Chicago Injury Law Blog

"The U.S. Food and Drug Administration (FDA) today proposed that makers of all antidepressant medications update the existing black box warning on their products' labeling to include warnings about increased risks of suicidal thinking and behavior, known as suicidality, in young adults ages 18 to 24 during initial treatment (generally the first one to two months).

The proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults ages 65 and older taking antidepressants have a decreased risk of suicidality. The proposed warning statements emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide."

Read the FDA's full press release here.

"FDA notified healthcare professionals and consumers of new safety information regarding taking medications used to treat migraine headaches (triptans) together with certain types of antidepressant and mood disorder medications (selective serotonin reuptake inhibitors (SSRIs) and selective serotonin/norepinephrine reuptake inhibitors (SNRIs). A life-threatening condition called serotonin syndrome may occur when triptans are used together with a SSRI or a SNRI.

Serotonin syndrome occurs when the body has too much of a chemical found in the nervous system (serotonin). Each of the above medications (triptans, SSRIs, and SNRIs), cause an increase in serotonin levels. Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, and diarrhea."

Read the FDA's full warning here.

"Some products advertised online as natural alternatives to impotence drugs such as Viagra illegally contain the same active ingredients as prescription medicines, the Food and Drug Administration said Wednesday.

The FDA warned consumers not to buy or use seven of the so-called dietary supplements sold online to treat impotence and enhance sexual performance. The list includes Zimaxx, which FDA testing showed contains sildenafil, the same active ingredient in Viagra. Viagra, made by Pfizer Inc., is sold in the United States only by prescription."

Read the full article in the LA Times here.               

The FDA recently asked the makers of Serevent Diskus, Advair Diskus, and Foradil Aeolizer to update thier labels to include risk of severe asthmatic attack. The drugs work to keep asthma episodes to a minimum with a medicine called "long-acting beta 2-adrenergic agonists" (LABA). All asthma drugs with this medicine will include this warning.
The problem is the drugs lower the frequency of asthma attacks, but actually greatly increase the severity of an attack when they occur. There is at least one death reported from the use of these drugs.

Read FDA's statement here.

Earlier this month, the FDA added a new warning to the popular Ortho Evra birth control patch. The patch exposes its users to a large amount of hormones which cause blood clots and other serious side effects.
According to records at MedWatch, about a dozen women in their late teens and early twenties died in 2004 from massive blood clots believed to be related to the birth-control patch. Dozens more had similar but non-lethal strokes and other clot related problems.
The warning comes nearly four months after an Associated Press report told of patch users die and suffer blood clots at a rate three times higher than woman taking the pill.

Read the FDA's FAQ page here.

The FDA recently released a warning to patient and caregivers regarding the use of the Duragesic patch for pain control. Deaths and overdoses have occurred with Duragesic and the generic form of the drug. The complete warning may be found here.

The FDA recently asked the makers of the most popular erectile dysfunction drugs to add label warnings for sudden vision loss. The blindess associated with these drugs is caused by non-arteritic ischemic optic neuropathy or NAION. This warning comes in the wake of recent problems with Viagra. The warning is to be placed on Viagra, Cialis, and Levitra.

FDA recently released a warning for antidepressants such as Effexor, Paxil and Zoloft. The warning is for suicidality, especially with adults taking these drugs for depression.
These drugs received a similar warning for use in children in March of 2005.

Read the FDA Healthcare and Patient information sheets here.

The FDA announced today that they are requiring a boxed warning be placed on all Non-Steroidal Anti-inflammatory Drugs (NSAIDs) including all Cox-2 inhibitors. The warning notifies patients of cardiovascular and gastrointestinal risks. The FDA warning includes popular over-the-counter NSAIDs, such as Aleve, Advil and Motrin.

This warning comes with little surprise, as indictors of a cardiovascular risk for NSAIDs have been around for years. The concern is that these warnings are too little too late.

A recent article in the USA Today looked into the effectiveness of the FDA's black box warning. This is the most stringent warning the FDA can place on a drug, and most recently placed the warning on antidepressants and the arthritis drug Celebrex...

On April 7, 2005, the FDA required Pfizer to put a “black box” warning on Celebrex labels. This is the strongest warning available to the FDA, and requires doctors to prescribe Celebrex as a last resort for patients suffering from pain. The drug is also contraindicated for those post-coronary artery bypass surgery.

This all sounds good, but the fact is that many doctors and patients will never receive this warning. Even with all the news surrounding Celebrex and the entire class of Cox-2 Inhibitors, some doctors and many patients are too busy to read and understand the new warnings. “Dear Healthcare Professional” letters are sent out to doctors for every label change. There is a serious question how many doctors have the time in their busy schedules to actually read all of them.

In February, an FDA advisory committee met to discuss the safety of the class of drugs known as Cox-2 inhibitors. Of course, this is the class getting a lot of press lately that includes Vioxx and Celebrex. Pfizer and Merck pharmaceutical companies where there, defending their drugs and making their plea to keep their money-makers on the market.

At the conclusion of the three day seminar, the 32 member panel voted on a variety of issues including whether these drugs increase the risk of heart attack and stroke, and if the drugs should be allowed to stay on the market. The panel voted unanimously that all Cox-2's increase the risk of cardiovascular events (a fact that Pfizer continues to deny to this day). More surprisingly, the panel also voted 17 to 15 in favor of letting Vioxx return to the market. The decision was summed up on the front page of the Chicago Tribune: “Vioxx Returns to the Market.” (A bit of irresponsible journalism, but that is another post for another day).

We have been bombarded this holiday season with bad news. Drugs distributed on a mass scale have the ability to actually kill its users. Vioxx, Celebrex, and Bextra, all members of a class of drugs called Cox-2 inhibitors, are the problem.
The first to fall is Vioxx. Merck Pharmaceuticals withdrew Vioxx from the market after a study indicated a two fold risk of heart attack with people who use the drug. About a month later, a similar study is halted when it is discovered that those on Celebrex have a 2.5 increase risk of heart attacks and strokes. Other studies indicate a similar problem with Bextra...