FDA staff say CardioMEMS device works

2011-12-05T14:30:27Z

WASHINGTON (Reuters) - U.S. health regulators on Monday said a CardioMEMs implant for treating heart failure met its main safety and effectiveness targets but warned of potential bias in the company's research.

A Food and Drug Administration staff review of the

FDA: CardioMEMS device meets top study goals

2011-12-05T08:30:08Z

WASHINGTON (Reuters) - A Food and Drug Administration review of CardioMEMS' device for treating heart failure found it has met its main safety and effectiveness goals, based on trial results.

But the FDA questioned on Monday how cl...

FDA sees rare but serious issue with stents

2011-11-18T13:30:52Z

(Reuters) - Health regulators are investigating a rare but potentially serious problem with a newer class of heart stents that causes the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation.

The problem appears to occur most frequently in the Promus and Ion devices made by Reuters) - Health regulators are investigating a rare but potentially serious problem with a newer class of heart stents that causes the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation.

The problem appears to occur most frequently in the Promus and Ion devices made by Reuters Health) - A study out Monday adds to evidence that a newer type of birth control pill may carry a higher risk of blood clots than older versions.

The study, of 330,000 Israeli women, found that those who used birth control pills with the hormone drospirenone -- found in brand-names like Yaz and Yasmin -- were more likely than other Pill users to develop blood clots called v...

Some birth control shows higher clot risk: US

2011-11-07T09:31:24Z

Some birth control products, including contraceptive pills, rings and patches for women, carry a significantly higher risk of blood clot than low-dose medications, US regulators said Thursday.

The US Food and Drug Administration said in its review of studies that have included more than 800,000 women that the higher risks are...

ADHD drugs do not increase heart problems in kids: study

2011-11-01T07:30:28Z

CHICAGO (Reuters) - Stimulants used to treat attention deficit hyperactivity disorder do not increase the risk of heart attacks, strokes or sudden death, U.S. researchers said on Monday, in a finding that should reassure millions of parents whose children take the drugs.

Researchers studied the medical records of more than 1 million children and ...

AtriCure heart device safe, with caveats: FDA staff

2011-10-24T16:30:18Z

(Reuters) - AtriCure Inc's device for treating a heart rhythm disorder is safe and effective, but its trial size and design raise some concerns, U.S. Food and Drug Administration researchers said.

AtriCure Synergy Ablation System is approved for ab...

GSK anti-nausea drug may pose risk to heart rhythm: FDA

2011-09-15T14:00:20Z

(Reuters) - U.S. health regulators said they are reviewing the safety of GlaxoSmithKline's anti-nausea drug Zofran to ascertain whether there is a potential risk of abnormal hearth rhythm.

The drug may increase the risk of deve...

Misunderstanding of drug approval common: study

2011-09-12T14:30:38Z

NEW YORK (Reuters Health) - Many people believe that drugs given the okay by the Food and Drug Administration are safer and more effective than they have to be to win approval, according to a new study.

Especially in the first few years after a drug becomes available, researchers note, there ...

Bayer drug unproven as stroke preventer: US

2011-09-06T14:30:31Z

US regulators said Tuesday that Xarelto, a Bayer-made drug approved in July for preventing blood clots, is so far unproven for a new proposed use as a stroke preventer.

"There is a lack of substantial evidence that rivaroxaban will have its desired effect when used as recommended in labeling," said documents released by the US Food and Drug Administration.

An advisory committe...

FDA panel OKs Edwards heart valve despite risks

2011-07-21T09:30:37Z

GAITHERSBURG, Maryland (Reuters) - Edwards Lifesciences Corp's heart valve for patients deemed too sick to have open-heart surgery was approved by a Reuters) - Drug reviewers said Edwards Lifesciences' heart valve "demonstrated superiority" in a trial that also showed the device's safety and effectiveness for patients considered too sick to have open-heart surgery.

The trial, however, also showed people were at a high ...

Pfizer stop-smoking pill raises heart risk: FDA

2011-06-16T14:00:25Z

WASHINGTON (Reuters) - Pfizer's drug to help smokers quit, which has already been linked to psychiatric side effects, can lead to a small increase in heart problems in those who have cardiovascular disease, U.S. health regulators said on Thursday.

The US Food and Drug Administration will meet next month to review a new type of heart valve that is inserted by catheter instead of in open heart surgery, the device-maker said Tuesday.

The FDA committee of experts is "scheduled to review the company's Premarket Approval (PMA) application for its Edwards SAPIEN transcatheter heart valve on July 20, 2011," Edwa...

US reviews birth control pill safety over clot risk

2011-05-31T17:30:21Z

The US Food and Drug Administration said Tuesday it is reviewing recently published studies which have pointed to an increased blood clot risk associated with a certain type of birth control pill.

The studies involve pills that contain drospirenone, as opposed to another type of progestin known as levonorgestrel. Some brand names include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Reuters) - The U.S. drugs regulator said it was not recommending changes in the use of stimulants such as Adderall XR and Ritalin to treat hyperactivity, after a review of a study into potential heart d...

Terumo to stop selling two cardiac products in US

2011-03-22T10:30:09Z

CHICAGO (Reuters) - A U.S.-based unit of Terumo Corp said it has entered into a consent decree with the U.S. Food and Drug Ad...

Too few women in heart device trials: study

2011-03-01T19:30:22Z

US studies on risky heart devices are skewed toward men and do not include enough women to accurately judge how they may affect the sexes differently, researchers said Tuesday.

The under-representation of women is concerning because heart disease affects women in different ways than men, said lead author Rita Redberg of the University of California, San Francis...

Women left behind in heart device tests: study

2011-03-01T19:00:07Z

NEW YORK (Reuters Life!) - Many heart devices are approved for use in the United States despite a lack of data on safety and effectiveness for women -- even though the devices don't work the same in the two genders, according to a study.

"We know the risks are different in women and men," said study author Rita Redb...

Women left behind in heart device tests

2011-03-01T14:30:25Z

NEW YORK (Reuters Health) - Many heart devices get approved by the U.S. Food and Drug Administration (FDA) despite a lack of data on safety and efficacy in women, researchers said Tuesday.

That could have serious consequences, say the authors of the new study, because the devices, which inclu...

Heart therapy works better in women

2011-02-07T19:30:14Z

For the first time in the history of heart disease research, a certain type of treatment has proven more effective in women than in men, according to a US study published Monday.

The research found that women saw a 70 percent reduction in heart failure compared to men who saw a 35 percent drop when using cardiac resynchronization therapy with defibrillator (CRT-D), indicating it works twice as well in women.

"In prior cardiac studies, men and women generally received similar ...

U.S. panel backs Abbott carotid stent for more patients

2011-01-26T15:00:14Z

GAITHERSBURG, Maryland (Reuters) - U.S. health advisers backed Abbott Laboratories' RX Acculink carotid stent on Wednesday as another option for a wider group of patients whose clogged neck arteries put them at risk for a stroke.

Wh...

US warns of liver damage with heart drug

2011-01-14T15:30:16Z

A heart drug by French pharmaceutical giant Sanofi-Aventis has been linked to liver damage in some patients, two of whom had to receive transplants, the US Food and Drug Administration said Friday.

Dronedarone, marketed as Multaq, was approved in 2...

Recall news

2010-12-30T17:30:34Z

The following recalls have been announced:

_About 180,000 pounds of breaded chicken wings sold by Pilgrim's Pride, of Boaz, Ala. The 20-lb. boxes of "Pierce Chicken Uncooked Hot & Spicy Breaded Chicken Wings Drummettes and Wing Portions" and 10-lb. boxes of "Sweet Georgia Brand Uncooked Hot & Spicy Breaded Chicken Wings 1st and 2nd Sections" contain egg, an undecl...

Orexigen diet pill faces U.S. panel, eyes on safety

2010-12-06T21:30:22Z

WASHINGTON (Reuters) - The last of a trio of new weight loss drugs, Orexigen Therapeutics Inc's Contrave, is set to face a panel of U.S. advisers on Tuesday who are likely to have tough questions on the pill's heart risks and other safety concerns.

Shares of Orexigen have fallen 36 percent this year as invest...

Reasons Cited for Recall of Darvocet and Darvon

2010-11-29T14:53:44Z

...

Wondering about High Potassium Levels

2010-11-29T15:01:53Z

...

Darvon, Darvocet Removed From Market

2010-11-29T14:29:40Z

...

FDA Pulls Darvon and Companion Drug Due to Heart Risks

2010-11-29T14:42:23Z

...

Pain Reliever Propoxyphene Withdrawn from Market

2010-11-29T14:53:28Z

...

FDA Pulls Darvon Painkiller off the Market

2010-11-29T14:53:14Z

...

Boston Scientific Investor Day – Transcript

2010-11-29T14:49:52Z

...

Drugmaker pulls painkillers from US market over heart risks

2010-11-19T16:30:29Z

Drugmaker Xanodyne Pharmaceuticals Inc. agreed Friday to pull two of its painkillers, Darvon and Darvocet, from the US market over heart risk concerns, the US Food and ...

Propoxyphene Withdrawn From U.S. Market

2010-11-29T14:46:41Z

...

FDA Pulls Pain Med Due to Heart Risks

2010-11-29T14:35:10Z

...

Darvon, Darvocet Banned

2010-11-29T15:01:52Z

...

Heart Drug Raises Questions

2010-11-29T14:35:10Z

...

New Blood Thinner a Promising Alternative to Warfarin

2010-11-29T14:42:22Z

...

Anthera Suspends Enrollment and Dosing in PEARL-SC Clinical Trial to Address Reports of Vial Problems

2010-11-29T14:35:07Z

...

Edwards heart valve improves quality of life: study

2010-11-15T14:31:28Z

CHICAGO (Reuters) - Edwards LifeSciences Corp's less-invasive replacement heart valve alleviates symptoms such as fatigue and breathlessness better than standard medical therapy, data released on Monday show.

Researchers evaluated the symptoms in patients from the company's successful Partner trial, whose key results on mortality wer...

New Blood Thinner a Promising Alternative to Warfarin

2010-11-29T14:35:05Z

...

Terfenadine

2010-11-30T13:49:16Z

...

Sibutramine

2010-11-30T13:49:04Z

...

Newest technology in heart stents

2010-11-29T15:49:29Z

...

VIVUS CEO Discusses Q3 2010 Results - Earnings Call Transcript

2010-11-29T14:49:09Z

...

Avandia Litigation and FDA Developments

2010-11-29T14:47:03Z

...

Yaz, Yasmin, and Ocella (Drospirenone) Litigation

2010-11-29T14:47:04Z

...

You Pop OTC Diet Pills

2010-11-29T14:47:21Z

...

A look at the safety of Avandia, a popular diabetes drug

2010-11-29T15:15:24Z

...

Can blood tests detect imminent heart attacks

2010-11-29T15:15:35Z

...

FDA freezes long term study on diabetes drug, Avandia

2010-11-29T15:15:24Z

...

Dilated cardiomyopathy (DCM) in cats: Symptoms and treatments

2010-11-29T15:38:15Z

...

FDA restricts diabetes drug Avandia

2010-11-29T15:15:22Z

...

The dangers of diet pills

2010-11-29T15:14:13Z

...

Grepafloxacin

2010-11-30T13:10:06Z

...

Diet herb supplement Slim 30 recalled for undeclared drug ingredient

2010-11-29T15:20:53Z

...

Stroke treatment options: Standard and new

2010-11-29T15:18:55Z

...

Covidien gets FDA approval for compression sleeve

2010-11-04T10:31:03Z

Covidien gets FDA approval for Kendall compression sleeve to treat deep vein thrombosis

Covidien said Thursday the Food and Drug Administration has approved its Kendall Sequential Compression Comfort Sleeve and Kendall SCD 700 Series Controller for the treatment ...

Pradaxa Approved to Fight Dangerous Irregular Heartbeat, Stroke

2010-11-05T06:44:00Z

...

Ofirmev Sanctioned for Pain and Fever

2010-11-05T06:59:49Z

...

AtriCure CEO Discusses Q3 2010 Results – Earnings Call Transcript

2010-11-29T14:48:54Z

...

Avanir Pharmaceuticals Announces FDA Approval of Nuedexta

2010-11-03T18:46:59Z

...

Warning: Your Doctor Maybe a Pawn for...

2010-11-29T15:03:21Z

...

FDA to drug companies: Include risk warnings for GnRH agonists

2010-11-03T15:45:32Z

...

Avanir's AVP-923: Is QTc Prolongation Above 'Threshold of Concern'?

2010-11-03T16:19:57Z

...

Replacement therapy for Protein C deficiency

2010-11-29T15:04:15Z

...

U.S. cautions on mixed use of Roche, Abbott HIV drugs

2010-10-21T12:00:28Z

WASHINGTON (Reuters) - U.S. health officials are cautioning patients and doctors about possible deadly side effects when using two HIV drugs together: Roche Holding's Inv...

If You Choose Ortho Evra, Consider This

2010-11-03T09:32:32Z

...

Digitek Recall Watch

2010-11-03T09:34:45Z

...

The Diabetes Drug Avandia Stays on with Restriction

2010-11-03T09:40:01Z

...

FDA seeks more data on Amylin, Lilly diabetes drug

2010-10-19T22:34:00Z

LOS ANGELES (Reuters) - U.S. health regulators declined on Tuesday to approve a diabetes drug being developed by Amylin Pharmaceuticals Inc's and Eli Lilly an...

Boehringer wins first US OK in blood-thinner race

2010-10-19T22:09:58Z

LOS ANGELES (Reuters) - German drugmaker Boehringer Ingelheim won the first U.S. approval for a new stroke-fighting medicine that will compete in an estimated $10 billion market for drugs to re...

A Generic Version of Weight-Loss Drug Meridia Taken off Market

2010-11-02T13:52:39Z

...

Meridia Banned

2010-10-15T10:08:21Z

...

Digitek Digoxin Recall

2010-11-02T22:09:49Z

...

Crook Alert! SmithKline Beecham Hid Heart Risk Test Data

2010-11-02T17:39:14Z

...

Meridia Withdrawn From the Market - and Watch Bitter Orange, Too

2010-10-11T08:33:38Z

...

Abbott withdraws diet pill in US, Canada

2010-10-08T11:30:36Z

Abbott Laboratories said Friday it will withdraw its diet pill Meridia in the U.S. and Canada, almost a year after studies showed the drug increases the risk of heart attack and stroke in patients ...

Dolasetron Information

2010-10-09T08:18:17Z

...

Meridia Recall : Meridia Lawsuits

2010-10-07T20:58:46Z

What You Need to Know About the Diet Pill Meridia:

Meridia is a diet pill that acts as an appetite suppressant that contains Sibutramide. This diet pill is manufactured by Abbott laboratories and requires a prescription. Meridia is used in conjunction with a proper diet and exercise plan to reduce weight and is suppose to affect that part of the brain that signals a sense of fullness. This diet pill is meant for people who have a body mass index (BMI) of 30...

Octagam Voluntarily Withdrawn From U.S. Market

2010-11-02T13:57:12Z

...

Managing Your Practice E-news - 402010

2010-11-02T13:57:08Z

...

FDA, Europe Curb Risky Diabetes Drug

2010-11-02T14:04:21Z

...

Timeline of events for diabetes pill Avandia

2010-09-23T15:00:35Z

U.S. health regulators dealt a major blow to the controversial diabetes pill Avandia Thursday, requiring doctors and patients to sign consent forms before starting a prescription of the drug. At the same time, European regulators ordered it off the market. The split decision underscores lingering safety questions about a once-blockbuster drug taken by millions of patients over the last dec...

US restricts, EU bans controversial diabetes pill

2010-09-23T09:45:16Z

European health regulators have banned sales of the once-blockbuster diabetes drug Avandia because of evidence it raises the risk of heart attack, but doctors in the U.S. will be able to continue prescribing it with some significant restrictions.

In simultaneous news briefings, the Avandia because of evidence it raises the risk of heart attack, but doctors in the U.S. will be able to continue prescribing it with some significant restrictions.

In simultaneous news briefings, the European Medicines ...

Gilenya Approved for Relapsing MS

2010-09-23T07:43:47Z

...

New Blood-Thinner Recommended by FDA Panel

2010-09-21T13:55:24Z

...

Three Cardiac Resynchronization Defibrillators Approved for New Use

2010-11-02T13:57:51Z

...

Star Scientific-Smokeless Tobacco

2011-01-04T12:31:04Z

FILE - In this Sept. 28, 2010 file photo, smokeless tobacco products, including Ariva, are displayed in Richmond, Va. Tobacco maker Star Scientific Inc. says it has developed a moist smokeless tobacco with lower levels of cancer-causing chemicals than any other tobacco product now on the market. Star Scientific says the "modified-risk" label that the

FDA Obesity Treatments

2010-12-03T21:31:29Z

In this product photograph provided by Allergan, Inc., the LAP-BAND System is displayed. An FDA panel will vote whether to recommend expanding the use of a stomach shrinking band currently approved just for the morbidly obese. (AP Photo/Allergan, Inc.) NO SALES

Sen. Tom Harkin, D-Iowa, speaks to reporters in Des Moines, Iowa. The Food and Drug Administration would have to step up inspections of food processors under legislation the Senate is expected to pass this week. The bill, which...

Novartis Settlement

2010-09-30T12:45:34Z

U.S. Attorney Zane David Memeger, from left, speaks as Nicholas DiGiulio from the Department of Health and Human Services and Thomas Doyle from the Food and Drug Administra...

Abortion Pill 10 Years

2010-09-26T21:30:31Z

FILE - In this Jan. 11, 1995 file photo, inventor of the RU-486 abortion-inducing drug, Professor Emile-Etienne Beaulieu, holds the pills in Paris. Ten years ago, on Sept. 28, 2000, after long and bitter debate, the Food and Drug Administration approved use of the abortion pill by American wom...

News on Food And Drug Administration

US regulators warn of heart risks of Sanofi's Multaq

FDA revises Sanofi Multaq label on heart risks

FDA advisers: Ortho Evra patch needs clearer label

FDA advisers: revise popular birth control labels

FDA panel votes against CardioMEMS device

FDA advisers: revise popular birth control

FDA eyes stronger warning on popular birth control

FDA staff say CardioMEMS device works

FDA: CardioMEMS device meets top study goals

FDA sees rare but serious issue with stents

Some birth control shows higher clot risk: US

ADHD drugs do not increase heart problems in kids: study

AtriCure heart device safe, with caveats: FDA staff

GSK anti-nausea drug may pose risk to heart rhythm: FDA

Misunderstanding of drug approval common: study

Bayer drug unproven as stroke preventer: US

FDA panel OKs Edwards heart valve despite risks

Pfizer stop-smoking pill raises heart risk: FDA

US reviews birth control pill safety over clot risk

Terumo to stop selling two cardiac products in US

Too few women in heart device trials: study

Women left behind in heart device tests: study

Women left behind in heart device tests

Heart therapy works better in women

U.S. panel backs Abbott carotid stent for more patients

US warns of liver damage with heart drug

Recall news

Orexigen diet pill faces U.S. panel, eyes on safety

Reasons Cited for Recall of Darvocet and Darvon

Wondering about High Potassium Levels

Darvon, Darvocet Removed From Market

FDA Pulls Darvon and Companion Drug Due to Heart Risks

Pain Reliever Propoxyphene Withdrawn from Market

FDA Pulls Darvon Painkiller off the Market

Boston Scientific Investor Day – Transcript

Drugmaker pulls painkillers from US market over heart risks

Propoxyphene Withdrawn From U.S. Market

FDA Pulls Pain Med Due to Heart Risks

Darvon, Darvocet Banned

Heart Drug Raises Questions

New Blood Thinner a Promising Alternative to Warfarin

Anthera Suspends Enrollment and Dosing in PEARL-SC Clinical Trial to Address Reports of Vial Problems

Edwards heart valve improves quality of life: study

New Blood Thinner a Promising Alternative to Warfarin

Terfenadine

Sibutramine

Newest technology in heart stents

VIVUS CEO Discusses Q3 2010 Results - Earnings Call Transcript

Avandia Litigation and FDA Developments

Yaz, Yasmin, and Ocella (Drospirenone) Litigation

You Pop OTC Diet Pills

A look at the safety of Avandia, a popular diabetes drug

Can blood tests detect imminent heart attacks

FDA freezes long term study on diabetes drug, Avandia

Dilated cardiomyopathy (DCM) in cats: Symptoms and treatments

FDA restricts diabetes drug Avandia

The dangers of diet pills

Grepafloxacin

Diet herb supplement Slim 30 recalled for undeclared drug ingredient

Stroke treatment options: Standard and new

Covidien gets FDA approval for compression sleeve

Pradaxa Approved to Fight Dangerous Irregular Heartbeat, Stroke

Ofirmev Sanctioned for Pain and Fever

AtriCure CEO Discusses Q3 2010 Results – Earnings Call Transcript

Avanir Pharmaceuticals Announces FDA Approval of Nuedexta

Warning: Your Doctor Maybe a Pawn for...

FDA to drug companies: Include risk warnings for GnRH agonists

Avanir's AVP-923: Is QTc Prolongation Above 'Threshold of Concern'?

Replacement therapy for Protein C deficiency

U.S. cautions on mixed use of Roche, Abbott HIV drugs

If You Choose Ortho Evra, Consider This

Digitek Recall Watch

The Diabetes Drug Avandia Stays on with Restriction

FDA seeks more data on Amylin, Lilly diabetes drug

Boehringer wins first US OK in blood-thinner race

A Generic Version of Weight-Loss Drug Meridia Taken off Market

Meridia Banned

Digitek Digoxin Recall

Crook Alert! SmithKline Beecham Hid Heart Risk Test Data