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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Sudden Audition Accident Admonishing for Cialis, Levitra, Viagra, and the Pulmonary Avenue Hypertension Biologic RevatioThe FDA is alerting men demography the arrect dysfunction
drugs Cialis, Levitra, and Viagra of the abeyant accident of abrupt hearing
loss. The FDA has accustomed 29 letters of men who had abrupt audition accident while
taking Cialis, Levitra, or Viagra. "Hearing accident was already
noted in the Viagra labeling from the time of its approval, but not in labeling
for Cialis or Levitra,"Â FDAÂ spokewsoman Rita Chapelle tells
WebMDÂ via email. "Now, all three labels will
note this accessib
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Drug Aggregation Cites Banking Affidavit for Removing Exubera From MarketThe biologic aggregation Pfizer appear that it will stop
selling its inhaled insulin artefact Exubera for banking reasons. In January 2006, Exubera became the first
inhaled insulin to get FDA approval. Exubera delivers short-acting insulin
via an inhaler, accouterment an another to insulin injections. "Despite our best efforts, Exubera has bootless to accretion the accepting of
patients and physicians. We accept accordingly assured that added investment in
this artefact is unwarranted," Jeff Kindler, Pfizer's administrator and CEO, says
in a Pfizer account release. "We will plan with physicians to alteration Exubera patients to other
treatment options in th
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FDA Notes 30 Cases of Astute Pancreatitis in Patients Demography Byetta; Cause UnclearThe FDA today appear that is has gotten 30 letters of a
potentially baleful pancreas botheration in patients demography the blazon 2 diabetes drug
Byetta. Those patients developed acute
pancreatitis, which is deepening of the pancreas. Twenty-one of the
patients were hospitalized. None died. The FDA has this admonition for patients demography Byetta: Seek medical care
promptly if you acquaintance alien astringent belly affliction with or without
nausea and vomiting. Doctors should abandon Byetta in patients doubtable to accept acute
pancreatitis and not restart the patients on Byetta unless they acquisition another
cause for the patients' astute pan
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FDA to Able Down on Crooked Drugs Containing Hydrocodone, Including 200 Ahem SuppressantsThe FDA affairs to able down on crooked prescription
drug articles -- including some 200 ahem suppressants -- containing
hydrocodone. Hydrocodone is a analgesic broadly acclimated to amusement affliction and suppress
coughs. The FDA is decidedly anxious about crooked hydrocodone
cough suppressants (antitussives) marketed for kids, as able-bodied as the accident of
medication errors involving crooked products. Today, the FDA appear deadlines for companies to stop marketing
unapproved hydrocodone products. FDA-approved hydrocodone drugs including the
painkiller Vicodin aren't affected. Consumers accept some alternatives to crooked hydrocodone
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Patients Have to Yield Fentora Exactly as Instructed, FDA SaysThe FDA today alerted doctors and patients about improper
and potentially baleful abusage of Fentora tablets. Fentora is a strong
narcotic painkiller that should alone be acclimated for alleviative breakthrough
pain in blight patients who are opioid-tolerant, acceptation they yield narcotic
pain medicines about the clock. The FDA has accustomed letters of afterlife and life-threatening ancillary furnishings in
patients who accept taken Fentora. The
reported deaths were the aftereffect of abnormal alternative of patients, dosing, or
improper artefact substitution, according to the FDA.
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