FDA won't ban diet drug, will monitor risk (Meridia)

SouthCaliDiva · 08-18-2005, 12:23 PM

This is the type of story that makes me want to go live in a grass hut on the moon. I should stick a copy in my purse for the next time my doc wants to give me shit about ephedra.

Find this article at:
http://www.cnn.com/2005/HEALTH/diet.....ap/index.html

FDA won't ban diet drug, will monitor risk

WASHINGTON (AP) -- The government won't ban the prescription diet drug Meridia but, faced with reports of deaths, says it will closely monitor a European study designed to better assess the pill's heart risks.

The consumer group Public Citizen had petitioned the Food and Drug Administration for a ban, citing Meridia users who died of heart problems as young as their 20s and 30s. Even before Meridia was approved for sale, the FDA knew it could increase users' blood pressure, the group contended.

The FDA denied Public Citizen's request for a ban in a ruling issued Aug. 9 but made public Wednesday by Meridia manufacturer Abbott Laboratories.

In that ruling, FDA drug chief Dr. Steven Galson acknowledged questions about Meridia's cardiovascular effects, and said the agency had ordered Abbott to take stronger steps to ensure that dieters with heart disease aren't prescribed the drug -- and to stress the importance of monitoring users' blood pressure.

But Galson said a two-year review of Public Citizen's complaints concluded the benefits of modest weight loss from Meridia outweigh the drug's risks.

Public Citizen wasn't the only one to complain about Meridia. Whistleblower David Graham, an FDA drug safety officer, testified to Congress last fall that his agency was allowing five unsafe medicines to stay on the market, including Meridia.

Between 1997 and 2003, the FDA received reports of 30 Meridia users who died of cardiovascular problems and 224 other reports of nonfatal strokes, heart attacks and other cardiovascular ailments, Galson wrote.

He didn't say how many additional complaints FDA has received in the ensuing two years.

But cardiovascular disease is common among the obese, Galson cautioned. There's no way to tell from these vague reports whether Meridia -- known chemically as sibutramine -- actually increased that risk, while earlier studies suggested it didn't, he concluded. What the hell? You couldn't prove it with ephedra either!

A study is under way that may settle the question, he wrote. It is tracking the heart health of 9,000 obese Europeans at particularly high risk for cardiovascular disease because of a previous heart attack or other problem. Half are taking Meridia, the other half a dummy drug. Independent safety monitors are checking the data monthly.

"FDA will be immediately notified and will take appropriate regulatory action if any serious safety concerns are identified," Galson wrote.

Abbott welcomed FDA's decision, saying about 15 million patients in more than 75 countries have used Meridia since it hit the market in 1997. But the company said it followed Galson's order to beef up warnings that Meridia is not for everyone.

Those warnings say Meridia substantially increases blood pressure or heart rate in some patients and should not be given to anyone with poorly controlled hypertension, a history of heart disease, stroke or severe liver or kidney disease, or by pregnant or breast-feeding women. A controlled substance because it works by affecting brain chemicals, Meridia is intended for people who need to lose 30 pounds or more.

Public Citizen's Dr. Sidney Wolfe blasted FDA's ruling as "dangerously flawed," comparing it to the agency's earlier decisions to keep on the market other drugs, such as the painkiller Vioxx, later deemed too risky.

Copyright 2005 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

Ghosting · 08-18-2005, 12:44 PM

I dont know the use to problem ratio between ephedra (OTC and readily available to all) and Meridia (prescription used much less frequently) over 97-03, but the FDA jumped all over ephedra and agree'd to "monitor" a pharmacutical compound. LOL.

Ghosting · 08-18-2005, 12:46 PM

Thats my nice way of calling the FDA shady.

**builtbeast** · 08-18-2005, 09:58 PM

The FDA was slow with Fenfluramine Phentermine (fen-phen), sounds like their doing the same here.

Ghosting · 08-18-2005, 10:04 PM

Quote:

Originally Posted by builtbeast

The FDA was slow with Fenfluramine Phentermine (fen-phen), sounds like their doing the same here.

Shady. LOL.

**DarkFalcon** · 08-19-2005, 10:11 PM

Quote:

Originally Posted by Ghosting

Shady. LOL.

Agreed, can you say kick-backs?

Ghosting · 08-19-2005, 11:55 PM

Quote:

Originally Posted by DarkFalcon

Agreed, can you say kick-backs?

Hmmm.... I need me a job at the FDA. :king:

08-18-2005, 12:23 PM	#1
SouthCaliDiva IronMass Donator Join Date: May 2005 Location: H-Town bound!!!!!!!! Posts: 515 Recipes: 0 Rep Power: 9	FDA won't ban diet drug, will monitor risk (Meridia) This is the type of story that makes me want to go live in a grass hut on the moon. I should stick a copy in my purse for the next time my doc wants to give me shit about ephedra. Find this article at: http://www.cnn.com/2005/HEALTH/diet.....ap/index.html FDA won't ban diet drug, will monitor risk WASHINGTON (AP) -- The government won't ban the prescription diet drug Meridia but, faced with reports of deaths, says it will closely monitor a European study designed to better assess the pill's heart risks. The consumer group Public Citizen had petitioned the Food and Drug Administration for a ban, citing Meridia users who died of heart problems as young as their 20s and 30s. Even before Meridia was approved for sale, the FDA knew it could increase users' blood pressure, the group contended. The FDA denied Public Citizen's request for a ban in a ruling issued Aug. 9 but made public Wednesday by Meridia manufacturer Abbott Laboratories. In that ruling, FDA drug chief Dr. Steven Galson acknowledged questions about Meridia's cardiovascular effects, and said the agency had ordered Abbott to take stronger steps to ensure that dieters with heart disease aren't prescribed the drug -- and to stress the importance of monitoring users' blood pressure. But Galson said a two-year review of Public Citizen's complaints concluded the benefits of modest weight loss from Meridia outweigh the drug's risks. Public Citizen wasn't the only one to complain about Meridia. Whistleblower David Graham, an FDA drug safety officer, testified to Congress last fall that his agency was allowing five unsafe medicines to stay on the market, including Meridia. Between 1997 and 2003, the FDA received reports of 30 Meridia users who died of cardiovascular problems and 224 other reports of nonfatal strokes, heart attacks and other cardiovascular ailments, Galson wrote. He didn't say how many additional complaints FDA has received in the ensuing two years. But cardiovascular disease is common among the obese, Galson cautioned. There's no way to tell from these vague reports whether Meridia -- known chemically as sibutramine -- actually increased that risk, while earlier studies suggested it didn't, he concluded. What the hell? You couldn't prove it with ephedra either! A study is under way that may settle the question, he wrote. It is tracking the heart health of 9,000 obese Europeans at particularly high risk for cardiovascular disease because of a previous heart attack or other problem. Half are taking Meridia, the other half a dummy drug. Independent safety monitors are checking the data monthly. "FDA will be immediately notified and will take appropriate regulatory action if any serious safety concerns are identified," Galson wrote. Abbott welcomed FDA's decision, saying about 15 million patients in more than 75 countries have used Meridia since it hit the market in 1997. But the company said it followed Galson's order to beef up warnings that Meridia is not for everyone. Those warnings say Meridia substantially increases blood pressure or heart rate in some patients and should not be given to anyone with poorly controlled hypertension, a history of heart disease, stroke or severe liver or kidney disease, or by pregnant or breast-feeding women. A controlled substance because it works by affecting brain chemicals, Meridia is intended for people who need to lose 30 pounds or more. Public Citizen's Dr. Sidney Wolfe blasted FDA's ruling as "dangerously flawed," comparing it to the agency's earlier decisions to keep on the market other drugs, such as the painkiller Vioxx, later deemed too risky. Copyright 2005 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed. __________________ It is by will alone I set my mind in motion. It is by the juice of sapho that thoughts acquire speed, the lips acquire stains. The stains become a warning. It is by will alone I set my mind in motion.

08-18-2005, 12:44 PM	#2
Ghosting IronMass Donator Join Date: Jun 2005 Posts: 1,801 Recipes: 0 Rep Power: 22	I dont know the use to problem ratio between ephedra (OTC and readily available to all) and Meridia (prescription used much less frequently) over 97-03, but the FDA jumped all over ephedra and agree'd to "monitor" a pharmacutical compound. LOL. __________________ Robcardu is the Jesus of the 90s.

08-18-2005, 12:46 PM	#3
Ghosting IronMass Donator Join Date: Jun 2005 Posts: 1,801 Recipes: 0 Rep Power: 22	Thats my nice way of calling the FDA shady. __________________ Robcardu is the Jesus of the 90s.

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08-18-2005, 09:58 PM	#4
builtbeast Großer Moderator Join Date: May 2005 Location: In a very red state Posts: 1,430 Recipes: 0 Rep Power: 94	The FDA was slow with Fenfluramine Phentermine (fen-phen), sounds like their doing the same here.