Drug Injury Watch

2008 Report Warns About Using Wikipedia, Only, To Research Prescription Drugs

One May Start There, But Be Sure To Check More Comprehensive Online Sites Such As MedlinePlus.gov And Medscape.com

(Posted by Tom Lamb at DrugInjuryWatch.com)

A November 25, 2008 Reuters Health article, "Wikipedia often omits important drug information: study", by reporter Anne Harding, had this precautionary advice for people who are are looking for information about their prescription drugs or over-the-counter medications:

Consumers who rely on the user-edited Web resource Wikipedia for information on medications are putting themselves at risk of potentially harmful drug interactions and adverse effects, new research shows.

The source for this Reuters Health article is a report from the December 2008 edition of The Annals of Pharmacotherapy, "Scope, Completeness, and Accuracy of Drug Information in Wikipedia", which was published early on the medical journal's web site.

From the Abstract for this December 2008 report, we get this overview:

OBJECTIVE: To compare the scope, completeness, and accuracy of drug information in Wikipedia with that of a free, online, traditionally edited database (Medscape Drug Reference [MDR])....

CONCLUSIONS: Wikipedia has a more narrow scope, is less complete, and has more errors of omission than the comparator database. Wikipedia may be a useful point of engagement for consumers, but is not authoritative and should only be a supplemental source of drug information.

The November 25 Reuters article provided some insights from one of the researchers who prepared this Wikipedia - drug information report:

"If people went and used this as a sole or authoritative source without contacting a health professional...those are the types of negative impacts that can occur," [Dr. Kevin A. Clauson of Nova Southeastern University in Palm Beach Gardens, Florida] told Reuters Health....

"I think that these errors of omission can be just as dangerous" as inaccuracies, Clauson told Reuters Health. He pointed out that drug company representatives have been caught deleting information from Wikipedia entries that make their drugs look unsafe....

Wikipedia can be a good jumping-off point for Internet research, Clauson said, but shouldn't be seen as the last word on any topic-and should certainly not be used as a resource by medical professionals. "You still probably want to go to medlineplus.gov or medscape.com for good quality information that you can feel confident in," he said.

If you are not familiar with Wikipedia, it is commonly described as a free, online encyclopedia covering millions of topics which allows the users, themselves, to add, delete, edit, or otherwise modify the content of its articles. 

It seems that this "unique" situation, alone, would be sufficient warning to patients that Wikipedia is not a reliable source for medical information -- but it never hurts to reiterate that warning.

Lastly, we remind everyone that the FDA advises that you should not stop taking any prescription medication before talking to your doctor.

Live Web Chat With Diana Levine, of Wyeth v. Levine, November 18, 2008, At 3 PM EST

Also, Alliance For Justice (AFJ) Has New Documentary Film, "Access Denied?: The Fight for Corporate Accountability", Which Covers Ms. Levine’s Drug Injury Situation

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Drug Injury Lawsuits Are Not Preempted By Federal Law (3/4/09)

On March 4, 2009 the U.S. Supreme Court, in a 6-3 decision, found that FDA approval was not a complete defense to plaintiff Diane Levine’s claim that Wyeth failed to adequately warn against a risk involved with the anti-nausea drug Phenergan. 

As stated by Justice John Paul Stevens: 

Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

Wyeth v. Levine, No. 06-1249 (U.S. Sup. Ct.)

For background information and materials regarding the Wyeth v. Levine case, visit the Federal Preemption of Drug Injury Lawsuits page over at the Drug Injury Law web site.

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I received an email earlier this afternoon from Kyle Murphy, Communications Specialist for the Alliance for Justice (AFJ), in Washington, D.C., that informed me about two items concerning Diana Levine -- named plaintiff in the relatively well-known Wyeth v. Levine case, for which oral arguments were heard by the U.S. Supreme Court on November 3, 2008.

The first item is a live web chat with Diana Levine on Tuesday, November 18, 2008, at 3 p.m. EST, on the FireDogLake.com site.  According to Mr. Murphy's email, "in order to have full commenting rights, you must register your email account (free of charge) with FireDogLake".

The second item is a new documentary film from the Alliance for Justice, "Access Denied?: The Fight for Corporate Accountability", which tells Diana Levine's powerful and sad story regarding how this musician lost her arm to a drug injury that was preventable.  This recently released AFJ film was produced in conjunction with 12-time Emmy award-winning producers/directors Jon Alpert and Matt O’Neill.

Mr. Murphy suggested in his email that the November 18 live chat with Diana Levine would be a good opportunity for people like you and me to ask Diana Levine questions about this new AFJ documentary film which delves into her drug injury situation, including the looming federal preemption issue.

Because there is not much lead time, I urge you to do your part in spreading the news about this November 18 live chat with Diana Levine to anyone who might be interested in listening or participating.  Thanks.

FDA And DOJ File Court Papers In November 2008 To Shut Down Actavis Totowa LLC

Federal Government Seeks A Permanent Injunction Against This Drug Company That Produced Defective Digitek Pills

(Posted by Tom Lamb at DrugInjuryWatch.com)

A November 13, 2008 Bloomberg article, "Actavis Sued by U.S. Regulators to Shut Heart Drug Manufacturer", got our attention due to the fact that this drug company, Actavis Totowa LLC, was responsible for the April 2008 Digitek recall as well as an August 2008 recall of all other generic drugs made at its Little Falls, New Jersey facility where the defective Digitek (digoxin) pills had been manufactured.

But the November 13 Bloomberg article did not have much information about this U.S. Department of Justice (DOJ) - FDA court action apart from what parent company Actavis Inc. stated in its November 13 press release, "Actavis Comments on Filing of DOJ Complaint".  Therein, the Actavis version of this situation is set forth:

"We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we've communicated regularly and candidly with the FDA, the public, our employees and our customers," said John LaRocca, Actavis Inc.'s Chief Legal Officer. "Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency and ourselves."

Of course, we will watch for additional news about this government shut-down of Actavis Totowa operations in the U.S., especially the FDA's reason for filing this lawsuit, now.

P.S.  On November 14, 2008 the U.S. Department of Justice (DOJ) issued a Press Release concerning the court papers that were filed against Actavis Totowa LLC, "U.S. Files Suit Against New Jersey Generic Drug Manufacturer That Distributed Adulterated and Misbranded Products", which tells the FDA side of this emerging story.  (11/14/08)

P.S.  If you are interested in knowing more, read the November 14, 2008 COMPLAINT FOR PERMANENT INJUNCTION document filed by the DOJ.  (11/17/08)

P.S.  In a November 26, 2008 article, "Reps attack FDA; call for Obama to 'clean house'", Representative Bart Stupak said the Complaint for an injunction stopping Actavis from manufacturing generic drugs at its Little Falls, New Jersey facility is “posturing” by FDA political appointees who have initiated actions like this, now, in an attempt to retain their positions under the new Administration.  (12/1/08)

When Will We Learn The Real Extent Of Generic Drug Recalls By Actavis And ETHEX

Numerous Instances Where Out-Of-Spec Oversized Pills With Double The API Dose Are Produced: How And When Did This Happen?

(Posted by Tom Lamb at DrugInjuryWatch.com)

In late April 2008, when the Digitek recall was announced by Actavis, most were surprised to hear that so-called "double-dose" pills were being produced by a drug company here in the U.S. 

But since then we have learned about several more instances of out-of-spec, oversized pills with double the dose of their respective active pharmaceutical ingredients (API), most recently the November 2008 (third and latest) recall by ETHEX involving these generic drugs:

Propafenone HCl Tablets: 150 mg, 225 mg, and 300 mg
Isosorbide Mononitrate Extended Release Tablets: 30 mg and 60 mg
Morphine Sulfate Extended Release Tablets: 15 mg
Morphine Sulfate Immediate Release Tablets: 15 mg and 30 mg
Dextroamphetamine Sulfate Tablets: 10 mg  

Other 2008 recalls by Actavis and ETHEX involving possible double-dose pills include:

• August 2008 Actavis Recall Of All Drugs Manufactured At Its Little Falls, NJ Plant

• A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.  (October 2008)

But we have had no explanation from Actavis, ETHEX, nor the FDA about what went wrong at these generic drug manufacturing plants such that we are able to know the extent to which these various defective pills were available for ingestion by unsuspecting patients.  That is, there has been little if any real information about the quantity of double-dose Digitek pills, for example, and when in time specifically those oversized pills were being produced by Actavis at its Little Falls, New Jersey facility.

In a November 10, 2008 article, "Big pills big problem for Ethex?", reporter Gareth Macdonald suggests that it may be difficult for us to learn how and when these generic pills were actually produced by ETHEX, and seemingly the same pertains to the Actavis recalls:

Details of any specific problem have not been released, making it difficult to ascertain if the oversized pills are a result of a manufacturing deficiency or simply that more out-of-spec tablets are being detected than previously as the sensitivity of analysis methods continues to improve.

Either way however, the growing safety focus following recent high-profile problems with branded products, generics and APIs is likely to result in the identification of more out-of-spec tablets as levels of regulatory scrutiny are increased.

Of course, there is always the possibility that FDA and Actavis will issue a Digitek update, for example, someday.  But with the passage of time since this FDA Class I Digitek recall was first announced in April 2008, it seems increasingly unlikely that Actavis or the FDA will be providing any clarification about the extent (in terms of quantity and time) of double-dose Digitek pills that were distributed to unsuspecting patients.

In early October 2008 Representatives John D. Dingell (D-MI) and Bart Stupak (D-MI) announced that Congress is investigating the Digitek recall to learn what the FDA knew about manufacturing problems at the Actavis facility in Little Falls, N.J.  Perhaps this investigation will yield some answers for us about the quantity and time questions.

Lastly, there will be what is called "discovery" in the Digitek litigation intended to figure out what led to the double-thickness problem at the Little Falls Actavis facility.  And, in the end, it may be this discovery process in the Digitek litigation is the only way that we will eventually learn the how and the when of what happened, there.

When Will FDA Report Its Findings About Any Link Between Fosamax And Atrial Fibrillation

In October 2007 The Agency Estimated It Would Need Up To 12 Months To Complete Investigation Regarding This Possible Bisphosphonate Side Effect

(Posted by Tom Lamb at DrugInjuryWatch.com)

The possible link between bisphosphonates such as Fosamax and the heart condition atrial fibrillation is the subject of an ongoing FDA safety review that should be finished, soon.

As background, from a previous post, "Bisphosphonate Safety Update: FDA Is Investigating Link With Atrial Fibrillation In October 2007"":

In October 2007 the FDA issued an Early Communication of an Ongoing Safety Review entitled "Bisphosphonates: Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)" which is largely based on the following:

An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine describe increased rates of serious atrial fibrillation (defined by the authors as life-threatening or resulting in hospitalization or disability) in two different studies of older women with osteoporosis treated with the bisphosphonates, Reclast and Fosamax....

This October 2007 FDA item states that the agency has requested additional information, presumably from the drug companies, in order to evaluate the extent of any association between these bisphosphonates and atrial fibrillation, which is a heart rhythm disorder.  Further, the FDA said this bisphosphonate safety evaluation would take up to twelve months for the agency to complete. 

Since this Early Communication was announced by the FDA in October 2007, the issue of whether there is a connection between serious atrial fibrillation (or "a-fib", for short) and bisphosphonates like Fosamax has surfaced a couple of times in the mainstream or medical press.

In April 2008 we saw this article, "Osteoporosis Drug Elevates Atrial Fibrillation Risk":

Women taking the bisphosphonate alendronate (Fosamax) for osteoporosis may have almost double the risk of atrial fibrillation, even after they stop taking the drug, researchers found.  
 
Those who had used alendronate at any time were 1.86 times more likely to develop incident atrial fibrillation than those who had never used a bisphosphonate, reported Susan R. Heckbert, M.D., Ph.D., of the University of Washington and Group Health in Seattle, and colleagues in the April 28 issue of the Archives of Internal Medicine.

More recently, the Fosamax - atrial fibrillation issue was addressed during an October 27, 2008 presentation made to the American College of Chest Physicians. From a HealthDay News article, "Osteoporosis Meds Linked to Heart Problem", which was published online by U.S. News & World Report, we get the essence of this presentation as well as some immediate reaction to it from Merck:

The overall difference in incidence of atrial fibrillation wasn't statistically significant between those taking bisphosphonates and placebo. However, when the researchers looked just at serious atrial fibrillation, meaning that it was significant enough to require hospitalization or caused death, they found a 68 percent increased risk for those on bisphosphonates.

[Jennifer Miranda, M.D., of the University of Miami in Florida,] said it's not clear why bisphosphonates might increase the risk of atrial fibrillation....

[Dr. Arthur Santora, executive director of clinical research at Merck Research Laboratories,] said his researchers have also done a meta-analysis to look at atrial fibrillation, but they included 40 studies, and they didn't find an increase in the risk of serious atrial fibrillation.

It seems that the FDA would have been provided the results from this Merck meta-analysis as part of the safety review concerning Fosamax that was started in October 2007.

Presuming such, we are anxious to see whether or not the FDA reached the same conclusion as Merck -- that there is no evidence that Fosamax causes an increased risk of serious a-fib incidents -- when the agency releases its report (hopefully soon) about there being any association between bisphosphonates and atrial fibrillation.

P.S.  Ask and you shall receive?...  Just two days after our article, above, was published a November 12, 2008 Reuters article, "Studies do not link heart risk to bone drugs: FDA", let us know that the FDA had finally issued its report, "Update of Safety Review Follow-up to the October 1, 2007 Early Communication about the Ongoing Safety Review of Bisphosphonates".  (11/12/08)

FDA's Delayed Announcement About Possible Insulin Overdoses Due To Recalled Syringes

Tyco Healthcare Group LP (Covidien) Recall Of ReliOn Disposable Syringes Was First Announced October 9, 2008; FDA Press Release About This Syringe Recall Is Dated November 5, 2008

(Posted by Tom Lamb at DrugInjuryWatch.com)

By means of an October 9, 2008 letter from ReliOn to its customers, the company announced a recall of a single lot of its syringes sold exclusively at Wal-Mart and Sam's Club stores.  In particular, this recall covered 1cc, 31-gauge, 100 units for use with U-100 insulin, syringes from the Lot Number 813900, which were shipped to Wal-Mart and Sam's Club stores during the period August 1, 2008 and October 8, 2008 by Can-Am Care or Tyco Healthcare Group LP (Covidien).

From this relatively short October 9 ReliOn letter we know that:

The U.S. Food and Drug Administration has been informed of this action.

The affected lot could have syringes mislabeled with inaccurate dosage increments, which could result in patients not receiving the correct dosage of their medication.

We did not learn until November 5, 2008, however, the extent and medical significance of this October syringe recall.  That was when the FDA finally let us know that 471,000 ReliOn disposable hypodermic syringes were recalled because they might be mislabeled such that a patient could receive up to 2.5 times more insulin than intended, potentially leading to "hypoglycemia, serious health consequences, and even death."  [emphasis added]

These additional, important details came from an FDA News press release, "FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes", issued by the agency on November 5, 2008 -- which is almost 30 days after the initial syringe recall announcement by ReliOn on October 9.

According to the November 2008 FDA News item about this ReliOn syringe recall:  "The manufacturer has received one adverse report related to a syringe from this product lot."

Well, here is my question:  If one's use of the mislabeled ReliOn syringes possibly containing more than two times the intended dose of insulin could lead to serious side effects such as hypoglycemia and even death, why was there a four-week delay by the FDA in getting more attention directed to this syringe recall?

All answers, comments, and opinions are welcomed.

Transcript Of Wyeth v. Levine Supreme Court Oral Arguments On November 3, 2008

Read What The Attorneys For Diana Levine And Wyeth Argued, And What Questions Were Asked By The Justices Regarding Possible Federal Preemption Of This Drug Injury Case

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: Drug Injury Lawsuits Are Not Preempted By Federal Law (3/4/09)

On March 4, 2009 the U.S. Supreme Court, in a 6-3 decision, found that FDA approval was not a complete defense to plaintiff Diane Levine’s claim that Wyeth failed to adequately warn against a risk involved with the anti-nausea drug Phenergan. 

As stated by Justice John Paul Stevens: 

Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

Wyeth v. Levine, No. 06-1249 (U.S. Sup. Ct.)

For background information and materials regarding the Wyeth v. Levine case, visit the Federal Preemption of Drug Injury Lawsuits page over at the Drug Injury Law web site.

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In the run up to the November 3, 2008 oral arguments in the Wyeth v. Levine case, there was an increasing amount of attention paid to the issue of whether or not the legal doctrine of federal preemption should be applied to drug injury lawsuits.

For those of you who are interested in what was said by the attorneys as well as the Supreme Court Justices during the Wyeth v. Levine oral hearing, we want to make available this information from the Argument Transcripts page of the Supreme Court's web site:

The Court's current Courtroom reporter, Alderson Reporting Company, provides transcripts of oral arguments that are posted on this Web site on the same day an argument is heard by the Court. Same-day transcripts are considered official but subject to final review. The following transcripts are for the cases argued during the October Term 2000 and subsequent Court Terms. These transcripts are permanently archived on this Web site. Persons wishing to purchase bound copies of individual transcripts should contact Alderson at (202) 289-2260, or www.aldersonreporting.com.

As of 12 noon, eastern time, on November 3 the Wyeth v. Levine transcript was not available, yet.  We will add a postscript, here, with the internet URL for this transcript as soon as it is available.

P.S.  The transcript of the November 3, 2008 Wyeth v. Levine Supreme Court hearing is now available on the Arguments Transcript page of Court's web site.  (11/3/08, 4:00 p.m.)