Drug Injury Watch

Fibromyalgia Drug Savella Should Be Pulled From Market, Says Public Citizen Group

January 2010 Petition Letter To FDA Is Sent One Year After The Medication Was Approved For Sale In U.S.

(Posted by Tom Lamb at DrugInjuryWatch.com)

On January 21, 2010 the Health Research Group arm of Public Citizen sent its "Petition to Ban Fibromyalgia Drug Milnacipran (Savella)" to FDA Commissioner Margaret Hamburg, M.D. 

This Public Citizen letter Petition begins as follows:

Dear Dr. Hamburg:

Public Citizen, representing more than 65,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA), pursuant to the Federal Food, Drug, and Cosmetic Act 21 U.S.C. Section 355(e)(3), and 21 C.F.R. 10.30, to immediately remove from the market the drug Savella (milnacipran; Cypress Bioscience, Inc. and Forest Laboratories, Inc.) because it has highly questionable clinical efficacy and has been found, in randomized controlled trials, to cause a large number of potentially serious adverse reactions including hypertension, increased heart rate, and increased suicidal ideation. On July 23, 2009, milnacipran’s approval for fibromyalgia was denied in the European Union for these very same efficacy and safety reasons....

For some contextual information we turn to a January 20 Bloomberg news article, "Forest’s Drug Savella Should Be Recalled, Public Citizen Says":

The FDA approved Savella, also known as milnacipran, as a treatment in January 2009 for fibromyalgia, a disorder characterized by a variety of pain-related symptoms including muscle pain and headaches. In July, European regulators rejected the drug, saying its benefits were marginal and didn’t outweigh the risks. Public Citizen said the drug is not effective in treating pain.

“The larger issue is this is a new kind of drug for fibromyalgia,” Sidney Wolfe, director of Public Citizen’s Health Research Group, said today in a telephone interview. “This is the first drug only approved just for fibromyalgia, and it shouldn’t have been. There are serious safety risks that outweigh the benefits, and the drug doesn’t work for pain alone.”

More information is found in Matthew Perrone's January 20 Associated Press (AP) article, "Group Urges Recall of Drug for Fibromyalgia -- Public Citizen questions benefit of pain pill for fibromyalgia, points to blood pressure risks":

Since the FDA approved Savella last January, doctors have written more than 250,000 prescriptions for the drug, according to data from IMS Health....

FDA has cleared two other treatments for fibromyalgia: Eli Lilly's antidepressant Cymbalta and Pfizer's anti-seizure treatment Lyrica. Both drugs were cleared based on their ability to decrease fibromyalgia pain, though it's not clear how.

The cause of fibromyalgia is not known, though some researchers point to abnormalities in how patients with the disorder process pain nerve signals.

We will continue to watch for developments concerning the relatively new fibromyalgia medication Savella, and we welcome any information that you may about this emerging drug safety issue.

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

Should Meridia Remain On Market? FDA Says "Yes" (For Now At Least), European Drug Regulators Say "No"

Difference Of Opinion Suggests There Could Be A Possible Meridia Recall In U.S. Before The FDA Holds Its Public Advisory Meeting In September 2010

(Posted by Tom Lamb at DrugInjuryWatch.com)

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UPDATE:  Abbott Pulls Meridia in U.S. Amid FDA Safety Concerns (10/8/10, Bloomberg)

Abbott Laboratories agreed to pull its 13-year-old diet pill Meridia off the U.S. market because of heart attack and stroke risks.

The company announced the removal today at the request of the Food and Drug Administration after a study linked Meridia to 16 percent more major cardiovascular side effects among 10,000 high-risk patients who were followed for as long as six years....

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The beginning of a January 23, 2010 newspaper article, "Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug" -- by Natasha Singer and Andrew Pollock for The New York Times (NYT) -- frames the issue:

European and American drug regulators had two starkly different reactions this week to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.

On Thursday, the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The Food and Drug Administration, looking at the same study data on Thursday, took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.

This January 23 NYT article also provided a glimpse of how the FDA might proceed as regards the fate of Meridia in the U.S.:

... the F.D.A. said it planned to wait for the company’s complete report on the study, due in March, before considering further action on the drug. An advisory panel of medical experts is to review the results of the study in a public meeting, most likely in September, an agency spokeswoman wrote in an e-mail message to a reporter.

So how did these respective drug regulators in Europe and the U.S. come to such different opinions about Meridia when apparently looking at the same efficacy and safety data?

Perhaps the answer can be found in, or between the lines of, one of the several documents issued in Europe last week about Meridia (sibutramine) -- which is sold as Reductil, Reduxade, Zelium, and various other tradenames in the European Union.

To start, from the so-called Dear Doctor letter which was issued on January 21, 2010 (available by using the link found at end of an MHRA web page titled "Sibutramine: Suspension of marketing authorisation as risks outweigh benefits"):

Dear Healthcare Professional,

We are writing to inform you that the European Medicines Agency (EMA) has completed a review of the obesity medicine sibutramine (Reductil) on the basis of new safety information from a large clinical trial, the Sibutramine Cardiovascular OUTcomes (SCOUT) study. The review has found that the cardiovascular risks of sibutramine outweigh its benefits. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended suspension of the marketing authorisation for this medicine across the European Union....

Although most of the patients enrolled within SCOUT are contraindicated from being treated with sibutramine under normal conditions of use, the Committee considered the cardiovascular risk to be relevant to normal clinical use because it is not always possible to identify underlying cardiovascular disease in patients who are obese or overweight. Therefore further restrictions on the use of sibutramine would be unlikely to reduce the risk to an acceptable level.

Other recent documents about Meridia from the European drug regulators include:

1)  December 18, 2009 press release: "European Medicines Agency updates on ongoing safety review of sibutramine -- Weight-loss medicine assessed over cardiovascular concerns";

2)  January 21, 2010 press release: "European Medicines Agency recommends suspension of marketing authorisations for sibutramine -- Weight-loss medicine associated with increased risk of cardiovascular events to be removed from all markets in the European Union"; and,

3)  "Questions and answers for recommendation to suspend sibutramine (Reductil) from the EU market".

Or, perhaps there is an explanation somewhere within the FDA's "Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia", issued on January 21, 2010.

Lastly, for those who want to dig deeper, you can read about the recent Meridia study, itself -- "A Long Term Study of Sibutramine and the Role of Obesity Management in Relation to Cardiovascular Disease in Overweight and Obese Patients. (SCOUT)" -- at the ClinicalTrials.gov web site.

What do you think?  Did the FDA get it right or wrong as regards the issue of whether Meridia should remain on the market in the U.S.? 

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

National Alert Network For Serious Medication Errors: New Drug-Safety Project From ISMP And ASHP

Will Send Email Alerts To Healthcare Providers When Dangerous Or Life-Threatening Prescription Drug Errors Are Reported To ISMP

(Posted by Tom Lamb at DrugInjuryWatch.com)

A January 19, 2010 article, "Catching Deadly Drug Mistakes", by The Wall Street Journal's health reporter, Laura Landro, brought to our attention a new project intended to reduce medication errors. 

From that WSJ article:

... Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United States, according to the Food and Drug Administration. Now, new efforts are underway to quickly spread the word about such errors and offer guidance on how to prevent similar mistakes.

The non-profit Institute for Safe Medication Practices [(ISMP)], which is certified by the federal government to collect error reports and other information about quality breaches, and the American Society of Health-System Pharmacists [(ASHP)]are launching a new National Alert Network for Serious Medication Errors. The network, which was unveiled last month, will be used to send email alerts to 35,000 pharmacists working in hospitals and health systems, as well as physicians and nurses, when a dangerous or life-threatening error is reported to ISMP....  The hope is that widely spreading the word about such errors will cause doctors and pharmacists to be more cautious—and ultimately prevent future mix-ups. Relevant alerts will also be sent to 20,000 drugstore pharmacists.

Hopefully this new National Alert Network for Serious Medication Errors will advance the cause of making medications safer for patients.

In her January 19 article, WSJ health reporter Landro also reminds us about two very good resources that are available to consumers and patients:

ConsumerMedSafety.org: A portal of information provided by the Institute for Safe Medication Practices (ISMP) where consumers can sign up for customized alerts about the medications they take and report problems they encounter with medications; and,

MedWatch: The U.S. Food and Drug Administration (FDA) site for safety information on prescription drugs and other medical products, where patients can submit reports of medication errors and other serious adverse reactions directly to the FDA.

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

When Will Michigan State Senate Vote Whether To Repeal Statute Prohibiting Drug Injury Lawsuits

State Senate Republicans Move In January 2010 To Delay, Again, Any Action Regarding This "FDA Defense" Law

(Posted by Tom Lamb at DrugInjuryWatch.com)

As you may be aware, Michigan is the only state in the country that has a statute, or law, which serves to shield pharmaceutical companies from drug injury lawsuits.

Enacted into law back in 1995, this statute -- commonly called the “FDA defense” -- states that pharmaceutical manufacturers cannot be sued if their medical products are approved by the FDA, unless the company intentionally withheld information or misled the FDA or misrepresented the product in advertising – which is very difficult to establish.

In more detail, the Michigan statute, MCLS § 600.2946(5), provides that an FDA-approved pharmaceutical product is not defective nor unreasonably dangerous where the product and its labeling were in compliance with FDA requirements at the time when the product was sold. 

In March 2009 the Michigan House of Representatives passed two bills (H.B. 4316 and 4317) that would repeal the statute which essentially gives legal immunity to pharmaceutical manufacturers from products liability legal compensation lawsuits brought by Michigan residents.  If passed by the Michigan state Senate, these two bills would: (1) repeal the statutory immunity provided by MCLS § 600.2946(5); and, (2) make the repeal retroactive so that Michigan residents who were previously prohibited from filing such any drug injury lawsuit could now do so within three years of the date the repeal law goes into effect, i.e., effective date of the statute. 

Now, ten months later, it is still unknown when, if ever, the Michigan Senate will vote on these two March 2009 Michigan House bills that eliminate the "FDA defense" in Michigan.

The most recent word on this continually contentious issue comes from a January 15, 2010 article, "Lawmakers push to end drug firms' immunity -- Whitmer, Meadows criticize GOP effort to delay measure", published by the Lansing State Journal.  In that article, reporter Scott Davis sets forth the developments from last week:

Thursday, state Sen. Gretchen Whitmer and Rep. Mark Meadows, both East Lansing Democrats, blasted Senate Republicans for moving this week to delay action this year on a House bill to lift the product liability shield....

On Wednesday, Republicans who control the Senate agreed to a parliamentary move to keep the bill in the Government Operations and Reform Committee and not bring it up for a vote this year. Similar tactics in recent years have stalled a vote on other versions of the bill.

Adam Knott, a spokesman for Drug Immunity Must End, a group that formed to battle the drug shield law, said the group merely wants an up or down vote in the Senate. He hopes voters will pressure Republicans to bring it to the floor for action.

We will continue to monitor the status of this "FDA defense" law in Michigan, and we welcome all points of view on this issue (Note: While Comments are moderated, all are published but for those which go beyond G-rated content.)

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

Safety "Cloud" Gets Removed From Spiriva By FDA In January 2010

This COPD Medication Had Previously Been Possibly Linked To Stroke, Heart Attack, And Death

(Posted by Tom Lamb at DrugInjuryWatch.com)

On January 14, 2010 the FDA issued a news release, "FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler -- Current data do not support increased risks for stroke, heart attack, or death", which began as follows:

The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.

As you may recall, an FDA Early Communication issued in March 2008 had described data submitted by the manufacturer of Spiriva HandiHaler as suggesting a small increased risk of stroke in patients treated with tiotropium, the medicine’s active ingredient.  Later, in October 2008, an Updated Early Communication highlighted two additional publications suggesting an increased risk of stroke, heart attack, and death in patients using tiotropium.

Now, as explained in the FDA's "Follow-Up to the October 2008 Updated Early Communication about an Ongoing Safety Review of Tiotropium (marketed as Spiriva HandiHaler)", we get the apparent final word:

FDA has now completed its review and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events.

As always, we encourage people to report any serious adverse events that may be related to Spiriva, or any other prescription medication, to the FDA MedWatch program.

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

FDA Introduces A New Web Site Intended To Give The Public More Insight About Agency's Work

FDA Basics:  Site Seeks To Present Information To Consumers And Patients In Useful And User-Friendly Format

(Posted by Tom Lamb at DrugInjuryWatch.com)

On January 12, 2009 Dr. Joshua Sharfstein, Principal Deputy Commissioner of the FDA, introduced FDA Basics, which is a new Web resource intended to answer questions from consumers and patients as well as to discuss other important public health topics in a useful and user-friendly format.

Structurally, FDA Basics consists of the following sections:

• FDA Fundamentals
• Animal & Veterinary
• Cosmetics & Color Additives
• Dietary Supplements
• Drugs
• Food
• Medical Devices
• Radiation-Emitting Products
• Tobacco Products
• Vaccines, Blood, and Biologics

Of particular interest to us is the Drugs section of FDA Basics.  It includes the three sets of questions set forth below, with each question linked to responsive information:

Drug Approval

What is the approval process for a new prescription drug?  

What are over-the-counter (OTC) drugs and how are they approved? 

What are generic drugs and how are they approved? 

Are generic drugs the same as brand name drugs? 

How do I find out if a drug is approved? Is there a Web site I can go to? 

How can I get access to a drug that is in testing but has not yet been approved? 

Does FDA approve the color additives used in drugs? If so, how does FDA determine their safety? 

Information About Drugs

What are the possible side effects of a drug and where can I find the most current information about my drug? 

Why do some drug labels get changed so often ? 

Does FDA approve the information given out by pharmacies when I pick up my medicine?

Can FDA ban direct-to-consumer drug advertising?

Safety

How does FDA decide when a drug is not safe enough to stay on the market? 

What is a Warning Letter? 

Why isn’t a drug taken off the market when a manufacturer gets a Warning Letter? 

How does FDA oversee domestic and foreign drug manufacturing? 

During a January 12 webinar for bloggers interested in health-related topics, the FDA's Dr. Sharfstein emphasized that this FDA Basics site was still in the development stage and he encouraged the public to submit comments or suggestions that might help the agency improve the site going forward.

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

GE Healthcare Seemingly Tries To Intimidate And Silence A Critic Of Its Omniscan Product

Drug Company Files Libel Lawsuit In UK Against Prominent Danish Radiologist Henrik Thomsen

(Posted by Tom Lamb at DrugInjuryWatch.com)

The Sunday Times (UK) recently ran a story that demonstrates how Britain's libel laws are possibly being used by GE Healthcare to intimidate a prominent Danish radiologist, Henrik Thomsen, M.D., into stopping his criticism of its Omniscan product, which has been in the news recently.

In the December 20, 2009 edition of The Sunday Times (UK) one found this descriptively titled article: "Libel gag on talk of 'medical hurricane' -- A healthcare firm is seeking to silence a Danish academic from expressing doubts about one of its products by using England’s draconian libel laws".

Another version of this article, "GE Suit Hushes Scientist Critical of Omniscan", was published online at ProPublica, which is a US-based independent, non-profit newsroom that produces investigative journalism in the public interest.  Therein, reporters  Jeff Gerth, of ProPublica, and Jon Ungoed-Thomas, of The Sunday Times (UK), tell us about this war being waged by GE Healthcare in the UK court system against Dr. Thomasen, a well-respected medical doctor who is not even a resident of Great Britain.  From this ProPublica version of the article:

Two years ago in a conference room in the Randolph hotel in Oxford, England, Henrik Thomsen gave his inside account of a medical "nightmare." In a presentation to about 30 colleagues, Thomsen, one of Europe's leading radiologists, revealed how patients treated at his Copenhagen University hospital had subsequently contracted a rare and potentially fatal disease....

Thomsen, however, now refuses to speak anywhere in England on the possible risks of Omniscan. The reason is that he faces another kind of storm: GE Healthcare is suing him for libel in the UK High Court.

The company claims his presentation in Oxford — entitled "Management Aspects of NSF" — was highly defamatory. GE has already racked up costs of more than £380,000 (about $615,000) pursuing the respected academic, who has authored or co-authored nearly 400 papers and delivered countless presentations to his peers. Thomsen will have to pay GE's costs if he loses the case.

Further, this online article at ProPublica about GE Healthcare, Omniscan, and Dr. Thomasen includes several background items in the sidebar of that web page:

• GE Omniscan Investigation
• About GE Healthcare
• Nephrogenic Systemic Fibrosis
• Omniscan and NSF
• How Three Hospitals Handled Omniscan
• Documents

The ProPublica site also has a 135 PDF presentation, "GE v. Thomsen: A British Libel Case", which contains the following related documents:

• Slides from Thomasen's 2006 presentation on Omniscan cases at Copenhagen University Hospital
• GE's legal filing accusing Thomsen of libel
• Thomasen's response to GE's accusation
• GE's response to Thomasen's defense

We are anxious to hear reactions from our readers about this apparent "beat-down" tactic by Big Pharma.  Please let us know what you think by submitting a Comment, below.

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

FDA Wants Studies Done On Byetta Safety, With Focus On Pancreatitis, Pancreatic Cancer, Thyroid Neoplasm, And Acute Renal Failure

FDA Letter About Byetta Sent To Amilyn In October 2009; Drug Company Tries To Downplay, But Investors React When They Learn About It In December 2009

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 30, 2009 Amylin Pharmaceuticals Inc. issued a press release, "BYETTA Approved for Expanded Use as First-Line Treatment for Type 2 Diabetes Prescribing Information Also Includes Updated Safety Information", in which they announced that the FDA had approved an expanded indication for BYETTA® (exenatide) injection:

BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. Previously, it was approved for use only in patients who were also taking other common diabetes medications and had not achieved adequate glycemic control.

It was not until the end of December 2009, however, that we got the rest of the picture.  From a December 23, 2009 Bloomberg article, "Amylin Falls as Analyst Says FDA Wants Byetta Study", by reporter Rob Waters:

San Diego-based Amylin and Indianapolis-based Eli Lilly & Co., which co-market the drug, announced Oct. 30 that the Food and Drug Administration had cleared the drug for use as standalone therapy for Type 2 diabetics and that prescribing information would warn about the risk of pancreatitis, an inflamed pancreas, in patients with severe kidney disease. That statement didn’t say the FDA wanted more studies.

Citigroup analyst Yaron Werber said today in a note to investors that he had obtained a copy of the FDA’s approval letter and that the agency was requiring animal and human studies aimed at clarifying the risk of pancreatitis posed by the drug. A statement e-mailed by Lilly and Amylin today said most of the requested studies are under way and have shown no increased risk of pancreatitis in patients taking Byetta.

“The FDA considers post-marketing reports of acute pancreatitis (fatal and non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure and thyroid neoplasms as ‘new safety information’ and is requiring Amylin to conduct additional studies,” Werber said in his note.

Amylin dropped $1.48, or 9.6 percent, to $13.97 at 4 p.m. in Nasdaq Stock Market composite trading, the most since April 2. The shares have gained 29 percent this year.

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From the October 30, 2009 FDA letter to Amilyn sent by Mary Parks, M.D. -- who is the Director of the agency's Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research -- we get these relevant excerpts:

Since Byetta (exenatide) was approved on April 25, 2005, we have become aware of postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and postmarketing reports of acute renal failure, sometimes leading to death or transplantation, in patients taking Byetta (exenatide). We have also become aware of postmarketing reports of thyroid neoplasms associated with the use of Byetta (exenatide) and of a signal of thyroid neoplasms observed pre-clinically with other GLP-1 analogues. We consider this information to be “new safety information” as defined in section 505-1(b)(3) of the FDCA.

After consideration of this new safety information, we have determined that postmarketing requirements are needed to assess the risk of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, and the risk of thyroid neoplasms, and that a REMS is necessary for Byetta (exenatide) to ensure that the benefits of the drug outweigh the risks of acute pancreatitis and acute renal failure....

We have determined that an analysis of spontaneous postmarketing adverse events reported under subsection 505(k)(1) of the FDCA will not be sufficient to assess the signal of a serious risk of acute pancreatitis, including hemorrhagic or necrotizing pancreatitis, and the signal of a serious risk of thyroid neoplasms.

Furthermore, the new pharmacovigilance system that FDA is required to establish under section 505(k)(3) of the FDCA has not yet been established and is not sufficient to assess this serious risk.

Therefore, based on appropriate scientific data, FDA has determined that you are required, to conduct [several studies about these possible Byetta side effects].

We are currently investigating cases of pancreatitis -- acute, hemorrhagic, and, necrotizing pancreatitis -- kidney failure, and renal insufficiency involving patients who have used Byetta.

P.S.  Excerpt from the Abstract for "Benefit-risk assessment of exenatide in the therapy of type 2 diabetes mellitus"  (Drug Saf, January 1, 2010):  "This review gives a benefit-risk assessment of exenatide."

(2/15/10)

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

 

Levaquin Has Been Associated With Dysglycemia Events Such As Hyperglycemia And Hypoglycemia

North Carolina Case Report: Man With Diabetes Develops Low Blood Sugar After Using Levaquin Together With Glucotrol

(Posted by Tom Lamb at DrugInjuryWatch.com)

Three years ago to the day we posted an article, back in January 2007, about the fact that Health Canada had received several reports of patients developing blood sugar problems after using Levaquin (levofloxacin) over the period January 1997 to June 2006.

On January 4, 2010 the American Journal of Health-System Pharmacy posted an article, "Hypoglycemia Associated with the Use of Levofloxacin" (free registration for access) which sets forth a case report concerning a malnourished 58-year-old man with diabetes in North Carolina who developed hypoglycemia after receiving Levaquin (levofloxacin) in conjunction with Glucotrol (glipizide).

From this 2010 medical journal article about Levaquin and dysglycemia we have extracted the following points -- with all footnotes omitted:

• Numerous cases of hypoglycemia associated with fluoroquinolones, particularly gatifloxacin [Tequin] and levofloxacin [Levaquin], have been reported. Most, but not all, reports occur in conjunction with impaired creatinine clearance and oral sulfonylurea use in elderly diabetic patients.

• Hypoglycemia typically occurs within 72 hours of fluoroquinolone initiation.

• The proposed mechanism by which the fluoroquinolones induce glycemic abnormalities is not clearly understood. Reports of fluoroquinolone-induced hypoglycemia are abundant, but reports of hyperglycemia induced by fluoroquinolones are also available.

• Use of the Naranjo et al. adverse-drug-reaction probability scale revealed that levofloxacin was possibly the cause of our patient's hypoglycemia (score = 4). Our patient had many of the risk factors often cited for fluoroquinolone-induced hypoglycemia, including renal insufficiency, diabetes, and sulfonylurea use. His age may have also been a contributing risk factor.

• Of interest, the patient had no significant hypoglycemia associated with his first dose of levofloxacin [Levaquin] and only experienced severe hypoglycemia when it was administered concomitantly with glipizide [Glucotrol]. This supports the theory that a drug–drug interaction may be responsible for the severe and resistant hypoglycemia noted in this and previous case reports.

• It is difficult to determine the most likely mechanism for the hypoglycemia observed in this patient; however, his hypoglycemia was most likely due to the concurrent use of levofloxacin [Levaquin] and glipizide [Glucotrol], his diabetes, and malnutrition.

We will continue to monitor for reports of blood sugar-related side effects associated with Levaquin use.

Some other, more well-known side effects linked to Levaquin are tendon ruptures, rotator cuff tears, and tendonitis.

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