Drug Injury Watch

Current Use Of Some Popular SSRI Antidepressants May Increase The Risk Of Developing Cataracts

Luvox, Effexor, And Paxil Seem To Have Highest Increased Cataract Risks, But Study Does Not Prove That Any Of These Drugs Cause Cataracts

(Posted by Tom Lamb at DrugInjuryWatch.com)

An article which appeared in the June 2010 edition of the medical journal Ophthalmology shows that the popular selective serotonin reuptake inhibitors (SSRI) antidepressants Luvox (fluvoxamine), Effexor (venlafaxine), and Paxil (paroxetine) raise the risk of cataracts by 39%, 33%, and 23%, respectively, in patients currently taking these drugs.  Overall, the adjusted relative risk for cataracts among current users of SSRIs was 15%.

A March 12, 2010 WebMD article, "Cataracts From Antidepressants?" -- which was written back when this Ophthalmology article was published early online --provided this summary of the practical effect of the overall cataract risks found by the underlying medical study:

Assuming that 10% of Americans take SSRIs, that the increased risk is 15%, and that 1.5% of cataracts in the U.S. are caused by antidepressants, the researchers calculate that SSRIs may cause 22,000 extra cases of cataracts each year.

The Abstract for this article, "Selective serotonin reuptake inhibitors and the risk of cataracts: a nested case-control study", by Mahyar Etminan, PharmD, and colleagues of the University of British Columbia, Vancouver, Canada, informs us that this nested case-control study included these two points:

• The average time to diagnosis of cataracts while on SSRI therapy was 656 days.
• The possibility that this observation may be the result of the effect of smoking, which could not be controlled for in the study, cannot be excluded.

The March 2010 WebMD article provided this additional contextual information:

SSRI antidepressants work by increasing the amount of serotonin in the brain. (Effexor is not strictly an SSRI, as it boosts norepinephrine as well as serotonin.)

Etminan and colleagues note that the lens of the eye has serotonin receptors -- switches that activate cellular functions. Animal studies show that serotonin can make the lens of the eye more opaque and lead to cataracts.

If the Etminan findings are confirmed, SSRI antidepressants would not be the first drug to increase cataract risk. Oral and inhaled steroids and beta-blockers have also been linked to cataract formation.

Of course, any patients concerned by these cataract risk findings should speak with their doctor, as the FDA always advises that one should not stop taking any prescription drug without doing so first.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Rheumatoid Arthritis Drug Arava Gets Increased Warning For Liver Injury In July 2010

The Bolded Warning About Severe Liver Problems Which Was Added In 2003 Is Replaced By "Black-Box" Warning

(Posted by Tom Lamb at DrugInjuryWatch.com)

On July 13, 2010 the FDA issued a MedWatch Alert about a new increased warning about the association between the rheumatoid arthritis drug Arava (leflunomide) and severe liver injury.

The basis for this new Arava "black-box" warning is explained in this July 2010 document, "FDA Drug Safety Communication: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)":

In 2003, a bolded warning statement about the risk of severe liver injury and a recommendation to monitor liver function tests every 6 to 8 weeks were included in the professional prescribing information for leflunomide. In 2009, based on continued reports of severe liver injury, FDA conducted an updated review of severe liver injury and leflunomide and identified 49 cases, 36 which required hospitalization, reported between August 2002 and May 2009.
 
The estimated duration of leflunomide treatment before the occurrence of severe liver injury ranged from 9 days to 6 years, with the majority of patients developing severe liver injury within the first 6 to 12 months of treatment.
 
Of the 49 cases, there were 14 deaths. An additional five patients required a liver transplant and nine patients experienced a life-threatening event....

As background, from the FDA's "Leflunomide (marketed as Arava) Information" page:

Arava (leflunomide) is indicated in adults for the treatment of active rheumatoid arthritis (RA):

1. to reduce signs and symptoms
2. to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
3. to improve physical function.

Returning to the July 2010 document, the FDA had this important advice for patients who are using Arava:

Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools. These may be signs of liver injury.

For physicians and others interested in knowing more about why a black-box warning abour severe liver injury was being added to the Arava label, the FDA has an audio podcast available: "FDA Drug Safety Podcast for Healthcare Professionals: New boxed warning for severe liver injury with arthritis drug Arava (leflunomide)" - mp3 (MP3 - 11276KB) 

Our law firm is investigating possible Arava lawsuits for patients who were hospitalized for serious liver problems, ranging from drug-induced hepatitis to liver transplant, and for the families of patients who have died from liver failure after using Arava.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

The European Medicines Agency (EMA) Launches Its New Web Site In July 2010

Similar To The U.S. Food And Drug Administration (FDA), This European Union Agency Approves And Monitors Safety Of Medicines

(Posted by Tom Lamb at DrugInjuryWatch.com)

The European Medicines Agency (EMA) is an agency of the European Union (EU).  The EMA is responsible for the evaluation and supervision of medicines for human use in Europe, like our FDA does here. 

On July 15, 2010 the new European Medicines Agency (EMA) web site was launched.

As background, the EMA is responsible for the scientific evaluation of applications for European marketing authorizations for human medicines, to start, and the EMA monitors the safety of medicines through a pharmacovigilance network, thereafter, taking appropriate actions if adverse drug reaction reports suggest that the benefit-risk balance of a medicine has changed since it was first authorized by the EMA.

From the June 2010 EMA announcement, "European Medicines Agency launches new website":

The site has been completely redesigned and rebuilt to optimize usability for the Agency's key online audiences and build on existing activities to improve openness and transparency.

The Agency website now receives an average of half a million unique visits per month and is a key resource for patients, healthcare professionals, regulators and those interested in the regulation and safety of medicines in the European Union.

Some of the website’s new features include:

Quick medicine searches: Allows you to search for human and veterinary medicines by name and active substance and for herbal medicinal substances by name

An online library: Enables you to search for all Agency documents currently online through a search on title and date published online.

Improved navigation: More intuitive labelling and improved organisation of content so that browsing is quicker for all audience groups

Audience landing pages: Flags information of specific value to different key users

Online calendar and news search: Allows you to keep up to date with the latest news and events at the Agency

RSS feeds: Brings information straight to you as soon as it is published online.

Through 2010 and 2011 the Agency will continue to work on improving the website by increasing the use of multimedia and improving search functionalities.

For those with an interest in the safety of prescription drugs, and to see how the EMA compares with our FDA, you may want to pay a visit to the new EMA web site when you have an opportunity.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

10,000 Avandia Lawsuits Settled For $460 Million While FDA Considers Possible Avandia Recall

During July 13-14, 2010 FDA Advisory Committee Meeting, Glaxo Settles Most Of The 13,000 Avandia Court Cases

(Posted by Tom Lamb at DrugInjuryWatch.com)

Bloomberg reporters Jef Feeley and Trista Kelley broke the news of a large (in terms of the number of claims, at least) Avandia settlement while most of the media's attention was on the July 13-14, 2010 FDA Advisory Committee meeting about whether Avandia should remain on the market in the U.S. or be recalled.

From this July 13, 2010 Bloomberg article, "Glaxo Said to Pay $460 Million to Settle Avandia Damage Suits", we get these facts and first impressions about this big Avandia settlement:

GlaxoSmithKline Plc agreed to pay about $460 million to resolve a majority of lawsuits alleging the company’s Avandia diabetes drug can cause heart attacks and strokes, people familiar with the accords said.

Glaxo, the U.K.’s biggest drugmaker, agreed to settle about 10,000 suits for an average of at least $46,000 apiece, the people said. The company had been facing more than 13,000 suits alleging Glaxo hid the drug’s heart-attack risk, according to a UBS AG analyst. The settlements come as Glaxo is set to face its first Avandia trial in federal court in Philadelphia in October.

“This is exceptionally good news given the market has discounted $6 billion in liability,” for Avandia litigation, Gbola Amusa, an analyst at UBS in London, said in an interview. “We had outlined an absolute worst-case scenario where $500,000 per case would have to be paid.”....

The [FDA Advisory Committee] panel could recommend Glaxo pull Avandia from the market. A withdrawal of Avandia “might prompt a limited number of additional suits but liability should be limited,” Amusa said.

The FDA review was a factor in the decision by Glaxo officials to start negotiating with lawyers for former Avandia users, the people familiar with the settlements said.

Previously, back in mid-May 2010, these same two Bloomberg reporters let us know about the first round of Avandia settlements, involving about 700 Avandia lawsuits, in this article, "Glaxo Said to Pay About $60 Million in First Avandia Heart-Risk Settlement".

I presume that Bloomberg reporters Jef Feeley and Trista Kelley will be following the remaining 3,000 Avandia lawsuits and be among the first to report on the outcome for those cases.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

A Brief History Of Prescription Drug Recalls In The U.S., 1997-2010

FDA Will Consider Next Possible Market Withdrawl During July 13-14 Hearing About Avandia

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Briefing Information from FDA and GSK released prior to July 13-14, 2010 Joint Advisory Committees Meeting about Avandia on FDA web site, now  (7/09/10)

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At the end of June 2010 reporter Marilynn Marchione wrote an article, "When is a drug too risky to stay on the market?", that was published by the Associated Press (AP).

This AP article provides good background information about how and why an FDA-approved prescription drug would be withdrawn from the market in the United States.  Further, this AP article seems to be intended as a "primer" for the July 13-14, 2010 FDA hearing on Avandia, the controversial diabetes pill made by GlaxoSmithKline PLC.

This June 2010 article sheds some light on the analytical framework used when determining whether there should be a drug recall or not, as seen from this excerpt:

The FDA can order a drug off the market, but that can be challenged in court. Usually, a company voluntarily withdraws the medicine at the FDA's request.

Many things influence whether such a request is made, said Dr. Brian Strom, a drug safety expert at the University of Pennsylvania. He is a longtime FDA drug safety adviser who has consulted for Takeda Pharmaceuticals, which makes Actos, an Avandia rival.

Some factors to consider:

_ How serious is the illness being treated?...

_ How big is the harm?...

_ How frequent are the risks versus the benefits?...

_ Are there safer alternatives?...

A related AP item, "Risky drugs pulled from the market in recent years", provides us with a history of drug recalls in the U.S. for the period 1997 to the first part of 2010.  That item provides this drug recall information, and more, which was compiled by Associated Press news researcher Rhonda Shafner:

• 2010: Mylotarg -- Risks: Liver disease
• 2009: Raptiva -- Risks: A rare brain infection
• 2007: Zelnorm -- Risks: Increased risk of heart problems
• 2007: Permax -- Risks: Heart valve damage
• 2005: Cylert -- Risks: Liver problems, including death
• 2005: Bextra -- Risks: May increase the risk of heart attacks and strokes; also may cause rare but serious skin conditions
• 2005: Tysabri -- Risks: Rare, but life-threatening side effect (Note: Drug returned to market in 2006 under a restricted distribution.)
• 2004: Vioxx -- Risks: Heart attacks, strokes
• 2001: Baycol -- Risks: Severe damage to muscle, sometimes fatal
• 2000: Lotronex -- Risks: Intestinal damage from reduced blood flow
• 2000: Propulsid -- Risks: Fatal heart rhythm abnormalities
• 2000: Rezulin -- Risks: Severe liver toxicity
• 1999: Hismanal -- Risks: With other drugs or high dose can cause fatal heart rhythm
• 1999: Raxar -- Risks: Fatal heart rhythm abnormalities
• 1998: Posicor -- Risks: Dangerous interaction with other drugs
• 1998: Duract -- Risks: Severe liver damage
• 1998: Seldane -- Risks: Fatal heart rhythm abnormalities
• 1997: Pondimin -- Risks: Heart valve abnormalities
• 1997: Redux -- Risks: Heart valve abnormalities

For those with an interest in serious side effects associated with unsafe drugs, I encourage you to look at each of these AP items using the links provided.

And, of course, we will let you know the fate of Avandia when that is determined.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects

Zithromax (Azithromycin) And Zmax Associated With Liver Failure And Pyloric Stenosis, Respectively

FDA Is Continuing To Evaluate These Emerging Drug-Safety Issues To Determine Whether Any Regulatory Action Is Needed

(Posted by Tom Lamb at DrugInjuryWatch.com)

In mid-May 2010 we wrote an article "Zithromax-Induced Liver Injury Case Report Where There Was No History Of Liver Problems".

It seems that Zithromax also had the attention of the FDA at about the same time.

On July 1, 2010 the FDA posted on its web site "Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2010", which had listed, among other possibly unsafe drugs, Zithromax (azithromycin) and Zmax (azithromycin extended release 2 g).  The side effect under scrutiny for Zithromax, according to this FDA document, is liver failure, while the side effect being looked at for Zmax is pyloric stenosis -- which is defined as "narrowing of the pyloric opening (as from congenital malformation or contraction of scar tissue)".

We point out that each Potential Signals list issued by the FDA -- which the agency describes as "showing newly identified potential signals of serious risks/new safety information identified from the [Adverse Event Reporting System (AERS)] database during the previous quarter" -- includes this important "disclaimer" language:

The appearance of a drug on this list does not mean that FDA has concluded that the drug has this 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.

Another antibiotic, Biaxin (clarithromycin), also appeared on the Potential Signals list issued by the FDA in July 2010, with the side effect being liver failure, also.

We will continue to monitor the safety profile of Zithromax and Zmax, as well as Biaxin, and will report significant developments, e.g., any FDA regulatory action in the future, here on Drug Injury Watch.

P.S.  As of February 2011 the FDA is continuing to evaluate liver failure as a potential drug safety issue for Zithromax and Biaxin to determine the need for any regulatory action.

• "Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between January – March 2010" (Quarterly Report issued by FDA on or about 2/1/11)

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects