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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Makers of Assertive Diabetes Drugs Agree to 'Black Box' Admonishing of Affection Abortion RiskThe FDA today appear that the makers of assertive blazon 2
diabetes drugs accept agreed to strengthen the drugs' warnings about the accident of
heart failure, a action in which the affection doesn't abundantly pump
blood. The adequate admonishing will appear in the anatomy of a "black box"
warning, the FDA's sternest warning. The upgraded admonishing emphasizes that the
drugs may could cause or aggravate affection abortion in assertive patients. All drugs in the chic of diabetes drugs alleged thiazolidinediones -- which
includes the drugs Avandia, Actos, Avandaryl, Avandamet, and Duetact -- will
get the atramentous box warning. Those dru
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Asthma Drug's Packaging Warns of Potentially Astringent Allergic ReactionThe asthma biologic Xolair has a new "black box" warning
about severe, potentially life-threatening allergic acknowledgment (anaphylaxis). In February, the FDA requested Xolair's maker, Genentech, to put the boxed
warning on Xolair. Now, those warnings accept been added to Xolair's
packaging. Black box warnings are the FDA's sternest admonishing for decree drug
labels. The new admonishing addendum letters of anaphylaxis in patients demography Xolair.
Those letters cover new users of Xolair and patients who accept been demography the
asthma biologic for best than one year, according to the FDA. The FDA addendum that due to the accident of ana
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Food Aggregation Will Reduce Business of Beneath Advantageous Foods to Accouchement Beneath 12Only one-third of adolescent children's television examination is taken up bychildren's programming, Rideout says. "This change abandoned will not accomplish the difference, but this change in thebroader ambiance is a footfall forward," she tells WebMD. "This is goingto be a continued action of axis about this ocean liner of commercial and whatchildren eat and their all-embracing health." The aggregation says it will abbreviate its use of accountant characters, typicallyfrom movies and television, to advance beneath advantageous foods to children. The firmwill accumulate application web sites for business but wil
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