This page has the latest updates on adverse reactions which may affect the prescriptions which you
are taking. As always consult your health care practitioner.
MedWatch - The FDA Safety Information and Adverse Event Reporting
Program
Elidel Cream (pimecrolimus)
Protopic Ointment (tacrolimus)
Audience: Dermatological and other healthcare professionals
[Posted 01/20/2006] The Food and Drug Administration announced the
approval
of updated labeling for two topical
eczema drugs, Elidel Cream
(pimecrolimus)and Protopic Ointment(tacrolimus). The labeling will be
updated with a boxed
warning about a possible risk of cancer and a
Medication Guide (FDA-approved patient labeling) will be distributed to
help
ensure
that patients using these prescription medicines are aware of
this
concern. The new labeling also clarifies that these
drugs are
recommended
for use as second-line treatments. This means that other prescription
topical medicines should
be tried first. Use of these drugs in children
under 2 years of age is not recommended.
The FDA has determined that exposure to paroxetine in the first trimester of pregnancy
may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer
has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the WARNINGS section of
paroxetine's prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data
related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated
with paroxetine.
Physicians who are caring for women receiving paroxetine should alert them to the potential
risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine
therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine
should consult with their physician about whether to continue taking it. Women should not stop the drug without discussing
the best way to do that with their physician.
Read the complete MedWatch 2005 Safety Summary, including links to the FDA Public Health
Advisory and the FDA Drug Information Page that includes links to the Healthcare Professional and Patient Information Sheets,
at:
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil3
Otober 9, 2005:
Study Links Paxil with birth defects:
AP Washington:
FDA is warning that a study has suggested that the antidepressant Paxil may be associated with birth defects.
Glaxo-SmithKline said it will include the results of the study in the drug's list of precautions.
A retrospective study found increased numbers of babies born with birth defects to women who were taking
Paxil during the first trimester of pregnancy as compared with women on other antidepressants, accorcint to the FDA and the
company.
This is classified as a Category C drug for pregnant women which meams that comprhenssive studies of its
effects on a pregnancy have not been performed.
The com;pany and FDA now believe there is a "definite causal link" between dthe drug and the increased incidence
of birth defects. Of course, the spin which the drug company will put on this will affect the actual truth of this drug.
September 19,2005 Monday
Black Box Warning on Pravachol:
CONTRAINDICATIONS
Active liver disease or unexplained, persistent elevations of serum transaminases.
WARNINGS
Myopathy, defined as muscle aching or muscle weakness in conjunction with increases
in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal, was rare (<0.1%) in pravastatin
clinical trials. (My note here: ANY "statin" anti-cholesterol drug can have the Myopathy problems
of muscle pain and liver and kidney damage, to a greater or lesser degree. Doctors should be aware that muscle pain may NOT
simply be the flu, as evidenced by several of the customers at the Pharmacy.)
September 9, 2005 Sunday
Trileptal Associated with Life-threatening Skin Reactions and Multi-organ Hypesensitivity: Health Canada
Alert
Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)
On April 28, 2005 Health Canada posted an alert on its web site concerning the association of Trileptal (oxcarbazepine),
an anti-epileptic medication, with life-threatening dermatological reactions and multi-organ hypersensitivity. It also
posted on its site a "Dear Health Care Professional" letter by Novartis Pharmaceutical Cananda, Inc., dated April 27, 2005
in which the drug's manufacturer informed doctors about new safety information concerning the risks of these serious side
effects. The letter can be viewed at:
http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_advisories_professionals_e.html#2005
A similar warning was issued by the US FDA and Novartis AG on April 19, 2005.
Trileptal is prescribed for the treatment of partial seizures in adults and in children ages 6 to 16 with
epilepsy.
According the April 27 Novartis letter, the reporting rate of Stevens Johnson Syndrome (SJS) and toxic epidermal
necrolysis (TEN) currently exceeds the background incidence rate estimates by a factor of 3-fold to 10-fold. Novartis
advises that most cases of SJS and TEN which have been associated with a patient's use of Trileptal occurred within the first
month. Some of these patients required hospitalization, and there were a few deaths reported.
Novartis has issued a revised Trileptal Product Monograph, also referred to as the "package insert", warning
that a diagnosis of SJS or TEN requires immediate discontinuation of Trileptal.
As a general rule, patients should not stop taking any medication prescribed by their doctor without first
consulting with that doctor. If, however, a patient taking Trileptal or any other prescription medicine experiences
a serious skin rash, that patient should not delay in reporting this condition to a doctor, be it the prescribing doctor or
another doctor.
Lastly, as always, Health Canada encourages people that any suspected adverse reaction to a prescription drug
should be reported to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP). Likewise, in the United States,
any serious side effects to prescription drugs should be reported to the FDA through their MedWatch Program.
July 10, 2005
Study finds that Milk Increases Risk of Parkinson Disease in Men
Milk consumption in midlife is directly related to an increased fisk of Parkinson's Disease (PD) in men,
according to a report in Neuroklogy (Neurology 2005;64:1047-51) The findings are based on dietary intake observed from
1965 to 1968 in 7,504 men ages 45 to 68 in the Honolulu Heart Program.
July 9, 2005 Saturday
FDA warns of Health Risks with Off-label Antipsychotics
Newly discovered health risks for seniors taking certain atypical anti-psychotic drugs for off-label
indications prompted the FDA to alert pharmacists and other health care providers to the problem.
These drugs are aripiprazole, olanzapine, clozapine, risperidone, and ziprasidone which are approved
only for the treatment of schizophrenia and mania. The FDA says that new, recent research suggests that when these products
are prescribed off-label to treat behavorial disorders in elderly patients with dementia, a higher risk of death may results.
Agency officials have raised the same concerns about a combination olanzapine and fluoexetine HCL which is brand name Symbyax,
which is a drug approved for the treatment of bipolar disorder.
The FDA is asking drug manufacturere to place new boxed warnings on their drug labeling for these
products. They are also urging patients and those patient caregivers who are taking the drugs for dementia or other
off-label behavorial symptoms to have their therapy reviewed. In my opinion, it is very hard to get a Physician to change
his mind about what he wants to prescribe. Should you present your physician with this information, and he refuses to
discontinue the drug, simply find another physician who will. The off-label uses of anti-depressants for children under
the age of 18 led to suicides, and many complications. Also, some of these new behavioral drugs lay the foundation for
diabetes and other health complications.
By January, 2006, with the new Medicare Part D regulations, each year every patient's drug protocol
must be reviewed and if there are therapeutic duplications these must be corrected.
July 7, 2005
1. Prozac.
This wonder drug whose side effects are now being uncovered. Aside from all the known
side effects, including insomnia, anxiety, anorexia and weight loss, Prozac has been known to affect nearly every system of
the body. Most recently, it’s been linked with sexual dysfunction and also long-term dependence.
2. Piroxicam (Feldene).
Numerous deaths have been linked to this nonsteroidal anti-inflammatory
drug, which causes some 110 known side effects, including stomach and intestinal bleeding or perforation, depression and hair
loss.
3. Predisolone
or routine use of steroids for anything other than the short term for life-threatening
conditions. Even inhaled or rub-on steroids cause the side effects associated with their oral cousins: thin skinning, growth
retardation or osteoporosis, buffalo hump and dementia.
4. Dex fenfluramine.
This dieting magic bullet makes you nine times more likely to develop pulmonary
hypertension, and also causes depression, insomnia and nervousness. In lab tests it caused brain damage.
5. Nifedipine
and other calcium-channel blockers. New revelations about this class of drug show
they increase the risk of cancer, heart attacks, stomach bleeding and suicide and is also dangerous for diabetics.
6. Larium.
At least 300 Britons are claiming severe, long-term effects from this supposed malaria
preventative, including hallucinations, anxiety attacks, seizures and severe mood swings.
7. Septrin.
This hybrid antibacterial drug, used to treat everything from traveller’s diarrhea
to HIV infection, even in children, is extremely toxic. American regulatory agencies warn the drug can cause the potentially
fatal skin disease Steven-Johnson syndrome, which also causes death of liver tissue and lowering of blood cell count. The
drug, given for HIVpositive AIDS patients, causes symptoms uncannily like those supposedly associated with advanced AIDS.
8. Sodium valproate.
Also known as valproic acid, this anti-epilepsy drug has a host of side effects,
including the capacity to cause potentially fatal liver failure in some patients.
9. Ritalin.
This drug of choice for children diagnosed with Attention Deficient Hyperactivity Syndrome
(ADHS), the latest name for the hyperactive child, can cause seizures in susceptible children, suppress height and weight,
cause nervousness and insomnia, anorexia, nausea, heart palpitations and, involuntary movements. It also can lead to dependence.
10. Minocycline.
This first-line treatment for severe acne has been linked with serious adverse
reactions, including liver failure, tooth discolouration, autoimmune hepatitis and lupus.
July 1, 2005
FDA Reviews Data for Antidepressant Use in Adults
In response to recent scientific publications that report the possibility of increased risk of suicidal behavior
in adults treated with antidepressants, the U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory (PHA)
to update patients and healthcare providers with the latest information on this subject.
Even before the publication of these recent reports, FDA had already begun the process of reviewing available
data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has
asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the
risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical
trials and may take more than a year to complete.
In the meantime, the PHA advises health care providers and patients to be aware of the following:
- Adults being treated with antidepressant medicines, particularly those being treated for depression, should
be watched closely for worsening of depression and for increased suicidal thinking or behavior.
- Close observation of adults may be especially important when antidepressant medications are started for the
first time or when doses for the specific drugs prescribed have been changed.
- Adults whose symptoms worsen while being treated with antidepressants, including an increase in suicidal
thinking or behavior, should be evaluated by their health care professional.
These recommendations are consistent with warnings already present in approved labeling for antidepressants
used by adults.
FDA will provide updated information as it becomes available. The Public Health Advisory is available on line
at http://www.fda.gov/cder/drug/advisory/SSRI200507.htm.
June 23, 2005
Migraine Headaches
"Rebound" phenomenon found for many patients taking migraine medications and also pain medications.
The body can become "used to" or "acclimatized" (I do not use the word addicted here) such that it literally "demands"
the medications. The actual migraine headache can be caused by many factors such as stress, muscular tension in the
trapezius muscles, rhomboids, occipitals, scalenes (neck and shoulder muscles), which when tense and contracted can stop or
short the blood flow to the brain. A typical muscle-tension-caused migraine can start around the medial shoulder blade
area, and the pain then can travel up the (right) side of the neck and to the right side of the head. An alert massage therapist,
properly trained in myofascial techniques can relieve this type of migraine very quickly, and indeed, teach your spouse, friend,
or significant other how to help relieve this particular type of headache through proper massage.
(Other types of migraines certainly have the auras, and other cluster symptoms.)
June 17, 2005
Researchers find
"higher incidence" of benign tumours in patients taking Johnson & Johnson's Risperdal
by William
Kanapaux
The Wall Street Journal said that a study by FDA researchers examining a database of adverse drug
reactions found that patients taking Johnson & Johnson's Risperdal had a higher incidence of benign pituitary gland tumours
than did patients taking similar drugs, as reported in CNN Money and Washington Times. However, the preliminary finding "doesn't
prove whether the tumours were caused by the drugs or other factors," the published report said.
June 16, 2005
FDA proposes label changes for all NSAIDs
by William Kanapaux
The FDA has sent proposed label changes to all makers of prescription and over-the-counter non-steroidal
anti-inflammatory (NSAIDs) drugs, as reported in USA Today. The agency asked that drugmakers of prescription NSAIDs include
a boxed warning that highlights the increased risk of heart disease and gastrointestinal bleeding linked to these drugs
__________________________________________________________________
Following is a quick list of those drugs which have serious side-effects and drug-drug interactions especially
in long-term care and elderly people. This happens whether or not the individual is in a nursing home environment, assisted
living, or living independently.
Warfarin - NSAIDS
Serious GI Bleeding
Warfarin - Sulfonamides Increased
effect of warfarin
Warfarin - Macrolides
Increased effect of warfarin
Warfarin - Fluoroquinolones Increased effect of warfarin
Warfarin - Phenytoin
increased effect of warfarin and/or phenytoin
ACE inhibitors - potassium supplements Elevated serum potassium
ACE inhibitors - Spironolactone Elevated serum potassium
Digoxin - Amiodarone
Digoxin toxicity
Digoxin - Verapamil Digoxin
toxicity
Theophylline - Fluoroquinolones Theophylline toxicity
