Yourlawyer.com (Meridia News) http://www.yourlawyer.com/topics/overview/meridia Sat, 21 Nov 2009 13:42:04 -0800 pixel-app en FDA Refuses to Ban Meridia Despite Reports of Serious Side-Effects and Deaths Linked to the Diet Drug http://www.yourlawyer.com/articles/read/10535 Thu, 18 Aug 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10535
Complaints about Meridia were brought to the FDA by the consumer watchdog group, Public Citizen (http://www.citizen.org/).

Public Citizen first petitioned for the removal of Meridia from the market in 2002 when Italian health authorities suspended the drug after reports of two patient deaths. The country later re-approved the drug and the European Union's Committee for Proprietary Medicinal Products ruled that the drug should continue to be sold in Europe.
Recently, Public Citizen claimed Meridia in only their 20s and 30s had died of heart problems and that even before Meridia was approved for sale, the FDA was aware it could increase blood pressure in some cases.
The group’s petition to pull the drug from the market was denied on August 9.

Although the FDA had directed Abbot Labs to ensure that dieters with heart disease aren't prescribed the drug and to stress the importance of monitoring patient’s blood pressure, the agency defended its decision to keep Meridia on the market saying that the drugs benefits still outweighed the side effects.

Whether this claim is true, however, is open to question. Public Citizen was not the first to raise questions about Meridia’s safety. David Graham, an FDA drug safety officer and well-known whistleblower, testified before Congress last fall that the FDA was allowing five medicines including Meridia to remain on the market despite serious concerns about their safety.

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

In response to these charges, and with somewhat circular logic, the FDA argues that cardiovascular disease is frequent among the group of obese people the drug is designed to help (those trying to lose at least 30 pounds) and it is difficult to decipher whether Meridia itself increased any of these risk factors.

Simultaneously, the agency ordered a stricter warning that the drug should not be given to those who suffer from poorly controlled hypertension, heart disease, stroke, or severe liver or kidney disease as well as breast feeding or pregnant women.

An upcoming study should help settle the question of Meridia’s effect on heart problems. The new study considers 9,000 obese Europeans at particularly high risk for cardiovascular disease because of a previous heart attack or other problem. Half will take Meridia and half will not. The groups will then be evaluated monthly by an independent monitor.

As expected, Abbott Laboratories was pleased with the FDA decision claiming that Meridia is helping 15 million patients in 75 countries lose 5% to 10% of their body weight in combination with a healthy diet and exercise program. The drug has also contributed significantly to the company’s profits with global sales of $300 million in 2004.

Public Citizen's Dr. Sidney Wolfe condemned the FDA's ruling as "dangerously flawed," and cited it as yet another instance of the government continually siding with the pharmaceutical industry in cases where drugs with highly questionable track records, clinical trials, and adverse event reports have been allowed to remain on the market far too long before being recalled or having their warnings made significantly stronger.]]> Woman's Death Highlights Risk of Herbal Diet Products http://www.yourlawyer.com/articles/read/10512 Mon, 15 Aug 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10512
A 53-year-old woman has died and hundreds of others may be risking their lives by turning to herbal diet products that contain unsafe western medical ingredients, the Department of Health has warned.

The woman died recently after using herbal health products found to contain the substances fenfluramine and propranolol.

Philippa Yu, executive officer of the Hong Kong Eating Disorders Association (HEDA), echoed the warning, saying the need to be slim has spiralled out of control in Hong Kong.

Dr Lo Kwok-wing, a member of the Hong Kong Society of Obesity, says it is hard to predict how many more dieters will fall victim to the remedies.

In addition to the death of the 53year-old woman, hundreds more may have fallen ill over the years and the numbers could soar, Lo warned.

The products are seen as a quick fix solution to dieters unwilling to lose weight the right way - exercising regularly and eating properly.

Natural or herbal health foods are not subject to the Pharmacy and Poisons Ordinance or the Chinese Medicine ordinance, which restrict the sale of drugs.

The herbal dietary products are considered to be health foods and no pre-market approval is required.

It is only when the Department of Health receives information from the general public that products are tested.

``The government needs to maintain a balance between market and public health,'' said Yu. ``I don't think the government has enough experience or policies to control the problem [of Western medicines mixed in herbal slimming products].''

Raymond Ho, representative of the engineering functional constituency of the Legislative Council, said while it is not possible to test all the health foods before they come into the SAR, ``selective testing of products from specific places could help.''

Ho also suggested collaboration between governments would help. ``We can't rely on our own government, we do not have enough resources and have to maintain close communication with other governments, including China,'' he said.

Legco passed an amendment to the Undesirable Medical Advertisements Bill last June that prohibits or restricts advertising claims of herbal or health foods which must also state the ingredients on the labels. The products are not tested before they reach Hong Kong and the government has to rely on the manufacturers to be truthful.

RS Slim & Fit, Trim Up Plus Birds Nest and other health foods have already been yanked off the shelves and banned by the Department of Health.

Fenfluramine was banned in the United States in 1997 after being linked to several deaths. Western dietary drugs can only be prescribed by doctors and are usually used to treat severe obesity.

The case of the unnamed woman who died is still being investigated. There is no English name for the product she consumed, believed to have contained fenfluramine, which is often mixed with phentermine.

The ``fen-phen'' craze in the US led to more than 50,000 product liability lawsuits filed by alleged victims.

In Hong Kong, fenfluramine was deregistered in 1998 after being linked to heart-valve disease. But slimming aids containing the drug can still be found in the territory and other parts of the world, according to health experts.

In a survey conducted by the Hong Kong Eating Disorder Association in 2003, 60 percent of 1,200 women of all ages surveyed in the SAR were considered normal weight, yet 90 percent of them said they had tried slimming products.

With increasing trade flows between Hong Kong and China, authorities are finding it difficult to control the banned products although importers, wholesalers and retailers selling unregistered pharmaceuticals face a fine up to HK$100,000 and two years in prison.

Since 2003, only 26 herbal slimming products, containing Western medicines, have been recalled.

Herbal slimming products containing Sibutramine, also known as Meridia, an appetite suppressant that causes increases in blood pressure and heart rate, are among the latest products banned in the SAR. Sibutramine was the first appetite suppressant to receive approval by the United States Food and Drug Administration after the fenfluramine ban. In 2002, 29 deaths were linked to the drug since its launch in 1998. Italy banned it in 2002 and withdrew all products that contained the ingredient after receiving 50 reports of health-related problems linked to the drug.

According to Public Citizen, a consumer advocacy group which petitioned to ban Sibutramine in the US, 19 of the deaths were caused by adverse cardiovascular effects in users of the drug. Abbott Laboratories, which produces the drug, continues to stand behind it.

In Hong Kong this year, five of the eight slimming drugs banned by the Department of Health contained Sibutramine.

In the Consumer Council survey on health foods released Monday, five percent of respondents reported side effects such as diarrhoea, insomnia, lassitude, dizziness, sweating and thirst. Some side effects were attributed to slimming or herbal tea products.

An analysis of 80 health food product labels found most of them gave no information on contra-indications and side effects.

The number of proprietary Chinese medicine samples for treatment of obesity sent to the government laboratory increased sixfold over 2003, according to a Hong Kong government laboratory report last year.]]> Five Brands of Risk http://www.yourlawyer.com/articles/read/8974 Tue, 07 Dec 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8974
That hearing was held to explore the FDA's record on warning people about drug risks. During his testimony, David J. Graham, associate director of the FDA's office of drug safety, said underpublicized safety risks of five drugs weight loss medication Meridia; acne drug Accutane; asthma medication Serevent; cholesterol drug Crestor; and painkiller Bextra could lead to restrictions or withdrawal of the drugs from the market.

More than 15 million prescriptions were filled for the five drugs during the first nine months of this year, according to IMS Health, a pharmaceutical information and health care consulting company. While the makers rigorously defend the drugs' safety when taken as directed, some people who take them are scared.

Michael Miller, director of the Center for Preventive Cardiology at the University of Maryland Medical Center in Baltimore, said at least 10 patients have called asking what to do. While some research suggests that Crestor carries greater risk of serious side effects than other statins, Miller said current knowledge does not warrant taking most patients off the drug. He will continue to monitor patients carefully and won't prescribe Crestor to those at high risk for the most serious side effects.

If you are taking one of these drugs and want to consider another treatment, experts recommend consulting with your doctor before stopping or changing any regimen. Some drugs interact with others, so you should tell your doctor about any drugs -- prescription or over-the-counter -- you're taking on a regular basis.

For those taking any of the five drugs, risks and options are discussed below.


Meridia Used for weight loss, works by "acting on the appetite control centers in the brain," according to its maker, Abbott Laboratories. The drug works best when combined with a low-calorie diet, the company says.

Risks Elevated risk of cardiovascular side effects, including heart attack and stroke.

Drugmaker Response Illinois-based Abbott says it stands behind the safety of the drug.

Alternatives The best way to drop pounds: Eat less, move more, doctors said. "I very much believe in behavior modification and lifestyle changes," said Tania Heller, medical director of Suburban Hospital's Center for Eating Disorders and Adolescent Obesity. For patients at high risk for complications of obesity -- such as those with type 2 diabetes -- drugs may help speed weight loss, Heller said. "But the key point to get across is not to rely only on medication" to lose weight, she said.

For patients who need medication, obesity drug Xenical, made by Roche Pharmaceuticals, is another option. The drug works by preventing about a third of the fat in the food you eat from being digested. Studies show that patients taking the drug lost twice as much weight as those on the same diet without medication. Side effects -- increased frequency and urgent need to empty the bowels, and gas with an oily discharge do not enhance its popularity.

Accutane A synthetic form of Vitamin A, used to treat severe acne.

Risks Can cause severe birth defects when taken by pregnant women.

Drugmaker Response The risk for birth defects when the drug is taken by pregnant women has been known since its 1982 approval, said Carolyn Glynn, spokeswoman for Roche Pharmaceuticals. Roche and the companies that distribute the three generic forms of Accutane require doctors to test women for pregnancy before prescribing the drug, and to sign forms stating they've educated patients about known risks.

Alternatives Oral antibiotics and topical medications should be tried before taking Accutane. But neither type of drug is considered as effective as Accutane in treating the most severe cases of acne, said Paula Bourelly, assistant professor of dermatology at Georgetown University Hospital. Since Accutane is the only medication considered effective for the most severe forms of acne, patients with the very worst cases have limited options. Bourelly said she has had new patients report taking antibiotics for months in an effort to clear up their acne.

Serevent A long-acting inhaled bronchodilator (a drug that widens the airways in the lungs) used for long-term management of asthma and chronic obstructive pulmonary disease.

Risks "Rare but serious asthma episodes and asthma-related fatalities occurred in a study with Serevent," GlaxoSmithKline reports on its Web site. "These risks may be greater in African Americans." Researchers think risks are higher for people with certain types of beta receptors (which exist on cells that line the surface of organs, including the lungs); this type of receptor seems more common in black patients. Some people of other races may have this type of beta receptor, too, doctors said.

Drugmaker Response GlaxoSmithKline says it addressed this concern by adding a "black box" to Serevent's label in August 2003, warning patients and doctors of this risk, according to a written statement the company issued on the day of Graham's testimony. Patients should not stop taking Serevent without their doctor's approval, the statement says.

Alternatives For those who don't want to take Serevent, there are several options, depending on the severity of the patient's asthma. Those with mild asthma may use a rescue medication like albuterol, which is taken only when the patient feels short of breath or has other asthmatic symptoms, said Martha White, an allergist at the Institute for Asthma and Allergy in Wheaton and Chevy Chase.

People with asthma who have symptoms at least twice a week need more treatment, White said. Options include another long-acting bronchodilator called Foradil, inhaled corticosteroids and Singulair, a leukotriene inhibitor (which is thought to work by blocking a substance that is released by cells in the lungs during asthma attacks).

Inhaled corticosteroids are considered the most effective at managing asthma symptoms, but they carry a heightened risk particularly at higher dosages of oral thrush (mouth infection), skin thinning and bruising with long-term use. The side effects for Foradil, usually used in combination with inhaled corticosteroids, include tremors, fast or irregular heartbeat, headache, muscle cramps or pain and, in rare cases, bronchospasms (narrowing of the airways). The side effects for Singulair which is not as effective as inhaled corticosteroids at controlling asthma symptoms include fatigue, fever, stomach pain and upset stomach.

Bextra A COX-2 painkiller often used to treat osteoarthritis.

Risks Bextra may have the same cardiovascular risks as those that caused Merck & Co. to pull Vioxx from the market in September. Some experts say that COX-2 drugs in general may be unsafe for long-term use. Existing research both confirms and refutes this risk, so more studies are needed.

Drugmaker Response Pfizer considers the drug to be "safe and effective," said spokeswoman Mariann Caprino. The drug company looks forward to the FDA's February 2005 meeting on the safety of Bextra and Celebrex, the only other COX-2 drug left on the market, Caprino said.

Alternatives Other choices include NSAIDs (nonsteroidal anti-inflammatory drugs), available by prescription (including Mobic and Daypro) and over-the-counter (including Motrin, Aleve and Advil).

Weight loss, if needed, and regular exercise may also ease pain. To relieve pain temporarily, heat and ice may help. Topical medications such as corticosteroids, Bengay and capsaicin may also ease soreness. Some patients may find relief through corticosteroid or hyaluronic acid injections into sore joints. Injection complications include infection, and repeated corticosteroid shots can increase risks of cataracts and bone weakening. In rare cases, skin whitens and thins at the injection site.


Crestor A statin drug used to treat high cholesterol.

Risks Kidney failure and rhabdomyolysis, a rare but potentially fatal muscle disease. Complications are more likely at higher doses (the highest approved dose in the United States is 20 milligrams; highest dosages elsewhere extend to 40 milligrams).

Drugmaker Response In a written statement issued Nov. 19, AstraZeneca said senior FDA officials reassured the firm that "there is no concern in relation to Crestor's safety and that they [the FDA] have issued a statement explaining that Dr. Graham's testimony does not reflect the views of the agency." The company has also run newspaper advertisements to reassure patients taking Crestor of the drug's safety.

Alternative treatments Other statin drugs include Lipitor, Zocor, Pravachol and Lescol. The decision on which to take should be made in consultation with your doctor, since dose and duration of treatment may vary depending on how high your cholesterol is, how low the target is and other factors. All statin drugs carry some risk for rhabdomyolysis, as well as risk of increasing liver enzymes. Liver function should be monitored regularly.

Diet and exercise are also powerful tools to help keep cholesterol and blood pressure in check, though doctors caution patients not to forego medication for levels deemed dangerously high by their doctors.

But don't stop taking your medication even if your cholesterol levels dip into safer territory. Former president Bill Clinton, who underwent emergency heart bypass surgery in September, had stopped taking his statin medication after losing weight and becoming more fit. His LDL or "bad" cholesterol level had decreased since his last presidential physical, from 177 to 114 when measured the week before his heart surgery. The recommended LDL level is less than 70.]]> Concern About Drug Safety Doesn't Stop With Vioxx http://www.yourlawyer.com/articles/read/8896 Mon, 22 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8896
That David Graham of the Food and Drug Administration's Office of Drug Safety named names was surprising. But to anyone who has kept up with the scientific literature and the drugs' evolving labels, the names themselves were not.

Steven Galson, an FDA administrator, attempted to temper Graham's testimony by saying the agency must consider benefits as well as risks, "so that safe and effective drugs remain available to patients who need them."

Some of what is known about the five drugs so far:

Accutane. Accutane can cause major fetal defects, and Roche, its maker, has warned against use during pregnancy since it came on the market in 1982. Yet, according to the March of Dimes, thousands of pregnant women have taken it.

In 2001, the FDA approved a voluntary system developed by Roche to prevent pregnant women from taking Accutane. But an FDA review found the proportion of Accutane users who were pregnant might actually have gone up in the year since the system went into effect.

In February, an FDA advisory panel recommended a more-restrictive program that would set up a registry of all Accutane prescribers, all pharmacists who dispense it and all users. It has not yet been implemented.

Bextra. As with Accutane, Graham did not call for Bextra in the same class of drugs as Vioxx to come off the market. But, he said, too little is known about Bextra's effect on heart attack or stroke risk. Last month, Pfizer sent a letter to health-care professionals mentioning results of two Bextra trials in heart-bypass-surgery patients. In both, the Bextra groups had more heart attacks and strokes than the placebo groups.

Crestor. This cholesterol drug has drawn regulators' attention in Europe and Canada.

At the Senate hearing, Graham said Crestor is the only statin drug that causes kidney failure. And, he said, it carries a higher risk of rhabdomyolysis than any other statin. Rhabdomyolysis is a potentially fatal muscle complication that benched another statin, Baycol, in 2001.

In June, Crestor maker AstraZeneca released a revised package insert for use in the European Union. It highlighted the rhabdomyolysis issue. Later that month, the Canadian government issued an advisory warning of a possible link between Crestor and rhabdomyolysis, especially at higher doses

Two months after the FDA approved Crestor in August 2003, consumer watchdog Public Citizen warned consumers not to use it because of kidney toxicity. The group has asked the FDA to ban Crestor.

Meridia. Graham said that few patients stay on the weight-loss drug very long because extended use can lead to increased blood pressure and stroke. Before Meridia was approved in 1997, an FDA advisory panel voted 5-4 that the drug's benefits did not outweigh its risks. Public Citizen has twice petitioned the FDA to pull it off the market.

Serevent. The Glaxo asthma drug, approved in 1994, dilates breathing passages. In 2003, its label began carrying a "black box" warning, the strongest type of warning, about the results of a large U.S. study that showed a small but significant increase in asthma-related deaths in patients who took Serevent. Advair, another Glaxo asthma treatment, which contains Serevent and a steroid, carries the same warning.

Richard Honsinger, a Los Alamos, N.M., asthma and allergy specialist, says he fielded some calls from worried patients after Graham's pronouncement. He says Serevent only relieves symptoms and should be taken along with a steroid to prevent permanent scarring in the lungs from inflammation.]]> Medical Experts Weigh Safety In Using Five Drugs http://www.yourlawyer.com/articles/read/8890 Fri, 19 Nov 2004 00:00:00 -0800 http://www.yourlawyer.com/articles/read/8890
David Graham, the Food and Drug Administration's associate director of drug safety, testified before a Senate committee Thursday that not only had his agency not given enough weight to safety concerns about the recalled painkiller Vioxx, but he also said regulators should be looking closely at five other drugs.

They are: Pfizer Inc.'s Bextra, a pain reliever in the same class as Vioxx; Crestor, a cholesterol-lowering drug manufactured by AstraZeneca PLC; Meridia, a weight-loss drug made by Abbott Laboratories; the acne drug Accutane made by Roche Holding AG; and Serevent, an asthma medicine from GlaxoSmithKline PLC.

Manufacturers of these drugs on Thursday defended their products, most of which already have the U.S. regulatory agency's "black box" warnings the strongest alert on their labels regarding safety issues. The five drugs Graham said warrant closer scrutiny have been approved as safe and effective by the FDA and "continue to be closely monitored with regard to safety and the balance of benefit to risk," FDA spokeswoman Kathleen Quinn said Friday.

Medical experts say patients taking those medications should not stop doing so without consulting with their physicians. Still, each of the medicines Graham criticized has been controversial. Here is why:

Bextra, in the same chemical class as Vioxx, was shown in a recent preliminary study to double the risk of heart attack and stroke among patients with heart disease, researchers reported at the annual meeting of the American Heart Association. Pfizer had already told regulators it intends to add to Bextra's packaging a black box warning that Bextra can cause potentially fatal skin reactions.

Crestor, a cholesterol medicine, has been linked to kidney failure and potentially life-threatening muscle damage. The consumer advocacy group Public Citizen asked the FDA in August to investigate AstraZeneca, alleging the drugmaker delayed reporting 23 cases of serious side effects. They included 19 cases of muscle weakening or rhabdomyolysis and four incidents of kidney damage.

Serevent, an asthma treatment, carries a boxed warning of a "small but significant increased risk" in asthma-related deaths in patients receiving the drug. The FDA said there were 13 deaths out of 13,174 patients treated for 28 weeks, versus four on placebo. The analysis also suggested the risk may be greater in black patients than Caucasians.

Meridia, an anti-obesity drug, increases blood pressure and heart rates and has been associated with a number of deaths and adverse reactions since it was introduced.

Accutane, an acne drug, can cause brain and heart defects, mental retardation and other abnormalities in babies of pregnant women taking the drug. Roche Holding and generic makers in February started a national registry mandating women cannot get their monthly supply of Accutane without a negative pregnancy test. They are told to use two forms of contraception while taking the drug.

Spokespersons for the five drugs' makers have said they are safe and effective when used as directed.

Public Citizen, founded by Ralph Nader, has asked the FDA to remove Crestor and Meridia from the market. Sidney M. Wolfe, the director of Public Citizen's Health Research Group, said Friday he also thinks Bextra should be pulled from the market.

"All these drugs are very problematic," Wolfe said. He added when people in the FDA like Graham raise questions, "their views are usually squelched. The FDA is too beholden to the manufacturers."

The problems "are generally known within the FDA, but the agency silences people who criticize the drugs or the policies," he said.

Daniel A. Hussar, a professor of pharmacy at University of the Sciences in Philadelphia, said Bextra was the only drug of the five Graham mentioned he thinks should be removed from the market. He said studies have indicated an increased risk of heart attacks and an association with a rare, but potentially fatal, skin reaction.

However, consumers should not be "unnecessarily alarmed" about health risks, he said. "Physician offices have to be overwhelmed with calls, but I think the alarm is excessive. When the drugs are appropriately used, and in appropriate doses, they can be safe."

Pfizer spokeswoman Mariann Caprino said her company is "committed to conducting long-term studies of Bextra" to detect possible problems.

AstraZeneca, maker of Crestor, said it remains "fully confident" the drug is safe. "We have been assured by the highest levels at the FDA that there are no new concerns about Crestor's safety and that Dr. Graham's testimony does not reflect the views of the FDA," said spokesman Steve Lampert.

Laureen Cassidy, a spokeswoman for Abbott Laboratories, said: "Science continues to support the safe use of Meridia to treat obesity, the leading health epidemic in the U.S. Meridia has been extensively studied in more than 100 clinical trials involving more than 12,000 patients throughout the world."

GlaxoSmithKline said Serevent "is safe and effective when used appropriately" and according to labeling guidelines, and it has a "black box" warning on its label.

LaRoche Holdings spokeswoman Carolyn Glynn said Accutane is reserved for "the most serious forms of acne unresponsive to other therapies."

The company and other generic manufacturers have a new national registry to monitor Accutane prescriptions. "This is something we have been very focused on for 23-plus years. It was a surprise to us that we ended up as one of the five drugs," she said. ]]> Weight-Loss Drug Fattens Heart Risks http://www.yourlawyer.com/articles/read/7274 Tue, 23 Dec 2003 00:00:00 -0800 http://www.yourlawyer.com/articles/read/7274
From the drugs introduction in February 1998 through March 2003, the FDA received reports of 49 deaths from cardiac arrest, heart attack, and heart arrhythmia in people who were taking sibutramine. Another 124 people developed cardiovascular conditions severe enough to require hospitalization. The manufacturer, Abbott Laboratories, declined to tell us how many people are taking the drug.

We would like nothing better than to see an effective weight-loss drug, but Meridia is not it, says Larry D. Sasich, Pharm.D., M.P.H., a researcher at Public Citizen. Obese people already are at risk for high blood pressure and heart problems. So, the very people who would benefit most from weight loss face substantial risk from this drug, says Sasich.

Sibutramine encourages weight loss in part by stimulating the sympathetic nervous system, which boosts heart rate and blood pressure. The mechanism is similar to that of amphetamines, as well as nutritional supplements containing ephedra, which have also been linked to cardiovascular problems.

A spokesman for Abbott says that several studies on obesity show significantly higher death rates than the fatalities that occurred with the use of Meridia. That tells us this is not related to drugs, but rather to the underlying disease that these patients have, says James Embrescia, D.O., who monitors product safety for Abbott.

In clinical trials, severely overweight people who used sibutramine for up to a year lost about 9 pounds more than patients who were given a placebo.

Still, the drugs effects on blood pressure and heart rate are exactly the opposite of what would be expected from similar weight loss achieved through diet and exercise. Our medical consultants advise against using this and other weight-loss medications, since none have been tested for more than about two years and none have been proved to reduce the long-term risk of obesity-related illness and death.

Sibutramine should not be used by people with a history of high blood pressure or coronary-artery disease, disorders common in obese people, who may not be aware of their presence. Those who insist on taking the drug should be informed of the risks and have their blood pressure monitored frequently. ]]> Dark Magic http://www.yourlawyer.com/articles/read/6643 Tue, 09 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6643
The public's hunger for weight-loss drugs makes them wildly profitable. But the same demand should increase the diligence of the U.S. Food and Drug Administration in making sure those "magic pills" are safe. Unfortunately, that's never been the case and now the FDA has another diet-pill scandal on its hands.

In 1998, Knoll Pharmaceuticals launched an aggressive, $50 million campaign for a new weight-loss aid called Meridia. The campaign showed smiling, active people, dinner plates with food left on them and a voice-over promising that the drug would help in the quest to eat less and lose weight. "You do your part," the voice-over crooned. "We'll do ours."

Even as the ads aired, however, Knoll Pharmaceuticals and the FDA knew that Meridia was potentially dangerous. In 1996, an FDA advisory committee charged with reviewing Meridia's safety voted 5-4 against approval, finding that it sharply increased blood pressure, leading to a risk of heart attack or stroke. That was particularly disturbing in a diet drug, since obese people already face increased blood-pressure risks.

For these risks, the payoff was relatively small: Weight loss among Meridia users averaged less than seven pounds.

The warnings are proving true. Since 1998, 49 Meridia users many of them young have died from cardiovascular disease, according to health watchdog Public Citizen, which requested FDA records through the Freedom of Information Act. An additional 124 people have been hospitalized for similar problems, and there have been nearly 400 reports of "serious adverse reactions." The drug has also been tied to a small number of birth defects in babies born to women who took Meridia.

Knoll Pharmaceuticals was also invesgated for under-reporting incidents associated with the drug including eight deaths and signed a multi-million consent decree with the FDA in 1999. The same year, the company was ordered to pull the TV and print advertisements that extolled the virtues of the drug, saying they didn't present a fair picture of the dangerous side effects.

The history of this drug raises disturbing questions about the FDA's approval process. Why is Meridia still available? Why was it ever approved in the first place? How much damage is being done by other drugs that should have been reviewed more carefully, and weren't?

The FDA seems to be hoping that the furor will go away or at least, go unnoticed. But pressure continues to increase. Last week, Public Citizen renewed its demand that the drug be banned.

The petition should be granted. But beyond that, the FDA must conduct a serious examination of how these dangerous drugs make it to market in the first place and do a better job of stopping them.]]> Diet Drug Ban Urged http://www.yourlawyer.com/articles/read/6639 Fri, 05 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6639
The Food and Drug Administration also has 54 reports of women who suffered stillbirths, miscarriages or had babies with birth defects while using Meridia, Public Citizen said Wednesday. Among them were four babies born with malformed hearts, similar to defects seen in some animal experiments with the drug.

Women are not supposed to diet during pregnancy, and the drug's label does not mention fetal harm if a woman becomes pregnant while taking Meridia. But Meridia does bear a warning that it can substantially raise some people's blood pressure, so users should be monitored and those with certain health problems should not take it.

Public Citizen's Sidney Wolfe said that warning is not enough. He said the FDA has received reports of 30 more Meridia users who died of heart attacks or cardiac arrest since he first petitioned the agency for a ban in March of last year.

"The number of victims is rising rapidly," Wolfe wrote FDA Commissioner Mark McClellan. "There is no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death."

FDA officials would not comment on Meridia's safety, saying only that they were evaluating Wolfe's petition.

Meridia manufacturer Abbott Laboratories called Wolfe's allegations irresponsible, saying recent re-examinations by European and Canadian regulators concluded the drug is safe.

Obesity itself puts people at serious risk of premature death from heart problems, Abbott noted.

Doctors voluntarily report possible side effects to the FDA, which monitors those reports for signs of drug risks. Filing a report does not prove a drug was to blame; conversely, the FDA says only a small fraction of side effects get reported.

An estimated 10 million people worldwide have used Meridia, which the FDA has called a "moderately effective" weight-loss aid for the obese. Just under 1 million Meridia prescriptions are written annually in the United States, an Abbott spokeswoman said.

Wolfe said in addition to the 49 deaths, 124 users have been hospitalized for serious heart and cardiovascular problems since the drug was approved.]]> Group: Meridia Must Be Banned http://www.yourlawyer.com/articles/read/6640 Wed, 03 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6640
Public Citizen said in a letter to Food and Drug Administration Commissioner Mark McClellan that it reviewed the FDA's database and found 49 cases of deaths from cardiovascular causes among Meridia users. The review covered the period from February 1998, when the drug was launched, through March 2003.

Most deaths occurred in people younger than 50, including two women aged 28 and 30, according to Public Citizen. The Washington-based group also found 124 reports to the FDA of cardiovascular problems that required hospitalization.

In a statement Wednesday, Meridia maker Abbott Laboratories said that obesity itself increases the risk of premature death and cardiovascular problems.

"There were more than a hundred clinical trials" of Meridia, says Abbott spokeswoman Catherine Bryan. "This is one of the most tested products in the obesity category." An estimated 10 million people in 70 countries have taken Meridia, Bryan says.

Obesity experts have said it would be hard to tell whether the drug approved for people 30 pounds overweight or more or obesity contributed to the deaths of Meridia users.

But Sidney Wolfe, director of Public Citizen's Health Research Group, notes that in the studies leading to Meridia's approval, patients on the drug were more likely to have a sustained increase in blood pressure than patients on a placebo. Since high blood pressure itself is a risk factor for heart disease, "that sort of trumps that whole issue that it's just because they're fat," Wolfe says.

Public Citizen also found 54 reports in the FDA database of "maternal drugs affecting fetus" or "complications of maternal exposure" where Meridia was listed as the main suspect drug, even though its label says use during pregnancy is not recommended.

Before Meridia was approved, an FDA staff member reported that animal studies had found cardiac abnormalities in pups born to rats and rabbits given the drug, according to Public Citizen. No such problems were seen in the offspring of animals that did not get Meridia, the group says.

FDA spokeswoman Laura Bradbard says the agency is working on a response to Public Citizen's petitions. "The agency is looking at all of the data," Bradbard says.]]> Consumer Group Renews Attack On Diet Drug http://www.yourlawyer.com/articles/read/6644 Wed, 03 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6644
Also, the Food and Drug Administration has 54 reports of women who suffered stillbirths, miscarriages or had babies with birth defects while using Meridia, Public Citizen said Wednesday. Among them were four babies born with malformed hearts, similar to defects seen in some animal experiments with the drug.

Women are not supposed to diet during pregnancy, and the drug's label does not mention fetal harm if a woman becomes pregnant while taking Meridia. But Meridia does bear a warning that it can substantially raise some people's blood pressure.

Public Citizen's Dr. Sidney Wolfe said that warning is not enough. He said the FDA has received reports of 30 more Meridia users who died of heart attacks or cardiac arrest since he first petitioned the agency for a ban in March 2002.]]> Petition To Ban Diet Drug Renewed http://www.yourlawyer.com/articles/read/6645 Wed, 03 Sep 2003 00:00:00 -0700 http://www.yourlawyer.com/articles/read/6645
Public Citizen, which initially petitioned the FDA regarding Meridia more than a year ago, supplemented its effort with new information from the FDA "adverse event" database through the end of March. In addition to the 49 deaths, Public Citizen said 124 users have been hospitalized for serious heart and cardiovascular problems since the drug was approved.

"There is no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death," the petition said. Many of the newly reported deaths, the petition said, were of people younger than 50.

Sidney Wolfe, director of Public Citizen's Health Research Group, said he had been told that the FDA is studying whether weight-loss drugs such as Meridia, which contain amphetamine-like compounds, cause more heart and cardiovascular disease than other weight-loss medications.

FDA spokeswoman Laura Bradbard said that after the initial Public Citizen petition, the agency began an additional review comparing adverse event reports for Meridia and for Xenical, another major weight-loss drug that doesn't have amphetamine-like components. She said no date had been set for a decision on the petition.

Meridia's manufacturer, Abbott Laboratories, said the drug is safe and has been used by more than 12 million people worldwide. Fewer than 1 million Meridia prescriptions are written annually in the United States, a company spokeswoman said.

"Sidney Wolfe's supplement to the March 19, 2002, Citizen's Petition to the FDA reflects a pattern of irresponsible conduct by Public Citizen," the company said in a statement. "The safety of Meridia has recently been comprehensively re-examined by regulatory authorities, including the European Committee for Proprietary Medicinal Products and Canadian Health authorities, and [they] have concluded that the risk/benefit profile of Meridia remains favorable. Obese patients are at serious risk for premature death and cardiovascular complications."

Because overweight people have a greater risk of heart attack and cardiovascular disease, the debate now is whether Meridia increases that risk. In its safety information on Meridia, the company says that the drug "substantially increases blood pressure in some patients" but also that weight loss with Meridia can decrease cardiovascular risks.

But Wolfe said, "It's clear this drug increases the risk of death."

Meridia has avid supporters, who say it has helped them lose significant weight. But in its petition, Public Citizen said the average weight loss announced at the drug's approval was 61/2 pounds after a year of taking 10 milligrams daily. The petition also said cardiovascular birth defects were reported in four babies born to women taking the drug.

Last year, the FDA reprimanded Abbott for not properly reporting the deaths of patients taking Meridia. The agency said information about seven deaths was not reported properly, one death was not reported at all and reports on three other deaths were incomplete. Abbott acknowledged the error but said it occurred before it owned the drug, which was developed by Knoll Pharmaceuticals. ]]> Abbott Warned On Side-Effect Report http://www.yourlawyer.com/articles/read/1233 Tue, 06 Aug 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/1233
The warning letter marks the second time in three months that the Food and Drug Administration has made public complaints about Abbott's violations of federal side-effect reporting rules.

The violations were uncovered during FDA's spring inspection of Abbott. The agency reiterated the complaints in a warning letter dated July 19 but posted on FDA's Web site Tuesday.

"Although your firm has taken some corrective actions ... you have not addressed many of our concerns," the letter said.

Abbott had previously said one of several deaths among Meridia users went unreported because it was considered "a rumor." But the FDA said that didn't excuse the company from reporting the case so it could be considered.

In three other deaths among Meridia users, Abbott submitted inaccurate information to the government, FDA inspectors concluded.

Other violations included improper reporting of serious reactions among users of the antibiotic Biaxin, the AIDS drug Norvir and the insomnia drug ProSom.

Federal law requires manufacturers to promptly report serious or unexpected reactions among users of their medications so that FDA can investigate whether the drugs are causing unforeseen side effects.

Abbott spokeswoman Jennifer Smoter said the violations raise no questions about the drugs' safety, but that Abbott has begun a new system to ensure proper reporting to FDA. ]]> Group Seeks Charges Over Diet Drug http://www.yourlawyer.com/articles/read/671 Wed, 22 May 2002 00:00:00 -0700 http://www.yourlawyer.com/articles/read/671
In one case, drug industry attorneys ordered a halt to attempts to check another Meridia patient's autopsy — while the Food and Drug Administration was told no further information was available, says the FDA inspection report, written in April.

A consumer group used the report Tuesday to ask the government to bring charges against Meridia maker Abbott Laboratories for illegally withholding risk information.

"The pattern seen by FDA inspectors ... reveals an Abbott scheme to conceal important information that could establish the causal role" of Meridia in certain deaths, Dr. Sidney Wolfe of Public Citizen wrote Health and Human Services Secretary Tommy Thompson, the FDA's boss.

Abbott defended Meridia as safe, calling Public Citizen's allegations "without merit" and "intentionally written to alarm and mislead physicians and patients."

The FDA said it still was trying to determine exactly what happened.

"We're carefully looking at the allegations," said FDA spokesman Lawrence Bachorik. "FDA has inspected that facility and will take the appropriate action if any further action is warranted."

Public Citizen urged the FDA to ban Meridia in March, citing 28 deaths among the drug's users. Wolfe argued FDA's scientific advisers had recommended against Meridia's initial approval because it offered only minimal weight-loss benefits while increasing certain patients' blood pressure and heart rate.

Abbott responded there was no evidence suggesting the drug was to blame for any deaths, noting obesity itself increases the risk of heart problems. Nor has the FDA officially blamed the drug for deaths.

But when it approved Meridia's sale in 1997, the FDA did caution that patients with poorly controlled hypertension, heart disease or irregular heartbeat shouldn't use it.

Wolfe's latest complaint stems from an April 3 FDA inspection of Abbott's Meridia safety database. Inspectors wrote that one death hadn't been reported to FDA, and other "adverse drug information reported to FDA was either not accurate, not supported by source data" or missing key additional facts.

Abbott responded that the allegedly unreported death was a rumor it couldn't substantiate, and that it had "fully responded" to the inspectors' other findings. Regarding FDA's autopsy complaint, attorneys for Knoll Pharmaceuticals — which then owned Meridia — ordered a halt to attempts to get another patient's autopsy records because the doctor and coroner didn't respond to repeated requests for them, said Abbott spokeswoman Melissa Brotz.

FDA was evaluating Abbott's explanations, Bachorik said.]]> Meridia Diet Drug Stroke Side Effects Injury Attorney http://www.yourlawyer.com/topics/overview/meridia Wed, 22 May 2002 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/meridia DOWNLOAD OUR Meridia INFORMATION PACKAGE

Injured by Meridia?

Meridia (generic: sibutramine hci monohydrate) has been linked to side effects such as rapid heart rate, increased blood pressure, heart disease, stroke, seizure and mental impairments. Meridia is a drug that is used to treat obesity by controlling appetite.

Italy has suspended the sale of weight-loss products containing sibutramine, marketed as Meridia in the U.S. by Abbott Laboratories. Italy's Health Ministry said on March 7, 2002 that it was immediately withdrawing all sibutramine products from the market due to 50 reports of health-related problems. Although Italy was the first country to take the drugs off the market, other nations' regulatory bodies have expressed concern about sibutramine. Britain's Drug and Therapeutics Bulletin, published by the Consumers' Association, warned that the weight-loss drug had limited benefits and unwanted side effects.

In addition to the risk of cardiovasular problems, seizures, and mental impairments, it is believed that two women have died as a result of complications from the drug. Abbott Laboratories estimates that 8.6 million people have used sibutramine-based drugs since they were approved in 1997.

If you or a loved one took Meridia and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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