Yourlawyer.com (Mobic News) http://www.yourlawyer.com/topics/overview/mobic Sat, 21 Nov 2009 11:03:25 -0800 pixel-app en Perils of Pain Relievers Often Disguised In Tiny Type http://www.yourlawyer.com/articles/read/9690 Sun, 08 May 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9690
For over a century, aspirin was the pain drug of choice, until data emerged on the rather large number of bleeding-related deaths this time-honored medicine caused each year. In fact, many pharmaceutical experts say that if aspirin had to go through the Food and Drug Administration's approval process today, it would never make it to market.

Along came some dandy substitutes, now also sold over the counter under brand names and as generics: ibuprofen (Advil, Motrin IB) and naproxen (Aleve). Ibuprofen and naproxen, known as nonsteroidal anti-inflammatory drugs, or Nsaids, can equal or outdo aspirin's action against painful inflammation but at less risk of bleeding.

But they, too, can have serious side effects: They can irritate the gastrointestinal tract and possibly cause ulcers. People who use Nsaids chronically are often told to take an anti-acid drug to protect their stomachs.

This problem opened up a market for a new kind of drug called a cox-2 inhibitor, sold as Celebrex, Vioxx, Bextra and Mobic. These drugs are as good or better than ibuprofen for pain, although as patented prescription medications they greatly multiplied the cost of pain relief.

The cox-2 inhibitors were considered safer because they reduced the risks of bleeding and gastrointestinal damage. And as major money-makers, they were heavily promoted, especially to the millions who need relief for chronic problems.

Alas, these too have come under serious fire as their use mushroomed and evidence emerged linking them to heart attacks and strokes among users already at risk for these problems. With many multimillion-dollar lawsuits looming, Vioxx was the first to be withdrawn from the market, recently followed by Bextra. Both drugs may come back, accompanied by more stringent warnings. Or their cox-2 cousins, Celebrex and Mobic, may join the ranks as drugs gone by.

Problems also accompany other prescription painkillers, like the opioids.

This brings us to an entirely different drug, acetaminophen, long used to counter fever and occasional aches and pains such as tension headaches. But now acetaminophen is being hailed as an excellent first choice for the relief of chronic pain.

Acetaminophen, often referred to by its most popular brand name, Tylenol, has no anti-inflammatory action. Nor does it cause bleeding or gastrointestinal distress. Many pain specialists say it should be considered first for relief for the persistent pain of osteoarthritis and prolonged pain of muscle or joint injuries.

All in all, acetaminophen is a safe drug for children and adults. Despite the many millions of doses taken by Americans each year, few reports of serious side effects emerge when acetaminophen is used in the dosages recommended by manufacturers.

For example, in a study published a decade ago evaluating the experience of 28,130 children who had taken acetaminophen, there was no increased risk of gastrointestinal bleeding, kidney failure, life-threatening allergic reactions or Reye's syndrome, a potential fatal side effect of aspirin when given to children with viral infections.

Acetaminophen is also considered safe for women who are pregnant or breast-feeding, although they are advised to check first with their doctors. And acetaminophen is the pain reliever of choice for those with serious allergies who may be at risk of severe allergic reactions from aspirin and Nsaids.

Perhaps as a testament to its safety, acetaminophen is found not only on its own in a variety of dosages, but also in combination with other medications, over the counter and prescription. If consumers are unaware of its presence in different medications, or if they fail to adhere to cautionary statements about dosages, it is possible to take too much acetaminophen inadvertently.

As with any other medicine, with acetaminophen it is critically important to keep in mind this irrefutable adage: The dose makes the poison.

For example, no one questions the safety of following recommended doses. If you can read the fine print on the label, it will tell you that for adults and for children 12 and older, two 500-milligram tablets or capsules can be taken every four to six hours, as long as no more than eight tablets (a total of 4,000 milligrams) are taken in a 24-hour period unless a physician says otherwise.

Taking more than 4,000 milligrams a day of acetaminophen on a chronic basis can damage the liver of an adult. The danger dose would be far smaller for young children.

It is easier than you may think to take more than 4,000 milligrams a day. With the higher-dose tablets (650 milligrams each) now sold to treat arthritis, you can easily exceed the safety limit if you do not follow the instructions to take two tablets every eight hours, for a maximum daily dose of six tablets in 24 hours, adding up to 3,900 milligrams a day.

Even if you follow these directions, you can exceed the recommended daily dose if you also take another medication say, an over-the-counter cold or flu remedy that contains acetaminophen.

The label on Tylenol Arthritis Pain has a clearly stated warning: "Do not use with any other product containing acetaminophen." But without a magnifying glass, many elderly people who are the most likely users of an arthritis drug would have trouble reading the labels on this and many other medicines like it.

A second warning on acetaminophen says: "If you drink three or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage."

So, if your liver is already under attack from alcohol, acetaminophen can be that last straw, resulting in liver failure.

This year, the journal Emergency Medicine warned physicians about the hazards of overdoses of acetaminophen. Dr. Shirley Kung and Dr. Kennon Heard wrote that acetaminophen poisoning could often be much worse than it seemed at first.

Nausea and vomiting can progress to complete liver failure in as little as 24 hours unless the problem is promptly recognized and the proper antidote given within 24 hours of a toxic dose. To fully prevent liver injury, the antidote should be given within eight hours.

Each year, more than 100,000 calls related to acetaminophen are made to poison control centers in the United States, and about 150 acetaminophen-related deaths are reported. Some cases result from deliberate overdoses by people trying to commit suicide. But many others are accidental, like the one described in the journal: an 18-month-old child with a fever and cough for three days who had been given acetaminophen every two to four hours.

Other cases result when people whose livers are damaged by other disease take acetaminophen for respiratory infections or pain.]]> Caution Urged On Alternative Painkillers http://www.yourlawyer.com/articles/read/9441 Tue, 08 Mar 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9441
Prescriptions for Mobic have tripled since September, when the maker of Vioxx voluntarily withdrew the COX-2-inhibiting painkiller because of findings of heart problems. Immediately, the maker of Mobic began courting former Vioxx users, through ads and company representatives' visits to doctors.

The marketing push paid off, making Mobic the fastest growing prescription drug for arthritis. Its share of new prescriptions soared from 5 percent to 19 percent, as of last month.

Weighing benefits, risks

But is Mobic safer than Vioxx, Bextra or Celebrex, which are all COX-2 inhibitors? Some researchers and doctors have expressed doubts. They say Mobic (meloxicam) and several other painkillers may actually work in similar ways and pose similar risks.

"I think they need to be looked at more closely," says University of Texas Southwestern gastroenterologist Byron Cryer, an expert on painkiller risks. "These drugs are getting a get-out-of-jail-free card."

Last month, a Food and Drug Administration advisory panel decided Vioxx, Bextra and Celebrex have significant cardiovascular risks, recommending the agency limit their use, but not recommending removal from the market. FDA action is expected within weeks. Agency officials say that as part of a review of all non-steroidal anti-inflammatories (NSAIDS), they are examining Mobic and similar drugs.

Researchers and public health advocates generally mention five drugs as potentially in the COX-2 inhibitor class: Mobic, diclofenac, etodolac, nabumetone and nimesulide.

Elsewhere, officials have gone further. Australia's drug regulatory agency, the Therapeutic Goods Administration, has placed Mobic in the COX-2 family.

"Meloxicam should not be prescribed for patients with increased risks of cardiovascular events such as heart attacks, and treatment should be limited to the shortest time needed," said University of Sydney Professor Dr. Martin Tattersall.

Vioxx, Bextra and Celebrex are classified as COX-2 inhibitors because they block the cyclooxygenase-2 enzyme. (All anti-inflammatory drugs block this substance, but the so-called COX-2 inhibitors do so more selectively.) When the COX-2 inhibitors first appeared in the late 1990s, pharmaceutical companies aggressively marketed them, emphasizing that the medicines seemed to have fewer gastro-intestinal side effects than older painkillers. The new products became top sellers.

New drugs are COX-2 blockers

Last fall, however, being a COX-2 inhibitor became a liability. Several studies found that the drugs raised the risk of heart attack and stroke. It turns out that the COX-2 enzyme has a dual role: It triggers pain and inflammation, but it also seems to protect the heart, perhaps by keeping blood thin or lowering blood pressure. So blocking it can decrease pain, though perhaps with a price.

Vioxx, Bextra and Celebrex aren't the only drugs that selectively inhibit the COX-2 enzyme. Researchers say that Mobic and some other painkillers, such as diclofenac, are also strong COX-2 blockers, even though they haven't been marketed as such.

Referring to Mobic and diclofenac, University of Pennsylvania pharmacologist Garrett FitzGerald said they would likely turn out to be "Celebrex in sheep's clothing." FitzGerald, also a cardiologist, is an expert on COX-2 inhibitors and heart disease.

The drugs' makers say their products are safe. "We are confident in Mobic. We have observed no trends that indicate an increased risk," said John Yonsky, a spokesman for Boehringer Ingelheim Pharmaceuticals, the German company that makes the drug and, along with Abbott, markets it in the United States.

Wyeth Pharmaceuticals spokesman Lowell Weiner defended etodolac, which is sold by the company under the name Lodine.

"Lodine is a non-steroidal anti-inflammatory drug. It is not a COX-2 inhibitor," he said. "Wyeth stands by the safety of Lodine." Most of the attention has so far focused on Mobic and diclofenac, which is sold as Voltaren. At the FDA's COX-2 hearing, FDA safety officer Dr. David Graham singled out Mobic.

Mobic as risky as Vioxx?

In a study that has yet to be published, he and a collaborator examined heart attack risks among 650,000 Californians taking pain relievers. They found that Mobic appeared to be as risky as Vioxx, which is generally seen as the COX-2 inhibitor that is the most dangerous to the heart.

Graham emphasizes that one study is not enough to prove that a drug is dangerous, yet says the results should encourage cautious use and more research: "If you've got lots of people using it, you want to find out if it's safe."]]> Fresh Warning Issued For Painkillers http://www.yourlawyer.com/articles/read/9380 Tue, 22 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9380
After reviewing the cardiovascular safety of the Cox-2 inhibitors, Celebrex, Arcoxia, Mobic, Bextra and Dynastat, Ministry of Health officials have concluded the risk of heart attack and stroke outweighs the benefits of the drugs.

People who are at high risk of "cardiovascular events" should see their doctor and switch to a different medication, the ministry says.

Ministry spokesman Dr Stewart Jessamine says those most at risk are people with a history of heart attack or stroke; a strong family history of heart disease; a history of diabetes; smoking; hypertension or who are on treatment for high cholesterol.

This latest warning is a result of a review by the ministry's medicines regulator, Medsafe, into the safety of Cox-2 medicines. Last October, a worldwide recall of the drug Vioxx was issued after international studies found it was associated with an increased risk of heart attack and stroke.

Since October, Medsafe has looked at data on the safety of Cox-2 drugs and concluded that their safety can't be guaranteed. Similar reviews by health experts in Australia, Europe and the US reached the same conclusion.

"There is still not enough information to quantify the risk associated with each of these medicines, or to determine which patients are at increased risk or whether aspects of treatment such as dose or duration of use affect the degree of risk," Jessamine says.

Cox-2 drugs are a relatively new type of anti-inflammatory medicine used to relieve pain, swelling and inflammation. These drugs also cause fewer stomach problems.

A final decision on the drugs will be made after March 15, when a medicines advisory committee will meet to consider the officials' findings, any new data, and submissions from the drug companies, doctors and patients.]]> Vioxx Alternative Risky, Official Says http://www.yourlawyer.com/articles/read/9361 Fri, 18 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9361
Graham said a large new study he and a colleague had just completed, which FDA officials initially did not want him to present because it was preliminary, indicates that the anti-inflammatory drug is a "bad actor."

Mobic is now the top-selling prescription arthritis painkiller, and the manufacturer strongly defended its safety record Thursday.

Graham, who was the star witness at an earlier Senate hearing into the withdrawal of Vioxx and the FDA's monitoring of drug safety, again delivered dramatic and controversial testimony Thursday.

In addition to strongly questioning the safety of Mobic, Graham said the cardiovascular risks of taking higher doses of COX-2 inhibitors are comparable to the dangers posed by smoking, high blood pressure and diabetes.

He said he did not see any good reason for consumers to use drugs in the class now that evidence is becoming more convincing that they all increase the risk of heart attacks and strokes and may not provide better pain relief than older analgesics such as ibuprofen, naproxen or aspirin.

Graham's conclusions about COX-2 drugs were supported by many other speakers at the FDA-convened conference, including some who studied COX-2 drugs that are still under development.

At the end of the unusual three-day session today, the expert panel is scheduled to recommend to the FDA whether it should issue warnings about COX-2 drugs or possibly restrict their use.

The difficult decisions facing the panel became increasingly clear with Graham's critique of Mobic and impassioned pleas from arthritis sufferers not to deprive them of drugs that relieve their pain.

Many said the experts are focusing too narrowly on drug risks and minimizing their benefits.]]> FDA Scientist Sees Problems With Entire Class Of Painkillers http://www.yourlawyer.com/articles/read/9362 Fri, 18 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/articles/read/9362
Graham, testifying on his findings on the safety of several painkillers widely used by arthritis patients, also raised the possibility of cardiovascular risk in taking Mobic, or meloxicam. The top-selling drug is from a more traditional class of anti-inflammatory medications.

The remarks by the FDA medical officer came on the second day of hearings by a joint panel of two advisory committees examining an entire class of painkilling drugs, Cox-2 inhibitors. The session at a hotel conference room here drew patients who urged the panel to continue to make the drugs available so they and their doctors can weigh the benefits and risks.

The advisory panel, composed of arthritis and drug safety experts, is expected to make a recommendation to the FDA today on whether to restrict or ban Cox-2 inhibitors such as Celebrex and Bextra. The two drugs, both made by Pfizer, remain on the market in the United States. Vioxx, which Merck voluntarily withdrew last fall, showed an increased risk of cardiovascular problems at all dosages.

Making clear that he was speaking for himself and not the FDA, Graham said he believed all drugs that work by suppressing the Cox-2 enzyme associated with inflammation are risky to the heart.

"I believe there is a Cox-2 effect, and that it is dose-dependent," said Graham, who made headlines in November by telling a congressional panel that the FDA was not able to protect the public against dangerous drugs such as Vioxx.

Pfizer, the maker of Celebrex, has defended it as "an effective and safe therapy."

Meanwhile yesterday, the European Union's public health officials concluded after four days of meetings in London that the entire class of Cox-2 drugs caused an increased risk of cardiovascular problems. They immediately imposed restrictions.

The European Medicines Agency said doctors should not prescribe Celebrex, Bextra or Merck's Arcoxia, which hasn't been approved in the United States, for patients with a history of heart disease or stroke.

They told doctors not to prescribe Arcoxia for patients with high blood pressure and instructed doctors to keep the dose as low as possible and prescribe the drug for the shortest treatment time possible.

In the hearing here yesterday, Graham also said he had concluded there was no need for the Cox-2 drugs, including Celebrex and Bextra, because they didn't seem to be easier on the stomach than older anti-inflammatory drugs. The newer drugs were originally billed as being gentler, but the FDA found only Vioxx to have such a gastrointestinal benefit.

Since Vioxx has been off the market and doctors have become wary of other Cox-2 drugs such as Celebrex, Mobic emerged in the last month as the No. 1 non-steroidal anti-inflamatory drug in the country for new prescriptions. It has been used worldwide by 11 million people since 1996 and in the United States since 2000.

Graham's findings about the drug were from a new study he co-authored with Stanford University adjunct professor of medicine Gurkirpal Singh. The study of California Medicaid beneficiaries has not yet been peer-reviewed or published. Graham had originally been asked by his FDA superiors to refrain from presenting it because of its preliminary status.

John Yonsky, a spokesman for Boehringer Ingelheim, the maker of Mobic, said the company had not heard before of any assertion of increased risk of heart problems with its drug.

"We have observed no trends in post-market studies that would indicate that increased risk." Yonsky said it was impossible to respond to Graham's charges because they were based on preliminary, unpublished data he had not seen.

Graham said the preliminary data from his study also showed an increased risk of cardiovascular problems in the drug indomethacin, marketed by Merck as Indocin, calling it "a bad actor." The drug is often used to treat acute gout.

Noting that the data Graham presented were from an unpublished study, Merck spokeswoman Casey Stavropoulos said the company has not had a chance to review his findings and could not comment further.

Asked by some of the panel members for guidance on deciding how to deal with the more traditional painkillers, given the fact that some of them suggest risks, Graham said his own advice would be to look at all the drugs individually.

"Weed the garden of the bad actors," he said. "Try to identify drugs that, based on the evidence we have, appear to be less risky, and then, in a rational way, shift the market toward them."

Doctors on the advisory panel said that in weighing the risk of the drugs against the benefits the key question they must consider in deciding what to recommend to the FDA they had to consider how much their patients rely on the drugs.

Dennis W. Boulware, rheumatologist at the University of Alabama, asked Graham whether he thought there were cases where the clinical benefit of the drugs made the risk acceptable: "For patients I see, not giving them any of these drugs will confer a great deal of risk on them and physical impairment."

During a session reserved for public comment, patients who rely on the Cox-2 drugs and doctors pleaded with the panel to keep them easily available.

"I am a standing benefit, in front of you," said Amy Leong, a health care consultant and arthritis sufferer. "It's my choice to work with my physician to determine what's at higher risk for me and what is not."

Judith Fogel of Ithaca, N.Y., said that after suffering for years with arthritis she started on Celebrex three years ago and now on most days feels "better than I did 30 years ago."

"I feel like Celebrex was created for me," she said.

An army doctor even told the panel that soldiers depend on Cox-2 painkillers because of the concern about excess bleeding associated with more traditional drugs such as aspirin. Dr. Christopher Grubb said drugs such as Celebrex are "essential to the global war on terrorism."]]> Mobic Heart Attack Stroke Blood Clot Bextra Vioxx Side Effects Attorney http://www.yourlawyer.com/topics/overview/mobic Fri, 18 Feb 2005 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/mobic DOWNLOAD OUR Mobic INFORMATION PACKAGE

Injured by Mobic?

Mobic (Generic: Meloxicam) carries a greater risk of heart attacks in early data than found with Merck & Co.'s Vioxx, a veteran U.S. Food and Drug Administration scientist told an FDA advisory panel. The drug, manufactured by Boehringer Ingelheim Pharmaceuticals, exhibited the effect in a new study that has yet to be published, said David Graham, associate director for science and medicine at the FDA's Office of Drug Safety.

"We found an increased risk," Graham said. "It's one study. It's the only study." Mobic has become the top-selling prescription pain drug since Merck pulled Vioxx in September 2004, and any possible heart attack risk is important as more patients take the drug, Graham said. Graham, along with other scientists outside the FDA, analyzed data from California's Medicaid program of more than 15,000 heart attack patients, making it the largest study to date on such risks. They found the statistical risk of heart attack was 1.37 for Mobic, compared to 1.32 with Vioxx and 1.09 with Celebrex.

Celebrex, Bextra and Vioxx, are part of a class called Cox-2 inhibitors, a newer type of non-steroidal anti-inflammatory drug (NSAID). Mobic is classified as a Cox-2 in some countries but is not considered part of that group in the United States, where it’s only classified as part of the larger NSAID class.  Abbott Laboratories, which co-markets Mobic in the United States, said it expects U.S. sales of the drug to hit $1 billion in 2005.

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