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 A severe form of epilepsy called Lennox-Gastaut syndrome will be treated with a new drug called Banzel, which has been approved by the Food and Drug Administration on Friday as an extra supplement against the terrible disease. The FDA approved the drug after several tests were made.Patients aged between 4 and 30 years old were the...
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 A German study made on patients who had strokes showed that many of them had been treated with an anemia drug released by Johnson & Johnson, as federal health official reported on Friday. The FDA now seeks answers for the higher death rates among those patients. The Food and Drug Administration said that 16% of the patients who were...
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 Pfizer Inc. will appear on Monday presenting its Fablyn osteoporosis drug on the market. Still, medical experts and the Food and Drug Administration will have to approve the drug by submitting it to various tests. This will be the third attempt of the drug to go out on the market and its approval stands to be very important for the...
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 The Food and Drug Administration has made a plan to release a list of drugs which are under a safety investigation. Every three months the FDA will post the list on which there will be drug companies, physicians and patients that brought drug and medication complaints to the agency. The FDA won’t describe how serious the complaint lists...
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 Methadone was used in treatments and replaced the heroin. In spite of the fact it is a very powerful drug, methadone is nowadays given by family doctors who seem to be unaware of the serious risks it may include. They prescribe the drug for throbbing backs, joint injuries and other severe pains.Methadone is a form of opium but is cheaper...
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 The US Food and Drug Administration
announced Tuesday it approved a new test for aggressive breast cancer called
the SPOT-Light test by Invitrogen Corp. of Carlsbad, Calif.
The test measures the number of copies of
the HER2 gene in tumour issue. A packet of 20 test kits will cost $1,400. Patients
who suffer from this form of...
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Some antibiotic medicines like Bayer AG's Cipro need
stronger "black box" warnings regarding the peril of tendonitis and
fractured tendons, U.S.
health regulators said yesterday.
Label for the antibiotics comprise warnings about the
tendon problems. Regardless of those alerts, "the FDA continues to...
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 A vaccine conceived in order to prevent cervical cancer is
due to be thoroughly analyzed as a result of thousands of reports which
associated it to a variety of health disorders.
According to the Centers for Disease Control and Prevention,
Merck & Co. Inc.’s Gardasil has been the topic of over 7,800 “adverse
event” complaints...
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 The U.S. Food and Drug Administration intends to add firm
warnings about suicidal behavior on the labels of 11 epilepsy medications, as
indicated by files posted on the organization’s Web site.
The FDA will require companies to bring the drugs’ labels up
to date, in order to include black-box warnings, the most severe warnings...
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 Pilots or air traffic controllers will no longer be allowed
to use the anti-smoking drug Chantix. This appeal of the Federal Aviation
Administration is argued by the side-effects of the drug, which have been
discovered and announced in the last months. These negative influences on the
human body may be a threat to the safe operation...
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 The Food and Drug Administration warned Friday about two drugs approved for use by organ transplant patients to prevent organ transplant injection. CellCept by Roche and Myfortic by Novartis can cause miscarriages and birth defects when used by pregnant women.It is also common practise to use these drugs “off-label” to treat other immune...
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A study showed that Trasylol, a heart-surgery drug produced
by Bayer AG, raises the risk of death compared to two other competing
medications. As a consequence, the company withdrew its remaining supplies of
the drug from the U.S. market, as Reuters informs.
The statement followed publication earlier on Wednesday of a
Canadian...
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 The Food and Drug Administration has announced yesterday that it received 62 reports of deaths during the last 15 months of patients who were treated with the blood-thinner heparin and suffered allergic reactions or low blood pressure. This is more than triple the initial estimate of 19 deaths.The figure includes deaths of patients...
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 The U.S. Food and Drug Administration announced yesterday that it approved the use of Rotarix, a rotavirus vaccine developed by GlaxoSmithKline Biologicals, in infants from 6 to 24 weeks of age. The regulator said that while there are many strains of rotavirus, the vaccine protects againts four of them, codenamed G1, G3, G4, and...
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 Although no actual proof that would imply such an action has
been found yet, supplies of Heparin, a blood-thinning drug, are being recalled
in France, Italy and Denmark due to suspicions of
contamination. The European Medicines Agency believes that the contaminant of
the drug, in all three countries, may be the same as the one found...
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 Merck has announced that the Food and Drug Administration has fast-tracked the cervical cancer vaccine Gardasil for review, pending approval for women ages 27 to 45. The priority review status granted to Gardasil will ensure that a FDA decision on older women will come within six months, about four months sooner than the average review...
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 Federal drug regulators announced that the blood-thinning drug Heparin that had been linked to several deaths and hundreds of allergic reactions was contaminated with a fake ingredient got there by mistake or by fraud. The New York Times now reports that the substance used to cut heparin appears to be made from animal cartilage and is...
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 U.S. researchers have found that letrozole, an oral non-steroidal aromatase inhibitor that blocks the production of estrogen, is effective in preventing the relapse of breast cancer even if it's taken years later than previously thought.The initial FDA approval for letrozole, known by its brand name Femara, targeted the use of the...
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 Amgen's experimental platelet-stimulating drug may have safety issues, although it seems effective. An analysis by the US Food and Drug Administration has concluded that an advisory panel will have to evaluate five safety risks which appear connected with the drug. The panel will meet tomorrow.Romiplostin, known for its trade name...
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 Concerns about the safety of heparin extended to Germany on
Thursday, after many patients reported problems caused by the blood thinner to
drug authorities.
A large number of dialysis patients in Germany experienced
racing heartbeats and rapidly dropping blood pressure, after taking the drug.
The number of adverse events was...
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 Studies show that drugs used for fatigue and anemia could actually
do more harm to patients than help them, especially if they are not given in
the correct doses, Reuters informs.
Researchers say that the drugs, erythropoiesis-stimulating
agents or ESAs, raise the risk of death by 10 percent in patients who took them
compared...
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 Despite the recommendation of an advisory panel, the U. S. Food and Drug Administration issued a preliminary approval for Genentech’s Avastin, for the treatment of breast cancer, the company announced on Friday. The decision, even though is not final and will require additional steps from Genentech, has already pushed the company's...
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 The second-largest group of doctors in the United States
has approved Friday the use of marijuana for medical purposes, issuing a policy
statement on medical marijuana this week.
The American College of Physicians, with 124,000 members,
asked the U.S. government to cancel the ban on using marijuana for treating
some patients or...
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 The anti-wrinkle drugs based on botulinum toxin, produced by
Botox Cosmetic and Myobloc may lead to severe cases of botulism and even cause
death, the government warned the population on Friday.
Generally known as Botox, the drug is mostly used in the
cosmetic industry, for reducing wrinkles. Botox injections block the...
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Shanghai Hualian – a division of Shanghai Pharmaceutical Group and the sole U. S. supplier of the abortion drug mifepristone is accused of having manufactured contaminated leukemia drugs that have paralyzed or otherwise harmed nearly 200 Chinese cancer patients, the New York Times notes. The case was presented last week in The Times in...
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 The Food and Drug Administration announced Friday that it is
likely that the well-known anti-smoking drug Chantix may be linked to some
serious psychiatric problems. The FDA alert comes two weeks after the drug-making
company Pfizer added stronger warnings on the drug’s label regarding behavioral
changes, mood swings and suicide...
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 According to government regulators, recent studies highlight
the potential fatal danger of anemia drugs sold by Johnson & Johnson and
Amgen when used in certain cancer patients.
The Food and Drug Administration said it is considering
taking "additional action" to increase the safe use of Amgen's Epogen
and Aranesp...
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 In an attempt to stop Merck & Co Inc's latest bid to
sell a cholesterol-lowering drug without a prescription, a U.S. advisory panel
urged the government on Thursday to reject the proposition.
The committee voted 10-2, with one abstention, against
recommending over-the-counter sales of Merck's cholesterol fighter Mevacor.
Most...
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 U.S. health officials said on Wednesday that a genetic test
can tell if patients of Asian ancestry are more likely to develop a
life-threatening skin reaction to certain drugs that treat epilepsy and other conditions.
Manufacturers of the drugs, which contain the active
ingredient carbamazepine, have agreed to add to the...
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 Government advisers recommended Wednesday that
GlaxoSmithKline add more language about risks in children to its asthma drugs
Serevent and Advair.
The Food and Drug Administration said it would continue
studying the safety of the treatments for children and plans to hold another
panel meeting to address that question.
Both drugs...
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 The FDA has appointed a Food and Drug Administration panel
on Tuesday which will review reports of abnormal behavior and other brain
effects in more than 1,800 children who had taken the flu medicine Tamiflu
since its approval in 1999, including 55 in the USA.
Twenty-two of the U.S. reports were considered
"serious,"...
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 Reports announce that the FDA has approved the antipsychotic aripiprazole (Abilify) as an add-on for patients whose major depressive disorder is not relieved by antidepressants alone.
Originally approved in 2002 for schizophrenia, as well as mixed and manic episodes in adults suffering from bipolar I disorder, aripiprazole is the first...
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 According to the U.S. Food and Drug Administration, Chantix,
Pfizer’s prescription drug for smoking cessation, may cause suicidal thoughts,
according to a statement issued yesterday by the federal agency.
Shares of New York City-based Pfizer Inc., which has about
2,000 employees in New Jersey, were down $0.30, or 1.3 percent, to...
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According to an announcement given by Bayer HealthCare
Pharmaceuticals and Onyx Pharmaceuticals, Inc.,
the U.S. Food and Drug Administration (FDA) has approved a supplemental
New Drug Application for Nexavar(R) (sorafenib) tablets for the treatment of
patients with unrespectable hepatocellular carcinoma (HCC), or liver...
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 According to health officials, Takeda Pharmaceutical Co. planned
to launch print ads today, touting the safety of its diabetes drug Actos, just
days after the Food and Drug Administration slapped new safety warnings on
rival drug Avandia from GlaxoSmithKline PLC.
Full-page ads set to run in about 60 newspapers and in several
news...
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 According to a FDA (Food and Drug Administration ) report released on Thursday, Trasylol, a clotting drug used to prevent excessive bleeding during heart bypass surgery, increases the risk of death when compared with other drugs.
The Canadian trial for the drug manufactured by Bayer AG had to be stopped early due to an increase in...
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 According to an FDA (Food and Drug Administration) press
release on Wednesday, warning is being added to Cephalon Inc's drug Provigil
for excessive sleepiness because of the risk of serious skin rash and
psychiatric symptoms
Provigil is used to treat adults with narcolepsy and
obstructive sleep apnea who have difficulty...
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 According to a statement, Sanofi Pasteur, the vaccines
division of sanofi-aventis Group, announced today that U.S. Food and Drug
Administration (FDA) has granted licensure to expand the indication for its
meningococcal conjugate vaccine, Menactra (Meningococcal [Groups A, C, Y and
W-135] Polysaccharide Diphtheria Toxoid Conjugate...
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 According to the Canadian health ministry, sale of
Novartis's anti-inflammatory drug Prexige was halted on Thursday due to high
risk of internal laceration to the liver, mainly hepatitis.
Health Canada
also stated that the drugs market authorization will be canceled.
Prexige, a non-steroidal anti-inflammatory drug, has...
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 According to the Wall Street Journal, research conducted by
the American Medical Association showed
that patients who had been administrated Avandia had a higher risk of heart
attack.
The results, compiled from four separate clinical trials of
Avandia lasting at least one year each, confirm earlier studies...
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 An advisory panel for the U.S. Food and Drug Administration has announced that it's backing a new HIV drug from Merck Co. for rapid government approval. The drug's brand name is Isentress (active substance: raltegravir) and belongs to the antiretroviral integrase inhibitor class. Integrase is an enzyme that HIV uses to integrate its...
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 Until now, only lithium was approved for the treatment of bipolar disorder in adolescents ages 12 and up and no drug could be used for pediatric schizophrenia. The U.S. Food and Drug Administration approved Risperdal (active substance: risperidone), an atypical antipsychotic medication made by Janssen, L.P. of Titusville, N.J., for...
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 The U.S. Food and Drug Administration (FDA) announced that AstraZeneca's two top stomach drugs, Prilosec (omeprazole) and Nexium (esomeprazole) do not appear to heighten the risk of cardiac disease over the long term. The two drugs were suspected to generate an increased risk of heart attack and other heart diseases after AstraZeneca...
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 A U.S. appeals court ruled on Tuesday that terminally ill patients do not have a constitutional right to receive experimental drugs not approved by regulators, reversing a May 2006 ruling by a divided three-judge appeals panel, which actually overturned a 2004 district court decision to discard the case.The judges making up the full U.S....
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 The FDA approved yesterday the first continuous use birth control drug for women which, unlike other similar products, completely excludes the menstrual period.
The new contraceptive approved Tuesday by the Food and Drug Administration is called Lybrel and is manufactured by Wyeth of Philadelphia, PA. The product comes in a 28-day-pill...
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 The FDA has ruled that FluMist, a nasal spray flu vaccine from MedImmune, is safe for children under 5.
FluMist is currently indicated for healthy children and adolescents 5 to 17 years of age and healthy adults 18 to 49 years of age.
Previous research showed that FluMist was associated with negative side effects in children under...
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 The federal government announced on Thursday that all the Chinese products that contain milk, like pet food, snacks or bakery products, will be detained at the border until further tests are made to see whether they are contaminated. The Food and Drug Administration stated that these products may be contaminated with melamine, a toxic...
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 FDA’s website posted a warning letter on its site, telling the Laboratory Corporation of America that they illegally sale a blood test to detect ovarian cancer. The LabCorp introduced the test in June and this has increased the hopes of women and doctors. The ovarian cancer test can easily detect the cancer from its earlier stages....
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 Peditricians called on ban on the cold medicinesand the over-the-counter coughs for young children, explaining that these could harm them. Still, a top government health official rejected the ban on Thursday even if the Food and Drug Administration also stated that they were a little concerned about those medicines since they have a lack...
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 Starting April 1, this year, Salmonella Saintpaul has sickened 1, 440 people and about 242 were hospitalized. The Food and Drug administration has tried to discover the produce infected since then.At first, tomatoes were accused to contain the virus. Certain raw tomatoes were got off the market on June 7. The FDA groceries and...
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The Food and Drug Administration announced on Friday that they will hold a public meeting about the chemical found in baby bottles and other products. The meeting will be held next month and the environmental groups say that the chemical, known as bisphenol A, could hurt little children and animals.Still, the U.S. Food and Drug...
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 Although federal health officials have not cut tomatoes off
the salmonella outbreak cause list, an eruption that has affected more than
1,270 people nationwide, tomato growers are demanding taxpayers to pay them
compensations them for their losses.
Rep. Tim Mahoney, a Democrat from Florida,
a major tomato producer in the...
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 Southern California stores began
to take serious measures on Tuesday and started pulling jalapeno peppers from
their shelves, as reported by the Los Angeles Times.
The vendors’ actions came one day after maintaining the
peppers on market in spite of the fact that the Food and Drug Administration declared
on Monday that the...
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 The Food and Drug Administration withdrew on Thursday its
warning against consuming certain types of fresh tomatoes, in spite of the fact
that officials said they still had to identify the source of a Salmonella
Saintpaul outbreak which affected the health of more than 1,200 people.
However, the U.S.
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 Intel Corp., the world’s biggest computer chip maker, won clearance from the US Food and Drug Administration (FDA) for “Health Guide,” a an 8lb gadget that functions as a personal health care system. It includes a small touch-screen PC running Windows XP and a web portal that helps connect patients and doctors. Doctors can monitor the...
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 Members of the Food and Drug Administration’s panel of
outside experts voted on Thursday against attaching black-box warnings, the
organization’s strongest cautions, on the labels of epilepsy drugs, saying that
studies did not prove a sufficiently high risk of suicidal behavior as to apply
such tough warnings.
The Food and Drug...
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 Officials who spent almost a month hunting the source of salmonella outbreak are now testing shipments of imported jalapeños at the Mexican boundary. Initially, they believed tomatoes are the culprit but then jalapeño peppers drew the attention, almost becoming their leading suspect for spreading the bacteria that triggered to ailments...
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 The US Food and Drug Administration warned physicians
that certain types of antipsychotic drugs can boost the risk of death in
elderly people who have dementia. FDA also announced that they will now require
stronger warnings on antipsychotic drugs. Manufacturers of older antipsychotic
drugs, such as Haldol and Thorazine, are required...
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The Food and Drug Administration recently asserted that
mercury in fillings might be harmful to pregnant women, fetuses, children, people
who are sensitive to mercury exposure and to those who have a weakened immune
system.
"Dental amalgams contain mercury, which may have neurotoxic
effects on the nervous systems of...
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The Food and Drug Administration
released today an update on the ongoing Safety Review of Regranex or
becaplermin.
Regranex is a medicine that is a genetically engineered form
of a human growth factor that helps wounds heal faster. It is very beneficial
to diabetic patients with slow-healing wounds on their legs or feet that...
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 The mercury in dental fillings may have
toxic effects on pregnant women, young children and fetuses, the Food and Drug
Administration said on Wednesday after settling a related lawsuit. The FDA’s
response came as part of a settlement with several consumer advocacy groups,
including Moms Against Mercury, that filled a lawsuit claiming...
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 The Food and Drug Administration will analyze the experimental
arthritis drug Actemra produced by Roche Holding AG and will consider whether
it should be approved or not.
Actemra is the first of a new class of drug created to
suppress the action of interleukin-6, a protein that acts as an activator for
the body's inflammatory...
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 Investigators continued the work to confirm
the source of the salmonella-contaminated tomatoes that have sickened 24 people
in Texas,
according to state officials. 40 cases of Salmonella infection have been
confirmed in New Mexico,
according to the New Mexico Department of Health.
The FDA yesterday warned consumers in Texas and...
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 Six people have died between May 22 and May 28 after being
injected with human immunoglobulin, proteins with features of antibodies. The
cases were registered in east China's
Jiangxi Province,
according to statements local authorities made on Sunday.
The immunoglobulin was produced by Jiangxi Yabo
Bio-pharmaceutical Co at a...
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 The Food and Drug Administration made a
proposal Wednesday to replace a 30-year-old system for classifying drugs. The new labels would
provide more detailed information about a medication's risks and benefits. The
measure was taken after more than ten years of analysis and aims to give
doctors a more precise view over the risks of...
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 Actor Dennis Quaid urged Congress on Wednesday not to
deprive people of the right to sue pharmaceutical companies in case of
discontent with their products.
The actor told the Congress about the accidental drug
overdose that almost killed his newborn twins last year.
Quaid and his wife have filed a lawsuit against...
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 The Ortho-Evra birth control patch is far riskier than the
pill, a consumer advocacy group said. The group petitioned the government to
remove the birth control patch from the market, as it represents a threat for
women who use it.
An investigation lead by the Associated Press in 2005 found
women who use birth control patch face...
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 Being concerned about the fact that several
healthcare centres haven’t yet recalled from the market their products
containing heparin, the Food and Drug Administration is still pulling alarm
signals and taking measures in order to solve this issue.
Baxter International Inc., the largest
producer of heparin, is among those who...
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 There were some concerns that prescription drug
advertisements can sometimes mislead and that are not always truthful. Sometimes
the drug’s effectiveness is put into question and consumers and patients should
know about these studies. The balance between the risks and the benefits of a
drug shouldn’t be a secret for...
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After a few tragic cases in which people died after being
treated with heparin, the Food and Drug Administration requires the American
Congress to extend the sum it assigns to the activities necessary for
inspecting foreign drug shipments in the U.S., the Los Angeles Times reports.
Heparin is frequently used during kidney...
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 There have always been situations when transfusion of blood
was compulsory for saving a patient’s life and blood was, for one reason or another, hard to obtain. A salutary
discovery in the form of blood substitutes diminished
this critical situation, especially at moments of emergency or during wars.
Nevertheless, blood substitutes...
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 According to the Associated Press, in ten years since it has been approved by the Food and Drug Administration, millions of Americans have had the Lasik eye surgery done and 140 of them have complained about its side effects. The most frequent unpleasant outcomes are blurred vision, dry eyes and halos around lights when seen at night....
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 The U.S. Food and Drug Administration made public a warning
to grocers to remove from their shelves all cantaloupes from Agropecuaria
Montelibano, because they had been contaminated with the salmonella bacterium.
The melon-processing company mentioned above is located on the Pacific coast in
southern Honduras.
“The United...
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 Federal drug regulators announced on Wednesday that the
blood-thinning drug that had been linked to several deaths and hundreds of
allergic reactions was contaminated with a fake ingredient got there by mistake
or by fraud.
"We still don't know whether this inadvertently got
into the supply or whether it was actually...
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 The Food and Drug Administration decided that drug producers
should give more details about the side effects of the drugs they make.
For years, the agency has insisted that the public-health
advisories should inform them if any medical problem was linked to the use of
some drug, but they were often announced to late, after the...
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 Baxter International Inc. declared yesterday that it was
recalling all of its remaining heparin products, after the officials at the
Food and Drug Administration said there was sufficient capacity from other
suppliers.
“We have assurance from the U.S. Food and Drug
Administration that there is an adequate supply in the market...
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 Commenting on an investigation into the recalled drug
heparin, China’s
State Food and Drug Administration declared Wednesday that it strictly
controlled chemicals used in pharmaceuticals, but the importing countries
should be the ones responsible for ensuring the imported products are safe.
The Chinese FDA said that it usually...
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 Despite the recommendation of the advisory panel, the U. S.
Food and Drug Administration issued a preliminary approval for Genentech’s
Avastin, for the treatment of breast cancer, the company announced on Friday.
Last week, Genentech said that a study of Avastin in
combination with chemotherapy prolonged progression-free survival...
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