Las Vegas Personal Injury Lawyer - FDA & Prescription Drugs

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

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

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

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

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

Inadequate Warnings: What is all the Fuss About?

Peter Wetherall — Wed, 20 Aug 2008 08:42:00 GMT

The “Warnings” section of themetoclopramide label contains a discussion of the possible side effects ofextrapyramidal symptoms. It reads:

WARNINGS:

Extrapyramidalsymptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treatedwith the usual adult dosage of 30-40 mg/day of metoclopramide. These usuallyare seen during the first 24-48 hours of treatment with metoclopramide, occurmore frequently in children and young adults, and are even more frequent at thehigher doses. These symptoms may include involuntary movements of limbs andfacial grimacing, torticollis, oculogyric crisis, rhythmic protrusion oftongue, bulbar type of speech, trismus, or dystonic reactions resemblingtetanus. Rarely, dystonic reactions may present as stridor and dyspnea,possibly due to laryngospasm.... Parkinsonian-like symptoms have occurred, morecommonly within the first six months after beginning treatment withmetoclopramide, but occasionally after longer periods. These symptoms generallysubside within two to three months following discontinuance of metoclopramide.Patients with pre-existing Parkinson’s disease should be given metoclopramide cautiously,if at all, since such patients may experience exacerbation of Parkinsoniansymptoms when taking metoclopramide.

Tardive Dyskinesia: Tardive dyskinesia, asyndrome consisting of potentially irreversible, involuntary, dyskineticmovements may develop in patients treated with metoclopramide. Although theprevalence of the syndrome appears to be highest among the elderly, especiallyelderly women, it is impossible to predict which patients are likely to developthe syndrome. Both the risk of developing the syndrome and the likelihood thatit will become irreversible are believed to increase with the duration oftreatment and the total cumulative dose. Less commonly, the syndrome candevelop after relatively brief treatment periods at low doses; in these casessymptoms appear more likely to be reversible.

Thereis no known treatment for established cases of tardive dyskinesia, although thesyndrome may remit, partially or completely, within several weeks-to-monthsafter metoclopramide is withdrawn. Metoclopramide itself, however, may suppress(or partially suppress) the signs of tardive dyskinesia, thereby masking theunderlying disease process. The effect of this symptomatic suppression upon thelong-term course of the syndrome is unknown. Therefore, the use ofmetoclopramide for the symptomatic control of tardive dyskinesia is notrecommended.

So what is all the fuss about? The warning is in the label right? Wrong! The risk that patients taking metoclopramide at the usualdosage will experience tardive dyskinesia is far greater than the “1 in 500” claim in the label. In fact, research literature suggeststhat the risk is as high as 1 in 4.

Originally posted at InjuryBoard by Peter Wetherall

Medical Literature and Advances in Science: Big Pharma Can't Read

Peter Wetherall — Tue, 19 Aug 2008 08:39:00 GMT

There are three ways that drug companies can ensure patient safety. First, of all, they can look at the adverse event reports which they are receiving or that they get from the Food and Drug Administration. The Food and Drug Administration makes available to anyone, you, me or the drug manufacturer, the adverse events that are in their database, which they get from other manufacturers, from patients directly, from pharmacists and so forth. So the drug company can get the information and look at its’ own adverse events, and, of course, look at what is in the FDA database. Secondly, they look to surveys of who is using the drug. In other words, if-- if you say that the top dose of this drug is 20 milligrams and the drug company find suddenly that people are writing prescriptions for 40 milligrams or 60 milligrams, then that alerts them that they need to do something to change that behavior. And the third thing, of course, is they look at the medical literature, even though that may be delayed by sometimes as much as a year, but that’s another very valuable source of information. These activities are referred to in the industry as "pharmacovigilance." This means that all scientific and data-gathering activities relating to the detection, assessment and understanding of adverse events, are monitored to ensure patient safety. The goal of pharmacovigilance is to minimize risk associated with prescription drugs. So, if the drug company isn’t reading the literature, as many drug companies don’t, then who is minding the store to ensure patient safety?

Originally posted at InjuryBoard by Peter Wetherall

Big Pharma:Too Lazy to Ensure Patient Safety?

Peter Wetherall — Mon, 18 Aug 2008 18:39:35 GMT

All manufacturers and distributors of prescription pharmaceutical products in theUnited States who hold an approved New Drug Application (hereinafter “NDA”) oran Abbreviated New Drug Application (hereinafter “ANDA”) have an independentobligation to inform and warn doctors and patients on how to use a drug, have aduty in maintaining a label that is current with scientific and medicalinformation to advise use, providing comprehensive responses to inquiries fromhealth professionals and patients, and promoting safe use through marketing andsales practices. If a drug company learns of a new adverse event associatedwith its drug or of a change in the risk of a particular adverse event, thatdrug company can change its label to reflect that change in adverse event priorto FDA approval. Specifically,there’s a specific regulation which is fondly known as 314.70(c). This regulation, in the industry isreferred to as a change being effected. What it does is that for certain things in the label such as safety, itallows a drug company to make the safety change and notify FDA at the time itimplements it so it can actually print a new label, send a copy to the FDA andprotect American consumers.

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

Hepatotoxicity: 35 Drug Products Require New Warnings

Peter Wetherall — Thu, 14 Aug 2008 16:16:10 GMT

The FDA recently posted a list of 35 drugs that required safety labeling changes. Readers know recent blogs discuss several unsafe drugs, such as Reglan, and the inadequacies in the warning labels. The FDA identified several drugs that had to have "boxed" warnings (the strongest warning). One of the boxed warnings applied to Tykerb (also known as lapatinib) which causes Hepatotoxicity. A boxed warning also applied to a well known drug, Strattera. This boxed warning will strong warn against the risk of suicide if given to children. See a complete listing of the 35 drugs

Originally posted at InjuryBoard by Peter Wetherall