Drug Recalls and Lawsuits: Lawyers Advertising for Business

We have all seen the latest television commercials on serious illnesses, injuries, and even deaths due to prescription drugs as alleged by lawyers. Drugs named by lawyers are Cipro, Levaquin, Heparin, Fentanyl, and Chantix. These advertisements (ads) state such claims as "you may be included" as a party in lawsuits against drug companies if you had any of these reactions.

Many people may be hesitant to take these medications based only on the lawyer's ads. This is concerning, because the ads are presented in a way that could frighten some patients. If you are presently taking these drugs, please discuss this information with your doctor. It is important to understand the reason for U.S. Food and Drug Administration (FDA) prescription drug recalls and alerts.

In this article, I will review the current drug alarms expressed by lawyers in their television ads. As a nurse, I understand some drugs have severe allergic reactions and side effects that occur in a few patients but not all. Many patients do not discover allergies until after consuming certain medications such as Penicillin and Sulfa drugs that continue on the market because the benefits outweigh the risks in those who are not allergic to them.

Several of these side effects are listed on labels though some are not prominently visible. Drug labels list adverse reactions as frequent, common, uncommon, serious, and rare. The FDA has a reporting system for drugs causing adverse reactions, serious side effects and injuries, even deaths. If reported, drug companies are required to perform an investigation, make changes to the label, issue alerts, and/or recalls. They will present the new medication information or changes to the FDA, for re-approval. Occasionally the FDA will make suggestions based on the type of reports received.

Cipro and Levaquin

Lawyers cite Cipro and Levaquin as causing tendon problems as if it is a new occurrence. These medications are members of the "fluoroquinolone antimicrobial family that possess an increased risk for developing tendonitis and tendon rupture." (www.fda.gov).

On July 8, 2008, the FDA issued an alert to the makers of all fluoroquinolone medications to add a "boxed warning to the prescribing information about the increased risk"... and "to develop a Medication Guide for patients." (www.fda.gov/cder).This was "added to the prescribing information to strengthen existing warnings about the increased risk" (www.nlm.nih.gov)

Information not reported by lawyers includes the many important uses of Cipro and/or Levaquin. They are used for the following infections (a much-abbreviated list):

Pneumonia in health facility or community acquired
Bacterial chronic bronchitis, sinusitis, chronic prostatitis
Kidney and urinary tract infections
Inhalational anthrax
Gonorrhea (www.fda.gov/cder)

Heparin

Lawyer's television ads relate to Heparin as poison, which is misleading. According to the FDA the "Baxter Healthcare Corporation announced the voluntary recall of nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The company began recalling the lots on January 17, 2008 as a precautionary measure due to an increase in the number of reports of adverse patient reactions that may be associated with the product." (FDA)

The recall applies only to Heparin used for hemodialysis and cardiac invasive procedures. Many bedridden, post surgical and patients at risk for developing blood clots are given Heparin injections from single dose vials. Nurses occasionally call them "belly shots" which is part of preventative measures, such as leg pumps and early ambulation, against deadly clots that can travel to the heart, lung, and brain. Nurses, including myself, have given "belly shot" Heparin for many years without major reported adverse reactions. Bruising is common. Blood clots can lead to a stroke or be instantly fatal.

Heparin is also used to flush central lines such as PICC, Hickman, and Infusaport catheters, to keep them open for use. If patients begin refusing injections based on this recall, they put themselves at risk for deadly clots. It is crucial to discuss concerns with the physician.

There are also IV Heparin drips, which are not included in this article. "To date, the company has not observed a significant increase in adverse event reports occurring with any other of its heparin presentations"(FDA).

Fentanyl

This recall is an "expansion of the Company's initial recall of fourteen lots of Fentanyl transdermal patches announced on February 17, 2008. That recall was due to the identification of a possible fold-over defect present in the product that potentially could cause leakage of the Fentanyl gel.

The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects" (FDA).

Prior to applying Fentanyl patches, the patient must fold them to remove the attached plastic protector then apply. This is a potent pain reliever, used often for cancer patients, that already has a warning on its label stating not to use patches if leaking or damaged.

The warning expresses the leakage may lead to serious fatal overdose and respiratory depression. The leakage may also cause a lower dose of medication available to control the patient's pain.

Chantix

The FDA issued an alert on 2/1/2008 to "highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide." (FDA). According to the FDA, some cases were complicated by the symptoms of nicotine withdrawal and in some who continued to smoke.
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This warning puts everyone on notice that this has occurred and can occur in others so all patients should be closely monitored for these adverse reactions. According to the FDA alert, the patients who already possessed a psychiatric disorder prior to the release of Chantix were not included in studies for safety and efficacy.

I have used Chantix in two courses while attempting to quit smoking. I did not develop any of these adverse effects so remember everyone responds in different ways to a medication. The warning states to stop taking Chantix and contact your doctor if any psychological symptoms occur.

Lawyers are hoping to zoom in on those unfortunate patients who suffered adverse reactions, serious side effects, and death that initiated these FDA alerts, changes in labeling, new warnings, and recalls. Whether anyone is successful in suing drug makers remains to be seen.

We must be careful not to vilify medications that are beneficial for many and a risk for a few. Penicillin and Sulfa was continued despite many of us developing allergic reactions. Death is a risk, not only for certain medications but also for all surgeries using general anesthesia; that has not affected the amount of surgeries done today.

The issue is whether, after extensive studies, drug companies knew, should have known, and listed serious and sometimes deadly effects prominently enough on prescribing information.

References:

http://www.fda.gov/oc/po/firmrecalls/baxter01_08.html

http://www.fda.gov/cder/foi/appletter/2008/019537s068,019847s042ltr.pdf

http://www.fda.gov/cder/drug/infopage/varenicline/default.htm

http://www.fda.gov/cder/foi/label/2008/021721s020_020635s57_020634s52_lbl.pdf

http://www.fda.gov/cder/foi/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf