Vioxx. Celebrex. Now Aleve. What's a Patient to Think?
December 28, 2004 14:52

Ms. Eisen, 64, a retired professor who lives in New York, had just returned from her drugstore with a package of Aleve. Her pharmacist allowed her to return it the next morning, no questions asked.

It was the third painkiller in four months that Ms. Eisen, who has degenerative spine and disk disease, had quit abruptly because of studies linking the drugs to heart attacks. She flushed her Vioxx down the toilet in September, after it was withdrawn from the market, and switched to Celebrex. But when problems surfaced with Celebrex this month, she had to stop that, too.

"I was extremely angry," said Ms. Eisen, whose father, two uncles, and grandparents died of heart disease. "Now I just don't trust the Food and Drug Administration anymore. I told a friend of mine, who had also been on Celebrex, that I was sure there'd be some other surprise in a few days."

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

The momentum for FDA reform is driven by the recent parade of drug problems dominating the nation's front pages, including antidepressants that heighten suicidal thoughts and behaviors among children, and the painkillers naproxen, Bextra, Celebrex, and Vioxx increasing the risk of heart attacks or strokes.

"Each one of these drugs has affected another large group of Americans and, collectively, the spotlight is now shining on the FDA -- more than any other federal agency -- as one in need of reform," said US Representative Edward J. Markey, Democrat of Malden. "I think Congress will be forced to act in the same way that Enron and MCI Worldcom forced an overhaul of the accounting industry in America."

On Thursday, the FDA issued a public health advisory cautioning doctors to restrict Bextra and Celebrex prescriptions to fewer patients, including those at high risk for gastrointestinal bleeding. From January through October this year, doctors wrote 30.7 million prescriptions for those drugs, according to IMS Health, a pharmaceutical information company. The agency did not change either drug's label or remove either drug from the market.

And US Senator Charles Grassley, an Iowa Republican, will introduce legislation to create an office of drug safety independent of the FDA. Markey is eyeing ways to speed the slow pace of safety studies that drug companies promise in exchange for swift FDA approval.

US Senator Edward M. Kennedy, a Democrat working with Republican US Senator Michael B. Enzi of Wyoming, is contemplating widespread FDA reform to bolster the safety of drugs once they're used by millions of Americans. The legislation, still under discussion, would increase the FDA's budget to conduct stepped-up drug safety surveillance.

Epidemiologists would scour massive databases -- such as health records kept for 8.2 million members of Kaiser Permanente, the nation's largest HMO -- to track side effects as drugs are used widely. When the epidemiologists spot a worrisome trend, as they did with Vioxx, targeted studies would look to find the drug's role in causing that side effect.

In addition, Kennedy is keen to add the force of law, so the FDA can require postmarketing safety studies that companies promise, but few complete. Full Story

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

Pfizer Inc. said it found an increased risk of heart attacks and strokes for patients taking high dosages of its top-selling arthritis painkiller Celebrex, the same problem that led to the withdrawal of its one-time competitor Vioxx.

The company said it has no plans to remove Celebrex from the market, but the disclosure on Friday sent Pfizer's shares tumbling because of fears that it could cripple sales of what had been the most-prescribed drug for treating arthritis.

Acting FDA Commissioner Lester Crawford said the government is advising physicians to consider prescribing drugs other than Celebrex to their patients.

"We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," said Crawford, during a press briefing. "We do have great concern about this product (Celebrex) and the class of products."

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC

Pfizer Inc. said it found an increased risk of heart attacks and strokes for patients taking high dosages of its top- selling arthritis painkiller Celebrex, the same problem that led to the withdrawal of its one-time competitor Vioxx.

The company said it has no plans to remove Celebrex from the market, but yesterday's disclosure sent Pfizer's shares tumbling because of fears that it could cripple sales of what had been the most-prescribed drug for treating arthritis.

Acting FDA Commissioner Lester Crawford said the government is advising physicians to consider prescribing drugs other than Celebrex to their patients.

"We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," said Crawford, during a news briefing. "We do have great concern about this product (Celebrex) and the class of products,"

Doctors are struggling to decide which pain relievers to prescribe... drugs like Vioxx and Celebrex pose potentially serious heart risks. ... the Kaiser Permanente health plan have been sharply limiting their use of Vioxx and Celebrex.... Vioxx, Celebrex and a related drug, Bextra, did not work any better than older pain relievers or provide any safety benefits beyond them....

"The pressures to prescribe are enormous," Dr. Matteson said. "You constantly have people at your door."... effectiveness of various procedures and drugs used to treat 10 of the most common health conditions, including stroke, arthritis, pneumonia, diabetes and ulcers. ... studies have linked Vioxx, Bextra and Celebrex - all of which are in the class of drugs known as COX-2 inhibitors - to increased heart risks under certain conditions. In late September, Vioxx was withdrawn from the market by its manufacturer, Merck. Pfizer, the maker of Bextra and Celebrex, continues to sell both drugs but has limited marketing.... Because responses to pain relievers varies among individuals, ... others doing similar studies decided that Vioxx, Celebrex and Bextra did not relieve arthritis-related pain any better than other drugs they had been tested against, like ibuprofen, which is also a nonsteroidal anti-inflammatory drug, or Nsaid.

... Vioxx showed the strongest evidence of reducing the incidence of stomach bleeding associated with older Nsaids. Stomach bleeding is a problem that is generally limited to older patients or those with a history of gastrointestinal problems. ... prescribing of COX-2 drugs by doctors ... Doctors working for the Veterans Affairs Department have been curtailing their use of COX-2 drugs since late 2001.... Kaiser Permanente, which also sharply limited its COX-2 prescriptions, saved money. Their actions may have also saved lives. A study conducted by an F.D.A. researcher that was released in September found that Kaiser patients relied on high doses of Vioxx, which can increase the risk of heart attacks, less than half as often as the general population.

... last month in a medical journal, Gastroenterology, found that the rate of stomach bleeding caused by etodolac was substantially lower than that caused by naproxen and comparable to that of Vioxx. ... Dr. David Campen, a medical director at Kaiser, said that his organization had not yet changed its prescribing guidelines for Celebrex, ... The Mayo system, ... has decided to reduce its use of the COX-2 drug even further. ... Previously, any patient over 60 qualified for Celebrex...
NY TIMES

Ask Monheit Law, "Do I have a Celebrex Case?"

For more information, contact:
Michael Monheit, Esquire, Monheit Law, PC