Drug Injury Watch

Possible Avandia Recall: Liver Failure Cases May Tip Balance Of Risk vs. Benefit

October 2008 Public Citizen Petition Wants Glaxo's Diabetes Drug Banned Due To "New" Side Effect, Liver Toxicity

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 30, 2008 Public Citizen's Health Research Group (HRG) submitted a petition to the FDA requesting that GlaxoSmithKline's diabetes drug Avandia (rosiglitazone) be banned due to the drug's several serious side effects, including some newly found cases of liver failure.

According to this "Petition to Immediately Ban Diabetes Drug Rosiglitazone (AVANDIA) (HRG Publication #1848)":

Our petition is based on [Avandia]’s multiple, serious risks, including one just documented by our new analysis of 14 cases of liver failure, of which 12 resulted in death.

Besides the Avandia-induced liver failure, this Petition by Public Citizen's HRG pointed out several other serious side effects associated with Avandia, including:

Myocardial Ischemia: Three recent meta-analyses have demonstrated an increased risk of myocardial ischemia or myocardial infarction with [Avandia]. The approximate increase in the risk of heart attacks is 40%.

Congestive Heart Failure:... Several meta-analyses estimate the increased risk
to be approximately two-fold.

In this October 2008 document Public Citizen compared Avanida to Rezulin (troglitazone) when it comes to the risk for drug-induced liver failure, as is seen from the following excerpt from the Petition:

[Rezulin], a thiozolidinedione similar in structure to [Avandia], was approved for marketing by the FDA in March 1997, but was withdrawn from the market in March 2000 after 94 cases of [Rezulin]-induced liver failure, the majority of which were fatal, were reported.  Although the premarketing signal for hepatotoxicity with [Avandia] was not as strong as the signal with [Rezulin], one of the most hepatotoxic drugs ever approved by the FDA, several cases of [Avandia]-induced hepatotoxicity have been reported in the literature, and many more via the FDA Adverse Event Reporting System (AERS). [footnotes omitted]

Overall, according to Public Citizen -- taking into account the newly found cases of liver failure together with "the accompanying lack of evidence of any clinical benefit" when Avandia is compared to other diabetes drugs -- the time has come for the FDA to order an immediate Avandia recall.

In October 30, 2008 article, "Glaxo's Avandia Should Be Banned, Public Citizen Says (Update2)", Bloomberg reporter Justin Blum let us know the drug company's initial reaction:

Glaxo hasn't read the petition and "we do not believe there is a connection between liver toxicity and this medicine," according to an e-mail from company spokeswoman Mary Anne Rhyne. She said Avandia is safe "for appropriate type 2 diabetes patients, when used according to the label."

Previously, in the article "Mixed Reactions To Avandia's Revised Warning In November 2007 About Risk Of Heart Attacks"", we reported that in November 2007 the FDA issued a news release entitled "FDA Adds Boxed Warning for Heart-related Risks to Anti-Diabetes Drug Avandia", which carried the sub-heading "Agency says drug to remain on market, while safety assessment continues". 

One wonders, now, whether this apparent new link to liver toxicity will compel the FDA to ban Avandia as requested by Public Citizen.

P.S.  Late in the day on October 30 GlaxoSmithKline issued its formal response to the HRG Avandia Petition submitted to the FDA by means of this press release, "GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition". 

The main point raised therein:

The safety of patients using our medicine is very important to us. On a continual basis, an external Hepatic Safety Board reviews any adverse event report received by GSK of liver failure, liver-related deaths and liver transplants for possible relationship to AVANDIA. As recently as July 2008, this panel of experts continued to endorse a favorable hepatic safety profile for AVANDIA.

There has been no word from the FDA about how long the agency will need to make a determination on the Avandia recall requested by Public Citizen.  (10/31/08)

FDA Wants To Change Its MedWatch Adverse Event Reporting System

October 2008 Federal Register: FDA Seeks Public Comments On A New MedWatch Portal; December 22 Deadline

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to a Notice in the October 23, 2008 edition (Volume 73, Number 206) of the Federal Register, the FDA is proposing to change its MedWatch web site and the manner in which it collects information about suspected adverse events involving prescription drugs and other regulated products.

An October 23 article, "FDA to Ease Adverse Event Reporting", published online by HealthData Management (HDM) Breaking News, summarized this FDA Federal Register Notice as follows:

The Food and Drug Administration is seeking comment on a new Web portal under development that would provide a one-stop place to file reports of adverse events associated with the use of regulated products.

FDA has launched the development and implementation of the MedWatch/Plus/Portal, an enhanced, Web-based version of its existing MedWatch collection system. "The agency believes that one central point-of-entry will better enable persons to submit their information,"....

The portal will include a data collection tool called the "Rationale Questionnaire" to ease the reporting of a safety problem, according to the FDA. The questionnaire will ask simple questions to help users determine what information they should provide.

Anyone--including consumers, clinicians, researchers and medical device makers--will be able to report adverse events, medical errors, product complaints and other adverse reports. "The system will compile the user's responses into a standardized report that would be routed to the appropriate FDA organizational components for review and analysis,"....

To learn more, you can read the actual FDA Federal Register Notice, entitled "Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Data Collection Using MedWatch\Plus\ Portal and Rational Questionnaire" [Docket No. FDA-2008-N-0546]. 

This October 23 Federal Register Notice tells you how to submit a written or electronic commentto the FDA about its proposed MedWatch Portal, and informs us that the deadline for such comments is December 22, 2008.

Learn More About Possible Federal Preemption of Drug Injury Lawsuits And Wyeth v. Levine

Get Background Information, Opinions, And Resources For This Important Legal And Public Policy Issue

(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.

**********

On November 3, 2008 the U.S. Supreme Court will hear oral arguments from both sides in the case of Wyeth v. Levine regarding whether the fact that prescription drugs are regulated by the federal government should shield drug companies from being sued by injured patients in state courts.

It is my position that any application of the federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation.

At our Drug Injury Law web site we have developed an information and news page called "Federal Preemption of Drug Injury Lawsuits".

There you will find some background about the the Wyeth v. Levine case, which involves Diana Levine, a Vermont musician and migraine sufferer who lost part of one arm due to side effects from Wyeth’s nausea drug Phenergan.

On the Drug Injury Law preemption page we also have:

• the October 2008 Wyeth press release concerning the Levine case and the issue of federal preemption;
• the U.S. Supreme Court docket and statement of issue for Wyeth v. Levine as well as the various "friend of the court", or amicus curiae, briefs that have been filed; and,
• several opinion articles about the federal preemption doctrine in the context of drug injury cases from various sources, ranging from The England Journal of Medicine to several blogs, including Ed Silverman's Pharmalot and Doug Bremner's Before You Take That Pill, as well as a piece by Henry Greenspan on the collaborative Tort Deform site.

If you want to recommend some additional items that we should make available on the Federal Preemption of Drug Injury Lawsuits page over at our Drug Injury Law site, you can let me know by submitting a Comment to this post, using the link below.

Of course, you can also use the Comment feature to let people know what you think about the possible application of this federal preemption legal doctrine to drug injury lawsuits -- the issue that is before our Supreme Court in the Wyeth v. Levine case.

Pfizer Settles Most Bextra And Celebrex Drug Injury Cases

Company Will Pay $745 Million In Settlements To Conclude 90% Of These Lawsuits

(Posted by Tom Lamb at DrugInjuryWatch.com)

An October 17, 2008 Wall Street Journal (WSJ) article, "Pfizer to Settle Celebrex and Bextra Suits", broke the news and provided the details:

Pfizer Inc. has agreed in principle to pay $894 million to settle litigation related to its painkillers Celebrex and Bextra.

The bulk of the settlement, $745 million, will resolve 90% of the known personal injury suits that allege the painkillers caused heart attacks and strokes, according to Pfizer, which will take a third-quarter pre-tax charge to earnings of $894 million, a statement provided by the company said.

Attorneys General in 33 states and the District of Columbia, who have filed suits relating to Pfizer's promotion of Bextra, will receive $60 million of the settlement; the remainder, $89 million, will resolve class actions alleging fraud in connection with the promotion of Celebrex and Bextra.

The settlement does not cover securities fraud litigation that has been filed in connection with Celebrex and Bextra.

Pfizer's Celebrex is the last among a group of painkillers called Cox-2 inhibitors that is still sold in the U.S.  From the October 17 WSJ article:

"Pfizer stands by the safety and efficacy profile of Celebrex," said Joe Feczko, Pfizer's chief medical officer.

Bextra was recalled in April 2005 by the FDA and Pfizer.  At the time, the FDA said it was the increased risk of serious skin reactions that was the reason for Bextra being pulled off the market.

Vioxx was recalled in September 2004 by the FDA and Merck due to cardiovascular side effects.  In late 2007 Merck agreed to pay $4.85 billion in a so-called "global settlement" of all personal injury and wrongful death cases involving Vioxx use in the U.S.

A New "Double-Dose" Pill Drug Recall Is Issued By ETHEX Corp.

First It Was Their Morphine Tablets; Now ETHEX Dextroamphetamine 5mg Pills May Be Oversized And Contain Two Times The Active Ingredient

(Posted by Tom Lamb at DrugInjuryWatch.com)

By means of an October 16, 2008 MedWatch Email Alert the FDA announced that ETHEX Corporation has recalled three lots of Dextroamphetamine Sulfate 5mg tablets because of the potential presence of oversized tablets that may contain as much as twice the labeled amount of the active ingredient. From the October 16 FDA Alert:

Taking a higher than expected dose of Dextroamphetamine Sulfate may be associated with an increased risk of adverse effects such as tachycardia, hypertension, tremors, decreased appetite, headache, insomnia, dizziness, blurred vision, stomach upset, and drug mouth. Consumers and their caregivers should not use any Dextroamphetamine Sulfate tablets that appear to be oversized and should consult their healthcare professional with any questions.

An October 15 drug company press release, "ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets -- Lot Number 77946, 81141 and 81142 NDC #58177-311-04", provides these details:

ETHEX Corporation announced today that it has voluntarily recalled three specific lots (77946, 81141 and 81142) of Dextroamphetamine Sulfate 5 mg tablets, as a precaution, due to the possible presence of oversized tablets. Oversized tablets may contain as much as about twice the labeled amount of the active ingredient. The recalled lots were distributed by ETHEX Corporation under an "ETHEX" label between January 2007 and May 2008. The 5 mg product is an orange round tablet debossed with "ETHEX" and "311" on one side.

... ETHEX Corporation is conducting this precautionary, voluntary recall because it found a small number of oversized tablets in lots which had not yet been distributed. These oversized tablets were removed before the lots were distributed.

Previously, in June 2008 ETHEX Corp. announced that it was recalling Morphine Sulfate 60 mg Extended Release Tablets.  With this earlier situation, initially there was the recall of a single lot due to a report of a tablet with twice the appropriate thickness.  Soon thereafter, however, that first ETHEX recall was expanded to all 30 mg and 60 mg Morphine Sulfate Extended Release Tablets made during a two-year period, June 2006 To May 2008.

As you may know already, in April 2008 Actavis Totowa LLC recalled all strengths of Digitek due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient.  These "double-dose" Digitek pills created a risk of ditigalis toxicity, especially in patients with renal failure.  Since then, numerous personal injury and wrongful death Digitek lawsuits have been filed against Actavis.

As I have asked rhetorically in the recent past:

Where is the FDA on taking steps to ascertain that Good Manufacturing Practices (GMP) are being adhered to so that our nation's supply of FDA-approved generic drugs is safe?

What do you think about this series of double-dose pill recalls involving ETHEX and Actavis?

Pfizer Is Accused Of Withholding Or Altering Drug Study Results About Neurontin That Were Not Favorable

If Drug Companies Put Sales Above Efficacy And Safety, Should They Get Legal Immunity By Means Of Federal Preemption Doctrine?

(Posted by Tom Lamb at DrugInjuryWatch.com)

In the first part of October 2008 we learned of yet another instance where a drug company chose to put profits over people.  Yet in the near future our U.S. Supreme Court may decide that the legal doctrine of federal preemption gives legal immunity to Big Pharma for drug injury lawsuits.

An October 8, 2008 Wall Street Journal article, "Suit Alleges Pfizer Spun Unfavorable Drug Studies", explained what is new as far as bad conduct goes in the pharmaceutical sector:

Documents and emails released this week in the case in U.S. District Court in Boston suggest Pfizer's marketers influenced the drug's scientific record to boost sales at least until 2003 by declining to release or altering the conclusions of studies that found no beneficial effect from Neurontin for various off-label conditions....

According to documents in the Boston case, a European study done in the late 1990s by Warner-Lambert to measure Neurontin's use for diabetic nerve pain produced consternation at Pfizer after it failed to find a significant effect. "I think we can limit the potential downsides of the ... study by delaying the publication for as long as possible," wrote Michael Rowbothan, then Neurontin's marketing team leader, in a 2000 email sent after Pfizer bought Warner-Lambert. He added that "it will be more important to how WE write up the study."

A second October 8 article, "Experts Conclude Pfizer Manipulated Studies", published by the New York Times, added some commentary and then put this latest incident in context:

One of the experts who reviewed the documents, Dr. Kay Dickersin of the Johns Hopkins Bloomberg School of Public Health, concluded that the Pfizer documents spell out “a publication strategy meant to convince physicians of Neurontin’s effectiveness and misrepresent or suppress negative findings.” ...

The expert reports, unsealed Monday in a federal court in Boston, add to accusations that the pharmaceutical industry has controlled the flow of clinical research data, blurring the lines between science and marketing.

In April, for example, a group of academic doctors questioned the validity of drug industry research after finding that Merck had hired ghostwriters to produce scientific articles about Vioxx, then recruited prestigious doctors to serve as their official authors. Vioxx, a painkiller, was withdrawn from the market in 2004 after research indicated it could cause strokes and heart attacks.

Last winter, Merck and Schering-Plough were criticized for delaying the release of a study on their best-selling cholesterol medication Vytorin that showed the drug did not slow the growth of plaque in arteries. In the case of Pfizer’s Neurontin, the negative studies would have increased doubts about the drug’s value for several unapproved uses — treating bipolar disorder, controlling certain types of pain and preventing migraine headaches, according to the expert opinions.

What is even more remarkable, in light of this type of misconduct, is that the U.S. Supreme Court, in the Wyeth v. Levine case, may soon give these drug companies immunity to drug injury lawsuits by application of the federal preemption legal doctrine to those cases.

It seems to me that this legal immunity is a get-out-of-jail-free card that the drug companies cannot and should not be trusted with for the sake of American drug safety.

Congress Will Investigate Digitek Recall And What FDA Knew About Actavis Manufacturing Problems

After Earlier Class 1 Recall Of Digitek, All Acvtavis Drugs Manufactured At Its Little Falls, NJ Plant Were Recalled In August 2008

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 8, 2008 Representatives John D. Dingell (D-MI), the Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), the Chairman of the Oversight and Investigations Subcommittee, issued a press release, "Dingell, Stupak Again Question Whether FDA Knowingly Allowed Dangerous Drugs to be Sold to U.S. Consumers".

On that same day Reps. Dingell and Stupak sent a letter to FDA Commissioner Andrew C. von Eschenbach to inform him that Congress will investigate the facts giving rise to the Class 1 recall of Digitek in the spring of 2008 as well as the August 1, 2008 recall of all generic drugs manufactured at the Actavis Totowa LLC at its plant in Little Falls, New Jersey (formerly operated by Amide Pharmaceuticals).

From the October 8 press release we get these comments from Reps. Dingell and Stupak:

“Once again our Committee is forced to examine whether FDA can do its job to protect Americans from drugs produced in a manner that threaten the health and lives of American consumers,” said Dingell. “Apparently, companies such as Actiavis and Ranbaxy are allowed to operate and continue to receive approvals to manufacture other drugs long after FDA knew or should have known that their manufacturing operations were out of control and potentially lethal.”

“The Center for Drug Evaluation and Research (CDER) has ignored its mission to protect the public health,” said Stupak. “In case after case, we have seen FDA bend over backward to keep scofflaw companies in business and highly-questionable drugs on the market. A wholesale change in the decision-making apparatus at CDER is clearly needed if Americans are to trust the drugs prescribed by their doctors.”

In their October 8 letter to Dr. von Eschenbach, Reps. Dingell and Stupak revisit the reason for the spring 2008 Digitek recall, and go on to explain the basis for this Congressional investigation of what the FDA knew about Actavis manufacturing problems and when the agency knew it:

That drug was recalled

"due to the possibility that tablets with double the appropriate thickness may
have been commercially released. These tablets may contain twice the
approved level of active ingredient than is appropriate. Digitek is used to treat
heart failure and abnormal heart rhythms .... Death can also result from
excessive Digitalis intake."

Recalls of this seriousness causes us to question whether FDA was deceived regarding the current good manufacturing practices (cGMPs) of this company, or did FDA simply fail to conduct adequate and timely inspections of these facilities. A more important question is whether FDA permitted additional products from this firm onto the market while the agency knew or should have known about the breakdown of manufacturing practices at Actavis or its subsidiaries.

Among the items requested by Reps. Dingell and Stupak as part of this investigation by Congress:

...for all FDA-regulated products that Actavis has received approval to sell
into domestic commerce since January 1, 2003, or that Actavis imports into this country from abroad regardless of approval date, please provide:...

3. All documents relating to any "for cause" inspection of the Actavis firm, its
subsidiaries, or its active pharmaceutical ingredient (API) suppliers;...

7. A list of FDA personnel that conducted or reviewed each inspection listed above.

This type of information may help determine the extent, in terms of quantity and time, of the so-called "double-dose" Digitek pill problem, which has remained unclear since Actavis first announced the Digitek recall on April 29, 2008.

According to the October 8 letter to the FDA, the requested documents are to be produced "no later than two weeks after the date of this letter."

We will report further on this Congressional investigation of Digitek, Actavis, and the FDA as we learn more about it.

October 2008 List Of 50 Blogs Covering Various Aspects Of The Pharmaceutical Realm

Interested In Reading About Pharmacy, Pharmacists, Pharmacology, Or Big Pharma?  Then This List Is For You

(Posted by Tom Lamb at DrugInjuryWatch.com)

Over at the Nursing Degree Guide web site, Joel West has an article, "Top 50 Pharmacist Blogs", which is seemingly intended to let people know where they can go on the web to read daily posts about various topics having to do with prescription drugs and medications.

This list of 50 blogs is broken down into the following categories:

• Pharmacy Opinion Blogs

• Pharmacy News and Informational Blogs

• Professional Development Blogs

• Pharmacology Blogs

• Pharmaceutical Blogs

I want to thank Mr. West and the Nursing Degree Guide web site for including Drug Injury Watch on this October 2008 blog list under that last category.

While I am familiar with some of the various blogs listed there, others are new to me and I look forward to visiting them over time. 

Each of the 50 blogs in the "Top 50 Pharmacist Blogs" article has a link for easy access. I encourage you to take advantage of this convenient "tour" around the so-called Pharma blogosphere to see what else is out there for you.

And while you will probably like some of those other blogs, I hope you keep reading Drug Injury Watch.

New Warning About Dostinex Side Effect Fibrotic Cardiac Valvulopathy In U.K.

September 2008 Dear Doctor Letter From Pfizer Follows 2007 EMEA Safety Review Of Cabergoline

(Posted by Tom Lamb at DrugInjuryWatch.com)

Pfizer's Dostinex (cabergoline) remains on the market despite the January 2007 reports in the New England Journal of Medicine that Dostinex, like Permax, was linked to valvular heart disease.

In June 2007 the European Medicines Agency (EMEA) initiated a safety review of ergot-derived dopamine agonists, including cabergoline, which is sold in Europe under the brand name Cabaser as well as Dostinex.

More recently, in September 2008 the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) brought renewed attention to the association between Dostinex / Cabaser and fibrotic cardiac valvulopathy when the agency posted online the item "Information sent to healthcare professionals in September 2008 about the safety of medicines". 

Therein was listed the so-called "Dear Doctor" letter about Dostinex and Cabaser which Pfizer Ltd. sent out in the U.K. on or about September 15, 2008.  From the Dostinex section of that Septmeber 2008 Dear Doctor letter we get these warnings:

Dostinex—treatment of hyperprolactinaemic disorders

• Contraindication in patients with a history of fibrotic disorders and evidence of cardiacvalvulopathy as determined by pre-treatment echocardiography

• Warnings including mandatory echocardiography monitoring before initiating treatment and regularly during treatment and clinical monitoring of other fibrotic events

• Undesirable effects to include cardiac valvulopathy and related disorders (pericarditis and pericardial effusion) as very common side-effects

• The recommended initial dose remains 0.5 mg per week given in one or two doses per week and titrated according to prolactin levels. The therapeutic dose is usually 1 mg per week.

We will let you know when any similar "Dear Doctor" letter about Dostinex is sent by Pfizer in the U.S.  If somehow we missed that corresponding Dostinex letter, here, and you have a copy of it, please let us know.

FDA Alerts Doctors That Revlimid Can Cause Serious Skin Reactions In Patients

Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, And Erythema Multiforme Are Associated With Revlimid Use

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Summer 2008 edition of the US FDA's Drug Safety Newsletter included an article concerning Revlimid (lenalidomide), a thalidomide analogue marketed by Celgene Corp.

Revlimid was approved initially by the FDA in December 2005 to treat a bone-marrow disorder known as myelodysplastic syndromes.  Revlimid was later approved for multiple myeloma, a type of blood cancer.

This FDA newsletter article, titled "Lenalidomide (marketed as REVLIMID) -- Serious skin reactions", reviews 14 postmarketing reports of serious skin reactions possibly linked to Revlimid.

In more detail, this FDA article about the safety of Revlimid includes a discussion of the differences between Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and erythema multiforme (EM).  The article also provides details about the 14 case reports of serious skin reactions in patients using Revlimid, going into some depth with two cases in particular.

The Summer 2008 Drug Safety Newsletter Revlimid article concludes as follows:

Although some patients in this case series may have received previous or concurrent medications labeled for SJS/TEN (see above), in all cases, the skin reactions manifested while patients were taking lenalidomide. Some of these patients recovered or improved after discontinuation of lenalidomide. Lenalidomide is an analogue of thalidomide, a drug which is known to cause SJS/TEN, strengthening the probable association between lenalidomide and SJS/TEN in one case. In all cases, the events were serious, required hospitalization and/or medical interventions.

This case series suggests that serious dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur with lenalidomide therapy.

FDA encourages physicians to:

• Be aware of the possibility of rare serious skin reactions when prescribing lenalidomide
• Discontinue lenalidomide treatment if a skin rash occurs and only resume lenalidomide therapy after appropriate clinical evaluation
• Discontinue and not resume lenalidomide treatment if the rash is exfoliative, purpuric, or bullous, or if Stevens-Johnson syndrome or toxic epidermal necrolysis is suspected

A September 19, 2008 Wall Street Journal article, "FDA Says Celgene Drug May Cause Skin Reaction", provides some additional information:

Earlier this month, Revlimid appeared on a list of about 20 drugs that the FDA said it was investigating after receiving reports of various postmarketing safety issues, but details weren't released....

Brian Gill, a spokesman for Summit, N.J.-based Celgene, said it was likely the label for Revlimid would be updated to include reports of the skin reactions. He said about 60,000 patients have been treated with Revlimid.

Insofar that it is estimated that just one out of ten adverse drug reactions are reported to the FDA, it is reasonable to suppose there are more cases of SJS, TEN, and EM in patients using Revlimid in addition to the 14 covered in this Summer 2008 FDA newsletter article. 

We will continue to watch for reports of Revlimid causing these serious skin side effects, and if you are aware of such an instance, please share your information with our readers by submitting a Comment, below.