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Product Alert

No Approval for Rifaximin in IBS

The FDA has indicated that, before the antibiotic drug rifaximin (Xifaxan) can be approved for treating irritable bowel syndrome, its manufacturer must provide data on how the agent should be used in retreating patients with recurrent symptoms, the company said.

Japan Stops Some Vaccinations After Deaths

Japanese health officials have suspended the use of two pediatric vaccines as a precaution following the deaths of four young children, according to multiple media reports.

FDA Warns GERD Drugs May Deplete Magnesium

WASHINGTON -- Use of prescription or over-the-counter proton pump inhibitors (PPI) for a year or longer may lead to low levels of circulating magnesium, which may increase the risk of leg spasms, arrhythmias, and seizures, according to an FDA warning.

New ARB Cleared for Hypertension Treatment

The FDA has approved azilsartan medoxomil (Edarbi), an oral angiotensin II receptor blocker (ARB) for hypertension, expanding the ranks of ARBs now available to U.S. patients.

FDA Raises Risk on Nonsterile Lubricant Recall

WASHINGTON -- The FDA listed a recall of a "sterile" lubricating jelly as Class II due to the product's potential lack of sterility.

Use Dabigatran Within 30 Days of Opening

Unbeknownst to many physicians, bottles of the new oral anticoagulant dabigatran (Pradaxa) must be used within 30 days of opening, according to information from the manufacturer.

FDA Panel: Keep ECT Devices as High Risk

GAITHERSBURG, Md. -- The FDA should continue to regulate electroconvulsive therapy (ECT) machines as high-risk devices for treating depression and most other conditions for which ECT is typically used, members of the agency's Neurological Devices Advisory Committee agreed.

EMA Calls Halt to Reduced Dosing of Fabry Drug

Europe's equivalent of the FDA has advised that patients with Fabry disease receive the full label-recommended dosage of Genzyme's agalsidase-beta (Fabrazyme) despite the ongoing shortage of the drug, which is one of two enzyme replacement products available to treat the genetic disease.

FDA Orders Most Colchicine Products Off the Market

WASHINGTON -- The FDA has warned manufacturers, marketers, and distributors of single-ingredient oral colchicine products to stop distribution of the unapproved drugs.

Folate-Fortified Birth Control Pill Approved

The FDA has approved an oral contraceptive containing folate to help prevent birth defects after women go off the pill.

Eye Vitamin Recalled Over Reports of Choking

The manufacturers of a softgel supplement marketed as an eye vitamin issued a voluntary recall of the product due to a potential choking hazard.

FDA Recalls Eye Surgery Machine

WASHINGTON -- The FDA issued a class I recall -- its most serious -- on the line of Constellation Vision ophthalmic microsurgical systems due to software and hardware power errors which may cause eye injury or blindness.

Take Rosiglitazone Off the Market, Says FDA Staff

WASHINGTON -- Rosiglitazone (Avandia) should be pulled from the market because of the "serious" cardiovascular risk the diabetes drug poses, which exceeds that of competitor pioglitazone (Actos), FDA staff reviewers again recommended.

New Study Looks at Long-Term Effects of Cell Phones

A consortium of five European countries has launched a new cohort study to monitor the health effects of human exposure to radio frequencies emitted by mobile phones.

MS Walking Drug Gets FDA Nod

WASHINGTON -- The FDA approved the first drug for improved walking in patients with multiple sclerosis, the tablet dalfampridine (Ampyra).

Ziprasidone Okayed for Bipolar Disorder

The FDA has approved another antipsychotic agent -- ziprasidone (Geodon) -- for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.

AMA Reverses Stance on Medical Marijuana

The American Medical Association has changed its policy on medical marijuana, urging the federal government to review the drug's status as a top-tier controlled dangerous substance.

FDA Finds Oral Insulin Spray Safe for IND Use

The FDA approved Oral-lyn, an insulin spray treatment for type I and type II diabetes, for its Investigational New Drug program.

FDA Panel Recommends Limited Use of Investigational Antipsychotic

SILVER SPRING, Md. -- An FDA advisory panel voted to recommend FDA approval for sertindole (Serdolect) to treat schizophrenia, but only for a subgroup of patients that the agency would have to define.

With Boxed Warning, Oral Eltrombopag Okayed by FDA for Chronic ITP

PHILADELPHIA -- The FDA has approved oral eltrombopag (Promacta) for refractory chronic immune thrombocytopenic purpura (ITP), the drug's maker announced.

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.

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.

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.

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.

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).

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.

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.

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.

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.

FDA Approves Smoking-Cessation Drug

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.