Drug Injury Watch

Gardasil Vaccine Associated With 28 Deaths In 2008 According To Judicial Watch Report

This Public Interest Group Reviewed Gardasil Cases Found In FDA’s Vaccine Adverse Event Reporting System (VAERS)

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to the Gardasil web site:

GARDASIL is the only cervical cancer vaccine that helps protect against 4 types of human papillomavirus (HPV): 2 types that cause 70% of cervical cancer cases, and 2 more types that cause 90% of genital warts cases.

On June 22, 2009 the public interest group Judicial Watch issued a press release regarding the Gardasil vaccine which had the following attention-getting headline and sub-headline:

New FDA Records Obtained by Judicial Watch Indicate 28 Deaths Related to Gardasil in 2008

• View Discussion Records Document 6,723 Adverse Reactions in 2008, Including 1,061 Considered "Serious" and 142 Considered "Life Threatening"

According to this June 22 press release Judicial Watch is basing their numbers on the group's review of the FDA’s Vaccine Adverse Event Reporting System (VAERS), during which they found:

...28 deaths in 2008 associated with Gardasil, the vaccination for human papillomavirus (HPV), up from 19 deaths in 2007. The total number of Gardasil-related deaths is 47 since the vaccine was approved in 2006. Overall, the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening."

The June 22, 2009 Judicial Watch press release has links to the VAERS case reports for some Gardasil adverse reactions that are cited as examples.

The press release closes with this "position statement" by Judicial Watch:

"The FDA is supposed to be a guardian of public health, and yet the agency continues to turn a blind eye to what seems to be an extremely serious public health problem. The public relations push for Gardasil by Merck, politicians and public health officials needs to pause so that these adverse reactions can be further studied," said Judicial Watch President Tom Fitton. "The already serious problems associated with Gardasil seem to be getting worse. No one should require this vaccine for young children."

We would be interested in hearing about any Gardasil adverse reactions you know of, as well as your opinion about whether the Gardasil vaccine should be required for young children.  To participate in this conversation, you only need to submit a Comment, below.

Beware The Potential Dangers Of Free Drug Samples

Some Ways That Free Drug Samples Can Harm Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

PLoS Medicine-- which is a peer-reviewed open-access journal published by the Public Library of Science -- published an essay by Susan Chimonas and Jerome P. Kassirer in May 2009 called "No More Free Drug Samples?" which provides a fresh perspective on a well-established practice in doctors office across the U.S.

This essay starts with the ideas that many of us may have about this practice:

Everybody likes something free, and free prescription drug samples are no exception. Patients love to receive them, and doctors feel good about handing them out. The practice of providing free drug samples is based on the tacit assumption that “sampling” does much more good than harm.

Chimonas and Kassirer go on from there to deconstruct these preconceptions, working at various levels:

In this essay, we question the assumption that good trumps harm when prescription drugs are provided free to practicing doctors. We argue that “sampling” is not effective in improving drug access for the indigent, does not promote rational drug use, and raises the cost of care.

I want to focus on the drug-safety aspect of this free drug samples issue. 

In their May 2009 PLos Medicine essay, Chimonas and Kassirer make these points in support of their contention that samples can have "negative consequences" when it comes to patient-health:

• In drugstores, pharmacists often identify potentially harmful drug interactions, intercept inadvertent medication errors, and offer a patient-friendly printout of instructions. In doctors' offices, however, detailed patient education regarding sample use rarely occurs, and when it does, it usually lacks information about drug interactions or instructions on how the drug should be taken. [footnote omitted]

• Moreover, if distribution is inadequately documented in patients' records, some people who receive samples in doctors' offices may not be notified or told to discontinue the medication in the event of a product recall or the emergence of new drug complications.

• The samples that drug representatives offer are almost never time-worn and well-tested drugs, nearly never generics, and usually comprise the newest agents on the market. As such, they expose patients to risks not yet identified in clinical trials. The experience with Vioxx is a case in point.

Chimonas and Kassirer discuss in this insightful essay, also, several other concerns they have with the seemingly "generous" practice of doctors dispensing free drug samples to patients.  It total, the authors conclude that:

The tradition of physicians dispensing samples has many serious disadvantages and is as anachronistic as bloodletting and high colonic irrigations. As the profession begins to slowly extract itself from the influential grip of industry, it must also deal with the undue influence of free samples.

If this topic interests you, "No More Free Drug Samples?" is a relatively short essay that is worth reading when you have an opportunity.

Off-Label Prescribing Of Drugs: An Explanation And Some Practical Guidance For Patients

Don't Be Afraid To Talk With Your Doctor About Any Medication You Are Prescribed -- Especially If The Drug Is Being Used As A Treatment NOT Approved By FDA

(Posted by Tom Lamb at DrugInjuryWatch.com)

Let's start with an informal and short definition of so-called "off-label" prescribing: A drug is being prescribed "off-label" when it has not been approved for treatment of the patient's medical condition and, instead, is being used experimentally.

To put this practice into context, we draw from a provocative article, "Informed Consent and Shared Decision-Making: A Requirement to Disclose to Patients Off-Label Prescriptions", written by Michael Wilkes and Margaret Johns, which was published November 11, 2008 by the Public Library of Science (PLoS):

Because a basic premise of the US Federal Food, Drug, and Cosmetic Act is that manufacturers are prohibited from marketing drugs or devices without FDA approval, the public commonly assumes that all uses of prescription drugs have been approved by the FDA. However, after a drug is approved for one set of indications, researchers and doctors often discover new applications for it. Even when the FDA approves a drug for a single, specific use, doctors may legally prescribe the drug to any patient for any use. Physicians are not restricted to prescriptions that comply with the FDA approval. The FDA considers such treatments “off-label” because substantial evidence regarding their safety and efficacy has not been presented or evaluated. But such uses are perfectly legal. In fact, FDA policy explicitly states that “once a [pharmaceutical] product has been approved for marketing, a physician may prescribe it for uses in treatment regimes of patient populations that are not included in the approved labeling”. Indeed, as the Supreme Court has recognized, off-label prescribing “is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering with the practice of medicine”.  [footnotes omitted]

This PLoS article by Wilkes and Johns points out that, in fact, there are many examples of responsible off-label prescribing -- one is aspirin being prescribed to reduce the risk of heart attack long before it was FDA-approved for this purpose -- but cautions that other off-label uses can be dangerous -- a prime example is fenfluramine for weight loss, which caused heart valve damage to thousands of people (it was onepart of the notorious "fen-phen" combination).

So what should a patient do when it seems that their doctor is suggesting, or prescribing, a drug for an "indication", or treatment use, other than what that drug was approved for by the FDA?

The Agency for Healthcare Research and Quality (AHRQ) publishes online an advice column from Carolyn M. Clancy, M.D., who wrote "Off-Label Drugs: What You Need to Know".  Here is some guidance for patients offered by Dr. Clancy in that April 21, 2009 article:

Talk with your doctor if you have concerns about any medicine or treatment, particularly if it may be off label. Here are several questions to ask:

• Is this the approved use of the medicine? You may not know if the use is off label. This question can help you start the conversation with your doctor about your medicines. 
• Is the off-label use of this drug likely to be more effective than one approved to treat my illness? This is important because the off-label drug may not be as well tested for your condition.
• What evidence shows that this off-label drug can treat my condition?
• What are the risks and benefits of off-label treatment with this drug? Will my health insurance cover off-label treatment with this drug?

As we like to say at AHRQ, "Questions are the answer," meaning that it's important to ask your doctor plenty of questions about any medicines he or she prescribes. When you understand why you are taking certain medicines—including off-label drugs—you are more likely to take them correctly.

The bottom line is that you should not be afraid to talk with your doctor if you know or suspect that a drug is being prescribed off-label, i.e., as a treatment which has not been approved by the FDA.

Drug Interaction Prevention Is An Ongoing Process For Doctors And Patients

An Introduction Using Examples And Facts Relevant To Avoiding Drug-Drug Interaction Risks

(Posted by Tom Lamb at DrugInjuryWatch.com)

Patients who require multiple prescription drugs at one time, i.e., concomitant use, are sometimes placed at risk for developing drug-drug interactions (DDIs), where one drug alters the effect of another drug. In turn, drug-drug interactions can lead to decreased therapeutic benefit or efficacy, adverse effects of varying degrees, or even patient death.

To further complicate this type of situation, non-prescription medications and herbal preparations or supplements can contribute to the potential for developing DDIs.

The following examples and facts are intended to help doctors and patients avoid drug interactions and their potentially serious, even fatal, consequences.  They are taken from an educational article, "Managing Drug-Drug Interaction Risks" (free site registration required), which is intended for physicians, pharmacists, nurse practitioners, physician assistants, nurses, and other healthcare workers -- but the information therein could be helpful to patients and their families.

• DDIs contribute to patient morbidity and may cause emergency department visits, hospitalizations, and re-admissions.Examples of patient morbidity caused by DDIs include gastrointestinal (GI) bleeding, renal dysfunction, electrolyte imbalance, hypertension, hypotension, bradycardia, arrhythmia, drug toxicity, and decreased drug effect.
• Examples from the literature of mortality associated with DDIs include ciprofloxacin in fatal seizures, moclobemide-clomipramine overdose in fatal serotonin syndrome,and fatal outcome from a warfarin and nonsteroidal anti-inflammatory drug (NSAID) interaction.
• [T]he risk for DDIs increases significantly after 44 years of age and is greatest for patients over 74 years of age. The need for multiple medications often arises with advancing age that may further the risk for DDIs.
• Patients taking 2 medications had a 13% risk while patients taking 5 medications had a 38% risk for DDIs. Patients taking 7 or more medications had an 82% risk of developing adverse drug interactions.
• Other patient-related risks for DDIs... include very young age, female sex, genetics, decreased organ function, use of a medication having a narrow therapeutic range (eg, warfarin, digoxin, and cyclosporine), major organ impairment, metabolic or endocrine risk conditions (eg, hypothyroidism, hypoproteinemia), and acute medical issues (eg, dehydration).

In the U.S., with our aging population and an ever-increasing use of prescription medications, it seems safe to say that the more one knows about the how to avoid possible drug-drug interactions, the better.

If you are aware of any additional guidance or resources regarding how to avoid drug interactions, please let us know by submitting a Comment, below.

April 2009 FDA "Patient Safety News" Videos For Doctors Online

Covers Bowel Cleansing Agents Visicol and OsmoPrep, As Well As Methadone Overdoses, Ethex Generic Drug Recall, And Medication Errors

(Posted by Tom Lamb at DrugInjuryWatch.com)

The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences.

Subjects covered in the April 2009 edition of the FDA Patient Safety News include the following:

Stronger Warnings for Bowel Cleansing Agents

FDA is announcing new safety measures for oral sodium phosphate (OSP) products used for bowel cleansing before colonoscopies and other procedures. These products are associated with acute phosphate nephropathy, a rare but serious type of kidney injury. The events have been reported with the prescription products Visicol and OsmoPrep, and also over-the-counter sodium phosphate products when they are used as bowel cleansers.

Preventing Overdoses when Using Methadone to Treat Chronic Pain

A report from the Institute for Safe Medication Practices (ISMP) lists several reasons for the serious and sometime fatal overdoses that have occurred when methadone is used to treat moderate to severe chronic pain.

ISMP points out that methadone differs from other opioids in a number of ways. For example, methadone remains in the body long after its analgesic effect has worn off. Also, a patient may not experience the full analgesic effect of methadone until 3-5 days of use, so it must be titrated more slowly than other opioids.

Ethex Corp. Expands Recall of Generic Drugs and Supplements

The generic drug company Ethex Corporation is expanding earlier recalls to now include over 60 generic drug products, including narcotics and cardiac medications, as well as several dozen prescription prenatal vitamins and iron supplements. The company is taking this action as a precautionary measure because these products may have been manufactured under conditions that didn't comply with current Good Manufacturing Practices. Certain lots of some of these products were recalled earlier because of defects such as oversized tablets.                                                   

Avoiding Medication Errors with Multiple Brand Names

The Institute for Safe Medication Practices (ISMP) recently highlighted medication errors that can occur when a drug is marketed under more than one brand name, especially when one of those names is well established.

ISMP says that health professionals can reduce the risk of errors by conducting a thorough drug history and reviewing drug information if they encounter unfamiliar product names. ISMP also suggests that health professionals encourage patients to fill their prescriptions at the same pharmacy where possible, to help avoid taking the same product under different names.

One can find more information about this April 2009 PSN edition and the series in general on the Patient Safety News section of the FDA's web site.

March 2009 List Identifies Some Of The Best Pharmaceutical News and Research Blogs

The Pharm Tech Blog Presents A Top 50 List Which Includes Many Fine Pharma Sites, And Drug Injury Watch

(Posted by Tom Lamb at DrugInjuryWatch.com)

Earlier this week I learned that the Drug Injury Watch blog -- which I started in April 2005 -- was listed as one of "The Top 50 Pharmaceutical News and Research Blogs" by The Pharm Tech Blog.

This March 2009 list has some of the top Pharma blogs broken down into several categories:

• Industry News

• Insider Perspectives

• Research

• Consumer Advocates

I am proud that Drug Injury Watch was listed under that last category, together with some very fine web sites such as Eye on the FDA and Pharma Gossip-- two of the many blogs about pharmaceutical and healthcare issues that I read on a regular basis.

As stated in the introduction to this March 2009 list of top 50 Pharma blogs:

More and more, blogs and news releases are becoming the primary way that consumers and industry professionals remain up to date on information that can affect things ranging from insurance coverage and rates, industry market conditions, drug advancements as well as their health.

I thank The Pharm Tech Blog for including this blog on their list, and I thank you for reading Drug Injury Watch.

March 2009 Update: Sprint Fidelis Heart Device Connected To At Least 13 Deaths

Newly Released FDA Report Indicates Medtronic Had First Reports Of Lead Wire Problems In Late 2004

(Posted by Tom Lamb at DrugInjuryWatch.com)

A March 14, 2009 New York Times (NYT) article, "Medtronic Links Device for Heart to 13 Deaths", by reporter Barry Meier gave us the latest developments regarding the problems that gave rise to the October 2007 recall of Sprint Fidelis lead wires used in defibrillators.

Mr. Meier's March 14 NYT article was published a day after Medtronic sent a March 13, 2009 "Dear Doctor" letter, "Sprint Fidelis® Model 6949 Lead Performance".  In that document, the medical device company states:

Approximately 268,000 Fidelis leads have been implanted worldwide. The FDA’s MAUDE database currently has 107 Medical Device Reports (MDRs) that include allegations that the Fidelis lead may have caused or contributed to a patient death. Most of these MDRs were not initiated by medical professionals; the majority were initiated by family members or attorneys with minimal supporting data. Medtronic’s Independent Physician Quality Panel has reviewed 89 of the 107 reports. It is not possible to determine cause of death with certainty.

The Panel has identified 13 patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. The Panel noted that four of the 13 deaths were associated with lead extraction, highlighting the risks associated with that procedure. With the exception of the appearance of deaths associated with lead extraction, no new or unexpected trends have been observed.

Building upon this March 2009 Sprint Fidelis "Dear Doctor" letter, Mr. Meier adds some contextual information:

The death statistics Medtronic released [March 13] underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.

Along with fatalities, the F.D.A. has received about 2,200 reports of serious injuries related to the leads. Medtronic officials said they believed that reflected the number of people who had undergone surgery to have a failed lead replaced with a new one.

But the larger part of Mr. Meier's March 14 article has to do with a "new" FDA report that was provided to this NYT reporter by lawyers involved with product liability lawsuits concerning serious injury or death caused by the defective Sprint Fidelis lead wires.  Here is how Mr. Meier describes that FDA report:

[A] previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing....

The F.D.A. report is based on a visit by regulators to a Medtronic facility in Mounds View, Minn., soon after the device was removed from the market, where the officials interviewed executives and inspected records.

The report shows that by late 2005 the company had received 30 complaints about device fractures and had identified several possible ways in which the lead might be failing. About that time, the company opened an internal investigation into the problem, according to the report.

What happened next is not clear, because the F.D.A. redacted portions of the report before releasing it. But the document indicates that Medtronic engineers met often about the problem throughout 2006 and that they performed a “statistical analysis of the three failure modes” of the lead in October of that year, the report states.

This FDA report is significant as regards some critical issues in any Sprint Fidelis lawsuit filed against Medtronic, specifically: (1) When did Medtronic first learn about the potentially fatal failures involving its Sprint Fidelis lead wire products; and, (2) What did Medtronic do about these Sprint Fidelis failure reports from that point time up until when the company finally issued its October 2007 Sprint Fidelis recall?

We will continue to provide updates on this Sprint Fidelis recall and the thousands of related legal claims.

2008 Emory Law Journal Article Presents Ketek As A Case Study In FDA Regulatory Failure

Discusses The Dire Consequences Of Fraudulent Science, Federal Preemption, And Corporate Deregulation

(Posted by Tom Lamb at DrugInjuryWatch.com)

Thomas O. McGarity, of the University of Texas School of Law, is uniquely positioned to give us a history of the beleaguered antibiotic Ketek in his 2008 article, "Corporate Accountability for Scientific Fraud: Ketek and the Perils of Aggressive Agency Preemption", which was published in the Emory Law Journal, Volume 58, Number 2 (58 EMORY L.J. 287, 2008).

From an introductory footnote we get this background information about Professor McGarity and this 2008 law review article about Ketek:

This Article lies at the intersection of three major projects on which the author has labored for the past several years and will continue to pursue during the next two years. The first, an inquiry with my colleague Professor Wendy Wagner into the strategies that advocates in the private sector employ to “bend science” to support predetermined policy agendas, resulted in a recently published book....  The second project describes and analyzes the efforts of common law defendants, joined more recently by some regulatory agencies, to persuade courts to find that state common law claims against the manufacturers of federally licensed products and activities are preempted by federal regulatory action....  The final project, a forthcoming book, Freedom to Harm, examines the thirty-year project of free market advocates in corporate America, conservative think tanks, and academia to free companies of “unnecessary and burdensome” regulatory responsibilities and common law obligations.

I understand not many of you may have the appetite nor the time to consume all that Professor McGarity has to offer in his 58-page law review article.  Anyone wanting to learn about the various "irregularities" in how Ketek was approved by the FDA, however, should at least be aware that this McGarity article is available as a resource.

To give one a sense of what this Ketek law review article by Professor McGarity has to offer, I have excerpted the following from the Introduction section:

• Part I briefly describes the new drug approval process through which a manufacturer of a prescription drug must obtain approval from the Food and Drug Administration (FDA) for new products and for new uses of existing products.

• Part II provides a case study of the dramatic failure of this process to protect consumers by using recently uncovered information concerning the antibiotic Ketek.

• Part III briefly describes the role that state common law can play in providing a backup for ensuring that manufacturers behave responsibly during the drug approval process and are held accountable when they do not.

• Part IV describes the Supreme Court’s decision in Buckman Co. v. Plaintiffs’ Legal Committee, in which the Court held, in a fairly unique factual setting, that the plaintiffs’ common law claims based upon the fraud allegedly perpetrated by a consultant for a medical device manufacturer was preempted by federal law.  [footnote omitted]

• Part V analyzes the arguments for and against preemption of fraud-on-the-agency claims in light of the Ketek experience and concludes that, on balance, preemption is a bad idea because federal enforcement alone provides inadequate incentives to companies that, because they face powerful economic pressures to show large profits to their shareholders, are inclined to cut corners.

• Part VI offers suggestions on how the lower courts should react to Buckman, how the Supreme Court can avoid extending Buckman when it next takes up the issue, and how Congress might go about reversing or limiting Buckman and empowering common law courts to reassume the vital backstop role that they have played in the past.

One may wonder why Professor McGarity chose Ketek as his example for depicting what is currently wrong with the FDA and its drug-approval process.  From the Conclusion section:

Why does Ketek matter? Because FDA broke its own rules and allowed Ketek on the market; because dozens of patients have died or suffered needlessly; because FDA allowed Ketek’s maker to experiment with it on children over reviewers’ protests; because FDA ignored warnings about fraud; and because FDA used data it knew was false to reassure the public about Ketek’s safety.  [footnote omitted]

For those of you who are not familiar with Ketek (telithromycin), it is in a class of drugs called ketolide antibiotics and is to be prescribed only for community-acquired pneumonia. Ketek has been associated with adverse side effects such as liver damage, liver disease, liver failure, and hepatitis.

Some Drugs Can Cause Stevens-Johnson Syndrome And Toxic Epidermal Necrolysis In Children

Parents Need To Be Aware Of These Two Serious And Potentially Fatal Skin Reactions Which Are Associated With Certain Medications

(Posted by Tom Lamb at DrugInjuryWatch.com)

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are two rare but life-threatening skin reactions. 

SJS and TEN are regarded as variants within a continuous spectrum, and have been distinguished by the extent of the skin area involved.  Generally, when less than 10% of the total body surface is involved, the condition is defined as SJS; when more than 30% is involved, it is defined as TEN; and, the cases between 10% and 30% are defined as SJS/TEN–overlap.

The mortality risk is high for TEN cases insofar that greater than 40% are fatal, with sepsis being the most important cause.

In January 2009 the medical journal Pediatrics published online the early release of a report, "Medications as Risk Factors of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in Children: A Pooled Analysis", which informed us about a study that examined which drugs were most often associated with SJS and TEN in children under the age of 15-years old.  This report was published (print version) in the February 2009 edition of the Pediatrics journal.

From the "Conclusions" section of that Pediatrics article we get this summary of the study findings:

SJS and TEN are rare diseases among children with a mortality rate estimated at 7.5%. In our study, children had mucous membrane lesions in 95% of cases and the median percentage of skin detachment was 20% of the body surface (10% to 40%). We did not confirm any suspected nonmedication risk factors. We confirmed 4 highly suspected drugs in children, antiinfective sulfonamides, phenobarbital, carbamazepine, and lamotrigine. Among other suspected drugs, we assume that acetaminophen may substantially increase the risk of SJS/TEN in children.

Concerning the anti-infective sulfonamides mentioned above as the first of these suspected drugs, according to the web site MedicineNet.com:

The sulfonamide family includes sulfadiazine, sulfamethizole (brand name: Thiosulfil Forte), sulfamethoxazole (Gantanol), sulfasalazine (Azulfidine), sulfisoxazole (Gantrisin), and various high-strength combinations of three sulfonamides.

In turn, phenobarbital is available as a generic medication.

The drug carbamazepine is sold under the brand names Tegretol, Tegretol XR , Equetro, and Carbatrol.

Then there is lamotrigine which is marketed as Lamictal; and, acetaminophen is the generic name for Tylenol products.

A February 6, 2009 Reuters Health article, "Medications Tied to Stevens-Johnson Syndrome in Children", that provided us with some insights from the one author of this report:

Dr. Jean-Claude Roujeau of INSERM, Creteil, France, and colleagues came to this conclusion after studying pooled data from two international studies of adverse cutaneous reactions.

"Our study combined the results because the conditions are rarer than in adults," Dr. Roujeau told Reuters Health. Even so, he added, "The present study on drug causality in children had a lower statistical power than each of the prior studies done on a whole population."...

The researchers say they confirmed the role of anti-infective sulfonamides, phenobarbital, carbamazepine, and lamotrigine. "Among other suspected drugs, we assume that acetaminophen may substantially increase the risk."

However, added Dr. Roujeau, "this latter result still needs confirmation."

This study was conducted in France, Germany, Italy, Portugal, the Netherlands, Austria, and Israel.

February 2009: FDA Releases Its Quarterly List Of Drugs With Possible Safety Problems

FDA List Is Based On Reports Made To Adverse Event Reporting System (AERS) Between July And September 2008

(Posted by Tom Lamb at DrugInjuryWatch.com)

On February 4, 2008 the FDA posted on its web site a new list of prescription drugs it will be studying for potential safety problems.  The FDA's list, "Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between July - September 2008", is presented in the form of a table with the following fields:

• Product Name: Active Ingredient (Trade) or Product Class
• Potential Signal of Serious Risk/New Safety Information
• Additional Information Available as of January 30, 2009

The preface to this FDA list has some very important qualifying language:

The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

A February 4, 2008 Reuters article, "US FDA lists drugs under review for safety issues", provided this overview of the FDA's current list of drugs with so-called "safety signals":

The products under review included schizophrenia drug Abilify, one of Bristol-Myers Squibb Co's (BMY.N) fastest- growing products. Post-marketing data raised concern about possible liver toxicity and other issues, the FDA said.

The FDA also said it was reviewing Roche Holding AG's (ROG.VX) diet drug, Xenical, for the risk of rectal bleeding to see whether any agency action was needed.

In addition, the agency said evaluating the risk of birth defects with widely-used SSRI and SNRI antidepressants, which already carry strong warnings about suicidal behavior.

Well-known antidepressants include Eli Lilly and Co's (LLY.N) Prozac, Pfizer Inc's (PFE.N) Zoloft, GlaxoSmithKline Plc's (GSK.L)(GSK.N) Paxil and Forest Laboratories Inc's (FRX.N) Lexapro and Celexa.

Insofar that the newly listed drugs are under an ongoing safety review by the FDA, anyone with information about a patient experiencing a possible serious side effect that may be associated with any of these drugs should submit a MedWatch report to the FDA for the agency's consideration.