Drug Injury Watch

Iclusig: Leukemia Drug With Many Different Serious Side Effects Had More Warnings Added In November 2016

Black-Box Warning Now Includes Venous Thromboembolism As Well As Various Types Of Arterial Occlusions, And There Are More New Safety Issues

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Iclusig (ponatinib) is a kinase inhibitor approved by the FDA as a treatment for certain types of leukemia in adult patients.

On November 28, 2016 we learned about several alerting and wide-ranging safety labeling changes for Iclusig which were recently approved by the FDA Center for Drug Evaluation and Research (CDER).

The complete set of new side effects warnings can be seen on the FDA's Drug Safety Labeling Changes (SLC) page for Iclusig.

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Here is overview of this rather significant and substantial November 2016 Iclusig Prescribing Information revision which was mandated by the FDA.

In the Boxed Warning section of the Iclusig drug label there was some additional safety information put in the pre-existing parts about (1) various types of arterial occlusions and (2) heart failure. Also, there is a new part entitled Venous Thromboembolism which addresses venous occlusive events.

Under the Warnings and Precautions section of the Iclusig drug label there were some additional facts and new information put in the following pre-existing parts, which are presented the order in which they were set forth on the FDA CDER SLC page for Iclusig:

5.1 Arterial Occlusion
5.10 Hemorrhage
5.11 Fluid Retention
5.12 Cardiac Arrhythmias
5.13 Myelosuppression
5.14 Tumor Lysis Syndrome
5.17 Embryo-Fetal Toxicity
5.2 Venous Thromboembolism
5.3 Heart Failure
5.4 Hepatotoxicity
5.5 Hypertension
5.6 Pancreatitis
5.8 Neuropathy
5.9 Ocular Toxicity

Further, under Warnings and Precaution, this new part now appears: 5.15 Reversible Posterior Leukoencephalopathy Syndrome (RPLS).

Finally as regards this limited Iclusig label changes overview, under the Adverse Reactions section of the Iclusig drug label there were some additional facts and new information put in this pre-existing part, 6.1 Clinical Trial Experience.

We point out there were more revisions mandated by the FDA in November 2016, which can be viewed on the FDA CDER SLC page for Iclusig.

We will continue to monitor the safety profile of the leukemia drug Iclusig and to report significant future developments.

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Potential Retinal Detachments Link With Avelox, Levaquin, And Cipro Cannot Be Ruled Out According To Health Canada Safety Review

These Popular Fluoroquinolones Antibiotics Have Been Suspected Of Causing Serious Vision Problems And Visual Side Effects During Past Several Years

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

In January 2016, Health Canada issued the latest drug safety alert concerning Avelox, Levaquin, and Cipro, this one having to do with a serious side effect concerning the eyes.

From this document "Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment", we get these summary points about the current situation:

• Health Canada's follow-up safety review concluded that a link between the use of fluoroquinolones and the occurrence of retinal detachment cannot be ruled out at the present time.
• Given that retinal detachment is a medical emergency, the recommendations of the review were that the current labeling for oral fluoroquinolones be revised to highlight the urgency to see a health care professional if patients experienced vision problems during or following oral fluoroquinolone administration.

We will wait to see what label changes are made in Canada by the drug companies responsible for Avelox, Levaquin, and Cipro concerning this apparent retinal detachment side effect. And we will watch for any similar revisions to the Prescribing Information for these popular antibiotics here in the US.

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As regards this January 8, 2016 Health Canada announcement regarding Avelox, Levaquin, and Cipro, here are some additional details:

A Health Canada safety review was carried out as a follow-up assessment on the potential risk of retinal detachment with the use of oral fluoroquinolones. Health Canada's previous safety review examined the risk of retinal detachment with oral fluoroquinolones and had concluded that limited evidence was available to support a link at that time. Since Health Canada's initial review, many other studies have been conducted regarding the potential link between the use of oral fluoroquinolones and retinal detachment triggering this follow-up safety review.

Retinal detachment is a painless separation of the retina from the layer of support tissue and blood vessels at the back of the eye that provides the retina with oxygen and nourishment. Symptoms related to retinal detachment depend on the location and extent of the detachment, and may include the sudden appearance of debris in the field of vision (look like spots, hairs or strings and seem to float across one's vision -- floaters), the perception of flashes of light in the affected eye, the sensation that a shadow or curtain has come down over a portion of the visual field, or even sudden and complete loss of vision in the affected eye. Retinal detachment is considered a medical emergency and requires immediate attention to prevent permanent visual damage.

We have previously written several articles about serious vision problems and visual side effects associated with Avelox, Levaquin, and Cipro during the past several years, as seen below:

Levaquin / Cipro / Avelox: Retinal Detachments Are Visual Side Effects Of Oral Fluoroquinolones Antibiotics (7/22/13)

Current Use Of Cipro And Levaquin Associated With Increased Risk Of Detached Retina Eye Injury (4/4/12)

Current "First-Time" Users Of Avelox Who Received A Prescription In The Past 15 Days Had 3-Times Higher Rate Of Developing Uveitis, An Eyes / Vision Drug Side Effect (10/8/14)

We will continue to monitor the safety profile of these controversial antibiotics in the fluoroquinolones class of drugs.

 

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Current "First-Time" Users Of Avelox Who Received A Prescription In The Past 15 Days Had 3-Times Higher Rate Of Developing Uveitis, An Eyes / Vision Drug Side Effect

And An Increased Risk Of Uveitis For Current "Repeat" Users Of Avelox Who Were On At Least Their Second Term Of Taking This Fluoroquinolone Antibiotic Pill

(Posted by Tom Lamb at DrugInjuryWatch.com)

The popular antibiotic Avelox (moxifloxacin) appears to significantly increase the risk for developing an eye disorder called uveitis, which is swelling and irritation of the uvea, the middle layer of the eye.

This new finding comes from what seems to be the first epidemiologic study to examine the relationship between Avelox use and uveitis.  The medical journal article reporting on this case-control study, "Risk for Uveitis With Oral Moxifloxacin: A Comparative Safety Study", was published online October 2, 2014 in the JAMA Ophthalmology medical journal.

This new Avelox - uveitis study also found that Cipro (ciprofloxacin) was associated with a smaller increased risk of uveitis, but there was little to no increase for this particular eye-related side effect seen for Levaquin (levofloxacin).

From an October 7, 2014 news report at Medscape.com, "Evidence Linking Some Fluoroquinolones to Uveitis Grows", we get get this summary of the recent Avelox study done by researchers at the University of British Columbia, Vancouver, British Columbia, Canada:

"The results of the present study are consistent with those of case reports that have suggested an association between oral [Avelox (moxifloxacin)] and uveitis," the investigators maintain. In addition, the study confirms that this adverse effect most commonly occurs with a first dispensed prescription.

Results also suggest that [Avelox (moxifloxacin)] was the riskiest of the three fluoroquinolones studied, possibly because it may have a higher tissue-binding affinity, the authors propose....

Current first-time users of [Avelox (moxifloxacin)] who had received a prescription in the past 15 days had a 2.98-fold higher adjusted rate of uveitis compared with men not taking the drug. Current first-time users of [Cipro (ciprofloxacin)] had a 1.96-fold higher adjusted rate.

The risk for uveitis was likewise elevated, but to a smaller extent, for current repeat users of [Avelox (moxifloxacin)] and [Cipro (ciprofloxacin0], who were on at least their second prescription (with respective 1.81-fold and 1.73-fold higher adjusted rates), as well as for past users who had received a prescription more than 15 days ago (with respective 1.31-fold and 1.14-fold higher adjusted rates).

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In terms of drug safety, the 3-times increased rate of developing uveitis in current first-time users of Avelox who received their prescription in the past 15 days is very concerning.  Accordingly, the researchers said doctors should be aware of the possible risk for uveitis with Avelox use.

However, returning to the Medscape news report:

The authors noted several study limitations, including restricting the study population to older men, which may limit the generalizability of the findings. Furthermore, as uveitis often has an unknown etiology, analyses may not have captured all potential confounders.

"Future studies, if able, would benefit from analyzing relationships between individual [Avelox (moxifloxacin)] dosing regimens and uveitis," the authors note.

We will continue to follow this emerging drug injury issue and monitor the safety profile of Avelox as regards eyes / vision side effects.  (Note: Avelox, Cipro, and Levaquin have also been associated with retinal detachments.)

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Mirena Associated With Levonorgestrel-Related Neurological Conditions PTC/IIH Caused By Increased Buildup Of Cerebrospinal Fluid On Brain

PTC/IIH Symptoms Include Migraines With Blurred Or Double Vision, Temporary Blindness, Other Visual Problems, And Wooshing Or Ringing In The Ear

(Posted by Tom Lamb at DrugInjuryWatch.com)

Mirena is an intrauterine system (IUS) from Bayer Healthcare Pharmaceuticals, Inc. that releases 20 μg/day of levonorgestrel.  Basically, the Mirena releases levonorgestrel, a synthetic progestogen, directly into the uterus for birth control.  The FDA approved Mirena in December 2000 and it is used by more than 2 million women in the US.

The Prescribing Information for Mirena (accessed 5/30/14) does not warn about neurological conditions such as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH) or benign intracranial hypertension. In fact, the Mirena Prescribing Information (also known as the package insert or label) makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH.

Pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) is a non-stroke neurological condition that develops in the skull when a person’s cerebrospinal fluid becomes elevated, causing increased pressure.

PTC/IIH symptoms include:

• severe migraines or migraine-like headaches
  with blurred vision
• diplopia (double vision), temporary blindness, blind spots, or other visual
  deficiencies
• papilledema, or optic disc swelling, due to
  increased intracranial pressure
• a “whooshing” or ringing in the ear, clinically called tinnitus

When patients present with symptoms of PTC or IIH they often first undergo an MRI, CT scan, and/or other diagnostic radiology tests to rule out an actual tumor or blood clot in the brain.  This differential diagnosis is warranted because PTC derives its name from the fact that the condition acts like a tumor but it is not actually a tumor.

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It is important to note, here, that because the current Bayer label for Mirena does not have any warnings of PTC or IIH, once a woman's doctor rules out transient cerebral ischemia or stroke as a cause of the above symptoms her doctor does not know to advise her to remove Mirena.  And with the Mirena left in place, it causes or contributes to the development and/or progression of PTC/IIH.

Unfortunately, the failure to timely diagnose and treat PTC or IIH may lead to permanent vision loss and even blindness.

Ultimately, a lumbar puncture, or spinal tap, is how pseudotumor cerebri or idiopathic intracranial hypertension is frequently diagnosed.

Notably, there is currently no treatment to reverse permanent injury to the optic nerves that is caused by increased intracranial pressure. Because of this, once the PTC/IIH is correctly diagnosed, treatment going forward is focused only on halting visual loss that has already occurred.

Although PTC or IIH is considered reversible in some patients, it may take years before normal pressure is maintained. In other patients, PTC/IIH may be irreversible, or the condition recur throughout the patient’s lifetime.

In severe cases of PTC/IIH a lumbarperitoneal shunt (“LP shunt”) or a ventriculo-peritoneal shunt (“VP shunt”) may be used to help drain cerebrospinal fluid from the lower back or from the skull.
 
Because of Bayer's failure to warn in the Mirena package insert or label about the risk of developing pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) due to the release of levonorgestrel by the Mirena, women have filed products liability lawsuits against the drug company.

We are currently reviewing possible Mirena drug injury cases involving these non-stroke neurological conditions PTC and IIH at our firm.

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Levaquin / Cipro / Avelox: Retinal Detachments Are Visual Side Effects Of Oral Fluoroquinolones Antibiotics

Health Canada Suggests That Low Level Or Under-Reporting For These Adverse Reactions Involving Eyesight Is Due To The Limited Information Available

(Posted by Tom Lamb at DrugInjuryWatch.com)

Back in April 2012 we posted this article, "Current Use Of Cipro And Levaquin Associated With Increased Risk Of Detached Retina Eye Injury".

Now, the July 2013 edition of the Canadian Adverse Reaction Newsletter brings us up to date on this emerging drug safety issue concerning Levaquin, Cipro, Avelox, and similar antibiotics with this report, "Oral fluoroquinolones and retinal detachment".  From this Health Canada publication we get this information: 

In Canada, there are 5 marketed oral fluoroquinolones... The risk of retinal detachment is not described in any of the oral fluoroquinolone Canadian product monographs.

Retinal detachment is characterized by a separation of the retina from the underlying tissue in the eye. Among the different types of retinal detachment, rhegmatogenous retinal detachment (RRD) is the most common. RRD results from retinal breaks caused by vitreoretinal traction. Risk factors commonly associated with retinal detachment include advancing age, previous cataract surgery, myopia and trauma. Patients generally present with symptoms such as light flashes, floaters, peripheral visual field loss and blurred vision. Retinal detachment is a serious medical emergency that generally requires prompt surgical intervention.

According to a pharmacoepidemiological study, current use of oral fluoroquinolones was associated with an increased risk of developing retinal detachment....

As of Dec. 31, 2012, Health Canada received one report of retinal detachment suspected of being associated with the use of an oral fluoroquinolone. The report described a 52-year-old woman who experienced retinal detachment after a course of ciprofloxacin prescribed to treat a bladder infection.  Limited evidence linking retinal detachment to oral fluoroquinolones may explain the low level of reporting to Health Canada.  [Footnotes omitted]

This Health Canada report notes that further research is needed to confirm whether there is a potential association between retinal detachment and fluoroquinolones, e.g., Levaquin, Cipro, Avelox, as well as to clarify the mechanism of action for this possible side effect drug injury.

We will continue to monitor this situation and report significant developments here.

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Use Of Oral Bisphosphonates Such As Boniva And Fosamax Associated With Inflammatory Eye Diseases

Greater Risk For Uveitis, Scleritis, And Other Ocular Side Effects According To Two Recent Medical Journal Articles

(Posted by Tom Lamb at DrugInjuryWatch.com)

Fosamax, Boniva, and other osteoporosis medications in the bisphosphonates drug class have been linked to osteonecrosis of the jaw (ONJ) and atypical femur fractures, with both of these side effects getting considerable coverage in the popular press for some years now.

In early April 2012 there appeared two medical journal articles which brought attention to a lesser known and relatively new set of side effects associated with drugs like Boniva and Fosamax which involve not the bones but the eyes.

First, according to a retrospective cohort study in the Canadian Medical Association Journal (CMAJ), "Inflammatory ocular adverse events with the use of oral bisphosphonates: a retrospective cohort study", we learned that first-time use of oral bisphosphonates is associated with greater risk for two inflammatory eye diseases, uveitis and scleritis.

This CMAJ article by Mahyar Etminan and his collegues, concludes with these three important practical points:

• Bisphosphonate-induced uveitis and scleritis are potentially reversible conditions, if there is early intervention by an ophthalmologist.
• The risk of inflammatory ocular adverse events, including scleritis and uveitis, is not highlighted in most package inserts included with oral bisphosphonates.
• Patients taking oral bisphosphonates must be familiar with the signs and symptoms of these conditions, so that they can seek immediate assessment by an ophthalmologist.

Next, from the Orbit medical journal, "Bisphosphonate-associated orbital inflammation-a case report and review". From the Abstract for that article:

Several ocular side effects due to bisphosphonates have been described, among the most potentially serious of which is orbital inflammation. Thirteen case reports of this side effect exist in the literature, with an additional case reported here. The most common presenting signs are lid edema, conjunctival hyperemia, and chemosis, while common symptomatology includes pain, diplopia, and blurry vision. A concomitant anterior uveitis is present in 30% of cases, and some degree of bilaterality is also seen in 30% of cases. There are two reported instances of profound visual loss, highlighting the importance of prompt recognition and treatment of this entity.

We will continue to monitor this new set ocular or vision side effects associated with the bisphosphonate drugs like Boniva and Fosamax.

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Possible Avandia / Actos Drug-Related Eye Disease: Diabetic Macular Edema; Increased Risk For Type 2 Diabetes Patients

New Medical Journal Article Provides More Information About Emerging Drug Safety Issue Involving Avandia / Actos Side Effect Affecting Sight And Vision

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to a recent medical journal article, "Association between thiazolidinedione treatment and risk of macular edema among patients with type 2 diabetes", published online in June 2012 by the Archives of Internal Medicine, the diabetes drugs Actos (pioglitazone) and Avandia (rosiglitazone) may be responsible for an increased rate of diabetic macular edema (DME) eye disease in type 2 diabetes patients. 

From that 2012 medical journal article about Avandia and Actos being associated with diabetic macular edema (DME) eye disease:

In conclusion, this large-population study has shown that, even after adjustment for a range of confounding variables, thiazolidinediones [(TZD) diabetes drugs, such as Actos and Avandia] are associated with an increased risk of DME in patients with type 2 diabetes, especially those undergoing insulin therapy. The risk increased continuously over the 10-year duration of this study. The explanation for this association is unclear, but plausible mechanisms described previously exist by which these drugs might adversely influence this important ocular complication of type 2 diabetes...

From a June 11, 2012 news report about this medical journal article, "Avandia, Actos May Raise Risk of Macular Edema", found on the MedPage Today site:

Incidence of diabetic macular edema was 1.3% at 1 year on [Actos or Avandia] compared with just 0.2% among type 2 diabetes patients not on one of those agents, Iskandar Idris, MD, of Sherwood Forest Hospitals Foundation Trust in Nottingham, England, and colleagues found.

The risk remained 2.3 times higher out to 10 years of follow-up after adjustment for use of other diabetes and cardiovascular drugs, glucose control, and other factors....

The odds ratios were similar at 3.6 for [Actos (pioglitazone)] and 3.1 for [Avanida (rosiglitazone)] at 1 year of follow-up.

The combination of insulin and a thiazolidinedione [i.e., Actos or Avandia] boosted that adjusted risk to 4.4-fold, whereas concurrent use of aspirin or an ACE inhibitor significantly reduced the risk.

As seen by the two articles below, we have been reporting on this still emerging drug safety issue for the past few years:

Actos And Avandia Use Associated With Diabetic Macular Edema, Which Can Lead To Blindness -- New UK Study Found Three To Six Times Increased Risk Of Developing This Retinal Eye Disease Side Effect  (June 2011)

New Studies About Avandia And Actos Side Effects Other Than Cardiovascular Conditions -- Glitazone Class Of Diabetes Drugs Can Increase The Risk Of Bone Fractures And Diabetic Macular Edema (April 2009)

Of course, we will continue to monitor this Avandia / Actos - diabetic macular edema (DME) eye disease situation and report further developments here.

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Current Use Of Cipro And Levaquin Associated With Increased Risk Of Detached Retina Eye Injury

Neither Recent Nor Past Use Of These Antibiotics In Fluoroquinolones Class Was Related To Retinal Detachment

(Posted by Tom Lamb at DrugInjuryWatch.com)

Patients taking oral antibiotics known as fluoroquinolones such as Cipro (ciprofloxacin) and Levaquin (levofloxacin) are at an increased risk for developing a detached retina, an eye injury which can lead to permanent blindness if not medically treated in a timely manner.

This new drug safety finding comes from a case-control study, "Oral Fluoroquinolones and the Risk of Retinal Detachment", which was published in the April 4, 2012 edition of the Journal of the American Medical Association (JAMA).

From the Abstract for this April 2012 JAMA article concerning Levaquin, Cipro, and similar antibiotics possibly causing damage to one's eyes:

Context  Fluoroquinolones are commonly prescribed classes of antibiotics. Despite numerous case reports of ocular toxicity, a pharmacoepidemiological study of their ocular safety, particularly retinal detachment, has not been performed.

Objective  To examine the association between use of oral fluoroquinolones and the risk of developing a retinal detachment....

Results  From a cohort of 989 591 patients, 4384 cases of retinal detachment and 43 840 controls were identified. Current use of fluoroquinolones was associated with a higher risk of developing a retinal detachment (3.3% of cases vs 0.6% of controls; adjusted rate ratio [ARR], 4.50 [95% CI, 3.56-5.70])....

Conclusion  Patients taking oral fluoroquinolones were at a higher risk of developing a retinal detachment compared with nonusers, although the absolute risk for this condition was small.

For some insight about the underlying medical study and its significance from one of the researchers, Mahyar Etminan, PharmD -- who is from the Therapeutic Evaluation Unit, Child and Family Research Institute of British Columbia, and the Department of Medicine, University of British Columbia, Vancouver, Canada -- we move to this Reuters news report, "Common antibiotics tied to eye emergencies: study", published on April 3, 2012:

People treated by ophthalmologists for the emergency condition were five times more likely to be taking drugs known as fluoroquinolones, which include ciprofloxacin (marketed under names including Zoxan, Proquin and Cipro) and levofloxacin (Levaquin, Cravit), than those who didn't have retinal detachment.

"We know that these drugs are toxic to connective tissue and cartilage," said Mahyar Etminan, the study's lead author, noting past studies linking fluoroquinolones with damage to Achilles and shoulder tendons.

"We wanted to see whether this damage also may translate in the eye, because there's lots of connective tissue in the eye," Etminan, from the Child and Family Research Institute of British Columbia in Vancouver, told Reuters Health.

Retinal detachment, which starts as the appearance of lines, dots or "floaters" across the eye, can cause permanent blindness in some cases if it's not surgically treated within a few days....

Retinal detachment is rare, Etminan concluded, "but because the condition is quite serious, I don't think it would hurt to let someone know... if you notice these flashes of light or floaters, be sure you get it checked out."

Of course, we will continue to monitor this emerging drug safety issue involving Levaquin, Cipro, and other antibiotics in the fluoroquinolones class of drugs.

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Actos And Avandia Use Associated With Diabetic Macular Edema, Which Can Lead To Blindness

New UK Study Found Three To Six Times Increased Risk Of Developing This Retinal Eye Disease Side Effect

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Avandia, Actos May Raise Risk of Macular Edema (MedPage Today, June 11, 2012)

The diabetes drugs pioglitazone (Actos) and rosiglitazone (Avandia) appear to substantially boost risk of macular edema in type 2 disease, an observational study found.

(6/13/12)

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A study presented at the American Diabetes Association’s annual meeting in San Diego on June 26, 2011 finds taking the diabetes treatments Actos (pioglitazone) and Avanidia (rosiglitazone) -- both in the Thiazolidinediones (TZDs) class of drugs -- have a three to six times increased risk of developing diabetic macular edema (DME), an eye disease in which the retina thickens and swells, possibly leading to blindness.

Takeda Pharmaceutical Co. markets Actos, the world’s best-selling diabetes treatment, and GlaxoSmithKline Plc. (Glaxo or GSK) markets Avandia.

According to a June 24, 2011 Bloomberg news article, "Takeda, Glaxo Diabetes Treatments Raise Risk of Eye Disease, Study Finds":

Diabetic eye disease is the most common cause of blindness in working-age Americans, according to the National Eye Institute. Macular edema damages the retina and can eventually cause blindness. The best way to prevent the side-effect of diabetes is to keep blood sugar under control, according to the National Eye Institute.

“Patients at high risk of sight-threatening DME should avoid” the class of drugs including Actos and Avandia, the study authors, led by Richard Donnelly at the University of Nottingham, wrote in their study abstract. High-risk patients include those who have poor control of their blood sugar and those with a previous history of macular edema.

For more about this new study finding a significant (3 to 6 times) increased risk of developing diabetic macular edema (DME) when using Avandia or Actos, we look to this June 27, 2011 Medical Economics eConsult, "TZDs, GLP-1 agonist may worsen diabetic retinal disease":

In the TZD [Avanida and Actos] study, Iskandar Idris, MD, and colleagues at Sherwood Hospital Foundation Trust and the Universities of Sheffield and Nottingham, UK, retrospectively reviewed data from a cohort of 103,368 patients in more than 400 general practices in England and Wales. The patients all had type 2 diabetes, and only patients with no prior exposure to TZDs were included.  Follow-ups were conducted at 1 and 10 years after the study index date.

In an unadjusted analysis, the 1-year incidence rate of DME in patients taking a TZD was 1.3%, compared with 0.2% for patients with no TZD exposure (odds ratio [OR] 5.7, 95% confidence interval [CI] 4.1–7.9, P<.001).

In adjusted analyses controlling for mean HbA1c and blood pressure during follow-up, weight, body mass index (BMI), lipids, insulin treatment, oral antidiabetic agents, and other parameters, the hazard ratio (HR) for DME with a TZD with no insulin was 3.29 (95% CI 2.21–4.91, P<.0001). The HR for a TZD with insulin was 8.44 (95% CI, 4.23–16.85, P<.0001).

“The increased risk of DME was observed after 1 year of exposure and continued to accrue over the 10-year follow-up of the study even when adjusting for confounding factors,” Idris said.

Returning to the June 24 Bloomberg news report:

Actos may raise the risk of bladder cancer in patients who take the medicine more than a year, the U.S. Food and Drug Administration said in a June 16 safety announcement. The medicine has sales of 387.9 billion yen ($4.8 billion) in the fiscal year ended in March, according to Bloomberg data.

We wrote about the Actos bladder cancer safety issue earlier this month in our "Actos-Related Bladder Cancer: June 2011 Review Of Regulatory Actions And Safety Warnings" post.

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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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