FDA Rules That Over-the-Counter Ahem and Algid Medicines Shouldn't Be Given to Kids Younger Than 2 Mathis provided thefollowing tips for parents who accept to accord over-the-counter ahem andcold medicines to accouchement age-old 2-11: Always bethink that thesemedications do not cure the cold. They don't abbreviate the time that your childhas a cold, and they're alone meant to advice a child's symptoms. Look at the alive capacity inthe Drug Facts label. This will advice you accept what a
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FDA Rules That Over-the-Counter Ahem and Algid Medicines Shouldn't Be Given to Kids Adolescent Than 2The FDA today apprenticed parents and caregiversnot to accord over-the-counter (OTC) cough and algid medicines tochildren adolescent than 2 because of dangerous ancillary effects. "We acerb acclaim thatover-the-counter ahem and algid articles should not be acclimated in breed andyoung accouchement beneath 2 years of age because austere and potentiallylife-threatening ancillary furnishings can action from use of theseproducts," Charles Ganley, MD, administrator of the FDA's Office ofNonprescription Produc
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FDA Addendum 'Further Evidence' of Blight Accident From Anemia Drugs Known as ESAsThe FDA today appear that it's reviewing added abstracts on
cancer risks angry to the anemia
drugs Aranesp, Epogen, and Procrit. Those drugs are erythropoiesis-stimulating agents (ESAs). They boost
production of red claret beef and already bear a "black box
warning" (the FDA's toughest warning) about blight risk. That warning, launched in March
2007 and revised in
November 2007, is based on six studies. Now, the FDA is reviewing two more
studies from Amgen, the aggregation that makes all three ESAs. An FDA advising board will altercate the abstracts and revisit the drugs' risks
and allowances in the next few months. Meanwhile, the
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Second Admonishing Reminds Patients to Use the Painkiller Exactly as DirectedSpurred by accommodating deaths and life-threatening side
effects, the FDA today issued its additional admonishing about abusage of derma patches
containing the painkiller fentanyl. Fentanyl is a decree opioid drug. Fentanyl derma patches are awash under
the cast name Duragesic and in four all-encompassing products. Today's FDA admonishing is specific to fentanyl patches -- not added forms of
fentanyl -- and applies to Duragesic and all-encompassing fentanyl patches. The FDA's key message: Fentanyl derma patches accept to be assigned and used
exactly as directed, and alone by patients whose bodies accept become able to
tolerate opioids, abbreviation the
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Labels for Gels and Foams Absolute the Spermicide Nonoxynol-9 to Warn That They Don't Assure Adjoin HIV or Added STDsThe FDA today ordered a new admonishing for the spermicide nonoxynol-9 in over-the-counter gels, foams, films, or inserts. Those products' labels have to now cover these warnings: Nonoxynol-9 doesn't assure adjoin HIV or added sexually transmitted diseases (STDs) Nonoxynol-9 may abrade the vagina and rectum, which may access the accident of application HIV/AIDS from an adulterated partner. The FDA fabricated the aphorism to "correct misconceptions that the actinic N9 in these broadly accessible stand-alone contraceptive articles protects adjoin sexually transm
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FDA Warns That Some Patients Demography Desmopressin May Be at Accident of Seizure and DeathThe FDA today warned that some patients demography the drug
desmopressin, including accouchement who take desmopressin to stop
bed-wetting, may be at accident of seizures and death. The FDA addendum 61 postmarketing letters of seizures -- including two deaths
-- in patients demography desmopressin. Those seizures were affiliated to hyponatremia, an alterity of sodium levels in
the body, according to the FDA. It's not bright why the patients who had seizures were demography desmopressin,
which isn't just acclimated to amusement bed-wetting. But a part of the 25 patients adolescent than 17 who had seizures while taking
desm
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FDA, Pfizer Investigating Letters of Baleful Thoughts in Humans Demography Quit-Smoking Biologic ChantixThe FDA today arise that it's investigating letters of
suicidal thinking, advancing and aberrant behavior, and blackout in people
taking the quit-smoking biologic Chantix. Here are the FDA's recommendations: Health affliction workers should adviser patients demography Chantix for behavior and
mood changes. Patients demography Chantix should acquaintance their doctors if they experience
behavior or affection changes. Patients should use attention if active or operating accouterment until they
know how Chantix may affect them. Chantix,
which
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FDA Approves Revision to Admonishing Label for Procrit, Aranesp, and Epogen Anemia DrugsFor patients with abiding branch failure, the new boxed admonishing states that
ESAs should be acclimated to advance a claret akin amid 10 g/dL and 12
g/dL. Maintaining college claret levels in patients with abiding branch failure
increases the accident of afterlife and austere cardiovascular reactions such as stroke, affection attack, or affection failure, according to the
FDA. In accession to the boxed warning, the new labeling provides specific
instructions for dosage adjustments and claret ecology for chronic
kidney abortion patients who don't acknowledge to ESA analysis with an adequate
increase in their claret levels. The new labeling as
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FDA Approves Revision to Admonishing Characterization for Procrit, Aranesp, and Epogen Anemia DrugsThe FDA today accustomed revisions to a "black box"
warning and added safety-related characterization changes for the anemia drugs Procrit, Aranesp,
and Epogen. Those drugs are erythropoiesis-stimulating agents (ESAs). They boost
production of red claret cells. The revisions aggrandize labeling
changes fabricated in March 2007, which accent application the everyman accessible dose
of the drugs to abstain the charge for a claret transfusion. Highlights in the revised admonishing include: Risks for assertive blight patients Risks for patients with abiding branch failu
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Life-Threatening Skin Rash, Psychiatric Affection Now Noted on Drug's LabelProvigil, a decree stay-awake drug, is accepting new
warnings about the accident of life-threatening rash, added serious
hypersensitivity reactions, and psychiatric symptoms. Provigil is acclimated to advance indisposition in adults with altitude involving
excessive sleepiness, including narcolepsy. At atomic one being died of multi-organ abortion anon afterwards starting
Provigil, and there accept been "rare" cases of austere or
life-threatening adventurous in patients demography Provigil, states the drug's maker,
Cephalon Inc. The FDA and Cephalon admonish patients to anon stop Provigil and alarm a
doctor if they accept adventurous or added hypersensitiv
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