Injuryboard Commentary - Drugs

FDA Watch List on Potentially Dangerous Pharmaceutical Drugs Recently Updated

Randy Appleton — Sat, 05 Dec 2009 19:50:00 GMT

A list of drugs which may present potential health hazards was recently published by the FDA and can be accessed at the FDA's website. The list includes some antidepressants which have been widely prescribed and may lead to suicidal ideations.

The following are just a few of the drugs that have landed on the FDA’s list:

Prozac, Zoloft, Lexapro, Celexa, Able, Maprotiline, Atomexitine, Bupropion, Ablify

Drugs which are under investigation have been identified as having potential side effects. Physicians who prescribe any medication engage in a balancing approach in which they try to insure the patient receives the intended benefit from the medication without an adverse reaction. If a patient begins to experience an adverse reaction while taking a medication it is important to work with the physician to address the side effects and, if possible, avoid any potential harm.

Many times simple changes in dose or the frequency of taking a medication may relieve side effects while still providing the benefit of the medication. The best source of information describing symptoms which a patient suspects are side effects of any medication is the patient. If a patient suspects they are experiencing an unusual reaction while taking any medication, a full description of the symptoms should be reported to the treating doctor. It may be helpful to make notes describing the symptoms including when they began, how long they lasted and whether any other medication had been taken when the symptoms began. In cases of visible symptoms such as hives or rashes, a photo to show the doctor is a good idea. It is also important that a patient being treated by multiple physicians be sure each physician is aware of all the medication being prescribed by other doctors.

Prescription medications are intended to produce beneficial effects for the patient and should generally be taken specifically as instructed by a doctor. The FDA investigation should warn the public of some risks associated with the medications under investigation. If you, or someone you know, are concerned about the use of any medication, consult with the prescribing physician and discuss your concerns thoroughly. Physicians are concerned about the well being of their patients and such discussions provide an opportunity to address issues which directly deal with a patient's care.

About the Editors: Shapiro, Cooper Lewis & Appleton personal injury law firm is based in Virginia (VA), near the NE North Carolina (NC) border and handles car,truck,railroad, and medical negligence cases and more. Our lawyers proudly edit the Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard as a pro bono public information service. Lawyers licensed in: VA, NC, SC, WV, DC, KY.

Originally posted at InjuryBoard by Randy Appleton

Preemption Victory in Generic Drug Labeling Case Mensing v. Wyeth

Camryn Hansen — Thu, 03 Dec 2009 20:15:40 GMT

Following on the heels of the preemption victory in Wyeth v. Levine, in which the Supreme Court decided that consumers can sue a drug company for inadequate prescription drug labeling even if the FDA has approved the label, the US Court of Appeals for the Eighth Circuit has ruled that generic drug manufacturers cannot claim federal preemption to avoid liability for inadequate drug warning labels.

According to the ruling, FDA approval of a generic drug’s label does not preempt claims against the drug makers for failing to sufficiently warn consumers of a drug’s risks.

The case involves Gladys Mensing, who was prescribed metoclopramide to treat her diabetic gastroparesis. The drug caused her to suffer serious and permanent tardive dyskinesia, a neurological disorder that causes facial grimacing, lip twisting, tongue thrusting, gait instability, difficulty swallowing, and difficulty controlling her hands and arms. Ms. Mensing sued several manufacturers of generic metoclopramide, among others, alleging that the manufacturers failed adequately to warn of the drug's side effects. -Public Justice

The generic drug manufacturers moved for dismissal, on grounds that an FDA regulation requiring generic drug labels to contain the same language as the labels of brand-name versions conflicted with, and thus preempted, failure-to-warn claims. The district court agreed to dismiss the case, but the Eighth Circuit overturned the dismissal, disagreeing with the preemption argument.

The Eight Circuit emphasized that generic manufacturers, like name-brand drug companies, "bear primary responsibility for their drug labeling at all times." Lawsuits like Ms. Mensing's, the court said, do not "obstruct the purposes and objectives" of federal drug regulation "in any way." Instead, they help achieve the "fundamental" purpose of federal regulation—ensuring that "all marketed drugs remain safe." -Public Justice

This is a great win for the American consumer. It’s gratifying to see all drug companies being held accountable for the harms they cause when they’re not careful enough with their products.

Originally posted at InjuryBoard by Camryn Hansen

Pharmaceutical Companies Use Rx Data Mining to Boost Sales Tactics, Patient Advocates Argue

David Mittleman — Thu, 03 Dec 2009 16:06:36 GMT

When your doctor prescribes you a medication you probably expect that the information stays between you, the doctor, and your insurance company. However, prescription data miners are changing that dynamic in scary ways: by spying on your prescription data they are able to provide pharmaceutical companies with information to entice doctors to prescribe their medications more frequently. In fact, pharmaceutical companies are able to learn how to “fine-tune” their messages so that when a sales-rep calls a doctor, they are able to give a good pitch. Furthermore, pharmaceutical companies can entice doctors to prescribe their medications with free samples of drugs. While the individual identities of patients is not disclosed in data mining, government officials are concerned about doctors’ decision-making becoming distorted because of the new sales tactics of pharmaceutical companies with access to prescription information.

The process of prescription data mining begins with medical data firms. Medical data firms have access to billions of prescription records, which they purchase from pharmacies and health insurers who have physician data from the American Medical Association, as well as other sources. They then are able to sell this information to pharmaceutical companies. According to critics, the end result is that drug companies are able to sell their newest and costliest medications, not necessarily the most effective medications.

Patient advocates and government officials are also concerned about the interference in the patient-doctor relationship, as well as increased spending on expensive drugs. However, data miners argue that they are actually helping contain the cost of prescription medications by improving quality and by quickly providing doctors with information on which drugs work best.

Originally posted at InjuryBoard by David Mittleman

FDA Trying to Reduce Preventable Medical Error from Prescription and Over the Counter Drug Use

David Mittleman — Sun, 29 Nov 2009 10:39:08 GMT

Over 3 billion prescriptions are written annually in the United States, and tens of millions of people rely on prescription and over-the-counter (OTC) drugs to sustain their health. With such high numbers of drugs being used, the risk of preventable medical error from improper drug combination or the misuse of medication has led the Food and Drug Administration (FDA) to start the Safe Use Initiative.

As my Virginia-based colleague Greg Webb noted, the initiative calls upon doctors, health care professionals, and even patients to help the FDA identify specific, preventable medication risks and develop interventions to such risks. The initiative has a goal to implement some interventions within the first 12 months of the Initiative's existence.

Among the target groups the Initiative seeks to protect is children. One study cited by the FDA found that over 9,000 children were exposed to prescription opioid drugs from 2003 to 2006. Just as startling was the fact that 60,000 emergency room visits occur annually as a result of unsupervised ingestion of medication by children under the age of 12.

Some of the changes consumers can expect will be better information of the prescription and OTC drugs they take, including the proper dosage to take along with calibrated spoons or cups that are easier to read and correspond with the product's packaging.

Originally posted at InjuryBoard by David Mittleman

FDA Issues Letters To Web Sites For Selling Unapproved and Misbranded Drugs

Chrissie Cole — Fri, 20 Nov 2009 20:20:00 GMT

On Thursday, the Food and Drug Administration (FDA) issued 22 warning letters to Web site operators regarding illegal sales of misbranded drugs and/or unapproved drugs.

The move ends a weeklong international effort aimed at curbing illegal actions regarding medical products, including sales. In total, the agency and its partners in the program targeted 136 Web sites that appeared to be engaged in the illegal selling of medical products.

The involved pharmacies were not located in Canada or the U.S.

According to the letters, the sites sold powerful controlled substances including Valium and Xanax and also Viagra. Some sites also offered prescription drugs that are not yet approved for distribution or sale in the U.S.

Many of the Web sites listed in the complaint, such as 24-7meds.com and Wellknowndrugs.com have already been taken offline, according to Karen Riley and FDA spokeswoman.

More information can be found on the FDA Web site.

Originally posted at InjuryBoard by Chrissie Cole

Drug Makers Raise Prices Despite Promises of Cost Reform

David Mittleman — Wed, 18 Nov 2009 09:39:28 GMT

Drug makers pledged to help cut down healthcare costs by $8 billion a year, but now it doesn’t look like they are making good on that promise. Instead, in the last year alone, the pharmaceutical industry has raised their wholesale prescription drug prices by 9%. Instead of cutting down on costs, that raises the nation’s drug-related healthcare costs by $10 billion, and represents the highest annual rate of inflation on drug prices since 1992.

Originally, drug makers had touted their agreement with the White House and the Senate Finance Agreement chairman to trim $8 billion a year from the nation’s drug costs, or $80 billion over 10 years, by giving rebates to older Americans and the government. However, the recent increase in prices would essentially cancel out the savings for at least the first year of the plan, if not the entire 10 years.

Nevertheless, drug makers argue that there are valid business reasons for raising prices. Specifically, they argue that they are forced to raise their prices in order to invest in future research and development of new drugs, especially as patents expire on previous drugs. While drug makers claim their “reasons” for raising their prices, many Americans who do have drug insurance will be forced to pay out-of-pocket for the leftover cost of overpriced drugs that insurance won’t entirely cover.

Originally posted at InjuryBoard by David Mittleman

Hit And Run Intoxicated Driver Apprehended In St Cloud

Mike Bryant — Mon, 16 Nov 2009 06:26:00 GMT

Friday morning, a hit and run was reported in the 300 block of Seventh Avenue South. The driver was apprehended and was intoxicated and under the influence of a prescription drug, according to police. Officers also found a large amount of marijuana and drug paraphernalia inside the vehicle.

Recent research indicates that deaths involving motor vehicles are down in Minnesota, but at the same time those deaths linked to drinking and driving have increased. The rules are simple and must always be followed:

Don't Drink and Drive
Use designated drivers
Always remember that the more you drink, the more your odds of making bad choices increase.
As drivers on the road: It's also worth keeping in mind, the deadliest roads in Stearns county to try to stay away from at night.

Stories about hit and run collisions are yet another reminder why your uninsured motorist coverage is so very important. It is what protects you and your family is the other vehicle is uninsured or runs away.

Originally posted at InjuryBoard by Mike Bryant

Eli Lilly Will Pay Utah 24 Million to Settle Zyprexa Suit

Bret Hanna — Wed, 11 Nov 2009 18:17:31 GMT

Utah Attorney General Mark Shurtleff announced today that the state has settled a 4-year-long battle with Eli Lilly over its marketing unapproved uses, so-called "off-label" uses, of its anti-psychotic drug Zyprexa. His news release indicates that the pharmaceutical giant will pay 24 million to resolve the matter:

Attorney General Mark Shurtleff recently reached a $24,000,000 civil settlement with pharmaceutical manufacturer Eli Lilly and Company for its "off-label" marketing of the anti-psychotic drug Zyprexa. The nearly 4-year investigation conducted by the Utah Attorney General's office revealed that Lilly concealed its knowledge of Zyprexa's association with significant weight gain and obesity, and that its sales force illegally promoted Zyprexa for uses not approved by the FDA.

"Drug companies are an important part of our health care system," says Shurtleff. "But when they engage in illegal marketing practices they are endangering the health and safety of patients."

It is a crime for pharmaceutical manufacturers to market their drugs for uses that are not approved by the FDA. Zyprexa was only approved for the treatment of schizophrenia and certain types of bipolar disorder in adults, but in 1999, Lilly's long-term care sales force, its marketing branch that focuses on doctors who treat the elderly, began encouraging doctors to prescribe Zyprexa for dementia, Alzheimer's, agitation, aggression, hostility, depression and generalized sleep disorder without prior FDA approval. The Attorney General's investigation showed that there were 1,769 Medicaid patients over the age of 65 who took Zyprexa but never had a diagnosis of either schizophrenia or bipolar disorder.

"Lives are endangered and costs are unnecessarily increased when pharmaceutical companies interfere with the FDA's mission to insure that drugs are used safely," says Robert Steed, Assistant Attorney General and Director of the Utah Medicaid Fraud Control Unit. "Today's announcement should send a clear message that those who would put corporate profits ahead of patient safety will be held accountable."

In October 2000, Lilly began instructing its general sales force to recommend Zyprexa to primary care physicians for the treatment of behavioral symptoms like agitation, aggression, hostility, sleep disturbances, depression and mood disorders even though schizophrenia and bipolar disorder are not conditions normally treated by these doctors. Lilly also trained its sales teams to avoid discussions with health care professionals about the weight gain side effect.

"I would like to commend the Department of Health and the Attorney General's office for their work on this critical public health issue," says Representative David Clark, Speaker of the Utah House of Representatives. "The State Legislature will work to make sure this money is put to the best possible use to benefit all Utahns and particularly those that may have been affected by the off-label marketing of this drug."

"Today's announcement should not be considered an indictment against the pharmaceutical industry in general," says UDOH Executive Director Dr. David Sundwall. "The pharmaceutical industry is a key partner in treating illness and preventing complications from diseases. Appropriate use of drugs can save a great deal of money by controlling unnecessary hospitalizations and surgeries. Further, we count on our nation's pharmaceutical companies to fund research and development of the drugs we need to prevent, treat, and when possible, cure disease."

Assistant Attorney General Robert Morton, who assisted with this litigation stated, "This is by far the largest recovery ever in the State of Utah from our efforts to hold pharmaceutical companies accountable for their unlawful conduct. We are grateful to Director Sundwall and the excellent staff at the Utah Department of Health for the time, resources and expertise they provided during this litigation."

The Utah Attorney General's Office oversees the Medicaid Fraud Control Unit to protect the integrity of Utah's Medicaid program. The public can learn more about Medicaid fraud or report abuse at: http://www.attorneygeneral.utah.gov/145.html.

Utah's House Speaker David Clark, R-Santa Clara, has indicated that the legislature will work to use the money to benefit those affected by off-label marketing. Let's hope he follows through with this promise because this is a big victory for the people of Utah.

Originally posted at InjuryBoard by Bret Hanna

Susan Galinis Warning to Other Women Taking Yaz Birth Control

Aileen Wu Viorel — Tue, 10 Nov 2009 11:24:05 GMT

Take the time to watch the linked video below. Susan Galinis speaks out in efforts to warn other women who may be at risk due to taking Yaz birth control. Like many other cases that have recently surfaced, Susan suffered a stroke only a month after she started taking Yaz. Susan's life will never be the same. Susan's story is just one of many. Yaz is still on the market and many women taking this birth control are still at risk.

View Video

Originally posted at InjuryBoard by Aileen Wu Viorel

FDA Addresses Medical Errors And $4 Billion Pricetag

Eddie Farah — Fri, 06 Nov 2009 13:29:47 GMT

As we look at saving money on health care spending, Americans should consider drugs, specifically the huge cost of medical errors involving prescriptions.

Medication interactions, a mix-up in the pharmacy such as switching out the wrong prescription, an inability read a doctor’s handwriting, all can lead to drug dosage errors which cost us all about $4 billion a year, not to mention lives and injuries.

Now the Food and Drug Administration (FDA) says it is trying to identify the most serious threats to better understand and get a handle on the problem. Consider this- errors with medication happen often - about 1.5 million errors every year according to a two- year-old study by the Institute of Medicine.

A recent Hearst Newspaper group investigation, "Dead By Mistake" profiles many who lost their lives through medication errors.

It so astonishing that even the new FDA commissioner, Margaret Hamburg, who is a doctor, was stunned by the numbers. She announced a new plan called “Safe Use Initiative” by saying it “doesn’t require a new scientific discovery or a budget appropriation.”

In holding public hearing and gathering information from the public about that problem, the FDA would be wise to speak with personal injury attorneys.

Every week we hear of the adverse events that can occur from drugs, even when they are used as directed of prescribed. Consider Tylenol that can cause liver damage when taken in excess, and the devastating outcomes of drugs when they are not.

Public Citizen is onboard with this scrutiny of package labels, and inserts, and instructions given to dispensing pharmacists. Dr. Sidney Wolfe says that about 99.5 percent of pamphlets are missing critical information.

While medication is supposed to make us feel better and perhaps save lives, patients and doctors forget almost every medication eventually has a side effect. The presumption of safety needs to be challenged.

Instead of relying on a “Pill for every Ill” Americans need to remember that “safe medication” is an oxymoron. #

Originally posted at InjuryBoard by Eddie Farah