Author: Tom Lamb

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

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)

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

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

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

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 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