Adverse events

Adverse event reports hit record high

Tracy Staton — Thu, 23 Oct 2008 11:04:40 -0400

Prescription drugs posted a new record during the first quarter of this year, but it's a milestone drugmakers would probably rather forget. The number of deaths and serious injuries associated with prescription drug use rose to new highs, with 4,825 deaths and nearly 21,000 injuries, a watchdog group said. That's nearly a threefold rise from the previous quarter and 38 percent more than last year's quarterly average.

According to the Institute for Safe Medication Practices, the Pfizer stop-smoking drug Chantix tallied the most adverse reports, with 1,001 injuries and 50 deaths. As you know, Chantix has attracted widespread media attention for the psychiatric effects--even suicide attempts--seen in some of its users. (That attention probably boosted the number of reports, too.)

Second on the list was the blood thinner heparin--subject of a much-publicized recall and an international investigation--which was associated with 779 injuries and 102 deaths. These adverse reactions were traced back to contamination of raw heparin used to make the drug.

The Institute took its stats from the FDA's adverse events reporting system, which can be problematic for a couple of reasons. One, adverse events often go unreported, so the numbers can understate the problem. But--and this is the second reason--the individual reports don't prove that the drug caused the problem.

- read the story in the Los Angeles Times
- check out the WSJ Health Blog post

New Chantix scrips drop by almost half

Tracy Staton — Mon, 02 Jun 2008 10:57:16 -0400

Talk about an image being worth a thousand words. A Wall Street Journal chart tracking new Chantix prescriptions since January shows the kind of downward slope you only want to see on a double black diamond ski run. From close to 150,000 per week, the numbers have dropped to a point just north of 85,000. That's gotta hurt at Pfizer, which had counted the stop-smoking med among its few recent success stories.

Can Pfizer turn the Chantix tide? It launched a PR campaign last week, highlighting the undeniable fact that more than 6 million people have now taken the drug, and while some of its side effects can be severe--it's been blamed for suicides, accidents, and more--smoking itself has deadly side effects, and they're a lot more prevalent, percentage-wise, than adverse events related to Chantix. Even docs who've slowed down on firing off Chantix scrips tell the WSJ Health Blog that the fall--off is "fear-driven--not science-driven."

- see the Health Blog post

Chantix side-effects news prompts FAA ban

Tracy Staton — Thu, 22 May 2008 10:27:02 -0400

Chantix suffered a one-two punch yesterday, as a watchdog group's report linked the stop-smoking med to a wide variety of health and safety problems, and the Federal Aviation Administration told pilots and air traffic controllers not to use it. The FAA's decision directly affects only 150 pilots and 30 air traffic controllers known to be taking the drug, but it could lead to bans by other transportation agencies.

Potentially more damaging is the Institute for Safe Medication Practices' report, which analyzed the hundreds of adverse events reported to the FDA. More than 200 reports of suicide attempts or suicides, almost 400 of possible psychosis, and 525 of hostility or aggression were sent to the agency between May 2006 and December 2007. (Putting this in perspective, an estimated 6.5 million people have used the drug.)

Okay, we've known about Chantix's link to psychiatric side effects for some time; the FDA asked Pfizer to add warning language to the drug's label. And the Institute allowed that the number of reports might have been spurred upward by publicity surrounding a Dallas musician's bizarre behavior on Chantix. But nevertheless, the report said, Chantix's risks have been underestimated. The study's lead author called on Pfizer and the FDA to "immediately" strengthen warnings on Chantix's label and launch careful studies of the safety issues.

The new report also linked Chantix to other side effects: accidents and falls, potentially lethal heart rhythm problems, heart attacks, seizures, and diabetes. Rattled by the data--and by recent prescription trends, which have been decidedly downward--Wall Street analysts cut their sales forecasts for Chantix. Year over year, Chantix scrips have dropped 30 percent, and if they continue falling at that pace, "forecasts for Chantix could be too high by as much as $500 million to $1 billion by 2012," a Sanford Bernstein analyst wrote. That firm, for one, is cutting its 2008 forecasts--to $909 million in global sales from $1.14 billion--and 2012 numbers to $700 million from $1.6 million. For 2007, Chantix sales were $883 million.

- see the story in the Los Angeles Times
- check out the WSJ article
- find the item in the WSJ Health Blog
- read the New York Times' take
- get the Pharmalot item

U.K. pharma intensifies self-policing rules

Fri, 09 May 2008 06:59:55 -0400

U.S. lawmakers aren't the only ones toughening up on pharma. In the U.K., the industry itself is strengthening its code. The Association of the British Pharmaceutical Industry is adding rules on disclosure--of support for patient organizations, of sponsorships, of donations and grants to institutions that support healthcare and research--and on reporting side effects. Promo materials must "prominently" state that "adverse events should be reported" and offer contact information for those reports. And all clinical trials have to be made public; hiding data would be a violation of the rules. The new code will come into effect July 1.

- read the release from ABPI
- see the Financial Times article
- check out the item at PharmaGossip

Related Article:
Pharma CEOs mull industry "trust deficit"

U.S., China trade blame on heparin

Tue, 22 Apr 2008 06:59:58 -0400

Call it the blame game. The U.S. FDA says it's traced contaminated heparin back to 12 companies in China. Chinese officials, however, claim the problem started in the U.S.--and they plan to visit a New Jersey plant this week to investigate. So much for the new spirit of cooperation our drug watchdogs pledged not so many weeks ago.

Now, China doesn't dispute that the blood thinner was adulterated with over-sulfated chondroitin, the almost-heparin contaminant FDA uncovered in batches of the drug linked to allergic reactions and as many as 81 deaths. But Chinese officials say that the contaminant did not cause the allergic reactions. They claim that untainted batches also were linked with 100 adverse events.

The FDA, however, says that China's screening tests aren't as sensitive as the ones the U.S. used, and that the heparin China deems contaminant-free actually is tainted. Baxter, which sold the tainted med until problems with it arose, confirmed the FDA's assessment. Plus, the FDA says contaminated heparin made its way to 11 countries. If the problem originated in the U.S., it would be limited to the U.S.

Meanwhile, the FDA also sent a warning letter to Changzhou SPL, the Scientific Protein facility in China that provided active ingredient to Baxter. Changzhou didn't adequately respond to deficiencies FDA inspectors found at the plant--and some pretty scary ones at that. No adequate systems for evaluating heparin suppliers or their crude materials, for instance.

- find the FDA's letter to Changzhou SPL
- see the story in the Wall Street Journal
- read the New York Times article
- check out the item at Pharmalot
- get the Changzhou news at the LA Times
- see a summary of the FDA's probe at MoneyControl

ALSO: A new bill designed to quash counterfeit meds was introduced in Congress last week. The Safeguarding America's Pharmaceuticals Act would create federal standards for packaging and tracking drugs and establish minimum standards for wholesale licensing. Chain drugstores immediately protested, saying the requirements would be too expensive and complicated to implement. Report

FDA to piggyback on insurers' databases

Tue, 15 Apr 2008 06:59:55 -0400

Remember that drug-safety database Congress required the FDA to set up? The idea was for the FDA to actively monitor drugs and possible adverse effects, rather than waiting for doctors and drug companies to report problems. Well, the agency is ready to announce its plans--and they don't include setting up a database. Instead, the FDA will contract with insurers, such as WellPoint and UnitedHealth, to scan their members' records for potential problems. The agency also plans to bring other health systems into the effort.

"We're bringing together all these different groups in a network so that we can ask them to look at the same question at the same time," Janet Woodcock (photo), CDER director, told the Wall Street Journal.

The FDA will use the databases to monitor potential problems that showed up in a less-than-statistically-significant way during clinical trials. The insurers and other network participants also will build computer models to detect signals of potential problems that weren't suspected before. To show that it could do so, WellPoint tested its 1999 data and found that it could have spotted the heart-related problems associated with Vioxx within four months of the drug's introduction.

- read the WSJ story

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Should FDA's info be in all DTC ads?

Thu, 03 Apr 2008 07:59:56 -0400

First consumers, now Congress. Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. The impetus? A Consumer Reports poll that showed 16 respondents had a side effect serious enough to send them to the doctor or hospital--but 35 percent of respondents didn't know they could report side effects to the FDA.

FDA tracks side effects from prescription and OTC meds, but officials estimate they learn about fewer than 10 percent of drug reactions. Consumers Union, which publishes Consumer Reports, sent the agency a petition with 55,000 signatures, requesting that a toll-free number and web address be included in TV drug ads. An agency spokeswoman said it's reviewing the petition.

Already, Congress passed legislation requiring contact info to be placed in all DTC print ads and calling for an FDA study of doing the same in TV commercials. That study is still ongoing, the spokeswoman said.

- check out the Consumers Union survey
- read the Los Angeles Times story
- see the item in the WSJ Health Blog

ALSO: The FDA appears to be close to unveiling its plans for a national surveillance network to keep tabs on drug safety. The "Sentinel" project has to address a number of key questions first, though. Such as, how will prescription info be kept private and secure? And how will the system be insulated from political and industry influence? Report

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More heparin recalled

Mon, 24 Mar 2008 07:59:57 -0400

The heparin recall broadens again. Another manufacturer, B. Braun Medical, said it was recalling 23 lots of the blood thinner as a precautionary measure. No adverse events have been reported in connection with its product, the company said. But Braun buys some of its heparin ingredient from Scientific Protein Laboratories, the same company that supplies Baxter Healthcare--the same company whose Chinese-sourced ingredient was tainted with chemical that mimics heparin.

At the same time, American Health Packaging recalled some Baxter heparin vials that it had repackaged for use in pharmacy automation equipment. Hospitals that bought those vials were notified last month.

Baxter, of course, recalled nearly all its heparin products in the U.S. after the med was linked to severe allergic reactions and deaths. Since then, scientists have found oversulfated chondroitin sulfate in suspect batches. Investigators are still trying to figure out how the chemical got into the drug.

Meanwhile, China's top drug watchdog is ordering local bureaus to step up their oversight of heparin production. China's SFDA says producers now have to get their raw material from registered suppliers, and suppliers have to use more rigorous checks on quality and safety. That's an about-face; previously, the agency had said that importing countries bore responsibility for ensuring heparin's safety. But it's still unclear how SFDA intends to supervise the thousands of small workshops that gather raw materials for heparin from pig intestines.

- find the press release on Braun's recall
- read the AHP recall release
- see the WSJ story on the recall
- check out the China article in the New York Times

ALSO: Cedars-Sinai Medical Center was fined $25,000 by California regulators for giving overdoses of heparin to Dennis Quaid's newborn twins and one other infant. The Quaids' lawsuit against heparin maker Baxter Healthcare remains outstanding. Report

Related Articles:
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Scientists say heparin tainted deliberately. Report
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Baxter waited 10 days to recall

Mon, 03 Mar 2008 06:59:57 -0500

Want to know what happens inside a pharma company during a recall crisis? Check out Sunday's Chicago Tribune, which details the behind-the-scenes scramble at Baxter as the company first found problems with its heparin product, then recalled millions of doses, then stopped production and eventually recalled the rest.

CEO Robert Parkinson started having early meetings every morning, for one thing, and making surprise visits to key execs throughout the day--and that was how he found out that the FDA had never inspected the Chinese plant suspected as a source of the tainted product. One interesting tidbit in the piece: By the time the first doctor linked heparin with allergic reactions among patients at St. Louis Children's Hospital in early January, Baxter already had found nine suspect lots of the product, and adverse reactions were being reported at rates 20 times normal numbers. But 10 more days passed before Baxter issued the recall. The company wouldn't comment on why it delayed.

And the FDA doesn't come out of the story smelling rosy, either. Though the agency claims it has inspected every foreign plant sending medical products to the U.S., its own Science Board begged to differ, saying that millions of regulated products come into the country annually from foreign facilities that have never been examined by the FDA. "Unless the deficiencies can be addressed rather urgently," said board member Gail Cassell, an Eli Lilly VP, the heparin debacle "is not the last such situation. We will have more of them."

- see the Chicago Tribune article

Related Articles:
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Heparin suspected in more deaths

Fri, 29 Feb 2008 06:59:58 -0500

It's a grim trifecta of heparin news today. Regulators say they've now found 21 deaths that may be linked to Baxter's recalled blood thinner. FDA inspectors uncovered quality-control problems at the Chinese plant where crude heparin was processed for Baxter's supplier. And Baxter widened its recall to include, not just its multidose heparin vials, but single-dose packaging and diluted heparin, Hep-Lock.

Now, there are a few caveats. The 21 people who died while taking Baxter's heparin were very ill and may have died from other causes. The FDA hasn't found a smoking gun at the Chinese plant, so the jury's still out on whether impurities and supply-chain problems there caused the whole debacle. And Baxter's widened recall is a precautionary measure, prompted by the news that rival APP Pharmaceuticals can step in to fill demand.

Nevertheless, the whole episode reads like a tale of globalization gone wrong. Whether the Chinese plant eventually is blamed is, at this point, irrelevant. The curtain has been whipped aside to reveal pig intestines, contaminated vats and overlooked inspections. Not to mention supply chains too convoluted and opaque--and inadequately monitored--to be trusted. Let's hope it's a wake-up call for the FDA and drug makers alike.

- see Baxter's press release about the widened recall
- get the FDA's inspection report
- read more on the possibility of additional deaths in The New York Times
- check out the FDA inspection story in the Washington Post
- find more on the FDA's investigation

Related Articles:
Heparin snafu prompts call for legislation. Report
Heparin supply chain full of loopholes. Report
Baxter stops making multidose heparin. Report
Baxter recalls heparin on adverse events. Report

Probe reveals convoluted supply chain

Thu, 28 Feb 2008 06:59:57 -0500

Any attempt to track down the source of problems with the blood thinner heparin are likely to run into trouble following a convoluted supply trail in China, according to an article in The New York Times. Regulators are trying to determine if the active ingredient for the drug--which is extracted from the lining of pig intestines--became contaminated on the journey from Chinese slaughterhouses. The Chinese factory that makes the drug, which is majority owned by the U.S. company Scientific Protein Laboratories, insists its supply chain is safe and raw materials are sourced from only two reputable wholesalers whose suppliers are audited. But an investigation by the Times revealed a more complicated process that relied on multiple suppliers that had been roiled by an outbreak of pig disease. One wholesaler confirmed that he had obtained crude heparin from a variety of factories, which he did not inspect.

"We are not the government," he told the Times in a telephone interview. "We have no right to inspect their pigs or intestines or facilities."

Heparin has now been linked to more than 400 adverse events and no one has reached any determination on what could be the cause of those adverse events. But the incident is sure to raise fresh fears over the quality of pharma products manufactured in China.

- read the article in The New York Times

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Heparin snafu prompts call for legislation

Fri, 22 Feb 2008 06:59:58 -0500

Pharma's favorite dynamic duo, Reps. John Dingell and Bart Stupak, are threatening to force the FDA to inspect foreign plants before drugs or ingredients are exported to the U.S. You'll recall that an FDA staffer mistook the Chinese plant that supplied Baxter with raw heparin for another plant with a similar name, which had been inspected. So the Baxter supplier's facility wasn't ever checked out by the agency. As yet, there's no conclusive evidence that the plant was the source of problems with the heparin, which Baxter first recalled and then stopped making altogether.

To the Congressmen, the FDA's clerical error is bad enough. But it's "the further assertion by FDA that it is free to ignore its own preapproval policy [that] raises concerns" about the safety of our drug supply, Stupak said in a statement. So the two men are considering introducing a bill that would make preapproval inspections not just a matter of policy, but mandated under law.

Dingell and Stupak also wrote Baxter CEO Robert Parkinson, asking for detailed records about its heparin supply chain and any adverse events associated with the med. (The FDA has said that it received 350 reports of adverse reactions; four patients died after taking the drug.) Did the FDA mislead Baxter into thinking the supplier's plant had been inspected? If not, the letter states, "then we are concerned that your company was knowingly distributing an unapproved drug." Of course, Parkinson has said that his company wouldn't have known whether the Chinese plant had been FDA-inspected because it doesn't keep that close a watch on its supply chain.

All of this raises at least two questions. First, will Congress put its money where its mouth is and fund any new mandate for foreign inspections? Second, can we expect drug makers who aren't watching their supply chains for possible problems overseas to start doing so?

- read the press release
- check out the letter to Baxter's CEO
- see this story in the International Herald Tribune
- find the Wall Street Journal piece in the
- get more on the committee's correspondence with FDA at Pharmalot

Related Articles:
Heparin supply chain full of loopholes. Report
Baxter tests point to Chinese problem. Report
FDA inspected wrong Chinese plant. Report
Baxter stops making multidose heparin. Report
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Baxter tests point to Chinese problem

Wed, 20 Feb 2008 06:59:54 -0500

Baxter is zeroing in on the possibility that a supplier's uninspected Chinese plant faltered while processing the active ingredient in its heparin drug, the Los Angeles Times reports. Testing found irregularities in samples processed in China; the same irregularities were absent from samples from the same supplier's Wisconsin plant. When the Times sent a reporter to the Chinese plant, guards turned him away, but an unrelated heparin-making facility nearby let him in to see its thumbprint-access security system and other safeguards.

You'll recall that Baxter stopped making its multiuse vials of heparin after the FDA received reports of hundreds of adverse reactions to the med. The company also recalled some 32 million vials. Much of the active ingredient in the drug came from a plant in China never inspected by Chinese or U.S. regulators.

- read the LA Times article

Related Articles:
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FDA inspected wrong Chinese plant

Tue, 19 Feb 2008 06:59:58 -0500

It was a glitch. That's what the FDA said last week when confronted with the news that it hadn't inspected the Chinese plant that made the main ingredient for Baxter's recalled batches of heparin. Now we know just how big that glitch was: The FDA inspected and approved the wrong plant. No wonder some in the blogosphere are calling it the "Fundamentally Defective Agency."

When the company that makes that active ingredient applied for FDA approval, the agency thought the app had come from a similarly named company whose plant had already been checked out. No new inspection--until now, after a big spike in adverse reactions to the med. Four patients who took it died, and Baxter stopped selling the product.

Chinese watchdogs don't even try to inspect plants that make drugs solely for export. So not only this plant fell through those particular regulatory cracks, but every plant that, like it, only exports its products. And as all sorts of audits have shown, FDA has an enormous blind spot in Asia, where scant numbers of manufacturing facilities have seen agency inspectors.

One bright spot in this big heparin mix-up is the fact that Baxter's leading heparin rival APP Pharmaceuticals is quickly picking up new customers. The company is ramping up production to deal with the increased demand.

- read the report about FDA's mix-up in the Washington Post
- check out the Chinese inspection angle in the Chicago Tribune

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Overseas drugmaking goes unsupervised. Report

Chinese plant linked to recalled heparin

Thu, 14 Feb 2008 06:59:58 -0500

A Chinese plant never inspected by the FDA turned out an active ingredient in the heparin vials recalled last month. The Baxter-made blood thinner has been implicated in hundreds of adverse reactions and four deaths. Now the FDA is investigating, planning an expedited examination of that plant and its records.

Baxter last year inspected the plant and a U.S. finishing facility that also handled the ingredient. As part of its internal investigation into the heparin problems, the company will re-inspect both facilities soon. The plant should have been checked out by the FDA before products made there were sold in the U.S.

Earlier this week, Baxter said it was suspending production of the injectable heparin, and the FDA told doctors to switch to other meds. The drug's active ingredient may or may not have triggered the intense side effects, but it's one avenue that has to be investigated, a Baxter spokeswoman said.

Even if the Chinese facility isn't fingered, the scenario is emblematic of the FDA's current shortcomings. As government reports and Congressional hearings have made clear recently, the agency's foreign oversight is worse than bad. As the Wall Street Journal notes, China is now the world's largest producer of active pharmaceutical ingredients. How many food and drug problems have to arise before FDA gets the funding it needs--and makes the internal changes required--to ensure product safety?

- see the news from the Wall Street Journal
- read the Los Angeles Times story
- check out the article in the New York Times

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Baxter stops making multidose heparin

Tue, 12 Feb 2008 06:59:58 -0500

Docs needing blood-thinning drugs may be in a fix. Allergic reactions prompted Baxter to stop making multiple-dose vials of heparin, and the FDA told physicians to stop using them except when absolutely necessary--and then, very carefully. Baxter makes 35 million vials of heparin annually, about half the U.S. supply, making officials worry about shortages.

You'll recall that late last month, Baxter recalled nine lots of the injectable heparin after dialysis patients had allergic reactions to it. Now, the FDA says it has received 350 reports of side effects including vomiting, nausea, and difficulty breathing. Four people died while taking the drug, but it's not clear the drug was to blame. The FDA is inspecting Baxter's manufacturing facilities in search of the problem.

- check out Baxter's release
- read the report
- get more details from the Chicago Tribune

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Stopping Plavix may boost heart risks

Wed, 06 Feb 2008 06:59:57 -0500

Patients had better be careful when they stop taking the anticlotting drug Plavix. A new study shows that those treated with Plavix for a heart attack or angina had a "rebound effect" risk of heart attack or death. Published in the Journal of the American Medical Association, the research found that the rate of those adverse events nearly doubled during the 90 days after patients stopped Plavix.

But this doesn't mean docs should toss aside the drug. The researchers said that the rebound might be managed by weaning patients gradually from the drug or by adding aspirin as dosage is reduced. Or, they suggested, patients might avoid the problems by continuing to take Plavix indefinitely.

The latter suggestion could be good news for manufacturer Bristol-Myers Squibb and marketer Sanofi-Aventis, at least till the drug's patent expires in 2011 or generic versions make it to market, whichever comes first. BMS has been fighting off various generic challenges--and briefly lost, as Apotex launched a copycat Plavix in late 2006. Plavix sales were up substantially in 2007, helping fuel 65 percent growth in BMS' pharma revenues.

- see the study abstract
- check out the article in the Wall Street Journal
- read BMS' earnings release

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Baxter recalls heparin on adverse events

Mon, 28 Jan 2008 06:59:55 -0500

More than 100 allergic reactions, including one possible death, prompted Baxter International to recall its anti-clotting drug heparin. The move affects nine manufacturing lots, or thousands of doses of the injectable med.

Since January 1, 150 patients reported possible reactions to the drug, including nausea, vomiting, dizziness, fainting, and throat swelling. One reported death "may be associated" with heparin as well. In contrast, the company typically receives 60 to 70 reports of adverse events each year, Baxter officials said.

The company isn't sure how many doses from the nine lots have been given to patients, but they were distributed to hospitals across the country--where even now, pharmacy staffs are scanning shelves for the recalled vials.

- check out the release
- read this article from the Wall Street Journal

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Lawsuit seeks black box on antibiotics

Fri, 04 Jan 2008 06:59:55 -0500

Lobbying didn't work, but maybe a lawsuit will. Public Citizen sued the FDA yesterday, hoping to force the agency to pin stronger warnings on a class of antibiotics known as fluoroquinolones, which includes Bayer's Cipro and Johnson & Johnson's Levaquin.

The consumer group had petitioned the agency for a "black box" warning that the drugs can cause tendon rupture. Currently, that potential side effect is included in a long list of possible adverse events on the drug's label. Public Citizen said that 262 tendon ruptures, 258 cases of tendonitis, and 274 other cases of tendon disorders in patients using the antibiotics were reported to the agency between 1997 and 2005.

Of course, the reports don't prove that the antibiotics caused the problems. But Public Citizen maintains that a stronger warning is warranted so that tendon problems can be flagged before major injuries happen. Neither the FDA nor Schering-Plough, which makes the drug in partnership with Bayer, would comment on the suit. J&J says the current warning is perfectly adequate.

- see Public Citizen's release
- read the legal complaint
- here's more from the AP

Avandia, Actos don't boost death risk

Fri, 28 Sep 2007 06:59:55 -0400

Teva's timing may, in fact, be pretty good: A new study in this week's Lancet shows that while Avandia and its counterpart/rival Actos do boost the risk of heart failure, they don't increase the risk of death from cardiac problems. Study researchers say they wanted to clarify the risks so that doctors could choose which patients should get one of these drugs and which should opt out.

This study follows the now infamous Nissen study, published in June in the New England Journal of Medicine, which indicated that Avandia increased the likelihood of heart attack and death. The Lancet researchers said they analyzed data from trials that had all been peer-reviewed and published, whereas Nissen relied in part on unpublished work.

But also in today's Lancet is an editorial pushing an idea newly in vogue, but quite commonsensical--that diabetes drugs shouldn't be judged just on their effects on blood sugar, but on their ability to combat the effects of the disease.

- see the study abstract from The Lancet
- read the article from the Boston Globe

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