Procrit

J&J's anemia med linked to stroke deaths

Tracy Staton — Mon, 29 Sep 2008 11:22:32 -0400

The FDA is sifting safety data on Johnson & Johnson's epoetin drug, which has come under a red flag thanks to a German stroke study. The study was testing high doses of Eprex (sold in the U.S. as Procrit) as a treatment for stroke patients. But it turns out that patients taking the J&J anemia drug appeared more likely to die than patients treated with placebo were. Some 14 percent of the Eprex patients died, versus 9 percent of the control group.

J&J took a proactive stance on this data: It notified the FDA of the findings last week. Now, the agency is taking a look at the German trial. It's also going to monitor several other ongoing trials that are testing the neurological effects of epoetin alfa, which also is sold by Amgen under the name Epogen.

As you know, this isn't the first time anemia drugs have come under the safety spotlight. In July, the FDA added warnings to this class of meds, aimed at limiting their use in cancer patients. Studies had shown that the drugs might cause tumors to spread and raise the risk of bleeding, too. Patients whose cancer is curable shouldn't use them, an FDA advisory panel said.

- read the story from US News
- see the Forbes article

Procrit linked to deaths in stroke trial

Tracy Staton — Thu, 18 Sep 2008 10:26:03 -0400

Another potential safety problem for anemia drugs: Johnson & Johnson announced that Procrit was linked to the deaths of some patients in a stroke study. Participants in the European trial were given Procrit (Eprex in Europe) or placebo within six hours of an ischemic stroke, on the theory that anemia drugs might help stroke patients recover. But according to preliminary study data, more patients in the Procrit group died.

J&J says it has reported the data to European regulators and the FDA, and that it's further analyzing the data. The German scientist who designed the study said he plans to publish the results "promptly."

As you know, Procrit is one of the epoetin alfa drugs that's been dogged by safety concerns for about a year now. Strong warnings of heart complications and tumor growth--especially at high doses--have been added to the drugs' labels. The FDA has also limited their use, ruling out the treatment for cancer patients who might be cured, and for patients with certain types of cancer.

So why test it in stroke patients? The German study leader had done previous research that yielded a more positive result. We'll see how the data analysis goes.

- check out Ortho Biotech's release
- read the story in the Washington Times

Anemia meds get tougher warnings

Tracy Staton — Thu, 31 Jul 2008 09:59:41 -0400

The labeling on Amgen and Johnson & Johnson's anemia meds is about to get even more restrictive. Using its new authority to force label changes, the FDA is ordering the drugmakers to say the drugs shouldn't be used in chemotherapy patients whose cancer might be cured. The new label will also say that the drugs shouldn't be given when hemogrlobin levels are 10 grams per deciliter or more.

The label changes follow an FDA advisory panel meeting in March, when experts recommended usage limits--and another not adopted, that any patients with breast or head-and-neck cancers avoid the drugs. According to the Wall Street Journal, Amgen and the FDA had been negotiating new label language, but failed to come to an agreement.

You'll recall that a debate has been raging for months about the safety of these meds, which Amgen markets as Epogen and Aranesp, and J&J sells under the Procrit name. Medicare set up some restrictive guidelines for their use, saying it wouldn't reimburse for the meds outside those parameters. Given that Medicare's hemoglobin threshold was 10 grams per deciliter, it's unlikely that the new warnings will help loosen its purse strings.

- see Amgen's release
- read the WSJ story
- check out the article in the New York Times

EMEA advises against anemia meds

Tracy Staton — Fri, 27 Jun 2008 09:32:17 -0400

European regulators are taking a stand against anemia drugs. The European Medicines Agency says cancer patients with a "reasonably long life-expectancy" should get blood transfusions instead of taking the meds, such as Amgen's Aranesp and Johnson & Johnson's Eprex (sold in the U.S. as Procrit). The EMEA guidance follows an FDA advisory committee's recommendation that the drugs shouldn't be given to cancer patients who might be cured. That's because some studies found a link between the drugs and tumor growth.

Analysts were "somewhat surprised" by the EMEA's "aggressive stance" on the meds, the Wall Street Journal Health Blog notes. No doubt it will further erode sales of the drugs, which already have taken a beating because of safety concerns. In Europe, half of anemia med use is in cancer patients, and some 40 percent of those patients could be affected by the EMEA warning.

- read the Health Blog item

Drugmakers to delay new-drug ads

Tracy Staton — Tue, 17 Jun 2008 09:25:00 -0400

There's a waiting period for marriage licenses, IPOs, and flood insurance--and now, drug advertising. Several big drugmakers called on the Congressional carpet for their advertising campaigns now say they'll wait six months after FDA approval to start touting new meds to the public. They also said they'd follow AMA guidelines for using actors to play doctors on TV.

But Michigan Dems Bart Stupak and John Dingell aren't satisfied with these concessions. They'd asked for a two-year waiting period, for one thing. And as Merck explained in a letter to the House Committee on Energy and Commerce, a six-month quietus after FDA approval is already somewhat customary, because drugmakers like to educate docs about new products before driving patients into their offices with DTC ads. The committee also had asked the companies to advertise drugs only when they've proven effective in outcomes studies.

You'll recall that Stupak and Dingell have been breathing down pharma's neck all year, with hearings on everything from clinical trials to outsourcing to, of course, DTC advertising. The DTC hearing focused on Pfizer's Lipitor ads starring artificial-heart inventor Robert Jarvik, on Johnson & Johnson's commercials for the anemia treatment Procrit, and Merck and Schering-Plough's food-and-family ads for their combo cholesterol med Vytorin.

- see the committee's statement about the six-month wait
- check out the Advertising Age story
- find the post at the Wall Street Journal Health Blog

New drug-spending leader: Diabetes

Thu, 15 May 2008 06:59:58 -0400

New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, for one thing; generic competition is reining in cholesterol costs even as usage of the meds is increasing. Meanwhile, there's been growth in overall diabetes-drug use, and a shift toward pricier treatments, boosting 2007 spending by 12 percent. Overall drug spending grew by only 2 percent last year as patients used more generics.

Plus, safety concerns affected spending on antidepressants, hormone replacement therapy, and anemia drugs, Medco Health Solutions reports. Safety warnings on Procrit, Epogen, and Aranesp depressed sales by 15 percent, while hormone replacement therapy usage dropped by 9.2 percent. Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market.

A separate report from IMS Health showed that the global market for cancer meds is advancing by leaps and bounds, twice as fast as the growth in all other pharmaceuticals. As emerging countries spend more on healthcare, they're investing more in cancer treatments; they're expected to power up spending on these meds by 12 to 15 percent a year through 2012. The overall global drug market, by contrast, is expected to grow by 6.4 percent.

- find the news at the Wall Street Journal Health Blog
- see the Pharmalot item
- check out the story from the Associated Press
- read the article at CNN Money

Did FDA counsel save Procrit ads?

Tue, 13 May 2008 06:59:56 -0400

Remember that DTC hearing in Congress last week, when Rep. Bart Stupak alleged that Johnson & Johnson kept pushing its anemia drug Procrit as a fatigue-buster, despite the FDA's admonitions? Testimony on the subject came with a bunch of documents, which The Cancer Letter dug through--to find that the FDA's chief counsel may have intervened on J&J's behalf to keep the ads on the air.

The agency had questioned J&J's advertising, saying its implication that Procrit improved strength and perhaps survival was misleading. Somewhere along the line, the Office of Chief Counsel became involved; notes from a 2002 teleconference show that the OCC asked the staff to "try to find middle ground" and to avoid "yanking" the ad campaign. (The chief counsel at the time of the teleconference is now in private practice.) The ads continued to run through 2005. Experts told The Cancer Letter that they think the episode should be reviewed by agency ethics officials.

Meanwhile, a Government Accountability Office report shows that the FDA drags its heels on issuing warning and untitled letters about DTC ads: Six months on average, and in one case, more than three years. Before 2002, when the FDA decided to submit all draft letters for legal review--by the Office of Chief Counsel--they went out in less than a month.

- find the GAO report here
- see the brief in The Cancer Letter
- get more from Pharmalot
- check out the article at FDA News

AMA calls for tighter DTC regulation

Fri, 09 May 2008 06:59:57 -0400

We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. We expected Chairman Bart Stupak to call for tighter controls on the ads. What we didn't expect was for the American Medical Association to join the fray. President-elect Nancy Nielsen told lawmakers that the FDA should be given more authority to pre-approve DTC ads. Striking directly at drugmakers' usual defense of the ads as "educational," Nielsen said, "It is frankly clear that the majority of what's happening has a marketing effect and not an educational effect."

Nor did we know that the feds' own watchdog, the Government Accountability Office, would say the FDA isn't completely effective at regulating those ads; the agency takes more than six months to issue warnings about ads that violate the rules.

During the hearing, ads such as those for Merck/Schering-Plough's Vytorin and Johnson & Johnson's Procrit were called misleading and not completely truthful. Pharma officials struck back, saying that the claims made in those ads were "supported by research" (M/S-P) and "true, responsible, and substantiated by scientific studies" (J&J). And Republicans on the committee said the (unfunded) standards Congress set last year for drug commercials should be paid for and given a chance to work.

- read the AMA's press release
- see the story from ABC News
- check out the USA Today piece
- read the Star-Ledger article

ALSO: The feds need to add rules governing drug product placements, too, according to a report from University of California-Los Angeles researchers. Report

Will DTC hearing lead to new regulation?

Thu, 08 May 2008 06:59:56 -0400

Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak (photo) hopes. The chairman of the House Energy and Commerce's subcommittee on oversight says he'd like to tighten controls on drug marketing to consumers. For one thing, he'd give the FDA power to force changes in TV ads before they're aired.

Of course, Congress has tried before to stiffen DTC rules, but the TV industry--which reaps billions from the ads--and pharma lobby have fended off those changes. But several recent controversies may aid the reform cause this time. Merck and Schering-Plough have drawn fire for heavily promoting their Vytorin cholesterol drug while dragging their feet on data that questioned its effectiveness. Pfizer pulled its Lipitor campaign when critics assailed its use of artificial-heart inventor Robert Jarvik. And then, says Stupak, there's Johnson & Johnson, which advertised its anemia med Procrit as an anti-fatigue drug, a use for which it was not approved. The FDA repeatedly asked J&J to revise those commercials, but the company didn't. Stupak told the Wall Street Journal: "They advertised this for seven years."

J&J disputes that assertion, saying that the commercials were accurate and consistent with their FDA-approved labeling at the time. But expect to hear more argument of these points during today's hearing, which you can watch on the committee's website, among other places.

- see the Wall Street Journal article
- find the video link at the committee website

J&J laying off 400 in marketing overhaul

Wed, 30 Apr 2008 06:59:56 -0400

With Procrit under siege, Johnson & Johnson wants to divert its promotional efforts elsewhere--a strategy that will lead to some 400 job cuts in its sales-and-marketing ranks. The company told employees it would consolidate sales-and-marketing operations of Ortho Biotech and Centocor and shave the payroll accordingly.

With Procrit sales sinking ever since the FDA put new safety warnings on its class of anemia drugs, J&J wants to "free up resources that can be redeployed to opportunities that will make the greatest difference to patients and to our own future success as a business." Translation: Heavily marketing Procrit won't help that drug, so why not concentrate sales efforts somewhere we can see some ROI?

- read the Star-Ledger article

Congress probes Amgen, J&J promos

Tue, 01 Apr 2008 07:59:55 -0400

Did Amgen and Johnson & Johnson over-promote their anemia drugs? Congress is asking the companies for documents detailing their advertising and promotions, including a "bundling" discount Amgen allegedly offered to doctors on Neupogen and Neulasta in return for Aranesp scrips. "We are concerned that such 'bundling' practices may have helped fuel excessive and dangerous off-label use of Aranesp," Rep. John Dingell wrote to Amgen in a letter demanding the documents.

Meanwhile, Dingell's Energy and Commerce Committee is also asking J&J for records on its DTC ads for Procrit, which claimed the med could offer "strength for living."

The ad/promo investigation comes at a time when the anemia drugs have been under scrutiny for safety risks. The meds have been linked to increased risk of death at high doses, and have been linked to tumor growth and death risk in certain cancer patients.

- see Dingell's letter to J&J (.pdf)
- check out Dingell's Amgen letter (.pdf)
- read the Boston Globe article

Related Articles:
Amgen--Big Biotech's Stock Report. Report
FDA's worst-case anemia scenario. Report
Do anemia warnings signal new limits? Report
Study: Anemia meds hike death risk 10%. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
FDA: More risks from anemia drugs. Report

FDA panel votes to restrict anemia drugs

Fri, 14 Mar 2008 07:59:58 -0400

Look on the bright side: It could have been worse. An FDA advisory panel voted to keep Amgen and Johnson & Johnson's anemia remedies on the market for cancer patients. So the drugs appear to have dodged the feared silver bullet, an outright revocation of that indication; FDA generally follows its panels' advice, but isn't required to.

The bad news--and there is bad news--is that the drugs' use could be severely limited. The panelists voted to restrict them to patients with uncurable cancers. Under the recommendations, the drugs wouldn't be approved for patients with breast cancer or with cancers that affect the head-and-neck region; studies show it's those patients that are most at risk for severe side effects, which include accelerated tumor growth and shortened survival.

One analyst estimated that the restrictions could shave off 40 percent of Aranesp's sales. Another said Amgen and J&J each would lose about a third of their market in cancer patients. Amgen, of course, is more dependent on the drugs; Aranesp is its top seller, and together Aranesp and Epogen (marketed mostly for kidney patients) account for $6.3 billion in sales. J&J's Procrit brought in $2.9 billion last year, but that's just a small fraction of the mega-pharma's $63.6 billion in overall revenues. Sales of the drugs had already been dropping because of safety concerns, prompting job cuts at both Amgen and J&J.

What's next? FDA will have to mull the panel's choices and make its own decisions. Then we'll be watching Medicare to see if it sharply restricts reimbursements for the drugs' use in cancer patients.

- check out the Los Angeles Times story
- read the New York Times article
- see the Forbes market report

ALSO: Yesterday, we reported that J&J CEO William Weldon chalked up $25.1 million in pay last year, relying on the Associated Press' calculations. Well, the Wall Street Journal comes up with a different figure, and it's even more eye-popping: $31.9 million. Report

Related Articles:
FDA's worst-case anemia scenario. Report
Study: Anemia meds hike death risk 10% Report
Amgen in new talks over ESA safety. Report
Medicare upholds anemia drug cuts. Report
Epogen/Aranesp-Top 10 Warnings and Recalls. Report

J&J hikes CEO's pay to $25.1M

Thu, 13 Mar 2008 07:59:58 -0400

Another day, another CEO pay raise. Johnson & Johnson honcho Bill Weldon (photo) nabbed a 22 percent hike in compensation in 2007. Between base salary of $1.73 million, incentive pay of $9.19 million, plus stock awards and options and various miscellaneous perks, he raked in $25.1 million in compensation. In 2006, his package amounted to $20.6 million.

Now, J&J grew sales by nearly 15 percent last year, to $61.1 billion. But profits fell by 4 percent to $10.6 billion, mostly on restructuring charges. And that sales growth came despite falling revenues from the anemia drug Procrit, which attracted safety-related scrutiny during the second half of the year. That med, along with sister products made by Amgen, are on the agenda at an FDA advisory panel today and may see sales limits as a result.

And discussion of J&J's 2007 can't leave out the company's big restructuring plan, which involves cutting up to 4,820 jobs. How, we wonder, do those pink-slipped workers feel about Weldon's raise? We know how shareholders feel: J&J stock jumped by 21 cents to $62.65 yesterday, about a dime of that after the proxy was filed.

- read the article from CNBC

ALSO: A J&J unit warned that some patients using its AIDS drug Prezista developed liver damage and others died; cautionary language about liver injuries was added to the drug's label. Article

Related Articles:
AstraZeneca's CEO sees 19% pay cut. Report
Merck chief got 80% pay hike. Report
J&J CEO talks tech. Report
J&J restructures pharma unit, laying off workers. Report

Do anemia warnings signal new limits?

Mon, 10 Mar 2008 07:59:58 -0400

Is it a pre-emptive strike? Late Friday Amgen added new warnings to the embattled anemia drugs Aranesp (Amgen) and Procrit (Johnson & Johnson). The labeling for those drugs now warns that they sped up tumor growth and increased the risk of death in patients with breast cancer and cervical cancer. The additional "black box" warnings came less than a week before an FDA advisory committee meeting where experts will review safety data for the drugs.

The anemia meds have been under public scrutiny since last March; since then, the FDA, Canadian regulators, the Center for Medicare Services, and the Department of Veterans Affairs all have issued warnings or restrictions on the use of the drugs. Sales of the drugs have fallen off by a quarter, and Amgen's shares have dropped by some 27 percent.

Most analysts are expecting sales to drop further after Thursday's advisory panel meets. The group could recommend halting use of the drugs for certain cancers or in all cancer patients. Even if the FDA cuts off only some cancer indications, Amgen's anemia drug sales could lose between $150 million and $250 million, one analyst said. The effect would be worst if FDA changes led to tougher restrictions from Medicare, which last fall stopped reimbursing docs who administer the drugs unless they're given at low doses.

Amgen scientists are expected to fight against new limits by arguing that any safety problems have arisen in patients given higher-than-recommended doses. Also, the company contends that the drugs' risks don't outweigh the hazards of the alternative treatment: blood transfusions.

- read the report from the Houston Chronicle
- check out the AP article
- see the analysis in Business Week

ALSO: Amgen CEO Kevin Sharer said last year was the most difficult in Amgen's history. "This is the most challenging time," he told The Wall Street Journal in a Q&A published today. Sharer also talked about innovation and new drugs.

- find the Q&A in the WSJ

Related Articles:
Study: Anemia meds hike death risk 10%. Report
Medicare: Right to restrict anemia meds. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
Amgen income hammered as anemia drug use drops. Report
FDA: More risks from anemia drugs. Report
Analyst: Anemia drug warnings 'not bad'. Report

Judge blocks Roche's Mircera--for now

Fri, 29 Feb 2008 06:59:56 -0500

Victory for Amgen--and maybe for Roche, too. The California drug maker persuaded a judge to temporarily ban Roche's competing anemia drug Mircera in the U.S. But the judge also said he'd consider letting Roche sell the med under certain conditions.

You'll recall that Roche got approval late last year for the anemia fighter, which would compete with Amgen's Epogen and Aranesp and Johnson & Johnson's Procrit. But Roche was enjoined from launching the drug because of patent-infringement questions. Later, Roche offered Amgen 20 percent royalties on Mircera, but Amgen rejected the figure.

Apparently the judge agreed that 20 percent was too low: He suggested 22.5 percent. And he said that Roche would have to agree to set prices no higher than those for existing anemia drugs. Predictably, both sides balked. Amgen said making a deal would amount to "rewarding theft of intellectual property." And Roche said its original offer was "fair and aggressive;" it may appeal the ruling. In any case, the judge gave Roche three months to think over his offer.

- check out the coverage in Business Week
- read the story at CNN Money

Related Articles:
Mircera--2007 FDA approvals. Report
Amgen calls Roche 'snake-oil salesman.' Report
Mircera gets FDA nod, but blocked by patent case. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in UK and Germany. Report

Study: Anemia meds hike death risk 10%

Wed, 27 Feb 2008 06:59:58 -0500

The drumbeat of data is getting louder. A new analysis of the blockbuster anemia drugs sold by Amgen and Johnson & Johnson concludes they raise the risk of death among cancer patients by about 10 percent. It's the first meta-analysis to show a statistically significant increase in the risk of death from these drugs, said the lead author of the study, to be published in the Journal of the American Medical Association today.

The FDA is convening an advisory panel March 13 to discuss whether to further restrict the drugs, which already have seen their usage limited by Medicare, the U.S. Department of Veterans Affairs and Canadian regulators. The FDA ordered stronger warnings on the drugs--Amgen's Epogen and Aranesp and J&J's Procrit--last year. Since then, sales have declined by hundreds of millions of dollars.

Monday, the U.K.'s National Institute for Clinical Excellence posted proposed guidelines that advocate their use only in patients with ovarian cancer or in cancer patients whose anemia became life-threatening. The guidance didn't offer changes to the meds' use in kidney patients. NICE is accepting comment on the proposal through March 7.

- see the article in the New York Times
- check out the FDA's advisory meeting announcement
- read the proposed NICE guidelines (.pdf)
- find links to related NICE documents (.pdf)

Related Articles:
Medicare: Right to restrict anemia meds. Report
New Medicare cap on anemia drugs could hammer Amgen. Report
Amgen income hammered as anemia drug use drops. Report
FDA: More risks from anemia drugs. Report
Analyst: Anemia drug warnings 'not bad'. Report

Amgen calls Roche 'snake-oil salesman'

Wed, 20 Feb 2008 06:59:56 -0500

No way, Roche. Amgen rejected a royalty offer from the Swiss drugmaker, which wants to sell an anemia drug that would compete against Amgen's signature blockbusters. Mircera, Roche's version, was approved by the FDA in November, but a jury ruled that the drug would infringe on Amgen's patents. Despite a juicy royalty offer of some 20 percent--twice that paid by Johnson & Johnson for its Procrit med--Amgen is holding fast.

In fact, according to court documents, the California company is scrapping for the fight. After likening Roche to a "snake-oil salesman," Amgen says in court documents, "The only thing more astonishing than Roche's false assertions of its public interests is it chutzpah now in proposing that the Court order a license at a royalty rate of 20 percent."

Amgen calls that figure "grossly inadequate"--language that should be familiar to Roche, which heard the same about its first offer to buy Ventana. Only after sweetening that deal did Ventana give its OK to the sale. And as of yesterday, it was a done deal.

- see the story in Forbes
- check out the snake oil item at the WSJ Health Blog
- read Roche's press release on the Ventana merger

Related Articles:
Mircera--2007 FDA approvals. Report
Mircera gets FDA nod, but blocked by patent case. Report
Roche: Patent ruling won't stop Mircera. Report
Roche to Launch Mircera in UK and Germany. Report

Medicare: Right to restrict anemia meds

Mon, 11 Feb 2008 06:59:58 -0500

A Medicare official says there's an even better case now for restricting payments for Amgen and Johnson & Johnson's big anemia drugs. According to the agency's chief medical officer, two more studies have cast doubt on the safety of Aranesp, Epogen, and Procrit, which together generated more than $5 billion in sales in 2007. The drugs are one of the biggest prescription costs for Medicare.

You'll recall that last year, the Centers for Medicare and Medicaid Services restricted its reimbursements for the drugs, after four studies suggested various safety problems, including a higher risk of death for patients using them. Now, the FDA has scheduled a hearing to consider two more studies that suggest the drugs are even more risky for some cancer patients. The companies and the American Society of Clinical Oncology continue to submit evidence for their argument that restricting the anemia drugs will only lead to an increase in blood transfusions.

- read the item at Pharmalot

Related Articles:
New Medicare cap on anemia drugs could hammer Amgen. Report
Amgen income hammered as anemia drug use drops. Report
FDA: More risks from anemia drugs. Report
Analyst: Anemia drug warnings 'not bad'. Report

FDA: More risks from anemia drugs

Fri, 04 Jan 2008 06:59:57 -0500

The FDA dealt another blow to embattled anemia drugs yesterday. The agency revealed two new studies that show cancer patients may be more likely to die while using Amgen's blockbuster drugs Aranesp and Epogen (also sold under the brand name Procrit by Johnson & Johnson).

The drugs, known as erythropoiesis stimulating agents (ESAs), are already under safety review by regulators. In November, new warnings of their cancer risks--that tumors might grow faster and patients may die sooner, according to four other studies--were added to their labels. Other research has shown that ESAs pose increased risk of heart attack, stroke, and heart failure. The risks are greatest with high doses of the drugs, so several months ago, Medicare limited reimbursement to lower doses. Some insurers followed suit.

Now, according to an FDA statement, the agency "may take additional action." If regulators further restrict the drugs, Amgen would be deeply wounded. ESAs account for more than half the company's profits.

- see the FDA release
- get details about the newly released data
- read the article from the Los Angeles Times

Related Articles:
Amgen in new talks over ESA safety. Report
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report
Amgen, J&J win a round in anemia controversy. Report

Study finds link from ESAs to leukemia

Tue, 11 Dec 2007 06:59:54 -0500

In another blow to anemia drugs, Mayo Clinic researchers announced today that erythropoiesis-stimulating agents--like Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit--may cause patients with a bone-marrow disorder to develop leukemia.

The researchers had been studying the risk factors for progression from primary myelofibrosis to leukemia, and in the process uncovered this link to ESAs. Though the lead investigator said the study results need to be validated in other trials, he also said that the findings should be taken into account when doctors and patients are deciding whether to use the drugs.

- check out this release

Related Articles:
Top 10 drug warnings and recalls of 2007. Report
Amgen in new talks over ESA safety. Report
Analyst: Anemia drug warnings 'not bad'. Report
Amgen income hammered as anemia drug use drops. Report