Drug Injury Watch

More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks

For "Low-T" Drugs Like AndroGel, Axiron, And Testim, Serious Side Effects Are Increased With Age -- Highest Risks In Men Over 65 And For Men With Pre-Existing Diagnosed Heart Disease

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products" 

FDA MedWatch Safety Alert issued January 31, 2014

(1/31/14)

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A new medical study regarding testosterone therapy (TT) medications like AndroGel, Axiron, and Testim published in January 2014 has found that a man's risk of having a myocardial infarction (MI) -- often referred to as a heart attack -- increases significantly in the first few months after he starts using the newly prescribed testosterone drug.

In summary, researchers compared the incidence of non-fatal MI events in the year before a first prescription for testosterone therapy (pre-rate) with non-fatal MI events in the 90 days after filling that prescription (post-rate).  The post-rate / pre-rate ratio for MI or heart attack was 1.36, increasing to 2.19 in those 65 and older, and to 3.43 in those 75 and older. Younger men with a history of heart disease also showed an increased risk of having a heart attack relatively soon after starting a testosterone drug like AndroGel, Axiron, or Testim.

These findings come from the medical journal article "Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men", which was published by PLoS ONE on January 29, 2014.

From the Discussion part of this recent article about testosterone therapy (TT):

Among men aged 65 years and older, we observed a two-fold increase in the risk of MI in the 90 days after filling an initial TT prescription, the risk declined to baseline in the 91 to 180 days after initial TT prescription, among those who did not refill their prescription....
 
Among younger men with a history of heart disease, we observed a two to three-fold increased risk of MI in the 90 days following an initial TT prescription and no excess risk in younger men without such a history. Among older men, the two-fold increased risk was associated with TT prescription regardless of cardiovascular disease history, although this analysis was based on relatively small numbers of MI cases in each subgroup....

Taken together, the evidence supports an association between testosterone therapy and risk of serious, adverse cardiovascular-related events–including non-fatal myocardial infarction–in men....

Given the rapidly increasing use of TT, the current results, along with other recent findings emphasize the urgency of the previous call for clinical trials adequately powered to assess the range of benefits and risks suggested for such therapy....

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As reported online by Medscape (free registration required), a leading academic cardiologist was both impressed and concerned about this new study that was funded by the US National Institutes of Health regarding the safety of testosterone therapy. From "Another Study Links Testosterone Therapy to MI Risk":

To heart wire, Dr Sanjay Kaul (Cedars Sinai Medical Center, Los Angeles, CA) said the nonrandomized design of the study is suitable for detecting the effect size observed in this study, that being a relative risk >1.5 or 2.0. "They have used sophisticated statistical tools to reliably adjust for bias and confounding and ensure validity of results," he added. "The use of a concurrent control [PDE5-inhibitor prescription] is particularly clever because it suggests that the results are not confounded by behavioral or other factors associated with prescription."

With the supportive observations from other studies, the biological plausibility of the findings, and temporal trend of increased risk observed within 90 days of starting the prescription, Kaul said the "overall quality and quantity of data provides credible evidence" linking testosterone therapy to an increased risk of cardiovascular events in vulnerable patients, such as those identified in this paper.

The take-away points from this PLoS ONE article about the association between testosterone therapy medications, e.g., AndroGel, Axiron, Testim, and non-fatal myocardial infarctions (MI), or heart attacks, seem to be two:

(1) The risk of having non-fatal MI or heart attack following the start of a testosterone therapy prescription increases with age, and was substantially increased in older men; and,

(2) This cardiovascular-related risk was also substantially increased in younger men with pre-existing diagnosed heart disease.

For more about this topic, you may want to see these recent Drug Injury Watch posts:

• The Growing Use Of Testosterone Creams, Gels, Injections, And Patches Raises Increased Concerns About Risks Of Cardiac Side Effects
• Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths

Be assured that we are continuing to monitor this emerging drug safety issue concerning testosterone drugs like AndroGel, Axiron, and Testim, which -- as you have probably seen -- are the subject of "direct-to-consumer" (DTC) advertising.  For more on that aspect of the problem, see: "'Low T' meds use differs markedly in U.S. and U.K."

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

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The Growing Use Of Testosterone Creams, Gels, Injections, And Patches Raises Increased Concerns About Risks Of Cardiac Side Effects

Critics Of "Low-T" Drugs Like Axiron, AndroGel, And Testim Blame Medically Unnecessary Use Of Androgen Therapy On Drug Company Advertising

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products"

FDA MedWatch Alert issued on January 31, 2014

 

"More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks"

Drug Injury Watch article posted January 31, 2014

 

(1/31/14)

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Testosterone replacement therapy (TRT), also called androgen replacement therapy (ART), is medically recommended for men whose body makes too little of this male hormone. For those men who have been tested and diagnosed with this condition, which is called hypogonadism, testosterone drugs like Axiron, AndroGel, and Testim can serve to boost strength and sexual functioning.

But how does one explain the fact that it is estimated the number of middle-aged men in the U.S. getting testosterone treatments has more than tripled over the last decade?

At least according to one study, this may be due to advertising campaigns for testosterone products that are arguably aimed men who do not have clinically low testosterone levels, i.e., had not undergone a blood test to see if they really needed TRT or ART.  In fact, there seems to be a growing number of older men using drugs like Axiron, AndroGel, and Testim for so-called "Low-T syndrome" (men who are tired or depressed) or for anti-aging reasons -- and some younger men taking these testosterone drugs for other physical purposes.

From a June 2013 Reuters Health news report, "More men treated for low T, some without evidence":

Androgen replacement therapy is recommended for men who make too little testosterone on their own, a condition known as hypogonadism. That's different from the natural decline in testosterone that happens to all men as they age.

But advertising campaigns may be reaching a bigger pool of men - who are tired or depressed, for example, but don't have clinically low testosterone.

"There's all sorts of messages out there that men should be aware of this thing called low T, that low testosterone levels can be the reason for almost all of the problems with life and aging" and that treatment can fix that, said Dr. Steven Woloshin from the Geisel School of Medicine at Dartmouth in Hanover, New Hampshire.

"The promise goes well beyond what we know, and that's what's worrisome," Woloshin, who co-wrote a commentary about testosterone marketing published in the same journal, told Reuters Health.

That marketing includes quizzes asking men about their energy, sex drive and mood, such as the "Is It Low T?" quiz [http://bit.ly/18LeuHk] sponsored by AbbVie, which makes the testosterone gel AndroGel.

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And from an April 2013 piece in The Atlantic Monthly, "Should the Modern Man Be Taking Testosterone?":

Dr. Adriane Fugh-Berman, associate professor of pharmacology and director of the industry watchdog group PharmedOut.org at Georgetown University School of Medicine, calls this kind of direct-to-consumer pharmaceutical advertising "evil." She likened the efforts to sell TRT to earlier campaigns to push hormone replacement therapy for post-menopausal women. "They stole the playbook," she said. "This hormone is being thrown around like sugar water."

In our recent article about these testosterone drugs like Axiron, AndroGel, and Testim, "Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths", we referenced a relatively recent medical journal article, "Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels".

In an accompanying editorial, "Testosterone therapy and risk of cardiovascular disease in men", also published in the November 6, 2013 edition of the Journal of American Medical Association, Anne R. Cappola, MD, ScM, of the Perelman School of Medicine at the University of Pennsylvania, wrote:

Perhaps the most important question is the generalizability of the results of this study to the broader population of men taking testosterone: men of this age group who are taking testosterone for "low T syndrome" or for antiaging purposes and younger men taking it for physical enhancement. Does the 29% increased risk of myocardial infarction, ischemic stroke, or mortality apply to these groups?  Are the benefits -- real or perceived -- for these groups of men worth any increase in risk?

In more detail, from a November 2013 MedPage Today report, "'Low T' Tx Tied to Higher Stroke Risk in Veterans":

"What is missing from the literature are data from randomized trials that include a sufficient number of men for an adequate amount of time to assess the long-term benefits and risks of testosterone therapy," said Cappola.

Establishing long-term risks will be difficult, she said. "There is no study involving men that is equivalent to the Women's Health Initiative, nor is it likely that there will be a trial of equal scale," she wrote. Because of this, she said, scientists will have to rely on observational data from existing cohorts of men, as the authors did in the current study.

The big question with the current study, said Cappola, is how generalizable the results are, because the men in the VA system are known to have more comorbidities and health problems than men in the general population.

But in light of the "mounting evidence of a signal of cardiac risk," cautious prescribing and additional investigation are called for, she said.  [Emphasis added]

We are monitoring the medical literature and news reports for more information about cardiac risks associated with testosterone products like Axiron, AndroGel, and Testim, which have became so popular while so little is known about their long-term safety.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

Increasingly Popular Testosterone Replacement Therapy Drugs Are Linked To Myocardial Infarctions Or Heart Attacks, Strokes, And Deaths

Medical Studies Show An Increased Risk Of Cardiovascular Events In Older Men Prescribed Testosterone Medications Such As Axiron, AndroGel, And Testim

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE: "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products"

FDA MedWatch Alert issued on January 31, 2014

 

"More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks"

Drug Injury Watch article posted January 31, 2014

 

(1/31/14)

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Testosterone replacement therapy (TRT) is also referred to as androgen replacement therapy (ART) and male hormone replacement therapy.

Older men who used testosterone gel, patch, or injection products for a medical condition called hypogonadism or for other reasons are more likely to have a serious cardiovascular event, some of which have been fatal, according to some medical research.

Unfortunately, while it is estimated that the number of middle-aged men in the U.S. getting testosterone treatment has more than tripled over the last decade, the long-term risks are largely unknown.

Some of the prescription testosterone drug products approved by the FDA and available for use to treat low testosterone, or "Low T" syndrome, include:

•AndroGel
•Androderm
•Axiron
•Bio-T-Gel
•Delatestryl
•Depo-Testosterone
•Fortesta
•Striant
•Testim
•Testopel

Men with certain cardiac conditions such as heart disease who are prescribed these testosterone replacement therapy medications face an increased risk of cardiovascular adverse events according to a medical study article, "Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels", published in the November 6, 2013 edition of the Journal of American Medical Association.

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To put this rather alerting drug safety information about testosterone replacement therapy into context we look to a November 2013 medical news report, "'Low T' Tx Tied to Higher Stroke Risk in Veterans":

Steven Nissen, MD, of the Cleveland Clinic, characterized the study results as a red flag that demands "attention not just from physicians but also from regulators."

Nissen, who was not involved the study, noted that he is among of group of physicians who "have been worried about testosterone replacement therapy, which is increasingly commonly prescribed and largely fueled by direct-to-consumer advertising that's urging men to get tested for low testosterone and then to seek replacement."

The risk with that approach, he said, is that clinicians feel compelled to treat a biochemical problem -- low levels of testosterone -- and that treatment could trigger a "clinical problem that's far more grave, which is coronary heart disease."  [emphasis added]

An earlier clinical trial entitled Testosterone in Older Men with Mobility Limitations (TOM) also associated testosterone drugs like Axiron, AndroGel, and Testim with a higher rate of cardiovascular events, as covered in this July 2010 article, "Increased CV Events Halts Testosterone Trial in Older Men":

Testosterone treatment in men aged 65 years and older who have limitations in mobility is associated with an increased risk for cardiovascular events, including myocardial infarction and hypertension, according to a study published online June 30 in the New England Journal of Medicine.

Because of these events, the treatment phase of the trial, which was supported by the National Institute on Aging of the National Institutes of Health, has been stopped....

The men in the trial were an average of 74 years old and had high rates of chronic diseases such as diabetes and cardiovascular disease....

The cardiovascular-related events included myocardial infarction, arrhythmias, hypertension, and 1 death from a suspected myocardial infarction.

You can read more about this TOM trial discontinued in 2009 and the drug-safety issues that were found during it in this July 2010 New England Journal of Medicine article, "Adverse Events Associated with Testosterone Administration".

We will continue to report about testosterone therapy and its increased risk of death, heart attacks, and strokes -- as well as how these "Low T" drugs like Axiron, AndroGel, and Testim became so popular -- in our next article about this emerging drug safety issue.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

FDA Drug Safety Concerns About Pradaxa And Serious Bleeding Side Effects Will Get Another Look By Means Of New 2014 Study

A Primary Focus Is Gastrointestinal And Intracranial Hemorrhages In Patients Using Pradaxa For Atrial Fibrillation

(Posted by Tom Lamb at DrugInjuryWatch.com)

Pradaxa, an anticoagulant drug from Boehringer Ingelheim, was approved by drug regulators in Europe in 2008 and later by the FDA in 2010.

In recent years personal injury and wrongful death lawsuits have been filed against the drug company in some instances where patients developed certain serious medical conditions while using Pradaxa, such as the following:

•  Serious bleeding side effects such as gastrointestinal (GI) bleeds and rectal bleeding
•  Irreversible life-threatening bleeding events
•  Trauma-induced atypical bleeding incidents due to lack of effective reversal agent
•  Hemorrhages such as brain hemorrhage, intracranial hemorrhage, and hemorrhagic stroke
•  Thromboembolic complications such as cerebrovascular accident (CVA)
•  Death as a result of excessive bleeding

On December 30, 2013 the FDA posted for public comment on a proposed protocol of a new study intended to be a one-time assessment of selected safety outcomes in adults with atrial fibrillation who are new users of Pradaxa (dabigatran) or Coumadin (warfarin).

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From these points taken from the MINI-SENTINEL ASSESSMENT PROTOCOL: A PROTOCOL FOR ASSESSMENT OF DABIGATRAN (PDF document) that was posted online, we can see where the FDA's focus will be in this new 2014 Pradaxa safety study:

• Questions remain, however, about the outcomes associated with [Pradaxa (dabigatran)] outside of the clinical trial setting and in typical clinical practice populations. To address this, this protocol aims to assess systematically the rates of bleeding and thromboembolic outcomes associated with the use of [Pradaxa (dabigatran)] and warfarin for patients with atrial fibrillation using data from the FDA Mini-Sentinel Distributed Database (MSDD).
• Toward that end, the primary comparison will be examining bleeding and thromboembolic outcomes between new use of [Pradaxa (dabigatran)] or warfarin in patients with nonvalvular atrial fibrillation in the MSDD.
• The primary outcomes will be the occurrence of ischemic stroke, intracranial hemorrhage, all strokes (ischemic stroke + intracranial hemorrhage) as well as episodes of major bleeding.

Some background information about this Pradaxa FDA study of can be found in this January 3, 2014 Forbes article by Larry Husten, "FDA Plans New Safety Assessment Of Dabigatran (Pradaxa)":

At this point there is no plan to assess the safety of the new oral anticoagulants that received approval after dabigatran, rivaroxaban (Xarelto, Johnson & Johnson) and Eliquis (Pfizer and BristolMyers Squibb).

A knowledgeable source said that the major purpose of the study will be to identify groups of patients who are at high risk for major bleeding events with [Pradaxa (dabigatran)]. Somewhat paradoxically, this might help bolster the drug, as it will then also identify groups more likely to benefit from treatment. On the other hand, the fact that similar studies are not being undertaken with the other new oral anticoagulants may well reinforce concerns about [Pradaxa (dabigatran)].

We will be watching the FDA and the medical news reports for future developments concerning this latest FDA safety review regarding Pradaxa and serious bleeding side effects, some of which can result in death.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

The Association Of Antipsychotic Drug Risperdal (Risperidone) With Gynecomastia / Male Breasts Side Effect Is Subject Of Pharmaceutical Litigation Against Janssen

Legal Issue In These Risperdal Lawsuits Is Whether The Drug Label Provided Timely And Sufficient Warning About The Development Of Breasts In Boys And Men

(Posted by Tom Lamb at DrugInjuryWatch.com)

Gynecomastia is swelling of the breast tissue in boys or men, caused by an imbalance of the hormones estrogen and testosterone. Gynecomastia can affect one or both breasts, sometimes unevenly.

Gynecomastia is triggered by a decrease in the amount of the hormone testosterone compared with estrogen. The cause of this decrease can be conditions that block the effects of or reduce testosterone or a condition that increases your estrogen level.

As regards drug-induced gynecomastia, i.e., the development of breasts in men and boys, the current Prescribing Information, or package insert, for Risperdal (accessed 1/9/2014) has this rather limited information under the WARNINGS AND PRECAUTIONS section:

5.6 Hyperprolactinemia

As with other drugs that antagonize dopamine D2 receptors, RISPERDAL® elevates prolactin levels and the elevation persists during chronic administration. RISPERDAL® is associated with higher levels of prolactin elevation than other antipsychotic agents.

Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects....

From a relatively quick review of the medical literature we could find that the association between Janssen Pharmaceuticals antipsychotic drug Risperdal and the development of breasts in boys or men, i.e., gynecomastia, has been known for some years now.

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To demonstrate this point, we list just a few of the articles which we found:

• “Risperidone-induced symptomatic hyperprolactinaemia in adolescents.” was published in a 2006 edition of The Journal of Clinical Psychopharmacology. (Hyperprolactinemia is an ailment characterized by elevated blood levels of prolactin, the hormone responsible for breast development.)
• “Hyperprolactinemia in mentally ill patients.” from 2011 discussed the link between antipsychotic drug use and hyperprolactinemia that results in male breast development (gynecomastia).
• “Drug-induced gynecomastia: an evidence-based review.” from 2012 aimed to clarify which drugs cause gynecomastia, the development of breasts in men.
• “Prolactin, hyperprolactinaemia and antipsychotic treatment: a review and lessons for treatment of early psychosis.” is a 2012 article that explored the association between hyperprolactinemia and antipsychotic use.
• “Antipsychotic-drug-induced hyperprolactinemia: Physiopathology, clinical features and guidance,”; this 2013 L’Encephale study pointed that “18% of men and 47% of women treated with antipsychotics for severe mental illness had a prolactin level above the normal range,” and that symptoms of hyperprolactinemia, including “sexual dysfunction, infertility, amenorrhea, gynecomastia [and] galactorrhoea” are “common”.

If you think that a boy might have developed breasts due to his use of Risperdal, the first thing to do is to have him see a medical doctor for gynecomastia tests and diagnosis.

In turn, if gynecomastia is diagnosed, there may be a possible legal claim seeking compensation that can be brought against the drug company, Janssen Pharmaceuticals, on behalf of the boy who has developed breasts from using Risperdal.  For that you should consult an experienced drug injury lawyer.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)

Pfizer's Lipitor Statin Drug For Treatment Of High Cholesterol Linked To An Increased Risk Of Type-2 Diabetes In Some Older And Post-Menopausal Women

February 2012 FDA Drug Safety Warning About Lipitor Label Change Concerning New-Onset Diabetes Mellitus (DM) Has Gone Largely Unnoticed To Date

(Posted by Tom Lamb at DrugInjuryWatch.com)

Statins are a class of prescription drugs used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (“bad cholesterol”). One of these medications is Lipitor (atorvastatin) from Pfizer.

From the February 28, 2012 "FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drug":

... High-dose [Lipitor (atorvastatin)] had also been associated with worsening glycemic control in the Pravastatin or Atorvastatin Evaluation and Infection Therapy – Thrombolysis In Myocardial Infarction 22 (PROVE-IT TIMI 22) substudy.

FDA also reviewed the published medical literature. A meta-analysis by Sattar et al., which included 13 statin trials with 91,140 participants, reported that statin therapy was associated with a 9% increased risk for incident diabetes (odds ratio [OR] 1.09; 95% confidence interval [CI] 1.02-1.17), with little heterogeneity (I2=11%) between trials. A meta-analysis by Rajpathak et al., which included 6 statin trials with 57,593 participants, also reported a small increase in diabetes risk (relative risk [RR] 1.13; 95% CI 1.03-1.23), with no evidence of heterogeneity across trials. A recent study by Culver et al., using data from the Women’s Health Initiative, reported that statin use conveys an increased risk of new-onset diabetes in postmenopausal women, and noted that the effect appears to be a medication class effect, unrelated to potency or to individual statin.

Based on clinical trial meta-analyses and epidemiological data from the published literature, information concerning an effect of statins on incident diabetes and increases in HbA1c and/or fasting plasma glucose was added to statin labels.  [footnotes omitted]

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Some of the medical journal articles reviewed by the FDA prior to issuing this Lipitor - diabetes warning include:

• High-dose atorvastatin associated with worse glycemic control: a PROVE-IT TIMI 22 substudy. Circulation. 2004;110(Suppl I):S834.
• Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010;375(9716):735-742.
• Statin therapy and risk of developing type 2 diabetes: a meta-analysis. Diabetes Care. 2009;32(10):1924-1929.
• Effect of statins on fasting plasma glucose in diabetic and nondiabetic patients. J Investig Med. 2009;57:495-499.
• Atorvastatin causes insulin resistance and increases ambient glycemia in hypercholesterolemic patients. J Am Coll Cardiol. 2010;55:1209-1216.
• Effects of maximal atorvastatin and rosuvastatin treatment on markers of glucose homeostasis and inflammation. Am J Cardiol. 2011;107:387-392.
• Do statins beneficially or adversely affect glucose homeostasis? Curr Vasc Pharmacol. 2010;8:612-631.
• Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials. QJM. 2011;104:109-124.
• Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med. 2012;172(2):144-152.

From the Abstract for this last medical article listed above, which was published in the January 23, 2012 edition of Archives of Internal Medicine (now called JAMA Internal Medicine), we get these points about this still-emerging drug safety issue concerning diabetes and Lipitor, as well as other statin cholesterol drugs:

Background This study investigates whether the incidence of new-onset diabetes mellitus (DM) is associated with statin use among postmenopausal women participating in the Women's Health Initiative (WHI).

Methods The WHI recruited 161 808 postmenopausal women aged 50 to 79 years at 40 clinical centers across the United States from 1993 to 1998 with ongoing follow-up. The current analysis includes data through 2005....

Results ....Statin use at baseline was associated with an increased risk of DM (hazard ratio [HR], 1.71; 95% CI, 1.61-1.83). This association remained after adjusting for other potential confounders (multivariate-adjusted HR, 1.48; 95% CI, 1.38-1.59) and was observed for all types of statin medications....

Conclusions Statin medication use in postmenopausal women is associated with an increased risk for DM. This may be a medication class effect. Further study by statin type and dose may reveal varying risk levels for new-onset DM in this population.

And from the final paragraph of that January 2012 medical journal article: "However, the consequences of statin-induced DM have not been specifically defined and deserve more attention."  [emphasis added]

We will continue to watch for medical and regulatory developments as regards new-onset diabetes mellitus (DM), or Type-2 diabetes, associated with Lipitor and other statins.

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DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Review done by attorney Tom Lamb)