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Akathasia: The Worst Condition of All

Peter Wetherall — Thu, 21 Aug 2008 08:43:00 GMT

Nearly all published literature on neuroleptic drugs documents that akathasia is the most common type of extrapyramidal symptom resulting from the use of metoclopramide. What is akathasia? It is an inner sensation that prohibits you from being still. It is restlessness. It is feeling like something is constantly crawling under your skin. In some studies of neuroleptic drugs (the same class as metoclopramide) up to 40 percent of patients may experience akathisia. Jungmann and Schoffling (Lancet, 1982) administered 10 mg of metoclopramide, IV to subjects and found about 25% of these patients complained of akathisia. Subjects reported a strong desire to get up and walk around and flee from the test. The feelings were most often combined with the inability to think properly or read newspapers. In a more recent study, Schroeder et.al. (Anesth Analg, 1994) administered metoclopramide 10 mg, IV to 30 patients undergoing tubal occlusion. They found 20% of the patients developed akathisia and 43.3% seemed restless. The changes were associated with subjective sensations of jumpiness and discomfort.

Unlike other extrapyramidal symptoms, the occurrence of akathisia is not necessarily directly related to cumulativedose or duration of therapy

Check out Some of the studies specifically discussing the high incidence of akathisia is:

Albibi R, McCallum RW. Metoclopramide: pharmacology and clinical application. Ann Intern Med 1983Jan;98 (l) :86-95. “Metoclopramide antagonizes the effect of dopamine in the central nervous system...”. “Adverse effects, which may occur in up to 20% of patients, include drowsiness, lassitude, and akathisia....”

Alavi JB, Torri S, Glover D,Hurwitz D, Glick JH. High-dose oral metoclopramide. An effective antiemetic agent. Am J Clin Oncoll985Jun;8(3):260-5 reported that 51% of patients became restless, 9% haddystonic reactions. The restlessness was coded as akathisia.

Navari RN. Comparison of intermittent versus Continuous infusion metoclopramide in control of acutenausea induced by cisplatin chemotherapy. J Clin Oncol 1989Jul;7(7):913-.6.“Dystonic reactions, akatbisia, or diarrhea occurred in 20 of 58 patients” given intermittent metoclopramide “but in only eight of the 58 patients” given continuous infusions of metoclopramide.

Miller LG, Jankovic J. Neurologicapproach to drug-induced movement disorders: a Study of 125 patients. South MedJ l990 May; 83 (5) :525-32. “Of 125 patients with neuroleptic (dopamineblocking) drug-induced movement disorder, 63% had TD, 30% had parkinsonism, 34% had dystonia, 7% had akathisia and 2% had isolated tremor.”“Metoclopramide—induced movement disorders were found in 10 (8%).”

Schroeder JA, Wolfe WM, Thomas NH,Tsueda K, Heine MF, Loyd GE, Vogel RL, Hood GA. The effect of intravenousranitidine and metoclopramide on behavior, cognitive function, and affect. Anesth Analg 1994Feb;78(2) :359-64. Compared placebo 30, ranitidine 50 mg (32),met 10 mg (30), or both (31) . After refit 1 restless 5 drowsy. After met 20% akathisia, 43% restless, 27% drowsy. After both akathisia in 32%,restless 12%, drowsy 36%.

1995 Zaben AA, Al Herbish AS. Neurological side effects associated with unnecessary use of metoclopramide inchildren. Physician Alert 1995(Mar);15(2) report 24 children presenting withextrapyramidal syndromes after metoclopramide. They cite a publication by Hymnan: “Side effects occur in 20%-30% of patients treated with effectivedoses. Side effects include somnolence, restlessness, and insomnia, but themost troubling are dystonic arid extrapyramidal movements. Tremors, trismus,facial spasm, and oculogyric crises improve after withdrawal of the drug oradministration of intravenous diphenhydramine 1 mg/kg. Tardive dyskinesias maynot respond to drug withdrawal. Pediatric Gastrointestinal Motility Disorders25:379.”

Patterson D,Abell T, Rothstein R, Koch K, Barnett J. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol 1999 May; 94(5):1230-4. Randomized IDDM to dornperidone 20 mg qid or metoclopramide 10 mg qid for 4 weeks. Met vsdom: somnolence 49% (severity 1.03) vs 29% (.49). Reduced mental acuity 33%(.62) vs 20% (.27). Akathisia, asthenia, anxiety, and depression more common and higher severity with met.

Anfinson TJ. Akathisia, panic, agoraphobia, and major depression following brief exposure tometoclopramide. Psychopharmacol Bull 2002 Winter;36(1) :82-93. Two days of metoclopramide led to akathisia, panic disorder, agoraphobia, and major depressive disorder leading to months of disability.

Originally posted at InjuryBoard by Peter Wetherall

New England Journal of Medicine Urges the U.S. Supreme Court to be Skeptical

Peter Wetherall — Tue, 26 Aug 2008 20:33:01 GMT

Last week, physicians came to the aid of Plaintiff's lawyers, citizens of Clark County and the American consumer of prescription medication. The editors of the New England Journal of Medicine filed a "friend-of-the-court brief" in the case of Wyeth v. Levine. Readers will know the Wyeth v. Levine case is pending before the United States Supreme Court.

The New England Journal of Medicine wrote in the brief, that lawsuits can serve as "a vital deterrent" and protect consumers if drug companies don't disclose risks of their drugs. The New England Journal acknowledged that the FDA is often called the "gold standard" in drug evaluation, but the journal urged the Supreme Court justices to be skeptical. The editors stated "The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety," The journal noted that discoveries made by plaintiff's lawyers through liability litigation serve an important function and that the "FDA would be stripped of an essential source of information that the agency has consistently relied on when making its regulatory decision, and the American public would be deprived of a vital deterrent against pharmaceutical company misconduct." Many consumers recognize that importance of litigation for harmful drugs such as Vioxx, Chantix, Ketek, Reglan and Digoxin.

The editors joined 47 state attorneys general and two former FDA commissioners-David Kessler and Donald Kennedy in supporting Levine's position. The Bush Administration is supporting the position of Wyeth, and if this position is successful, the ability of a consumer to sue drug companies for harmful side effects will be non-existent.

Journal Editor, Dr. Jeffrey M. Drazen in an interview, stated that the FDA is overwhelmed in trying to keep up with drug safety problems, which can range from rare but serious side effects, to shortcomings in manufacturing plants oversees. He also said that the "court system represents one of the key defense mechanisms that individuals have if a manufacturer has not made the risks of a product clear to the public.

Originally posted at InjuryBoard by Peter Wetherall

Sandoz Inc.'s Drugs Miss The Mark

Peter Wetherall — Wed, 27 Aug 2008 22:05:24 GMT

Sandoz Inc., recently received a Warning Letter, 08-ATL-13, from the FDA, advising Sandoz that an inspection of Sandoz's manufacturing facility located at 4700 Sandoz Drive, Wilson, North Carolina revealed that Sandoz was manufacturing Metoprolol tablets (used to treat hypertension) in violation of quality control procedures and guidelines.

These violations included multiple failures to ensure that the tablets were the proper dosage strength and were of quality ingredients. It was also discovered that Sandoz had failed to comply with their own internal company regulations and failed to undertake quality control steps or investigate problems that were brought to light within the company. Additionally, the FDA noted that Sandoz failed to inspect Doxycycline Hyclate DR Capsules, Lisinopril Tablets, Alprazolam ER Tablets, Fentanyl Citrate Lozenges, Azithromycin for Oral Suspension and Anagrelide HCl Capsules.

Originally posted at InjuryBoard by Peter Wetherall

Vioxx settlement and the client's money decision

Stewart White — Mon, 19 Nov 2007 17:02:51 GMT

Consideration of the Vioxx settlement and whether one is going to participate is going to take at least a 3-4 weeks. There are many questions still to answer before an attorney can advise his or her clients if the Settlement is best for him or her.

The Settlement Agreement is set up so that each individual's case is assessed separately. That is fair. A young person (in 40's say) with few risk factors having a serious heart attack probably should get more money for an injury like that than an older person (in their 70's say) that had several other risk factors that could cause a heart attack and who had a minor heart attack (if ANY heart attack can be called "minor").
But, what my Vioxx clients really want to know is: "How much will I get if I participate in the Settlement?" Completely understandable, that, and don't think attorneys don't ask the same thing. But, the answer is hard to say, instantly. In fact, the official settlement documents do include a "calculator" that allows a person to try to calculate his or her potential recovery "points." However, the calculator requires a person to fill in just a myriad of information, first to set out the starting # of points (more severe heart attacks and strokes start with more points), and then to set out reductions to the # of points (for risk factors, such as controlled hypertension, prior heart attack before starting on Vioxx and having a heart attack, prior migraine headaches before starting Vioxx and having a stroke, etc., etc.).
It seems to me that the attorney, if he's going to give the client the most information possible, must review all the client's medical records he's collected, and, for each client, figure out the # of points, as above, for each client. If it is possible to do for a client, we should try our best to do it, to give him or her the best guidance we can.
But, then, all you have is the # of points the client ended up with, say 280 points after all the additions and deductions. We won't know what a point is worth, completely, until every participating person who is in the settlement is "scored", when you can finally take the # of total points for all people in the settlement and divide that total into $4Billion for heart attacks and $850 Million for strokes. All you can do, before that, is estimate.
The good attorneys who worked out this settlement have, in a fairly complicated process, tried to estimate now the number of claimants that will make it thru all the many hoops of this settlement and get points calculated, and have also tried to estimate the total # of ultimate points. Thus, if a point is worth $1000, 280 points is worth $280,000; if it's worth $1500 per point, then the 280 points is worth $420,000. It's not likely that a point will be worth over $2000.
So, what we will be trying to do for our clients is run each of them thru the calculator and give each client a very conservative estimate of the # of points each will get, and then some conservative estimates of what each point will be worth. At this point, which is very early on in the process, that seems like the most reasonable thing to do to help our clients decide whether they want to participate in the settlement.
So, the settlement truly does look good, and that's a LOT of money, but there is still a lot of work to do. White Meany & Wetherall has sucessfully participated in many of these types of settlements, and we know, and hope our many Vioxx clients know, that there is a long road ahead before any payments will be made here. Stewart White

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Stewart White

Reglan and Phenergan: What They Have In Common with Wyeth v. Levine

Peter Wetherall — Sat, 09 Aug 2008 02:46:31 GMT

Diana Levine's arm was amputated after she developed gangrene from an injection of Wyeth's anti-nausea drug Phenergan. This week a brief was filed on Ms. Levine's behalf with the United States Supreme Court. Her case, Wyeth v. Levine Docket No. 06-1249, is set for oral argument before the United States Supreme Court on November 3, 2008. The case raises the question of whether Wyeth may be held liable under state law for inadequately warning about the dangers of a particular method of administering Phenergan. Many readers are already familiar with the facts of the case, but if you aren't check out Levine's brief

And if you are interested in learning more about this case and the implications it will have on the safety of America's prescription drug supply, follow this link to read other briefs filed in Levine.

You may already know that Levine is not a case where Wyeth studied (nor did the FDA consider) the risk-benefit of Phenergan's administration. Of course, the readers of my blog know that Phenergan is not the only drug where Wyeth has failed to study or weigh the risk of serious side effects. Wyeth did not weigh the risks of its drug Reglan. Wyeth didn't even study the long term effects of Reglan, even though it knew that a patient's risk of contracting serious neurological side effects (such as Tardive Dyskinesia) increased over time. Drug manufacturers should not get away with profiting from prescription drugs that they fail to study for safety or effectiveness because the American consumer will pay the ultimate price and will become the victim of dangerous prescription medications and will be subjected to the risk of very real catastrophic but avoidable injuries--all in the name of profit.

Originally posted at InjuryBoard by Peter Wetherall

FDA Adds Black Box Warning to "Conventional" Antipsychotic Drugs

Peter Wetherall — Tue, 17 Jun 2008 03:10:57 GMT

Today the FDA, by its new authority under the Food and Drug Amendments Act of 2007 (FDAAA), required drug manufacturers of "conventional" antipsychotics to change their label to warn about an increased risk of death in elderly patients being treated for symptoms associated with dementia (an off label use). Similar warnings were included in the warnings of "atypical" antipsychotics in 2005.
Antipsychotic drugs are commonly categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes of the drugs are dopamine receptor antagonists that work by blocking the naturally occurring dopamine in the brain.
It should be noted that these dopamine blocking drugs, as well as other similar prescription medications such as Reglan (prescribed for chronic heartburn) have been found to cause drug-induced neurological disorders such as Tardive Dyskinesia, particularly in the elderly, females and diabetics. Tardive Dyskinesia is a severe and often drug-induced permanent neurological disorder that is characterized by involuntary muscle movements of the face, lips, hands, and feet. It is a disfiguring condition and can be life-threatening.
Medical literature has long reported that the current warning for Reglan understates the risk of Tardive Dyskinesia to the elderly, females and diabetics. The literature also reports that the risk of Tardive Dyskinesia increases over time. Yet, the warning label for Reglan has never been updated to reflect this well documented problem, thus, creating a false sense of security in the safety of these types of drugs among prescribing doctors. Hopefully the FDA will also force a label change to reflect the very real risk of Tardive Dyskinesia either under its new found power or through the efforts of Plaintiff attorneys who are bringing this problem to light.

Originally posted at InjuryBoard by Peter Wetherall

Profits Over Patient Safety: Metoclopramide and Big Pharma

Peter Wetherall — Mon, 18 Aug 2008 18:38:07 GMT

As readers know, Reglan (the name brand) is also dispensedas Metoclopramide. Reglan wasWyeth and Schwarz Pharma’s product. But these two giant pharmaceutical companies aren’t the only companiesthat make this dangerous drug. Generic companies make the generic form,metoclopramide. One of the largestgeneric pharmaceutical companies is Teva. Click here to see a list of their holdings on the SEC website.

Teva is a pharmaceutical manufacturerlocated in North Wales, Pennsylvania, which manufactures and markets a genericform of the drug metoclopramide.

Teva’spredecessor first received approval of an ANDA for metoclopramide in or about1985. In order forTEVA Pharmaceuticals USA to become an ANDA holder for metoclopramide (genericterm for Reglan, which was initially made by AH Robins Company [Wyeth]) – TEVAhad to submit their own ANDA or acquire the rights to an ANDA application thatwas approved for another company. TEVA acquired the ANDA approved application that was owned by Biocraft,which obtained FDA approval for its ANDA of metoclopramide in 1985. TEVA obtained the rights to that ANDAin 1996. At that time TEVA alsoobtained the documents that Biocraft generated or collected concerning itsapplication for an ANDA for metoclopramide. When Teva bought the rights to metoclopramide from Biocraftthere was plenty of scientific literature documenting the problems withmetoclopramide. Did Teva doits due diligence? Did Teva checkout this problematic drug?

Today, Teva continues to marketmetoclopramide. Their label isstill the same as it was 20 years ago despite all that we know about theproblems with metoclopramide. Evidence of profits over patient safety?

Originally posted at InjuryBoard by Peter Wetherall

In Bed Together: The Potential Merger of Teva and Barr

Peter Wetherall — Fri, 22 Aug 2008 08:45:00 GMT

Las Vegas consumers of generic prescription medication andAmerican consumers have much to be worried about these days. We have discussed theinefficiencies of the FDA (given its current structure and underfunding) and the FDA’s tendency to side with BigPharma in the current administration. Now, we must all be concerned with a possible merger on thehorizon. Who? Teva Pharmaceuticals and Barr. For more on this possible deal clickthese links below:

Deal Information

Press release:

Conference Calls: 7/21/2008 Teva Barr Luncheon

7/18/2008 Teva to Acquire Barr:

If this deal goes through,two of the largest generic companies will merge and they will control a largepart of the generic prescription drug market. This should be a concern for usall. For instance, both of thecompanies manufacture metoclopramide. We know the problems with that drug, we should ask ourselves are thereother problematic drugs too? Howwill this merger affect the American consumer? Will they put patient safety first?

Originally posted at InjuryBoard by Peter Wetherall

Congress Demands Immediate Access to Clinical Data

Peter Wetherall — Tue, 26 Aug 2008 22:35:00 GMT

An FDA MedWatch Alert released Thursday, August 21, informed healthcare professionals that the FDA is investigating a report from the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial of a possible association between the use of Vytroni and an increased risk of cancer. The SEAS is a clinical trial designed to test whether using Vytorin to lower LDL-cholesterol will reduce the risk of cardiovascular events in individuals with aortic stenosis.

The data from the trial has revealed that a larger percentage of subjects treated with Vytorin were diagnosed and died from all types of cancer combined when compared to a placebo during the five year study.

The FDA is looking into the data. Congress demanded immediate access to the clinical trial data. Of course, if misconduct on the part of the pharmaceutical company is discovered then this will be yet another example of the importance of lawsuits and investigations as one method in assisting to ensure the safety of the American drug supply. Congress is looking into other incidents of pharmaceutical misconduct, most notably associated with the prescription drug Ketek. Other examples of misconduct related to the prescription drugs, Reglan and/or metoclopramide and the side effect, tardive dyskinesia are other examples.

Originally posted at InjuryBoard by Peter Wetherall

Dangerous Defective Digitek

Peter Wetherall — Tue, 05 Aug 2008 12:51:00 GMT

In the last blog, I briefly discussed Digitek. The active ingredient in Digitek is Digoxin. Digoxin overdose and digitalis toxicity can cause serious and life-threatening personal injury and death. The Digitek label states:
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Use in Patients with Impaired Renal Function: Digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin. Because of the prolonged elimination half-life, a longer period of time is required to achieve an initial or new steady-state serum concentration in patients with renal impairment than in patients with normal renal function. If appropriate care is not taken to reduce the dose of digoxin, such patients are at high risk for toxicity, and toxic effects will last longer in such patients with normal renal function.

* * *

Adults: Cardiac: Therapeutic doses of digoxin may cause heart block in patients with pre-existing sinoatrial or AV conduction disorders; heart block can be avoided by adjusting the dose of digoxin. Prophylactic use of a cardiac pacemaker may be considered if the risk of heart block is considered acceptable. High doses of digoxin may produce a variety of rhythm disturbances, such as first-degree, second-degree (Wenkebach), or third-degree heart block (including asystole); atrial tachycardia with block; AV dissociation; accelerated junctional (nodal) rhythm; unifocal or multiform ventricular premature contractions (especially bigeminy or trigeminy); ventricular tachycardia; and ventricular fibrillation. Digoxin produces PR prolongation and ST segment depression which should not by themselves be considered digoxin toxicity. Cardiac toxicity can also occur at therapeutic does in patients who have conditions which may alter their sensitivity to digoxin.

Gastrointestinal: Digoxin may cause anorexia, nausea, vomiting and diarrhea. Rarely, the use of digoxin has been associated with abdominal pain, intestinal ischemia and hemorrhagis necrosis of the intestines.

CNS: Digoxin can produce visual disturbances (blurred or yellow vision), headache, weakness, dizziness, apathy, confusion and mental disturbances (such as anxiety, depression, delirium and hallucination.)

* * *

Actavis manufactured and distributed the defective Digitek. Given the FDA warning letters, Actavis should have taken the time to correct their defective product. Several lawsuits have been filed across the nation against Actavis of Digitek. Many Clark County residents may have ingested the toxic tablets and need to be aware of the recall and serious side effects.

Originally posted at InjuryBoard by Peter Wetherall