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FDA Okays Estrogen Cream for Dyspareunia

COLLEGEVILLE, Pa. -- The FDA has approved conjugated estrogen cream (Premarin) to treat dyspareunia under a less-frequent dosing regimen, drug maker Wyeth Pharmaceuticals announced.

Nov 14, 2008

ACC: Senate Probe Finds Evidence that Drug Firms Worked to Delay ENHANCE Results

CHICAGO -- E-mails made public today described outrage more than a year ago by the ENHANCE trial's principal investigator because he perceived that a drugmaker was withholding bad results about ezetimibe/simvastatin (Vytorin) for non-scientific reasons.

Mar 31, 2008

FDA Approves Natalizumab (Tysabri) for Crohn's Disease

ROCKVILLE, Md. -- The FDA today approved natalizumab (Tysabri), the star-crossed multiple sclerosis agent, for refractory moderate-to- severe Crohn's disease showing evidence of inflammation.

Jan 14, 2008

Boxed Heart Failure Warning Added to Two Diabetes Drugs

ROCKVILLE, Md. -- The makers of rosiglitazone (Avandia) and pioglitazone (Actos), have agreed to add a black box warning to the type 2 diabetes drugs' labels about an increased risk of heart failure, the FDA said today.

Aug 14, 2007

FDA Approves Ambrisentan (Letairis) for Pulmonary Arterial Hypertension

ROCKVILLE, Md. -- The FDA has approved ambrisentan (Letairis), an endothelin receptor antagonist, for treatment of pulmonary arterial hypertension (PAH).

Jun 18, 2007

FDA Orders Black Box Warning for Gadolinium-Based Contrast Agents

ROCKVILLE, Md. -- The FDA today ordered black-box warnings for all gadolinium-based contrast agents for magnetic resonance imaging, detailing an increased risk for nephrogenic systemic fibrosis with kidney-disease patients.

May 23, 2007

Titration May Reduce Nausea from Anti-Smoking Drug

FARMINGTON, Conn. -- Many patients taking Chantix (varenicline tartrate) to help kick the smoking habit could be spared the side effect of nausea if introduced to the drug gradually, researchers here said.

Aug 15, 2006

FDA Warns on Mixing Antidepressants with Migraine Drugs

ROCKVILLE, Md. -- Mixing common migraine drugs such as Imitrex (sumatriptan) with antidepressants like Prozac (fluoxetine) or Cymbalta (duloxetine) can trigger a life-threatening condition called serotonin-syndrome, the FDA has warned.

Jul 20, 2006

Tysabri (Natalizumab) Allowed Back to Market with Restrictions

ROCKVILLE, Md. — The FDA has cleared the way for Tysabri (natalizumab), the multiple sclerosis drug, to go back on the market but under a special restricted distribution program.

Jun 06, 2006

FDA Approves Smoking-Cessation Drug

ROCKVILLE, Md. 芒鈧�鈥� The FDA today approved the smoking cessation drug Chantix (varenicline tartrate), which targets nicotine receptors in the brain.

May 11, 2006

ACP: Garlic, Ginseng, Ginkgo Biloba, and Ginger All Bad Actors with Coumadin

PHILADELPHIA - When it comes to adverse events associated with Coumadin (warfarin) therapy, beware of herbs and many supplements beginning with the letter G, according to a University of Washington investigator.

Apr 09, 2006

FDA Approves Erbitux for Squamous Cell Head-and-Neck Cancer

ROCKVILLE, Md. - The FDA has approved Erbitux (cetuximab) for treatment of squamous cell head-and-neck cancer, making the monoclonal antibody the first new agent for this indication in a half-century.

Mar 02, 2006

FDA Approves First Antidepressant Transdermal Patch

ROCKVILLE, Md. - The FDA has approved a once-a-day antidepressant patch that delivers a monoamine oxidase inhibitor. Called Emsam (selegiline), the patch can be used at its lowest dose without the dietary restrictions that accompany oral MAO inhibitors.

Mar 01, 2006

FDA Warns About Risks of Throat-Numbing Spray

ROCKVILLE, Md. - The Veterans Health Administration has halted the use of benzocaine sprays to numb mucous membranes in the mouth and throat, prompting the FDA to reissue warnings about the risk of methemoglobinemia.

Feb 13, 2006

FDA Warns of Two Eczema Agents' Possible Cancer Risks

ROCKVILLE, Md. - The FDA reported that two popular topical eczema drugs -- Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus) -- have had black-box warnings about skin cancers and lymphoma added to their labels.

Jan 20, 2006

FDA Says It Plans Label Changes for Concerta and Ritalin

WASHINGTON-The FDA said it plans to strengthen the warning label for Concerta, the popular long-acting version of Ritalin (methylpenidate) in response to post-marketing surveillance reports of psychiatric and cardiovascular adverse effects.

Jun 29, 2005

FDA Okays Single Dose Antibiotic for Pneumonia and Sinusitis

NEW YORK-The FDA has approved Zmax (azithromycin extended release) as a single-dose treatment for adults with pneumonia and certain types of acute mild-to-moderate bacterial sinusitis and pneumonia, Pfizer announced yesterday.

Jun 14, 2005

Crestor Called Less Safe Than Other Statins

BOSTON-Adverse event reports from the FDA suggest that Crestor is more likely to cause muscle and kidney damage than other major statins (Lipitor, Pravachol or Zocor), researchers here reported in the journal Circulation.

May 23, 2005

What a Pain! Now It's Tylenol Troubles

NOTTINGHAM, England-Acetaminophen, the popular painkiller found in Tylenol and generic analgesics, has been associated with a dose-related risk of lung disease, an effect not seen with ibuprofen (Motrin, Nuprin) and aspirin.

May 02, 2005

FDA Approves 'Gila Monster' Diabetes Drug

ROCKVILLE, Md.-The FDA announced today it has approved a new injectable diabetes drug synthesized from gila monster saliva, but says the drug should only be used in combination with older oral medications.

Apr 29, 2005

FDA Warns of Excess Mortality to Elderly With Antipsychotics

WASHINGTON-The FDA has issued a public health advisory on the entire class of atypical antipsychotic drugs, pointing to an apparent excess of mortality for older patients with dementia, particularly when the agents are used off-label to treat behavioral disorders.

Apr 12, 2005