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Product Alert

Medtronic Infusion Pump Recalled

Battery problems with two of Medtronic's SynchroMed II implantable infusion pumps have forced the company to recall them, according to the FDA, although the recall only affects products not yet implanted.

FDA Warns Against High-Dose Citalopram

Citing increased risk of cardiac arrhythmias and a lack of therapeutic benefit associated with high doses of the SSRI citalopram hydrobromide (Celexa), the FDA has reduced the recommended maximum to 40 mg/day.

Consumer Group Urges Boxed Warning for PPIs

Citing research showing that withdrawal of proton pump inhibitors (PPIs) leads to severe rebound acid secretion -- potentially leaving patients permanently dependent on the drugs -- the consumer group Public Citizen has told the FDA that it should require black-box warnings with the drugs.

Pill Mix-Ups Force Acetaminophen Product Recalls

Two drug manufacturers have recalled a number of products that contain acetaminophen because of mislabeling that could result in overdoses.

New Warning on Valproate Drugs in Pregnancy

Labels for valproate sodium and related drugs for epilepsy will carry new language warning that children exposed to these agents during gestation may suffer cognitive deficits, the FDA said.

OTC Wart Remover Yanked Because of Burn Risk

An OTC wart remover product has been recalled by its manufacturer after the company learned that its active ingredient -- calcium oxide -- can cause severe chemical burns, the FDA announced.

Cordis to Stop Making Cypher, Nevo Stents

Cypher, the first drug-eluting coronary stent to receive FDA approval, will be discontinued at the end of the year, according to manufacturer Cordis.

Cancer Risk Forces Actos Off French, German Markets

Drug regulators in Germany and France have ordered doctors to stop prescribing the type 2 diabetes drug pioglitazone (Actos), following a French study suggesting a heightened risk of bladder cancer.

FDA Warns Against Use of High-Dose Simvastatin

The highest approved dose of simvastatin -- 80 mg -- should be used only in those patients who have already been taking it for at least 12 months without signs of myopathy, the FDA announced Wednesday.

Topamax Added to List of Musty-Odor Recalls

Johnson & Johnson has recalled yet another product -- topiramate (Topamax) -- because of a strange odor thought to be caused by the chemical 2,4,6 tribromoanisole (TBA).

FDA Warns of Vitamin Product With Toxic A and D Levels

WASHINGTON -- The FDA has issued a warning against use of the vitamin solution Soladek because of dangerously high levels of vitamins A and D.

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.

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