Atlanta Personal Injury Lawyer - FDA & Prescription Drugs

Toxic Epidermal Necrolysis Jury Trial Awards $3.5 Million

M. Brandon Smith — Mon, 28 Sep 2009 11:59:38 GMT

A woman from Illinois was recently awarded a $3.5 million award by a jury in her case against the manufacturer of Children’s Motrin. She alleged that her severe skin injuries were caused by a rare complication that sometimes occurs with certain over-the-counter medications.

Stevens-Johnson Syndrome is a disease which is sometimes caused by medications containing sulfa-derived ingredients or compounds. Stevens-Johnson Syndrome is a severe skin reaction which may start out with flu-like symptoms before it develops into the serious inflammation of the skin and mucus membranes for which the disease is most noted. The disease in its most severe, elevated form is called Toxic Epidermal Necrolysis and it causes the blistered areas of the skin to actually die. Three to fifteen percent of all people who develop these syndromes will die from the affliction. The disease may also cause severe vision problems which may even lead to blindness.

The Illinois woman, Karen Robinson, was afflicted by the elevated form of the disease, toxic epidermal necrolysis and she had lesions over thirty percent of her body. Treatment for the disease may take weeks to months and if a medication is found to be the cause, not only must the medication itself be avoided for the remainder of the victim’s life but all medications related to it must also be avoided. Because of her severe complications from the illness and because of the fact that the disease can sometimes cause death, Ms. Robinson decided to sue McNeil Consumer Healthcare which is the company that manufactured the Children’s Motrin which Ms. Robinson claimed caused her injuries.

The jury which heard her case decided to award her $3.5 million as compensation for her injuries. This sum represented not only compensation for her but was likely also a punishment to a drug manufacturer which had printed warnings about the possibility of the skin condition with the knowledge that the risk of consumers developing the condition and possibly dying from it was very real. The jury awarded her the money after hearing her testimony about how her skin burned from the inside out.

However, because the case was tried under Virginia law as Robinson was a Virginia resident when her injuries occurred, and because Virginia maintains a set of contributory negligence law that does not permit any person who has in any way contributed to their injury to collect damages, her award has been reduced and she may not be able to recover the entire $3.5 TENS verdict amount.

Firms and lawyers, however, are continuing to fight for clients who have suffered because of the medications that have lead to these terrible skin disorders. If you or a loved one has suffered from either Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis, you may be able to recover for your injuries. Manufacturers of unreasonably dangerous drugs should be made to answer for the potentially deadly side effects their drugs may cause. As an innocent consumer, we trust that the drugs we take are reasonably safe and if they are not, we need to hold the manufacturers of such drugs accountable in order to prevent situations like this one from ever happening again.

Originally posted at InjuryBoard by M. Brandon Smith

Pfizer Fined $2.3 Billion For Illegally Advertising Its Drugs

M. Brandon Smith — Thu, 03 Sep 2009 12:04:44 GMT

Pfizer and its subsidiary, Upjohn, are paying $2.3 billion in order to settle criminal and civil liability that arose from illegal promotion of the painkiller Bextra.

Bextra, according to the Wall Street Journal, was pulled from the market in 2005. It was commonly associated with a life threatening condition called Stevens Johnosn Syndrome and Toxic Epidermal Necrolysis.

Pfizer, as part of the settlement agreement, “agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud.”

Other drugs Pfizer has settled civil charges related to Bextra include schizophrenia drug Geodon, antibiotic Zyvox and anti-epilepsy drug Lyrica.

According to the Department of Justice (DOJ), Pfizer’s settlement agreement is the largest health-care fraud settlement in DOJ history.

Other settlements are among attorneys and Pfizer in 42 states and the District of Colombia to cover state civil consumer protection allegations related to Geodon which include paying $33 million.

What exactly did Pfizer do?

According to DOJ, the company allegedly paid kickbacks to health-care providers in order “to induce them to prescribe Bextra and other drugs.” The company promoted Bextra for off-label uses that have not been approved by the FDA. Pfizer denies the kickback charges but does concede “improper actions related to the promotion of Zyvox.”

Originally posted at InjuryBoard by M. Brandon Smith

The Real Facts About Reglan And Its Effects On Consumers

M. Brandon Smith — Thu, 30 Jul 2009 18:32:50 GMT

The ugly truth about Reglan is finally beginning to surface even though its effects have been around for years. The generic name for Reglan is Metoclopramide. The drug is commonly used to treat patients suffering from gastrointestinal problems. Because more than 2 million Americans use products containing Metoclopramide, the real facts about the drug and its effects must be made known to consumers.

The Food and Drug Administration (FDA) only approved Reglan for short-term use (4-12 weeks). When Reglan is used for longer periods of time or at higher doses it can cause Tardive Dyskinesia. Those greatest at risk for developing tardive dyskinesia are the elderly, especially older women. Tardive Dyskinesia is a neurological syndrome characterized by repetitive and involuntary movements, such as lip smacking, puckering, rapid eye blinking. The disease can also cause rapid involuntary movements of the fingers, hands, arms, shoulders, torso and legs. Tardive Dyskinesia is an exhausting disease because its victims suffer from constant involuntary movements.

http://www.youtube.com/watch?v=dum81RdFrhM&feature=player_embedded

Unfortunately, both the manufacturer of Reglan (Wyeth Pharmaceuticals) and manufacturers of the generic metoclopramide (Actavis Elizabeth, Teva Pharmaceuticals USA, Pliva and Barr Pharmaceuticals) have placed profits before patient safety. Patients typically take Reglan for longer than 3 months because the drug treats chronic problems. Manufacturers have been well aware of these treatment trends and the fact that they go beyond FDA recommendations. Yet because Reglan is such a large money making drug, there is very little incentive for manufacturers to warn chronic users of the dangers associated with long-term use. Failing to warn consumers properly prevents them from making an informed decision about their treatment. In order to maintain profits and keep them on the rise, manufacturers have done their best to keep Tardive Dyskinesia out of the public’s awareness.

"The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in the agency's news release. "The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk."

The only reason that Tardive Dyskinesia was initially listed as a side effect on the drug’s information sheet is because the government required manufacturers to do so. However, as of February 26, 2009 the FDA now requires a “black box” warning for drugs containing metoclopramide. This warning is the strongest warning the FDA can order. The required warning highlights the risk of developing Tardive Dyskinesia with long-term or high-dose use, even after the drugs are no longer taken. In addition to the “black box” warning, manufacturers must implement a risk evaluation and mitigation strategy (REMS), which is a way to make sure patients receive a medication guide that discusses the risk of Tardive Dyskinesia.

The “black box” warning may have came too late for many consumers. Drug manufacturers have a responsibility to the public. They must determine the risks associated with a particular drug, research these risks further and then properly inform consumers and their doctors. Manufacturers of drugs containing Metoclopramide failed to research and disclose the link between their drugs and Tardive Dyskinesia. For this reason, many consumers are now pursuing a Tardive Dyskinesia lawsuit or a Reglan lawsuit due to the devastating effects and injuries they have sustained.

Our Reglan Lawyers are filing Reglan Lawsuits in Georgia and in every other state in the U.S. on behalf of those suffering from Tardive Dyskinesia and other known movement disorders. If you or a loved one has questions about your rights or any of these conditions, please contact our Reglan Attorneys now to see how we can help.

Originally posted at InjuryBoard by M. Brandon Smith

Reglan Induced Tardive Dyskinesia

M. Brandon Smith — Wed, 29 Jul 2009 15:47:31 GMT

Per the FDA and other medical literature, Reglan use has been linked to Tardive Dyskinesia. Tardive Dyskinesia is a central nervous system disorder that causes involuntary, repetitive movements of the body even after the drug is no longer being taken. There is no medical cure for Tardive Dyskinesia and it is rarely reversible even with medical intervention.

Reglan, whose generic name is Metoclopramide, is a prescription drug used to treat gastrointestinal problems in adults. It is not labled or FDA approved for use in children or infants. Reglan is used to control or treat: gastroesophageal reflux disease (GERD) , nausea and vomiting, reflux, heartburn, Gastroparesis and diabetic gastroparesis, decreased appetite, prolonged fullness after eating, persistent hiccups, and other conditions related to the stomach. The drug aids digestion by increasing stomach and small intestine contractions, which helps move food through the digestive process at a faster pace.

Reglan was approved by the Food and Drug Administration (FDA) in June 1985. The FDA approved Reglan for only short-term use (4-12 week treatment periods) in adults only. Also, the FDA stressed that Reglan should only be prescribed when traditional methods for treatment fail or in other rare cases. Unfortunately, the FDA’s guidelines have been increasingly overlooked, mismanaged and ignored. Despite these warnings, thousands of prescriptions continue to be written by doctors for intervals beyond the 12 week period allowed and this increase has caused many patients to develop Tardive Dyskinesia as a result. Prescribing Reglan beyond FDA guidelines and warnings appears to be common practice for some doctors because the drug is used to control chronic problems, which usually requires long-term treatment and care. Many doctors, ignoring FDA guidelines, have also been known to prescribe Reglan to children and infants despite warning against do so.

There are numerous side effects associated with taking Reglan, such as: nausea, depression, irritability, constipation/diarrhea, sleepiness, grimicing, lip smacking and Tardive Dyskinesia (TD) itself. Manufacturers have ignored these side effects and failed to adequately inform doctors of these life altering risks for years, choosing profit driven motives over patient safety. Even though manufacturers downplay the risk of developing Reglan induced Tardive Dyskinesia, studies indicate that about 29% of long-term Reglan patients may develop the disease.

Symptoms of Tardive Dyskinesia may include:

Lip Smacking
Involuntary Facial gestures, such as grimacing
Repetitive Chewing
Pursing and Puckering of the Lips
Tongue Protrusion
Rapid Eye Movements and Blinking
Impaired Finger Movements
Involuntary Movements of Fingers, Hands, Arms, Shoulders, Legs, or Torso
Difficulty Breathing, Swallowing, Walking and/or Talking

On February 26, 2009 the FDA required all Metoclopramide manufacturers to place a “black box” warning to their drug labels about the Reglan Tardive Dyskinesia risk. The “black box” warning is the strongest type of warning that can be placed on a medication. Unfortunately this warning has came too late for thousands of unknowing users. Reglan has been on the market for years without a proper warning and as a result many individuals have developed TD. The symptoms associated with TD are extremely debilitating and remain incurable in many cases. Individuals suffer not only physical and mental problems but emotional and social turmoil as well. Individuals who have taken Reglan or metoclopramide and suffered from an involuntary movement disorder should contact a one of our Reglan Lawyers immediately to consider pursuing a Reglan Lawsuit or a Tardive Dyskinesia Lawsuit.

It is critical to contact a Georgia Reglan lawyer if you want to pursue a Georgia Reglan Lawsuit. Our Reglan Lawyers are filing Reglan Lawsuits in Georgia and elsewhere on behalf of those suffering from Tardive Dyskinesia and other related movement disorders. An experienced and qualified Atlanta Reglan Lawyer can help you determine the validity of your Reglan claim and how to pursue it. If you or a loved one has questions about your rights, please contact our Reglan Attorneys now to see how we can help.

Originally posted at InjuryBoard by M. Brandon Smith

Tips To Prevent Medication Errors

M. Brandon Smith — Tue, 21 Jul 2009 13:27:10 GMT

Somewhere in the neighborhood of 1.5 million people are injured each year by medication mistakes, according to the Institute of Medicine. At least one quarter of these are preventable. The following are some tips to help make sure that you are as safe as you can be when taking a new or existing medication:

1. Make a list of the medications, both prescription and nonprescription, dietary supplements, and any vitamins that you take. Keep the list current and take it with you when you visit a doctor.

2. When you get a prescription from a doctor, ensure that he writes down the dose, the name of the drug, and instructions for its use. When you actually get the prescription filled, ensure that the instructions on the bottle match those from the doctor.

3. Be informed. Get as much information, from both the pharmacist and your doctor, regarding usage and side effects as you can.

4. Most prescription medications come with informational pamphlets. If yours doesn’t, ask the pharmacist for one.

5. Be involved in the process. In the hospital, especially before surgery, ask the doctor about potential harmful drug interactions. Are there any drugs you should stop taking, and when should you stop them. Also, you have the right to appoint a medical surrogate to make decisions for you, should you be incapacitated. This includes the right to have the surrogate present and informed whenever you are given medication.

6. Be aware. If your pills look different after a refill, DO NOT assume the manufacturer has changed the shape or color.

All too often, when we are at the pharmacist or the doctor’s office, we go along with attempts to shuttle us out the door after a very brief communication. Resist the urge to simply take the meds and go. If there is something you do not understand, ask questions until you do. Try not to make any assumptions about advice or medications. Above all, get the facts. You want to feel better and your doctor or pharmacist wants to help you in doing so. Putting another set of eyes on a problem never hurt anyone so why not do more to ensure you safety and well being is maintained. We should all be working to reduce medical mistakes and these tips can help ensure you do not become just another statistic.

Originally posted at InjuryBoard by M. Brandon Smith

New Labeling Added By FDA from Infections Linked to Transplant Drugs

Jessica Smagacz — Sun, 19 Jul 2009 16:00:58 GMT

According to MSNBC, this past Tuesday, Federal health regulators said they were going to add new labels regarding the risks of infection to organ transplant drugs made by several drugmakers. Some of those drugmakers include Roche and Novartis.

This move is a result of FDA receiving reports of dangerous viral infections in patients who took these drugs, “which are typically used to avoid rejection following kidney transplant.”

The drugs that will have these new labels include: Roche’s CellCept, Novartis’ Myfortic, Wyeth’s Rapamune, Neoral, and Sandimmune.

FDA is continuing to monitor any reports of safety problems with these medications. FDA has also said that “physicians should carefully monitor patients for signs of viral infection, which can sometimes lead to kidney failure.”

Originally posted at InjuryBoard by Jessica Smagacz

Eli Lilly’s Blood Thinner Approved by FDA

Jessica Smagacz — Sat, 11 Jul 2009 10:25:19 GMT

Associated Press reported that yesterday, FDA approved a blood thinner from Eli Lilly, even though this blood thinner has bleeding risks.

However, FDA has mandated that the drug must carry “the agency’s sternest warning because of its bleeding risks.”

Plavix is the world’s second best selling medication that will now have some competition with the approval of Lilly’s Effient. Plavix is made by Sanofi-Aventis and Bristol-Myers Squibb.

This decision to approve Effient has been delayed several times. FDA staffers reviewed Effient multiple times trying to weigh the drug’s risks versus its benefits.

Apparently, Effient has to carry a boxed warning to alert physicians of the risks of the bleeding and also is reserved for issues that may cause serious injury or death.

Lilly has conducted a study of over 13,000 patients with Effient. The results were that Effient prevents more heart attacks than Plavix; however, Effient causes more internal bleeding.

FDA said that Effient should not be taken by patients with a history of bleeding, stroke, or those patients who are undergoing surgery.

“Approval of Effient was considered crucial for Lilly because patents protecting its four best-selling drugs expire 2013.”

Do you think boxed warnings are effective?

Miller Tabak & Co. analyst Les Funtleyder says that “the boxed safety warning could curb sales, but not to a large extent. The FDA has been a lot more liberal with black box warnings than it was in the past, and in a way the black box has lost some meaning it had when it was rare.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA Requires Manufacturers of Smoking Cessation Aids Add New Boxed Warnings

Jessica Smagacz — Sat, 04 Jul 2009 13:26:13 GMT

A recent FDA alert reported that FDA is requiring the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) add new Boxed Warnings.

In addition to adding new Boxed Warnings, the manufacturers are required to develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.

Symptoms include:

-changes in behavior

-hostility

-agitation

-depressed mood

-suicidal thoughts and behavior

-and attempted suicide

These changes that are required to the prescribing information & Medication Guide for patients are also required for bupropion products (Wellbutrin and generics) that are for the treatment of depression and seasonal affective disorder.

FDA, as a result of receiving continued postmarketing adverse event reports for varenicline and bupropion, is requiring these added warnings.

“Healthcare professionals should advice patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA on the Option to Reduce Painkiller Overdoses

Jessica Smagacz — Wed, 01 Jul 2009 00:57:55 GMT

This past Monday, AP reported that the makers of Tylenol, Excedrin and other medications attempted to dissuade regulators from placing new restrictions on painkillers, including the possibility of removing some of them from store shelves.

35 experts were organized by the FDA to attend a two-day meeting in order to discuss ways to prevent overdose with acetaminophen.

Acetaminophen is the pain-relieving, fever-reducing ingredient in Tylenol and some other prescriptions and over-the-counter medications.

Currently, acetaminophen is “the leading cause of liver failure in the U.S., sending 56,000 people to the emergency room annually, according to the FDA.”

Please see our past post: FDA will Discuss Liver Risks with Tylenol & other Painkillers.

FDA asked its experts to consider a range of options:

-Adding a “black box” warning label to the products

-Lowering the drug dosage in some products or

-Pulling certain types of medications off the market

Companies such as the industry group that represents Johnson & Johnson defended the products “saying they pose a relatively small risk to patients.”

“Only 10 percent of deaths linked to acetaminophen medications involved over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.”

Although the FDA is not required to follow the advice of its panels, it usually does. This panel vote was supposed to occur earlier today.

According to AP, FDA is making it clear that it “will not play king-maker in the market for over-the-counter medications.”

Originally posted at InjuryBoard by Jessica Smagacz

FDA will Discuss Liver Risks with Tylenol & other Painkillers

Jessica Smagacz — Sat, 27 Jun 2009 02:13:12 GMT

Federal regulators and medical experts will debate next week on how to limit liver injury in patients who take painkillers such as Tylenol, according to CNN.com.

The main issue under the “microscope” is with the ingredient called acetaminophen. This is a drug found in over-the-counter painkillers (such as Excedrin, NyQuil and Theraflu). All of these drugs can cause liver damage, acetaminophen being the most widely used drug in America.

Around 100 people die yearly from accidently overdosing on this common drug, acetaminophen. Apparently, this drug is safe if you take the recommended dosage on the label.

However, FDA does say that “the drug’s prevalence in a variety of pain relievers, fever reducers and cough medicines means patients don’t realize they are taking several drugs that contain the same ingredient, often leading to an overdose of acetaminophen.”

Since 1977 when an agency committee recommended labels for pain relievers to contain a warning about the possibility that they can damage a patient’s liver, FDA has been “struggling with [this] issue.”

Here are the current options that are being discussed:

-reduce recommended dosing levels

-Limit the number of pills or liquid in each drug containing acetaminophen

-and eliminate medicines that combine acetaminophen with other ingredients

Originally posted at InjuryBoard by Jessica Smagacz