Pill Diet

Vivus diet pill carries risks, FDA warns

rich — Tue, 21 Feb 2012 22:01:25 +0000

WASHINGTON — Federal health officials say they still have safety concerns about an experimental diet pill from drugmaker Vivus, 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, Orexigen Therapeutics and Vivus. All three companies are in the process of resubmitting their products.

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.

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.

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 percent 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.

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.

If passed, would be first prescription diet pill in 13 years

rich — Tue, 21 Feb 2012 10:05:11 +0000

JACKSONVILLE, Fla. -

This week the FDA is set to re-consider a diet pill drug it has already rejected.

If it’s passed, it would be the first new prescription diet pill in 13 years.

The drug is called Qnexa, but there are serious health concerns, including heart risk and birth defects.

Pharmacist Gary Roberts said, “There is a place for them. You know they can give you that initial kick or that initial start.”

Gary Roberts with Roberts pharmacy said diet pills usually work, but they’re not the healthy way to shed unwanted pounds.

Instead, most diet pills have side effects, which is why many people refuse to take them.

Marty Cawley is against diet pills and said, “Chemically is what I would be concerned about. The chemical composition of the pills.”

The FDA declined to approve the drug Qnexa two years ago, citing the risks of birth defects and cardiovascular problems. But the California based company now wants limited approval of Qnexa, if it’s excluded from women in their childbearing years.

“Being a central nervous system stimulant, it can cause a lot problems nutritionally. It can hurt an unborn baby nutritionally. Also your stimulating the babies nervous system, and it could lead to problems down the road,” Roberts said.

Qnexa is a combination of two drugs, Phentermine, which is an appetite suppressant, and Topiramate, a drug that is used to treat seizures and migranes which can also be a mood stabilizer.

Because Qnexa isn’t available on the open market, some doctors have been prescribing the components, creating an off label brand.

Roberts along with other local pharmacists said diet pills in general are a crutch, and often do more harm than good.

“The FDA should look at this very closely,” Roberts said. “Some are linked to being fatal.”

Copyright 2012 by News4Jax.com. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

FDA raises safety concerns for Vivus diet pill

rich — Mon, 20 Feb 2012 12:27:40 +0000

WASHINGTON (AP) — Federal health officials say they still have safety concerns about an experimental diet pill 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.

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.

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.

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.

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.

FDA raises safety concerns for Vivus diet pill

rich — Sat, 18 Feb 2012 00:05:19 +0000

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.

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.

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.

Diet Pill Qnexa's Safety Still Questioned By FDA

rich — Sat, 18 Feb 2012 00:05:14 +0000

WASHINGTON — Federal health officials say they still have safety concerns about an experimental diet pill from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug’s safety next week.

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.

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.

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.

FOLLOW HUFFPOST HEALTHY LIVING

Vivus diet pill carries risks, FDA warns

rich — Sat, 18 Feb 2012 00:05:11 +0000

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.

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.

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.

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.

Experimental diet pill Qnexa to be reviewed by the FDA, again

rich — Fri, 17 Feb 2012 23:46:51 +0000

Qnexa, an experimental diet pill by drug maker Vivus, will be reviewed for a second time by the Food and Drug Administration next week, the Associated Press reported.

FDA officials have continued to voice their concerns about the safety of the drug, which was initially rejected in October 2010. Vivus is making second attempt to convince experts of the drugs’ safety on Wednesday, and have resubmitted the drug with additional follow-up information, hoping for a more favorable decision, USA Today reported.

Vivus, based in Mountain View, California, is one of three drug companies racing to put the first prescription weight loss drug on the market in over ten years, according to the AP. In the past two years, the FDA has rejected pills from Arena Pharmaceuticals, Orexigen Therapeutics, and Vivus. All three companies are in the process of resubmitting their products.

Qnexa is a combination of appetite suppressant phentermine and anti-seizure drug topiramate, and was initially rejected because of its negative side effects, which include elevated heart rate and the potential for birth defects in pregnant women who used the drug, Reuters reported.

Several experts have predicted that Qnexa is the most likely to succeed on the market out of all three new diet pills because of the high level of weight loss reported in company studies, USA Today reported. On average, patients lost more than 10 percent of their total body mass while taking the pill.

However, experts voted 10-6 to not recommend the drug’s approval at its’ first FDA panel in 2010.

Another panel of FDA doctors will review the pill on Wednesday, when they will take a final vote on whether the drug is safe and effective or not, according to the AP. The group’s recommendation is not binding, and the FDA is expected to make a final ruling on Qnexa in April.

US obesity rates are nearing 35 percent among adults, according to the New York Times, and doctors and public health officials have said that there is a desperate need for new weight-loss therapies.

Some obesity specialists have outlined a strong need for new obesity drugs to help with diet and exercise, which don’t work for many patients, and the more radical option of surgery, according to the Times. If approved, Qnexa could be used by millions of people.

http://www.globalpost.com/dispatch/news/health/120217/diet-pill-qnexa-reviewed-fda

Qnexa diet pill causes concerns for FDA

rich — Fri, 17 Feb 2012 21:33:36 +0000

WASHINGTON – Federal health officials say they still have safety concerns about an experimental diet pill from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug’s safety next week.

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.

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.

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.

Diet Treatment, Already in Use, to Get F.D.A. Review

rich — Fri, 17 Feb 2012 11:57:04 +0000

By ANDREW POLLACK

Published: February 16, 2012

LOS OSOS, Calif. — Next week, advisers to the Food and Drug Administration will recommend whether the agency should approve the first new prescription diet pill in 13 years.

The F.D.A. rejected the drug under review, Qnexa, in 2010, amid safety concerns, and the drug’s manufacturer is now presenting additional data to argue its case.

But thousands of people here in central California, where Qnexa’s inventor ran a weight-loss clinic, and others across the country have not had to wait for the drug’s approval. Through a regulatory loophole of sorts, many obesity doctors prescribe two separate drugs that, when taken together, are essentially the same medicine.

The widespread use of the unsanctioned combination reflects the often desperate desire for a medicine to help overcome the nation’s epidemic of obesity, doctors and patients say.

The experience in this idyllic coastal community about midway between San Francisco and Los Angeles also provides a look at what might happen if Qnexa were approved. Use of the close substitute grew as word spread that some patients had experienced substantial weight loss. Some people here regained weight after stopping the treatment, and some experienced unpleasant side effects such as memory loss.

“I can’t tell you how many people I sent to him because they saw the success I had,” said Lynn Adams, a retired teacher, referring to Dr. Thomas Najarian, the inventor of Qnexa who opened a weight-loss clinic here in 2001.

Ms. Adams said she took the two drugs for a year and lost about 80 pounds. She has taken the drugs from time to time since then but is off them now and has gained about half the weight back.

Qnexa, developed by the company Vivus, is a combination of two already approved drugs — a stimulant called phentermine and an anticonvulsant called topiramate — that seem to work together to quell appetite. Even though the F.D.A. declined to approve Qnexa two years ago, citing the risks of birth defects and cardiovascular problems, doctors are allowed to prescribe the components off-label as they see fit.

Many do. Dr. Christopher D. Still, director of the obesity institute at Geisinger Health System in Danville, Pa., estimated that 70 percent of obesity specialists prescribed the combination. “There is a subgroup of individuals that really feel satiated” when treated with the two drugs, said Dr. Still.

Only one drug, Roche’s Xenical, is currently approved for long-term use in treating obesity, and it is unpopular because of embarrassing digestive side effects. The F.D.A. rejected three obesity drugs, including Qnexa, in 2010 and 2011, citing different safety concerns for each.

The F.D.A.’s staff is expected to release its analysis of the new Qnexa data on Friday. On Wednesday, an advisory panel will review the drug and make its recommendation, and the F.D.A. will have until April 17 to make a decision about it.

Dr. Najarian, who sold his clinic in 2010, said Vivus would not allow him to talk about his experience treating patients with phentermine and topiramate. While doctors can prescribe drugs off-label, drug companies cannot promote such use. Dr. Najarian has been a part-time employee of Vivus since 2006.

Timothy E. Morris, the chief financial officer of Vivus, said Dr. Najarian’s practice did not constitute off-label promotion because Qnexa was “a separate product,” often with different doses, from the two components.

The weight-loss clinic, called Najarian Center, “certainly treated thousands of patients,” said Carol Rowsemitt, a nurse practitioner who worked at the clinic. Besides the drugs, the regimen involved modest exercise, a low-calorie diet and nutritional supplements, some sold by the clinic.

Ms. Rowsemitt said patients had been informed that the drugs were being used off-label and that Dr. Najarian had a financial stake in the combination.

She said side effects were carefully monitored, and she knew of no birth defects. She said, however, that some other doctors in the region had also started using the phentermine-topiramate combination “without being educated on how to use it.”

Phentermine, a stimulant, is approved for short-term use for weight loss. Part of the once popular fen-phen diet pill combination, it remained on the market after two other drugs were withdrawn in 1997 for damaging heart valves.

Topiramate, or Topamax, is approved for epilepsy and migraines, although half of the obesity specialists in one academic survey said they had prescribed it for weight loss. Critics say that using drugs for weight loss does little to change the underlying behavior leading to obesity.

“Everyone wants a quick fix,” said Dr. Sidney M. Wolfe, director of health research at Public Citizen. “But it’s also dangerous.”

Melané Lange of Los Osos once thought that way as well. When she worked for Weight Watchers here, she recommended diet and exercise and used those methods herself.

But it was hard work. So last October, she had her doctor prescribe the two drugs and lost more than 10 pounds in time for a vacation.

“Taking a pill in the morning, taking a pill at night, that’s not a lot of work,” Ms. Lang said. “I was losing patience this time. I didn’t want it to take six months.”

Dr. Philip A. Borgardt, who bought Dr. Najarian’s practice and moved it to nearby San Luis Obispo, Calif., said weight loss was not simply a matter of willpower.

“If it was that easy, they wouldn’t have come to see us,” he said. “The biggest barrier we have to treating obesity is we blame the patient.”

The practice says on its Web site that it provides “healthy and rapid weight loss!” Until about two weeks ago, the site said that the treatment resulted in “greater than 10 percent weight loss in clinical trials,” an apparent reference to the Qnexa results. But Vivus was concerned the information would look like off-label promotion, so the clinic posted its internal data instead, Dr. Borgardt said. The practice is also changing its name from the Najarian Center to TNC Weight Loss to distance itself from Vivus, he said.

Not everyone had success with the regimen. Kat Lauterback, a county worker, said the topiramate caused memory lapses, a well-known side effect.

She said she put up with it for a few months while losing 20 or 30 pounds. But when the weight loss slowed, tensions developed between her and Dr. Najarian. “I found the weight came back very quickly once I went off the drugs,” Ms. Lauterback said.

Roughly two-thirds of American adults are obese or overweight, so a safe pill that assists in weight loss would be lucrative for any company making it.

Wall Street analysts estimate that sales of Qnexa could reach at least several hundred million dollars a year. Although competitors could not copy the patented formulation, doctors could continue to prescribe the two component drugs, which are both available in cheap generic forms.

In addition to Vivus, the makers of the two other drugs rejected by the F.D.A. in recent years are marshaling new data to try again to persuade the agency that the health benefits from the weight loss provided by the drugs trump the side effects.

Of the three drugs, Qnexa provided the biggest weight loss, according to clinical data. Patients taking the highest dose lost an average of 10.6 percent of their body weight after a year, compared with 1.7 percent for those getting a placebo.

Dr. Najarian, a Harvard-trained physician, worked in the late 1990s at Interneuron Pharmaceuticals, near Boston, that had developed Redux, one of the fen-phen drugs withdrawn from the market.

He chanced upon a study showing that Topamax caused people to lose weight and thought that it might be a good new partner for phentermine, with the stimulant offsetting Topamax’s brain-numbing effects. Neither Interneuron nor Johnson & Johnson, the manufacturer of Topamax, wanted to pursue it, he said in a conversation at his home here overlooking Morro Bay. So he patented the combination and licensed it to Vivus.

As of Sept. 30, Vivus had paid Dr. Najarian $220,000 and given him options to buy 40,000 shares of stock, according to a company filing. Those shares would be worth nearly $500,000 at current prices. If Qnexa is approved, Vivus will pay him $1 million, provide options for 20,000 shares, and pay royalties.

“I don’t care about that stuff,” said Dr. Najarian, 64. “I’d just be happy if the drug gets on the market.”

Pill mills keep Sumner County drug agents busy

rich — Thu, 16 Feb 2012 11:53:46 +0000

HENDERSONVILLE, TN (WSMV) -

Ann is an undercover officer for the 18th Judicial District Task Drug Force in Sumner County. Weight loss and pain management clinics have been keeping drug enforcement agents busy. Since September, five clinics have been shut down in Sumner County because of drug abuse.

Optimal Wellness Pain And Weight Loss Clinic in Hendersonville is the latest. The clinic is suspected of selling Phentermine without even seeing patients.

“Phentermine is a stimulant that affects your central nervous system. It’s used for the treatment of weight loss,” said Ann.

Undercover officers believe hundreds of people are involved at this one clinic.

“There are people going in that need to lose 10 pounds, they shouldn’t be getting the medication,” said Ann.

On Feb. 13, an agent posing as a customer at the clinic asked about Phentermine for his wife. He was given the pills. The clinic was shut down.

“She knowingly gave the undercover officer medication that he told her he was gonna divert to someone else, there was no way she could ask her any kind of medical questions as to what may be wrong with her,” said Ann.

The clinic owner, Sandra Jackson Iveson, a nurse practioner who is licensed to prescribe medication, was arrested on drug charges.

Drug enforcement agents want both customers and owners of weight loss and pain management clinics to know that stopping drug abuse at the clinics is a top priority.

“If they haven’t heard that by now, they need to pay close attention, we are watching,” said Ann.

Drug agents say Phentermine is a powerful stimulant that, if improperly prescribed, can cause heart problems. Agents say if people need to lose 10 or 15 pounds, diet and exercise is the safest way to lose that weight.