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Once rejected by the FDA over safety concerns, the weight loss pill Qnexa on Wednesday will get a second chance before an FDA advisory committee.

Will the second time around be the charm? Qnexa maker Vivus Inc. hopes so. And the company will be showing off new safety data from patients who took Qnexa for a second year after completing a one-year clinical trial.

Whether that will sway the panel -- and, ultimately, the FDA -- is a tough call.

Qnexa combines two currently approved drugs. One is the appetite suppressant phentermine, the safer "phen" part of the infamously unsafe fen-phen diet drug.

The other half of Qnexa is the seizure/migraine drug topiramate. The topiramate label lists some scary side effects: eye problems, decreased sweating and increased body temperature, acidic body fluids, suicidal thoughts and behaviors, and fetal toxicity.

But Vivus' new data suggests that the FDA's main safety concerns, heart risk and birth defects, were not a big issue in the follow-up study. Neither were worries about increased suicide risk, mental dulling, or too much acid in body fluids.

These may not have been major issues in the clinical trials, but troubling safety issues persist. In the FDA's analysis of Qnexa safety, there were some ominous comments:

There was indeed evidence of increased heart rate and acidic body fluids in people taking Qnexa.
The FDA states that "only a long-term" study can tell whether Qnexa increases the risk of heart disease in obese people already at high heart risk. One question before the panel is whether Vivus must conduct such a study.
A disturbing number of women in the clinical trials got pregnant, even though they had agreed to be on birth control and had regular pregnancy checks. One of the ingredients in Qnexa is linked to birth defects, although none were seen in the clinical trial. Since 36% of U.S. women are obese, the FDA worries that a lot of pregnant women will be exposed to Qnexa.

While the argument over Qnexa approval isn't about efficacy, not everyone taking the drug loses a significant amount of weight:

On average, people taking the dose of Qnexa proposed for approval lost 6.6% of their body weight. For approval, the FDA requires that a drug result in average loss of at least 5% of body weight.
In one study, 62% of obese and overweight people taking Qnexa lost at least 5% of their body weight -- about three times as many as in the placebo group. The FDA standard is that 35% of people must lose 5% of body weight.
In a follow-up study, people continuing to take Qnexa for a second year regained some of the weight they lost the first year. They did not regain as much weight as people taking a placebo.

Since Qnexa exceeds the FDA's minimum effectiveness requirement, the question is whether the new safety data will sway the new FDA panel.

The last panel voted 10 to 6 against approval. But a lot of those voting said it was a close call.

This year, there are 22 panel members scheduled to vote. Twelve of them were on the last panel. Last time, seven of them voted "no" to approval, and five voted "yes."

By Daniel J. DeNoon

Reviewed by Laura J. Martin, MD

SOURCES:FDA web site.FDA briefing document, Feb. 22 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee.

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Panel to ponder fate of weight-loss pill

It's possible to eat whatever you want and still lose weight. In fact, it's possible to do away with confusing and contradictory diets and fads. It just involves a little mind over platter, says nutritionist and author Kathleen Alleaume in her new book, What's Eating You: Find Your Balance with Food and Lose Weight.

"Diets don't work and they will only cause you to yo-yo and gain more fat. Blacklisting carbs or going on heavily restrictive calorie-controlled diets are lousy ideas," she says.

"We all know what we 'should' be eating. Five serves of veg and two serves of fruit, mixed with moderate portions of lean meat, dairy, eggs, wholegrains and nuts, yet we are not doing it.

"The simple message of 'get back to basics' has been lost. Unfortunately we make certain things in life e.g. eating more complicated than it needs to be."

Alleaume is one of a growing number of health experts who say weight problems are not so much about what we are eating as why we are eating. "We [need to] learn to listen to the inner whispers of our body and learn to be very honest about what we are actually hungry for. For example, learn to eat primarily for physical hunger rather than emotional reasons. When we learn to rely on internal hunger – we get better at registering the fullness cues."

Alleaume sees a wide range of people with issues that vary from weight management to improving sleep, lowering cholesterol to nutrition for running a marathon. Yet, regardless of the issue or her clients' level of nutritional knowledge, she sees a common theme: they eat for other reasons apart from hunger. When they're stressed, bored, tired or upset, they turn to food.

It is for this reason that she decided to write her book. "I see so many people with this underlying cause of overeating and/or unhealthy eating 'behaviours' aka bad eating habits. With so much emphasis on 'what' we should be eating, I wanted to also put emphasis on 'why we eat what we eat' - which for many, is the missing link to long-term weight managements and improvements in eating habits."

The first step is to distinguish between 'hunger' and 'appetite.' "Hunger is the physical need for food. Appetite is the desire to eat food," Alleaume says. "The desire to eat is most often influenced by our emotions, habits, lifestyle, culture, memories, as well as the sight, smell and taste of food. So, if one can learn to eat when they are actually hungry, and not just because their appetite tells them to (because food is in front of them), [it] will make a huge difference to the total amount of food eaten."

Doing this involves getting back in touch with what you're really hungry for, she says. "Chances are it may not be food. It may be affection, or self-esteem or, perhaps, deep inside you don't really like your job or the career path you have chosen."

Once you are clear on what's eating you, the next step is bringing awareness to your thought patterns. "The average human has approximately 60,000 thoughts per day and many of them - around 95 per cent - are the same thoughts we had yesterday and the day before," Alleaume says. "Yet most people are aware of less than 5 per cent of their thoughts and the impact these thoughts have on their actions.....They will shape your attitude, how you feel, what you do."

The idea is not to berate yourself for thinking in a negative way, but simply notice certain thoughts and beliefs occurring. "The more you are aware of your thoughts, assumptions and beliefs, as well as the extent to which you are influenced by them, the more you can take responsibility and shift your internal paradigm."

Which means being mindful of the food choices you make and how your body responds to what you are putting in it. "They say old habits never die," Alleaume says. "However, I believe they just remain dormant. But, we can learn new habits and replace the bad ones."

Alleaume's top tips:

1. Learn to recognise true hunger. If you have just eaten within the last two hours, chances are you are not physically hungry.

2. Tweak your treats. Avoid stocking the cupboard or refrigerator with comfort foods laced with fat, sugar or salt. Gradually replace them with healthier versions. For example swap the banana bread for fruit toast.

3. Manage stress. We look for comfort when we are stressed. The goal is to lower stress with healthful strategies, including regular exercise and adequate sleep, rather than seeking comfort in food.

4. Figure out your triggers: Keep a food diary of what you eat, when you eat, and why you eat it. Knowing your motivations for why you eat will make you conscious of your triggers, and you can begin to change your patterns.

5. Practice mindful eating. Many times people eat without even realising what they are consuming. We become easily distracted, whether it's from work, the kids, or watching television. When it's time to eat, make the effort to sit and savour every mouthful. This technique can help increase awareness of the sensations, feelings and thoughts connected with food and eating.

What's Eating You: Find Your Balance with Food and Lose Weight, $32.95. Random House Books.

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Weight loss: it's all in the mind

Editor's Choice
Main Category: Obesity / Weight Loss / Fitness
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 19 Feb 2012 - 0:00 PST

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The FDA has expressed concerned regarding obesity drug Qnexa - a combination of phentermine and topiramate - and what associations there may be between long-term usage and birth defect risks, as well as its impact on the heart. The Food and Drug Administration (FDA) is reviewing Qnexa again, after turning down its submission for approval two years ago ("FDA Turns Down Weight Loss Drug Qnexa, But Makers See Short Timeline For Approval").

There is an FDA Advisory Panel (Endocrinologic and Metabolic Drugs Advisory Committee) meeting on 22 February. The Panel will look at 2-years' worth of clinical data. When Qnexa was last reviewed, the Agency only had 1-year's worth of data to look at.

The Advisory Panel consists of experts, none of whom work for the FDA. They will have to discuss and vote on whether to recommend supporting or declining the obesity drug after carrying out an overall benefit-risk assessment. The Panel's recommendation is not binding; the FDA can choose to ignore it; but this hardly ever happens. Therefore, Qnexa's future, at least this time round, depends on what happens this coming Wednesday.

When the FDA turned Qnexa down, it asked its makers Vivus Inc. for more clinical data on the medication's potential impact on major adverse cardiovascular events and birth defects.

The FDA now acknowledges that studies have demonstrated that Qnexa can help patients lose a considerable amount of weight during the initial 12 months of treatment. The Agency added that a number of participants put some of their lost weight back on during their second year. Concerns regarding birth defects and accelerated heartbeat were raised again.

Qnexa is a combination of phentermine and topiramate. Studies on topiramate have indicated that there may be a higher chance of having babies with birth defects. According to the FDA, pregnant women who are exposed to topiramate might have a higher risk of giving birth to babies with oral clefts.

At first, Vivus suggested limiting Qnexa use to adult males and females of specific age groups (non-child bearing ages). According to Vivus, the FDA responded by asking the company to come up with a plan of limited usage by pregnant women.

Qnexa consists of:

Phetermine, chemical formula C10H15N - a psychostimulant appetite suppressor. Its pharmacology is similar to amphetamine. Medically, it is currently used to suppress appetite. Topiramate, chemical formula C12H21NO8S - an anti-epilepsy (anticonvulsant) medication which also increases the sensation of feeling full (of food). Psychiatrists sometimes use topiramate for bipolar disorder. It is currently being investigated for the treatment of alcoholism The pharmaceutical industry has tried, mostly unsuccessfully, to bring new anti-obesity medications onto the market. Meridia, an Abbot Laboratories drug, was taken off the market in 2010 after it was linked to stroke and heart attack risk.

Written by Christian Nordqvist

Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today Visit our obesity / weight loss / fitness section for the latest news on this subject.

Sources: FDA, Vivus, Medical News Today archives

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Christian Nordqvist. "Qnexa Obesity Drug - FDA Concerned About Long-term Side Effects." Medical News Today. MediLexicon, Intl., 19 Feb. 2012. Web.
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Read more here:
Qnexa Obesity Drug - FDA Concerned About Long-term Side Effects

(Reuters) - Vivus Inc's obesity drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, U.S. drugs reviewers said.

Food and Drug Administration staff will ask an advisory panel to consider whether the drug's benefits for obese patients will outweigh its risk of birth defects and heart problems.

The FDA staff, in documents posted online on Friday, said patients taking Qnexa during a clinical trial lost more weight, and kept it off for longer, than patients taking a placebo, or sugar pill. These patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems than patients on a placebo, including memory loss, and these problems could get worse over time. They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

Shares of Vivus rose 2.4 percent to $11.45 in pre-market trading.

An advisory panel of outside experts will vote February 22 on whether to recommend the drug, and the FDA is due to make its final decision by April 17.

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October, proposing to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking the drug, in response to an FDA request.

(Reporting by Anna Yukhananov; Editing by Derek Caney and Steve Orlofsky)

View post:
Vivus obesity drug has safety risks: FDA staff

By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration said Vivus Inc.'s ( VVUS) obesity drug Qnexa was effective at helping people lose weight but raised concerns about possible long-term side effects such as birth defects and an unknown impact on the heart.

Qnexa is being reviewed by the FDA for a second time after previously being rejected by the agency in 2010. The agency posted a review of Qnexa to its website Friday in advance of an advisory panel meeting on Wednesday. The review of the drug includes two-year clinical data rather than one year's worth of data that was reviewed in 2010.

Qnexa will face the agency's endocrinologic and metabolic drugs advisory committee, which is made up of non-FDA medical experts. The panel is being asked to vote on and discuss a series of questions including whether the "overall benefit-risk assessment" supports approval of Qnexa. The FDA usually follows the advice of its panels but isn't required to.

In 2010 the FDA rejected Qnexa and asked Vivus for an assessment of the drug's potential to cause birth defects and for evidence that the product doesn't increase the risk for major adverse cardiovascular events.

On Friday, the FDA said Qnexa resulted in "significant" weight loss after the first year of treatment with Qnexa, but noted that patients regained some weight in the second year of the studies. The agency also raised the same concerns as it did in 2010 about a small increase in heart rate and a risk of birth defects.

Other studies of one of Qnexa's ingredients topiramate have suggested an increased risk of birth defect. The FDA said exposure to topiramate in pregnancy "is likely to be associated with a two- to fivefold increased prevalence of oral clefts," a defect of the mouth that can be later treated with surgery.

Vivus initially proposed limiting use of the drug to men, as well as women of nonchild-bearing age. But Vivus said the FDA asked the company to develop a plan to limit use by pregnant women. Vivus, in a document also posted to the FDA's website, said Qnexa produces durable weight loss, which "can be expected to contribute greatly toward ameliorating some of the consequences of obesity and weight-related [illnesses]."

Qnexa is a controlled-release formulation that combines low doses of two older drugs: the stimulant phentermine, which cuts appetite, and topiramate, which increases the sense of feeling full. Topiramate is sold under the brand name Topamax by Johnson & Johnson (JNJ) to treat migraines and seizures.

The development of obesity compounds has been a tough area for companies since the fen-phen drug combination was taken off the U.S. market in 1997 after one of the medication's components was linked to heart-valve damage. Abbott Laboratories (ABT) removed its weight-loss drug Meridia from the U.S. market in 2010 amid concerns about the drug's risk of side effects like heart attack and stroke.

-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

(END) Dow Jones Newswires 02-17-120910ET Copyright (c) 2012 Dow Jones & Company, Inc.

Read more from the original source:
FDA: Vivus Weight Loss Drug Effective But Has Safety Concerns

* Qnexa drug helped patients lose weight - FDA staff

* Vivus (Xetra: 893380 - news) shares up more than 5 pct

* Qnexa tied to heart, memory problems

* FDA staff say long-term safety with Qnexa unknown (Adds details from FDA review, context on obesity drugs)

Feb 17 (Reuters) - Vivus Inc's Qnexa helped people lose weight but may cause long-term health problems, U.S. drug reviewers said in their first assessment of an obesity drug after a series of high-profile rejections in recent years.

Food and Drug Administration staff will ask an advisory panel next week to consider whether Qnexa's benefits for obese patients outweigh its risk of birth defects and heart problems, or if the company needs to do more studies.

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.

But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug in 13 years.

The FDA rejected Qnexa in 2010 because of safety problems, and in documents posted online on Friday, still seemed skeptical about the drug's long-term health effects, especially on the heart.

"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said.

The FDA staff said they would ask an advisory panel on Wednesday whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision on the drug by April 17.

Shares of Vivus rose 5.2 percent to $11.76 in morning trading on Nasdaq (Nasdaq: ^NDX - news) .

FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

REAL-WORLD PROBLEMS

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

But in its review on Friday, the FDA staff said limiting the drug to nonpregnant women might be difficult in the real world, especially since 34 women managed to get pregnant during the clinical trial.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October with more data and proposed to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking it, in response to an FDA request.

Vivus is not the only company vying to get an obesity drug on the market.

Arena Pharmaceuticals (NasdaqGM: ARNA - news) and Orexigen Therapeutics have been pitching their own fat-fighters to the FDA, but like Vivus, have faced rejections.

In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug.

The FDA is also set to review Arena (Milan: ARE.MI - news) 's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.

Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.

Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.

The only prescription obesity drug approved for long-term use is Roche Holding AG's Xenical, which gained approval in 1999. GlaxoSmithKline (Other OTC: GLAXF.PK - news) markets a lower-dose, over-the-counter version called Alli. But both have their own problems, as they can cause serious liver problems, uncontrolled bowel movements and gas. (Reporting by Anna Yukhananov; Editing by Derek Caney, Steve Orlofsky and Lisa Von Ahn)

See the rest here:
UPDATE 2-Vivus obesity drug has safety risks-US FDA staff

* Qnexa drug helped patients lose weight - FDA staff

* Vivus (Xetra: 893380 - news) shares up 3.4 pct

* Qnexa tied to heart, memory problems-FDA

* FDA staff say long-term safety with Qnexa unknown (Recasts lead, adds analyst comments)

Feb 17 (Reuters) - Hopes were raised slightly on Friday that U.S. health regulators could approve a weight-loss pill for the first time in 13 years, after government reviewers did not flag fresh safety risks for an experimental obesity drug from Vivus Inc.

Food and Drug Administration staff said in documents posted online that the drug Qnexa did help people lose weight, though they reiterated concerns about the risk of birth defects and heart problems.

The FDA rejected Qnexa in 2010 because of safety problems, and on Friday agency staff still seemed skeptical about the drug's long-term health effects, especially on the heart.

However, analysts found some upside in the fact that the FDA did not raise new safety concerns.

"Our initial take is that we are incrementally more positive on approval," said Cory Kasimov, analyst at JP Morgan, in a research note. "Overall, we see no major surprises."

Shares of Vivus rose 3.4 percent to $11.56 in early afternoon trading on Nasdaq (Nasdaq: ^NDX - news) , well above the stock's low around $4.70 after the pill was first rejected.

FDA staff will ask a panel of outside experts next Wednesday to consider whether the benefits of Qnexa for obese patients outweigh its safety risks, or if the company needs to do more studies.

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population affected.

But the FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them. The agency has not approved a new obesity drug since 1999.

Qnexa is one of three obesity pills up for a second round of consideration from the FDA.

"Ultimately, only a long-term, cardiovascular outcome trial can define the effect of (Qnexa) treatment on risk for major adverse cardiovascular events in an obese at-risk population," FDA reviewers said about Qnexa.

The FDA staff said they would also ask the advisers whether Vivus needs to do a heart-focused study of Qnexa before it is approved. The FDA will make its final decision by April 17.

FDA staff said patients taking Qnexa during a clinical trial had lost more weight, and kept it off for longer, than those taking a placebo, or sugar pill. The Qnexa patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, the FDA staff said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They also said exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects in other studies.

REAL-WORLD PROBLEMS

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

Vivus resubmitted its application to the FDA in October with more data and proposed to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking it, in response to an FDA request.

Jason Butler, an analyst at JMP Securities, said the FDA's request to allow non-pregnant women to take the drug was a positive sign.

"The FDA is saying ... it's a small signal of risk, but it's not so great that we have to stop people using it," Butler said, adding he expected heart issues to be a greater concern.

However, in its review on Friday, the FDA staff said limiting the drug to nonpregnant women might be difficult in the real world, especially since 34 women got pregnant during the clinical trial.

Vivus is not the only company vying to get an obesity drug on the market.

Arena Pharmaceuticals (NasdaqGM: ARNA - news) and Orexigen Therapeutics have been pitching their own fat-fighters again to the FDA after rejections.

In February, Orexigen agreed with the FDA on the design of a 10,000-patient heart-safety trial required for the approval of its Contrave drug.

The FDA is also set to review Arena (Milan: ARE.MI - news) 's lorcaserin by June 27, after rejecting it in October 2010 because of a potential cancer risk.

Drugmakers have struggled for years to develop weight-loss drugs that are both effective and safe.

Back in 1997, the infamous diet drug "fen-phen" was pulled from the market after reports of fatal heart-valve problems in some users. Another diet pill, Meridia, was pulled from the U.S. market in 2010 after being linked to heart problems.

The only prescription obesity drug currently approved for long-term use is Roche Holding AG's Xenical, which got the FDA's nod in 1999. GlaxoSmithKline (Other OTC: GLAXF.PK - news) markets a lower-dose, over-the-counter version called Alli. But both have their own problems, as they can cause serious liver problems, uncontrolled bowel movements and gas. (Reporting by Anna Yukhananov; Editing by Steve Orlofsky, Lisa Von Ahn and Tim Dobbyn)

Excerpt from:
UPDATE 3-Modest hope for FDA approval of Vivus obesity drug

WASHINGTON — Federal health officials continue to voice safety concerns over an experimental diet pill from drugmaker Vivus Inc., which will make its second attempt to convince experts of the drugs' safety next week. The drug Qnexa helped people lose weight but may cause long-term health problems in overweight and obese patients, Food and Drug Administration reviewers said.

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The FDA staff will ask an advisory panel to consider whether the drug's benefits for obese patients will outweigh its risk of birth defects and heart problems.

In documents posted online on Friday, FDA reviewers said patients taking Qnexa during a clinical trial lost more weight, and kept it off for longer, than patients taking a placebo, or sugar pill. These patients also had lower levels of problems associated with obesity, such as issues with blood pressure and blood sugar.

However, patients taking the drug had more safety problems than patients on a placebo, including memory loss and birth defects, and these problems could get worse over time.

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate.

A company study in December showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

The FDA already rejected Qnexa in 2010 because of safety concerns -- including elevated heart rate in some users and the potential for birth defects if pregnant women used the drug.

Vivus resubmitted its application in October, proposing to limit the drug to only women who cannot have children. In January, the company broadened the label to just limit pregnant women from taking the drug, in response to an FDA request.

An advisory panel of outside experts will vote Feb. 22 on whether to recommend the drug. The group's recommendation is not binding, and the FDA is expected to make its final decision by April 17.

The Associated Press and Reuters contributed to this report

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Weight-loss drug works but has safety risks, FDA says

(CBS/AP) An experimental diet pill from drugmaker Vivus Inc. has federal health officials concerned.

Vivus, based in Mountain View, Calif., plans to convince experts of the drug's safety next week. It hopes to bring the weight loss drug to market for the first time in more than a decade.

PICTURES - 6 weight-loss supplements to avoid

In the past two years, the Food and Drug Administration has rejected pills from all of the three small drugmakers with such offers: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Vivus' pill, Qnexa, in October 2010, with concerns about two particular safety issues: potential heart problems and birth defects in women who become pregnant while taking the drug. The agency plans to ask experts to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss increased blood pressure and higher heart rates reported for patients taking the drug.

The panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.

With U.S. obesity rates close to 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

Qnexa is a combination of two older drugs. The amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in studies - on average, 10 percent of total body mass.

But at Qnexa's first FDA panel in 2010, experts voted 10-6 against the drug. Panelists said the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

If Qnexa is approved, Vivus plans to offer a follow-up study to monitor patients for any heart problems. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug. One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is not widely used because of insignificant weight loss results.

See the original post here:
Vivus weight loss drug faces FDA concerns

U.S. health officials say they still have safety concerns about experimental diet pill Qnexa, from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug's safety next week.

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus.

All three companies are in the process of resubmitting their products.

Qnexa is not authorized for sale in Canada, Health Canada says.

The FDA had rejected the diet pill Qnexa in October 2010. Vivus has resubmitted the drug with additional follow-up information, hoping for a more favorable ruling.

But in documents posted online Friday, the FDA reiterated concerns about two safety issues that plagued the pill the time first around: Potential heart problems and birth defects in women who become pregnant while taking the drug.

Final decision on Qnexa in April

On Wednesday the FDA will ask experts at a public meeting to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss increased blood pressure and higher heart rates reported for patients taking the drug.

The panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

Qnexa is a combination of two older drugs. The amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

High weight loss reported in company studies

Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in company studies. On average, patients lost more than 10 per cent of their total body mass.

But at Qnexa's first FDA panel in 2010, experts assembled by the food and drug regulator voted 10-6 to not recommend the drug's approval. Panelists said the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

On Wednesday, Vivus will offer to conduct a follow-up study to monitor patients for any heart problems, if Qnexa is approved. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug. One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is not widely used because of modest weight loss results.

Originally posted here:
Diet drug may cause long-term health problems, FDA says

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