell disease)
o Chronic lung disease [such as asthma or chronic obstructive pulmonary disease (COPD)]
o Diabetes
o Heart disease
o Kidney disorders
o Liver disorders
o Neurological disorders (such as epilepsy, cerebral palsy, brain or spinal cord injuries, moderate to profound intellectual disability [mental retardation] or developmental delay)
o Neuromuscular disorders (such as muscular dystrophy and multiple sclerosis)
o Weakened immune systems (such as people with HIV or AIDS or who are on medications that weaken the immune system )

Tags: flu

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