|
Brand Name
(generic name)
|
Side
Effects
|
Manufacturer
|
Prescribed For
|
|
Actonel
(risedronate sodium)
|
Brief:
Chest pain, digestive problems
OFFICIAL:
"Patient Information
Actonel and Actonel with Calcium are prescription
medications to treat and prevent postmenopausal
osteoporosis.
You should not take Actonel with Calcium if you are
allergic to any of the ingredients, if you have low blood
calcium (hypocalcemia),
have kidneys that work
poorly, or cannot stand or sit upright for 30
minutes. Do not take Calcium tablets if you have
high blood calcium
(hypercalcemia). If you have had
kidney stones please
tell your doctor before you start taking Actonel with
Calcium. Stop taking Actonel with Calcium and tell your
doctor if you experience difficult or
painful swallowing,
chest pain, or
severe or continuing
heartburn, as these may be signs of
serious upper digestive
problems. Follow dosing instructions carefully to
lower the chance of these events occurring.
Side effects for Actonel® (risedronate sodium
tablets) are generally mild or moderate and may include
back, muscle, bone or joint pain,
stomach pain or upset, or
constipation. Contact
your doctor if symptoms are severe. Calcium may cause
constipation, flatulence, nausea,
abdominal pain, and bloating. Tell your health
care providers, including your dentist, about all the
medicines that you take. See Patient Information for
information about Actonel with Calcium. If you have
questions, please talk to your doctor."
|
Aventis
(Proctor and Gamble)
|
osteoporosis
|
|
|
|
|
top
of page
|
|
Avodart
(dutasteride)
|
Brief:
Women must NOT EVEN TOUCH this poison due to birth defects
in unborn male children, plus liver problems, sexual
problems.
OFFICIAL:
"Important Information About AVODART®
(dutasteride):
AVODART is used to treat urinary symptoms of enlarging
prostate. Only your doctor can tell if your symptoms are
from an enlarged prostate and not a more serious condition,
such as prostate cancer. See your doctor for regular exams.
Women and children should not take AVODART. Women who are or
could become pregnant should not
handle AVODART due to the potential
risk of a specific birth
defect. Do not donate
blood until at least 6
months after stopping AVODART. Tell your doctor
if you have liver
disease. AVODART may not be right for you.
Possible side effects, including
sexual side effects and
swelling or tenderness of the
breast, occur infrequently."
|
Glaxo Smith Kline
|
enlarged prostate
|
|
|
|
|
top
of page
|
|
Boniva
(ibandronate sodium)
|
Brief:
Chest pain, severe heartburn, severe bone pain
OFFICIAL:
"Important Safety
Information
BONIVA is a prescription medicine for the management of
postmenopausal osteoporosis. You should not take BONIVA if
you have low blood calcium, cannot sit or stand for at least
60 minutes, have severe
kidney
disease, or are allergic to
BONIVA. Stop taking BONIVA and tell your healthcare provider
if you experience difficult or
painful swallowing, chest
pain, or severe or continuing
heartburn, as these may be
signs of serious upper
digestive problems. Follow
the once-monthly BONIVA dosing instructions carefully to
lower the chance of these events occurring. Side effects are
generally mild or moderate and may include
diarrhea, pain in the arms
or legs, or upset stomach.
If you develop severe bone,
joint, and/or muscle pain,
contact your healthcare provider. Your healthcare provider
may also recommend a calcium and vitamin D
supplement."
|
Roche
Glaxo Smith Kline
|
osteoporosis
|
|
|
|
|
top
of page
|
|
Celebrex
(celecoxib)
|
BRIEF:
Death, gastrointestinal hemorrhages, stomach bleeding,
cardiovascular problems, kidney and liver damage, ulcers,
indigestion, diarrhea, abdominal pain, allergic
reactions
OFFICIAL:
"Important Safety Information
Prescription CELEBREX is not for everyone. People with
aspirin-sensitive asthma or
allergic reactions due to
aspirin or other arthritis medicines or certain
drugs called sulfonamides should not take CELEBREX. IN rare
cases, serious stomach
problems such as
bleeding can occur
without warning. The most common side effects in clinical
trials wer indigestion,
diarrhea, and
abdominal pain. CELEBREX
should not be taken in late pregnancy. Tell your doctor if
you have liver or kidney
problems. If you think you are having an allergic
reaction, or if you have other severe or unusual symptoms
while taking CELEBREX, call your doctor, or other healthcare
professional immediately."
|
Pfizer
|
arthritis
and "off-label" uses
|
|
|
|
|
top
of page
|
|
Cialis
(tadalafil)
|
BRIEF:
Permanent, partial blindness - (story released
5-27-05)
OFFICIAL:
"CIALIS is available by prescription only and is not for
everyone. If you take nitrates, often used for chest pain
(angina) do not take CIALIS. Such combinations could cause a
sudden, unsafe drop in blood
pressure. Don't drink alcohol in excess
(to a level of intoxication) with CIALIS. This combination
may increase your chances of getting
dizzy or lowering your
blood pressure. CIALIS does not protect a man or his partner
from sexually transmitted diseases, including HIV.
The most common side effects with Cialis were
headache and
upset stomach.
Backache or
muscle ache were also
reported, sometimes with delayed onset. Most men weren't
bothered by the side effects enough to stop taking CIALIS.
As with any prescription ED tablet, in the rare event of an
erection lasting more than 4
hours (priapism), seek immediate medical
attention to avoid long-term injury. Discuss your medical
conditions and medications, including alpha blockers
prescribed for prostate
problems or high blood
pressure, with your doctor to ensure CIALIS is
right for you and that you are healthy enough for sexual
activity."
|
Eli Lilly
|
ED - erectile dysfunction
|
|
|
|
|
top
of page
|
|
Coreg
(carvedilol)
|
BRIEF:
OFFICIAL:
"Important Safety Information
It is important for patients to take their medicine
every day as directed by their doctors or health care
providers. Patients taking COREG should
avoid stopping therapy
abruptly. With certain beta-blocking agents,
stopping therapy abruptly has led to
chest pain and, in some
cases, heart attack. If
their doctor decides that they should stop taking COREG,
their doctor or health care provider may slowly reduce their
doses over a period of time before stopping it completely.
Some common side effects associated with COREG include
shortness of breath, a slow
heartbeat, weight gain, fatigue, hypotension, dizziness, or
faintness. People taking COREG who have any of
these symptoms should call their doctor. Additionally, if
patients experience fatigue or dizziness, they should sit or
lie down and avoid driving or hazardous tasks. Beta-blockers
may mask the symptoms of low blood sugar or alter blood
sugar levels. People with
diabetes should report any changes in blood sugar
levels to their physician. Contact
lens wearers may produce fewer tears or have dry
eyes. As with any medicine, patients taking COREG should
also first tell their doctor what other medications they are
taking.
As with any medicine, there are some people who should
not take COREG. The people who should not take COREG include
those with severe heart
failure who are hospitalized in the intensive
care unit. Also, people who require
certain intravenous
medications that help support their circulation
(inotropic medications) should not receive COREG. Other
people who should not take COREG are those who are
prone to asthma or
other breathing
problems, those with a
very slow heartbeat or
heart that skips a beat (irregular
heartbeat), and those with
liver problems."
|
Glaxo Smith Kline
|
hypertension
heart attack
heart failure
|
|
|
|
|
top
of page
|
|
Crestor
(rosuvastatin)
|
BRIEF: Unexplained muscle pain, weakness, liver problems,
constipation, weakness, abdominal pain, nausea, food
interactions, drug interactions
OFFICIAL:
"Important safety information about CRESTOR
CRESTOR is prescribed along with diet for lowering
cholesterol and is not for everyone, including people with
liver disease, and women who are nursing, pregnant or
may become pregnant. Tell your doctor promptly if you
experience unexplained muscle
pain or
weakness, as they may be
a sign of serious side
effects. Be sure to tell your doctor about
other medications you
are taking, including cyclosporine, warfarin, gemfibrozil,
or antacids. Simple blood tests are needed to check for
liver problems before
and 12 weeks after start of therapy or change of dose, and
periodically, eg, semiannually thereafter. Side effects
occur infrequently and include
muscle aches,
constipation,
weakness,
abdominal pain, and
nausea. They are usually
mild and tend to go away. CRESTOR has not been shown to
prevent heart disease or heart attacks."
|
Astrazeneca
|
statin
and "off-label" uses
|
|
|
|
|
top
of page
|
|
Detrol
(tolterodine tartrate)
|
BRIEF:
OFFICIAL:
"What are possible side effects of DETROL LA?
The most common side effects with DETROL LA are:
• dry mouth
• constipation
• headache
• stomach pain
Medicines like DETROL LA can cause
blurred vision, dizziness, or
drowsiness.
Use caution while driving or doing other dangerous
activities until you know how DETROL LA affects
These are not all the side
effects with DETROL LA. For a complete list, ask
your doctor or pharmacist."
|
Pfizer
|
bladder control
|
|
|
|
|
top
of page
|
|
Ditropan
(oxybutynin chloride)
|
BRIEF:
OFFICIAL:
"Important Safety Information
DITROPAN XL is contraindicated in patients with
urinary retention, gastric retention, or uncontrolled
narrow-angle glaucoma, and in patients who are at risk for
these conditions. DITROPAN XL is also contraindicated in
patients who have demonstrated
hypersensitivity to the
drug substance or other components of the product.
The incidence of side effects reported more commonly by
patients treated with DITROPAN XL in clinical trials using
10 mg daily compared to those permitting doses of 5 to 30 mg
daily was: dry mouth
(29% vs 61%);
constipation (7% vs
13%); drowsiness (2% vs
12%); headache (6% vs
10%); nausea (2% vs 9%);
diarrhea (7% vs 9%);
blurred vision (1% vs
8%) and dizziness (4% vs
6%).
Heat prostration (fever
and heat stroke due to
decreased sweating) can occur when anticholinergics such as
oxybutynin are administered in hot weather.
Tablets must be swallowed whole with the aid of liquids, and
must not be chewed, divided, or
crushed."
|
Ortho-McNeil
|
bladder control
and "off-label" uses
|
|
|
|
|
top
of page
|
|
Enbrel
(etanercept)
|
BRIEF:
Serious infections, fatal blood disorders, cancer
OFFICIAL:
"Important Product Information
. . . . . . . Since the product was first introduced, the
following have been reported in patients using ENBREL:
* Serious
Infections
* Many occurred in people prone to infection, such as those
with advanced or poorly controlled diabetes
* Some serious infections were
fatal
* Rare cases of tuberculosis
* What to do/Not do
* Do not start ENBREL if you have an infection or are
allergic to ENBREL or its components
* Tell your doctor if you are
prone to infection
* Stop ENBREL if a serious
infection occurs
* Contact your doctor if you have questions about ENBREL or
develop an infection
* Tell your doctor if you have ever been treated for
heart failure
* Serious nervous system
disorders, such as multiple sclerosis, seizures,
or inflammation of the nerves of the eyes.
* Tell your doctor if you have ever had any of these
disorders or if you develop them after starting ENBREL.
* Rare reports of serious blood
disorders (some fatal).
* Contact your doctor immediately if you develop symptoms
such as persistent
fever,
bruising,
bleeding, or
paleness
* In medical studies of all TNF inhibitors, a
higher rate of lymphoma
(a type of cancer) was seen compared to the general
population, however, the risk of lymphoma may be up to
several-fold higher in RA and psoriasis patients.
* The role of TNF inhibitors in the development of
lymphoma is unknown.
* The incidence of other cancers has not increased with
exposure to ENBREL and is similar to the expected rate.
* ENBREL can also cause
injection site
reactions.
* In a medical study of patients with JRA, infections,
headaches, abdominal pain, vomiting, and nausea occurred
more frequently than in adults.
* The kinds of infections reported were generally mild and
similar to those usually seen in children
* Other serious adverse reactions were reported rarely,
including serious
infections (2%) and
depression/personality
disorder (1%). . . "
|
Immunex
Wyeth
Amgen
|
arthritis
and "off-label" uses
|
|
|
|
|
top
of page
|
|
Fosamax
(alendronate sodium)
|
BRIEF:
Heartburn, difficulty swallowing
OFFICIAL:
"Selected Cautionary Information About FOSAMAX and FOSAMAX
PLUS D
You should not use FOSAMAX or FOSAMAX PLUS D if you have
certain disorders of the
esophagus (the tube connecting the mouth with the
stomach), are not able to stand or
sit upright for 30 minutes, have
severe kidney disease, low blood
calcium, or are allergic to FOSAMAX or FOSAMAX
PLUS D. Before use, talk to your doctor if you have or have
had stomach or digestive
problems or problems
with swallowing. You should tell your doctor
about all medicines you are taking, including prescription
and nonprescription medicines, vitamins, and herbal
supplements. In addition, for FOSAMAX PLUS D, you should
talk to your doctor if you have conditions that may cause an
overproduction of vitamin D (eg, sarcoidosis, leukemia,
lymphoma).
Stop taking FOSAMAX or FOSAMAX PLUS D and call your
doctor right away if you develop
new or worsening
heartburn, difficult or
painful swallowing, or
chest pain because these
may be signs of serious upper
digestive problems, which can include
irritation, inflammation, or
ulceration of the esophagus. (See the Patient
Product Information for more details.) If you develop
severe bone, joint, and/or muscle
pain at any time, contact your doctor. Digestive
side effects in studies were generally mild and included
stomach pain,
indigestion/heartburn, or nausea."
|
Merck
|
osteoporosis
|
|
|
|
|
top
of page
|
|
Humira
(adalimumab)
|
BRIEF:
Upper Respiratory infections, sinus infections
OFFICIAL:
"Important Safety Information
Do not start taking HURIMA®:
* if you are allergic to the drug or anything in it.
You should not start taking HUMIRA:
* If you have any type of infection. An infection can be in
one part of your body, such as an open sore, or it can be an
illness such as the flu.
Tell your doctor:
* if you have had any
infection in the past
that keeps coming back, or if you have any problems that
increase the risk of infections,
* if you feel any
numbness or
tingling,
* if you have ever had a disease that affects your nervous
system such as multiple sclerosis, or
* if you have ever been treated for heart failure.
Before you take HUMIRA, your doctor should test you for
tuberculosis, or TB. Tell your doctor if you have
ever had TB, or been near someone who had TB.
Signs of TB include:
* a dry cough that doesn't go away
* weight loss
* fever
* night sweats
If these or any other signs of infection appear after you
take HUMIRA, tell your doctor right away.
Also tell your doctor:
* about all the medicines you are taking or considering
taking &endash; the combination of HUMIRA and Kineret
(anakinra) is not recommended
* before you receive any vaccines
* if you are pregnant, become pregnant or plan to become
pregnant
Once you start taking HUMIRA, tell your doctor right away
or seek emergency care immediately if you have an allergic
reaction such as a bad
rash, swollen
face, or trouble
breathing. Tell your doctor right away if you
have signs of a blood disorder such as persistent
fever, bruising, bleeding or paleness. There have been rare
cases of severe allergic reactions after taking HUMIRA.
There have also been rare cases of serious and sometimes
fatal infections.
Lymphoma, rare cases of
nervous system
disorders, and serious
blood disorders have occurred in patients taking
drugs called TNF blockers such as HUMIRA.
The most common side effects of HUMIRA are:
* injection site
reactions
* upper respiratory and sinus infections
* headache
* rash
* injection site pain"
|
Abbott
|
rheumatoid arthritis
|
|
|
|
|
top
of page
|
|
Levitra
(vardenafil HCL)
|
BRIEF:
Permanent, partial blindness - (story released
5-27-05)
Drug interactions, headache, flushing
OFFICIAL:
"Men taking nitrate drugs, often used to control chest pain
(also known as angina), should not take LEVITRA. Men who use
alpha blockers, sometimes prescribed for
high blood pressure or
prostate problems, also
should not take LEVITRA. Such combinations could cause
blood pressure to drop
to an unsafe level. You
should not take LEVITRA if your doctor determines that
sexual activity poses a health risk for you. Men who
experience an erection for more
than four hours should seek immediate medical
attention. LEVITRA does not protect against sexually
transmitted diseases. The starting dose of LEVITRA is 10 mg
taken no more than once per day. Your doctor will decide the
dose that is right for you. In patients taking
certain medications such
as ritonavir, indinavir, ketoconazole, itraconazole, and
erythromycin, lower doses of LEVITRA are recommended, and
time between doses of LEVITRA may need to be extended. In
clinical trials, the most commonly reported side effects
were headache,
flushing, and stuffy or
runny nose. LEVITRA is
available in 2.5 mg, 5 mg, 10 mg, and 20 mg tablets."
|
Bayer
Glaxo Smith Kline
Schering Plough
|
ED - erectile dysfunction
|
|
|
|
|
top
of page
|
|
Lunesta
(eszopiclone)
(estorra)
|
BRIEF:
Morning drowsiness, dependency, head ache, dizziness
OFFICIAL:
"Important Safety Information:
Lunesta should only be taken immediately before bedtime. Be
sure you have at least eight hours to devote to sleep before
becoming active. You should not engage in any activity after
taking Lunesta that requires complete alertness, such as
driving a car or operating machinery. You should use extreme
care when engaging in these activities the morning after
taking Lunesta. Do not use alcohol while taking any
sleep medicine. All sleep medicines carry some risk of
dependency. Do not use
sleep medicines for extended periods without first talking
to your doctor. Side effects may include
unpleasant taste,
headache,
drowsiness and
dizziness."
|
Sepracor
|
sleeping pill
|
|
|
|
|
top
of page
|
|
Nexium
(esomeprazole magnesium)
|
BRIEF:
Headache, diarrhea, abdominal pain
OFFICIAL:
"Talk to your doctor or healthcare professional to see if
NEXIUM is right for you. Most erosions heal in 4 to 8 weeks
with NEXIUM. The most common side effects of NEXIUM are
headache,
diarrhea, and
abdominal pain. Symptom
relief does not rule out serious stomach conditions. Please
read the important Product Information about NEXIUM and
discuss it with your healthcare professional. "
|
Astrazenica
|
indigestion
(acid reflux disease)
|
|
Brand Name
(generic name)
|
Side
Effects
|
Manufacturer
|
Prescribed For
|
|
Paxil
(paroxetine)
|
BRIEF:
Suicide
OFFICIAL:
"WHAT DO I NEED TO KNOW ABOUT ANTIDEPRESSANTS AND POSSIBLE
SUICIDAL BEHAVIOR OR THINKING?
Paxil is approved only for adults 18 years and over. There
are benefits and risks when using antidepressants.
Depression and other illnesses can lead to
suicidal thoughts or
behavior whether or not you are taking
antidepressants. In some children and teens, antidepressants
increase suicidal thoughts or
actions. You and your family should watch closely
and call the doctor right away, if you have
worsening depression,
thoughts of suicide, or sudden or
severe changes in mood or behavior (for example feeling
anxious, agitated, panicky, irritable, hostile, aggressive,
impulsive, severely restless, hyperactive, overly excited,
or not being able to sleep), especially at the
beginning of treatment or after any change in dose.
CAN I TAKE PAXIL® (paroxetine HCl) WITH OTHER
MEDICATIONS?
In most cases, you can take Paxil with other medications.
However, medicines known as monoamine oxidase inhibitors
(MAOIs), thioridazine or pimozide
should not be taken while you are taking Paxil.
There may be other medicines that
don't react well wih Paxil, so be sure to tell
your healthcare provider about any prescription and
over-the-counter medications that you are taking.
DOES PAXIL CAUSE SIDE EFFECTS?
As with any prescription medication, Paxil may cause some
side effects, which are usually mild to moderate and may
fade or disappear completely over time. A common side effect
of Paxil is nausea,
which may be lessened by taking it with food. Other side
effects may include infection,
diarrhea, dry mouth, constipation, decreased appetite,
sleepiness, dizziness, sexual side effects, nervousness,
tremor, yawning, sweating, weakness or insomnia.
If you should experience any side effects, be sure to report
them to your healthcare provider as soon as possible and
follow his/her advice."
|
Glaxo Smith Kline
|
depression
|
|
|
|
|
top
of page
|
|
Plavix
(clopidogrel bisulfate)
|
BRIEF:
Excessive bleeding (sometimes
fatal), skin disorders
an allergic reaction (difficulty breathing; closing of the
throat; swelling of the lips, tongue, or face; or
hives);
bloody (or black) vomit or stools;
severe headache, confusion, or dizziness;
unexplained bruising or bleeding; or bleeding nose
upset stomach;
diarrhea or constipation;
headache or dizziness
many, many, drug
interactions
OFFICIAL:
There is NO "Important Safety Information" on the Plavix
website. For good reason.
|
Bristol-Myers Squibb
|
blood thinner
|
|
|
|
|
top
of page
|
|
Premarin
(conjugated estrogens tablets)
|
BRIEF:
Vaginitis, leg cramps, painful menstruation
OFFICIAL:
" . . . PREMARIN and PREMPRO should be used at the lowest
effective dose and for the shortest duration consistent
with your treatment goals and risks. If using PREMARIN or
PREMPRO only to treat your symptoms of vaginal dryness,
consider topical therapies first. If you do not have
symptoms, non-estrogen treatments should be carefully
considered before taking PREMARIN and PREMPRO solely for the
prevention of postmenopausal osteoporosis.
In a clinical trial, the most commonly reported (>5%)
side effects that occurred more frequently with PREMARIN
were vaginitis due to
yeast or other causes, vaginal
bleeding, painful
menstruation, and leg
cramps.
In a clinical trial, the most commonly reported (>5%)
side effects that occurred more frequently with PREMPRO 0.45
mg/1.5 mg and PREMPRO 0.625 mg/2.5 mg were
breast pain/enlargement,
vaginitis due to yeast
or other causes, leg
cramps, vaginal
spotting/bleeding, and
painful menstruation. In
a clinical trial, there was no difference in the commonly
reported (>5%) side effects for women taking PREMPRO 0.3
mg/1.5 mg compared to those taking placebo.
The most commonly reported side effects of PREMARIN Vaginal
Cream include vaginal discomfort or
pain, breast
pain,
vaginitis, and
itching. . . ."
|
Wyeth
|
menopause
|
|
|
|
|
top
of page
|
|
Prilosec
(omeprazole)
|
BRIEF:
Allergic reaction, drug interactions, headache
OFFICIAL:
The Prilosec website won't
say, but the FDA
DOES: headache, diarrhea,
constipation, upset stomach, vomiting, stomach pain, cough,
cold symptoms, dizziness,
rash
|
Proctor and Gamble
|
heartburn
|
|
|
|
|
top
of page
|
|
Procrit
(erythropoietin)
(Epoetin Alfa)
|
BRIEF:
Hypertension, increased death rate, seizures, thrombosis
OFFICIAL:
(presented as a graphic only on the
Procrit website, so search engines CANNOT read it)
The following is from the
National Institute of
Health -
"What side effects can this medication cause?
Epoetin may cause side effects.
Tell your doctor if any of these symptoms are severe or do
not go away:
* redness, swelling, stinging,
bruising, itching, or a lump at the place where you injected
epoetin
* headache
* joint or muscle pain
* upset stomach
* vomiting
* indigestion or "heartburn"
* stomach pain
* diarrhea
* constipation
* runny nose
* sneezing
* difficulty falling asleep or staying asleep
Some side effects can be
serious.
The following symptoms are uncommon, but if you experience
any of them, call your doctor immediately:
* leg pain or swelling
* shortness of breath
* coughing up blood
* cough that doesn't go away
* blue-grey color or darkening around mouth or nails
* dizziness
* fainting
* blurred vision
* temporary confusion
* slow or difficult speech
* loss of memory or ability to concentrate
* hallucinating (seeing things or hearing voices that do not
exist)
* extreme tiredness
* seizures
* weakness, numbness, heaviness, or tingling in arms or
legs
* floppiness or loss of muscle tone
* lack of energy
* increased or rapid heart beat
* irregular heart beat
* chest pain or tightness
* excessive sweating
* fever, sore throat, chills, cough, and other signs of
infection
* rash
* hives
* itching
* swelling of the face, throat, tongue, lips, eyes, hands,
feet, or ankles
* wheezing
* difficulty breathing or swallowing
* hoarseness
You should know epoetin and other
erythropoiesis stimulating medications may increase the
risk of cardiovascular
problems, including death,
especially in patients with heart disease. It is important
for your doctor to check your hemoglobin while you are
taking epoetin. If your hemoglobin rises too high or too
fast while using epoetin, serious problems may occur,
including edema (swelling of
the hands, feet, ankles, or lower legs), heart attack or
heart failure, high blood pressure, seizures, stroke, and
blood clots in your heart, legs, or
lungs. This increased risk
for high blood pressure,
seizures, and blood clots
reported with epoetin appears to be less in people with HIV
using zidovudine and epoetin, and less in people with cancer
using epoetin, than in people with serious kidney disease
using epoetin. Talk to your doctor about the risks of using
epoetin.
Epoetin may cause
other side
effects. Call your doctor
if you have any unusual problems while taking this
medication."
|
Ortho Biotech
|
anemia
|
|
|
|
|
top
of page
|
|
Strattera
(atomoxetine HCL)
|
BRIEF:
Jaundice, liver damage
Life-thretening if taken within 2
weeks of taking a MAO inhibitor.
OFFICIAL:
"Safety Information
* You should not take Strattera at the same time or
within two weeks of taking an MAOI, or if you have
narrow-angle glaucoma. Tell your doctor if you have a
history of high or low blood
pressure, increased
heart rate, or any heart or blood vessel
disease.
* Some children may lose weight when starting treatment with
Strattera. As with all ADHD medications, growth should be
monitored during treatment.
* In rare cases, Strattera can cause
liver damage. Call your
doctor right away if they have itching, dark urine, yellow
skin/eyes, upper right-side abdominal tenderness, or
unexplained "flu-like" symptoms.
* In children, the most common side effects were
upset stomach, decreased
appetite, nausea or
vomiting, tiredness,
dizziness, and mood
swings. In adults, the most common side effects were
constipation,
dry mouth,
nausea, decreased
appetite, dizziness,
problems sleeping,
sexual side effects,
problems urinating, and
menstrual cramps.
Most people in clinical studies who experienced side effects
were not bothered enough to stop using Strattera.
* Strattera has not been tested in children under 6 years of
age or in elderly adults."
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Eli Lilly
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ADHD
(attention deficit hyperactivity disorder)
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Valtrex
(valacyclovir HCL)
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BRIEF:
Headache, nausea, abdominal pain, constipation, allergic
reaction, dizziness, tremors, compromised immune system,
drug interactions
OFFICIAL:
"Important Information About VALTREX
There is no cure for herpes. Even with treatment, it may
be possible to spread herpes.
When daily VALTREX is used to reduce the risk of spreading
genital herpes, safer sex practices should be used.
It is not known if VALTREX reduces the risk of spreading
genital herpes in same sex couples.
While taking VALTREX for cold sores, you should not exceed
one day of treatment, two doses taken 12 hours apart.
VALTREX is intended for healthy adults and is available by
prescription only. To avoid a potentially serious
complication, tell your doctor if your
immune system is not
normal because of advanced HIV disease, bone marrow or
kidney transplant. Common side effects are
headache,
nausea,
vomiting,
abdominal pain, and
dizziness."
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Glaxo Smith Kline
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herpes
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Vesicare
(solifenacin succinate)
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BRIEF:
Abdominal pain, constipation, dry mouth
OFFICIAL:
"Important Information about VESIcare
VESIcare is for urgency, frequency, and leakage (overactive
bladder). VESIcare is not for everyone. If you have certain
types of stomach, urinary, or glaucoma problems, do not take
VESIcare. While taking VESIcare, if you experience a
serious allergic
reaction, severe
abdominal pain, or become
constipated for three or
more days, tell your doctor right away. In studies, common
side effects were dry
mouth,
constipation,
blurred vision and
indigestion."
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Glaxo Smith Kline
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leaky pipes
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Viagra
(sildenafil citrate)
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BRIEF:
Permanent, partial blindness - (story released
5-27-05)
OFFICIAL:
"We know that no medicine is for everyone. If you use
nitrate drugs, often used for chest pain (known as angina),
don't take VIAGRA. Taking these drugs at the same time could
cause your blood
pressure to drop to an
unsafe level. Talk with
your doctor first. Make sure you are healthy enough to have
sex. If you have chest
pain, nausea,
or other discomforts during sex, seek medical help right
away. Although erections lasting for more than four
hours may occur rarely with all ED treatments in this
drug class, it is important to seek immediate medical
attention. Erections lasting more than six hours can result
in long-term loss of
potency.
The most common side effects of VIAGRA are
headache, facial
flushing, and upset
stomach. Less common are bluish or
blurred vision, or being
sensitive to light. These may occur for a short time.
VIAGRA does not protect you from diseases that can be passed
on through sex. Make sure to protect yourself and your
partner.
If you take an alpha blocker drug for
high blood pressure or
prostate problems, talk
to your doctor. You should not take more than 25 mg of
VIAGRA and an alpha blocker within 4 hours of each other."
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Pfizer
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impotence
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Vioxx
(rofecoxib)
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BRIEF:
Fatal heart attack, fatal stroke
OFFICIAL: (October
2003)
"What are the possible side effects of VIOXX?
Serious but rare side effects that have been reported in
patients taking VIOXX and/or related medicines have
included:
* Serious stomach
problems, such as
stomach and intestinal
bleeding, can occur with or without warning
symptoms. These problems, if severe, could lead to
hospitalization or
death. Although this
happens rarely, you should watch for signs that you may have
this serious side effect and tell your doctor right away.
* Heart attacks and
similar serious events have been reported in patients taking
VIOXX.
* Serious allergic
reactions including
swelling of the face, lips, tongue,
and/or throat which may cause
difficulty breathing or
swallowing and wheezing occur rarely but may require
treatment right away. Severe skin
reactions have also been reported.
* Serious kidney
problems occur rarely, including
acute kidney failure and
worsening of chronic kidney
failure.
* Severe liver
problems, including
hepatitis, jaundice and liver
failure, occur rarely in patients taking NSAIDs,
including VIOXX. Tell your doctor if you develop symptoms of
liver problems. These include
nausea, tiredness, itching,
tenderness in the right upper abdomen, and flu-like
symptoms.
In addition, the following side effects have been
reported: anxiety, blurred vision,
colitis, confusion, decreased levels of sodium in the blood,
depression, fluid in the lungs, hair loss, hallucinations,
increased levels of potassium in the blood, insomnia, low
blood cell counts, menstrual disorder, palpitations,
pancreatitis, ringing in the ears, severe increase in blood
pressure, tingling sensation, unusual headache with stiff
neck (aseptic meningitis), vertigo, worsening of
epilepsy.
More common, but less serious side effects reported with
VIOXX have included the following:
Upper and/or lower respiratory
infection and/or inflammation
Headache
Dizziness
Diarrhea
Nausea and/or vomiting
Heartburn, stomach pain and upset
Swelling of the legs and/or feet
High blood pressure
Back pain
Tiredness
Urinary tract infection.
These side effects were reported in
at least 2% of
osteoarthritis patients receiving daily doses of VIOXX 12.5
mg to 25 mg in clinical studies.
The side effects described above
do not include all of
the side effects reported with VIOXX. Do not rely on this
leaflet alone for information about side effects. Your
doctor or pharmacist can discuss with you a more complete
list of side effects. Any time you have a medical problem
you think may be related to VIOXX, talk to your doctor.
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Merck
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arthritis
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Vytorin
(ezetimibe - Zetia/ simvastatin - Zocor)
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BRIEF:
Unexplained muscle pain, weakness, liver problems, headache,
food interactions, drug interactions
Merck
Committed Scientific FRAUD
OFFICIAL:
Important Safety Information
Can't find it. - See Zocor
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Merck/ Schering Plough
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statin
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Wellbutrin
(bupropion
HCl)
|
BRIEF:
Suicide
OFFICIAL:
"Side Effect Overview
WELLBUTRIN XL is well-tolerated
As with all medications, you may experience side effects
when you take WELLBUTRIN XL. Side effects may be more common
shortly after you start treatment. The most common side
effects with WELLBUTRIN XL are
weight loss, loss of appetite, dry
mouth, skin rash, sweating, ringing in the ears, shakiness,
stomach pain, agitation, anxiety, dizziness, trouble
sleeping, muscle pain, nausea, fast heartbeat, sore throat,
and urinating more often.
Seizures may occur
(studies showed an incidence of 1/1000 - 4/1000). The
chances of having seizures increases with higher doses. If
you have nausea, take WELLBUTRIN XL with food. If you have
trouble sleeping, remember to take WELLBUTRIN XL in the
morning. Do not change your dose or stop taking WELLBUTRIN
XL without talking to your doctor."
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GlaxoSmithKline
|
depression
Comment -
"WELLBUTRIN XL is well-tolerated" - nothing is farther from
the truth.
LOOK at the side effects! When they are this bad, you must
lie a lot harder!
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Zelnorm
(tegaserod
maleate)
|
BRIEF:
Headache, diarrhea, abdominal pain, fainting, dizziness,
rectal bleeding
OFFICIAL:
"What are the possible side effects of Zelnorm?
Headache and
diarrhea were the most
common side effects seen with Zelnorm.
Diarrhea was an occasional side effect of treatment with
Zelnorm. Most people who got diarrhea had it during the
first week after starting Zelnorm. Typically, diarrhea went
away with continued therapy. If you get bad diarrhea, or if
you get diarrhea together with bad
cramping, abdominal
pain,
fainting, or
dizziness, tell your
doctor. Your doctor may tell you to stop taking Zelnorm or
suggest other ways to manage your diarrhea.
There have been rare cases of
rectal bleeding and
severe abdominal pain in
patients treated with Zelnorm. Some of these problems were
related to insufficient blood flow to part of the bowel. It
is not known if this was related to Zelnorm use.
In studies, a very small number of patients were reported to
have abdominal surgery. In IBS with constipation studies
there were a few more reports of
abdominal surgery in
patients taking Zelnorm than in patients taking a sugar
pill. Most of these were related to the gallbladder. It is
not known if Zelnorm may increase your chance of abdominal
surgery. Gallbladder
surgery has been reported to occur more often in
IBS patients than in the general population.
This list is not
complete. Your doctor or pharmacist can give you
a more complete list of possible side effects. Talk to your
doctor about any side effects you may have."
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Novartis
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constipation
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Zocor
(simvastatin)
|
BRIEF:
Terrible leg pain
OFFICIAL:
"IMPORTANT CONSIDERATIONS
ZOCOR is a prescription tablet and isn't right for everyone,
including women who are nursing or pregnant or
who may become pregnant, and anyone with
liver problems.
Unexplained muscle pain
or weakness could be a sign of a rare but
serious side effect and
should be reported to your doctor right away. ZOCOR may
interact with other medicines or
certain foods, increasing your risk of
getting this serious side effect. So tell your doctor
about any other medications you are taking. Please read
additional important Patient Product Information
and Prescribing Information."
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Merck
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statin
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Zyprexa
(olanzapine)
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BRIEF:
diabetes, hyperglycemia, ketoacidosis
OFFICIAL:
"Important Safety Information for Olanzapine
Increased
Mortality in Elderly Patients with
Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated
with atypical antipsychotic drugs are at an increased risk
of death compared to placebo. Analyses of seventeen
placebo-controlled trials (modal duration of 10 weeks) in
these patients revealed a risk of death in the drug-treated
patients of between 1.6 to 1.7 times that seen in
placebo-treated patients. Over the course of a typical
10-week controlled trial, the rate of death in drug-treated
patients was about 4.5%, compared to a rate of about 2.6% in
the placebo group. Although the causes of death were varied,
most of the deaths appeared to be either cardiovascular (eg,
heart failure, sudden death) or infectious (eg, pneumonia)
in nature. ZYPREXA® (olanzapine) is not approved for the
treatment of elderly patients with dementia-related
psychosis.
Safety experience in elderly patients with
dementia-related psychosis
In placebo-controlled clinical trials of elderly
patients with dementia-related psychosis, the incidence of
death in olanzapine-treated patients was significantly
greater than placebo-treated patients (3.5% vs 1.5%,
respectively). Risk factors that may predispose this patient
population to increased mortality when treated with
olanzapine include age ³80 years, sedation, concomitant use
of benzodiazepines, or presence of pulmonary conditions (eg,
pneumonia, with or without aspiration). Olanzapine is not
approved for the treatment of patients with dementia-related
psychosis.
Cerebrovascular adverse events (CVAE), including
stroke, in elderly patients with dementia
Cerebrovascular adverse events (eg, stroke, transient
ischemic attack), including fatalities, were reported in
patients in trials of olanzapine in elderly patients with
dementia-related psychosis. In placebo-controlled trials,
there was a significantly higher incidence of CVAE in
patients treated with olanzapine compared to patients
treated with placebo. Olanzapine is not approved for the
treatment of patients with dementia-related psychosis.
Hyperglycemia and diabetes mellitus
Hyperglycemia, in some cases associated with
ketoacidosis, coma, or death, has been reported in patients
treated with atypical antipsychotics including olanzapine.
Assessment of the relationship between atypical
antipsychotic use and glucose abnormalities is complicated
by the possibility of an increased background risk of
diabetes mellitus in patients with schizophrenia and the
increasing incidence of diabetes mellitus in the general
population. All patients taking atypicals should be
monitored for symptoms of hyperglycemia. Persons with
diabetes who are started on atypicals should be monitored
regularly for worsening of glucose control; those with risk
factors for diabetes should undergo baseline and periodic
fasting blood glucose testing. Patients who develop symptoms
of hyperglycemia during treatment should undergo fasting
blood glucose testing.
Hemodynamic effects
In premarketing trials, some patients taking oral
olanzapine experienced orthostatic hypotension associated
with dizziness,* tachycardia,* and, in some cases, syncope
(15/2500, 0.6%). Hypotension, bradycardia with or without
hypotension, tachycardia, and, in some cases, syncope
(2/722, 0.3%) were reported during the clinical trials of
intramuscular olanzapine in agitated patients. In a clinical
pharmacology study in non-agitated patients with
schizophrenia, a maximal dosing regimen (three 10-mg doses
administered 4 hours apart) was associated with a
significant orthostatic decrease in systolic blood pressure
in approximately one-third of patients. The risk for these
effects may be greater in nonpsychiatric patients compared
to psychiatric patients who are possibly more adapted to
certain effects of psychotropic drugs.
Caution is necessary in patients who receive treatment
with other drugs having effects that can induce hypotension,
bradycardia, respiratory or central nervous system
depression. Concomitant administration of intramuscular
olanzapine and parenteral benzodiazepines has not been
studied and is therefore not recommended. If use of
intramuscular olanzapine in combination with parenteral
benzodiazepines is considered, careful evaluation of
clinical status for excessive sedation and cardiorespiratory
depression is recommended.
When subsequent intramuscular injections are considered,
patients should be assessed for orthostatic hypotension.
Additional injections are not recommended for patients with
a clinically significant postural change in systolic blood
pressure.
Transient, asymptomatic elevations of hepatic
transaminase
In placebo-controlled schizophrenia studies, clinically
significant ALT (SGPT) elevations (³3 times the upper limit
of the normal range) were observed in 2% (6/243) of patients
exposed to oral olanzapine compared to none (0/115) of the
placebo patients. None of these patients experienced
jaundice. Periodic assessment of transaminases is
recommended in patients with significant hepatic disease.
Drug interactions
Administration of intramuscular lorazepam 1 hour after
intramuscular olanzapine did not significantly affect the
pharmacokinetics of intramuscular olanzapine, unconjugated
or total lorazepam. However, this coadministration of
lorazepam IM and intramuscular olanzapine added to the
somnolence observed with either drug alone.
Coadministration of diazepam or ethanol with olanzapine
may potentiate orthostatic hypotension. Lower doses of
olanzapine should be considered in patients receiving
concomitant therapy with fluvoxamine.
No clinically significant effect on the pharmacokinetics
of commonly used medications, including:
* valproate
* imipramine
* fluoxetine
* lithium
* desipramine
* diazepam
Special populations&emdash;elderly
Esophageal dysmotility and aspiration have been
associated with antipsychotic drug use. In 5 studies in
elderly patients with dementia-related psychosis, adverse
events observed at a greater incidence with olanzapine than
with placebo were falls, somnolence, peripheral edema,
abnormal gait, urinary incontinence, lethargy, increased
weight, asthenia, pyrexia, pneumonia, dry mouth, and visual
hallucinations. As with other CNS-active drugs, olanzapine
should be used with caution in elderly patients with
dementia. Olanzapine is not approved for the treatment of
patients with dementia-related psychosis.
Effect on prolactin
Modest elevations of prolactin were seen with oral
olanzapine in acute-phase schizophrenia trials (incidence
34% vs 13% with placebo), although mean changes from
baseline to endpoint were not statistically significantly
different between olanzapine and placebo. Some patients may
have persisting modest prolactin elevations.
Medication dispensing and prescribing errors have
occurred between ZYPREXA® (olanzapine) and Zyrtec®
(cetirizine HCl). These errors could result in unnecessary
adverse events or potential relapse in patients suffering
from schizophrenia or bipolar disorder. To reduce the
potential for dispensing errors, please write ZYPREXA
clearly.
As with all antipsychotic medications, the following
considerations should be taken into account when prescribing
olanzapine:
Neuroleptic malignant
syndrome (NMS)&emdash;as with all antipsychotic
medications, a rare condition known as NMS has been reported
with olanzapine. If signs and symptoms appear, immediate
discontinuation is recommended.
Tardive dyskinesia
(TD)&emdash;prescribing should be consistent with the need
to minimize TD. If its signs and symptoms appear,
discontinuation should be considered.
Seizures&emdash;occurred
infrequently in premarketing clinical trials of oral
olanzapine (22/2500, 0.9%). Confounding factors may have
contributed to many of these occurrences. Oral Olanzapine
should be used cautiously in patients with a history of
seizures or with conditions that lower the seizure
threshold. Such conditions may be more prevalent in patients
age 65 years or older.
The most common treatment-emergent adverse event
associated with intramuscular olanzapine vs placebo IM in 3
short-term (24-hour treatment) trials involving agitated
patients with schizophrenia or bipolar mania was somnolence
(6% vs 3%). Also observed (intramuscular olanzapine vs
placebo IM) were
dizziness (4% vs 2%),
hypotension (2% vs 0%),
asthenia (2% vs 1%),
tremor (1% vs 0%), and
postural hypotension (1%
vs 0%).
The most common treatment-emergent adverse event
associated with oral olanzapine (vs placebo) in 6-week
acute-phase schizophrenia trials was
somnolence (26% vs 15%).
Other common events were
dizziness (11% vs 4%),
weight gain (6% vs 1%),
personality
disorderÝ (8% vs 4%),
constipation (9% vs 3%),
akathisia (5% vs 1%),
and postural hypotension (5% vs 2%).
The most common treatment-emergent adverse event
associated with oral olanzapine (vs placebo) in 3- and
4-week bipolar mania trials was somnolenceý (35% vs
13%). Other common events were dry mouthý (22% vs
7%), dizzinessý (18% vs 6%), astheniaý (15% vs
6%), constipation (11% vs 5%), dyspepsia (11% vs 5%),
increased appetite (6% vs 3%), and tremor (6% vs 3%).
The most common treatment-emergent adverse event
associated with oral olanzapine in combination with lithium
or divalproex (vs placebo) in 6-week combination bipolar
mania trials was dry mouth (32% vs 9%). Other common events
were weight gain (26% vs 7%), increased appetite (24% vs
8%), dizziness (14% vs 7%), back pain (8% vs 4%),
constipation (8% v s 4%), speech disorder (7% vs 1%),
increased salivation (6% vs 2%), amnesia (5% vs 2%), and
paresthesia (5% vs 2%).
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Eli Lilly
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mania,
bipolar disorder, schizophrenia
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