Reglan Tardive Dyskinesia Warning by FDA

FDA MedWatch – 2009 Safety Alerts for Human Medical Products
Metoclopramide-Containing Drugs

The FDA announced today that the side effects from metoclopramide, ( a main ingrediant in many Reglan products) and a Gastrointestinal Medication, should be warned of a very serious disorder called tardive dyskinesia.

The FDA alerted healthcare officials that makers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use.

Metoclopramide usage of a long period of time has been linked to tardive dyskinesia, which can include involuntary and repetitive movements of the body. Even if you have not taken the drug for a while it sometimes can still occour.

The symptoms are often if not almost never reversible and there is no known treatment.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections.

The Makers will be required to use a risk evaluation and mitigation strategy [REMS] to make sure that patients are provided with a medication guide that discusses this risk.

Makers include Baxter International Inc (BAX.N) and several generic drug companies.

More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.

Products that commonly contain metoclopramide:

1. Reglan Tablets
2. Reglan Oral Disintegrating Tablets
3. Metoclopramide Oral Solution
4. and Reglan Injection

According to Watergate Summer Whistle Blower,Mom and Nurse; “Many people take this med for Reflux and GI Ulcer symptoms and take for long periods of time.”

What is tardive dyskinesia?

Tardive tourettism is a tic disorder that can closely mimic Tourette Syndrome, sometimes to the point where the two can only be distinguished by the details of their onsets.

Tardive dyskinesia is a variety of dyskinesia (involuntary, repetitive movements) manifesting as a side effect of long-term or high-dose use of dopamine antagonists, usually antipsychotics. Other dopamine antagonists that can cause tardive dyskinesia are drugs for gastrointestinal disorders (e.g. metoclopramide) and neurological disorders.

Video: The Treatment of Tardive Dyskinesia with … MORE Drugs!

Other Drugs that can cause tardive dyskinesia are mainly antipsychotic medications and include:

• Thorazine (Chlorpromazine)
• Clozaril (Clozapine) (may also treat the condition)
• Haldol (Haloperidol)
• Seroquel (Quetiapine)
• Loxitane / Loxapac (Loxapine)
• Mellaril (Thioridazine)
• Navane (Thiothixine)
• Prolixin / Modecate (Fluphenazine)
• Piportil (Pipotiazine)
• Trilafon (Perphenazine)
• Orap (Pimozide)
• Stelazine (Trifluoperazine)
• Risperdal (Risperidone)
• Serentil (Mesoridazine)
• Zyprexa (Olanzapine)

Some of the non-neuroleptic drugs that may also cause tardive dyskinesia are:

• Prozac (Fluoxetine)
• Zoloft (Sertraline)
• Nardil (Phenelzine)
• Elavil (Amitriptyline)
• Asendin (Amoxapine)
• Sinequan (Doxepine)
• Tofranil (Imipramine)
• Lithium
• Cocaine and other street drugs

Symptoms of Tardive Dyskinesia
Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements such as:

• Fine, worm-like movements of the tongue
• Lip smacking
• Chewing or sucking movements
• Grimacing (making faces)
• Puckering or pursing the lips
• Tongue protrusion
• Rapid eye blinking

Thanks to about.com for this list

A Very Detailed Article about Tardive Dyskinesia on Medscape

Defective Drug News

Othe Resource: Soulful Sepulcher

Technorati Related: health, tardive, dyskinesia, reglan, side, effects, disorders

Studies Show Some Drugs do not Work

It’s a top selling drug that may not work. Simvastatin, which is also sold under the name Zocor, is supposed to help children with neurofibromatosis 1. It has been said that the drug will help “correct the learning and attention deficits” that kids with this genetic disorder experience.

According to studies conducted by a medical center in The Netherlands, 62 children part of their experient showed no improvement while taking the drug. Of course a sampling of these 62 children was given either a placebo or simvastatin during the three month duration. The results, published in the Journal of the American Medical Association this week, affirmed that this drug should no longer be recommended for improving the cognitive function of children with neurofibromatosis 1.

As with all medications there are side effects that may be unknown. If a drug like simvastatin was thought to be a drug that helps children with neurofibromatosis 1 and just recently has been proven that it has no affect, there is also no telling what drugs have been approved by the FDA but are actually harmful.

If you have had any adverse affects to a drug that you have been taking, it is important that you seek the medical attention you need, and secondly seek the proper legal consultation.

Carbatrol Lawsuit filed

Generic versus brand name drugs are always an issue for pharmaceutical companies. If there are drug companies producing generic versions of drugs illegally, then it should very well be an issue.

This is the case with Shire who has a track record of filing lawsuits against other drug companies. This time they are filing patent infringement lawsuits against Nostrum Pharmaceuticals and Apotex for attempting to apply to be able to market versions of its anti-seizure drug Carbatrol.

Carbatrol is used to treat patients who suffer seizures disorders and trigeminal neuralgia. Trigeminal neuralgia is described as episodes of “sudden, brief, recurrent, stabbing facial pain.”

There are rules and regulations that must be followed when producing generic drugs some of which are in place to protect consumers. If a company is not following these rules they can be detrimental to the public health.

This is the cause of some pharmaceutical drug recalls. Consumers use the recalled drug ignorant of its recall status and consequently suffer extreme adverse effects and sometimes death.

If you have taken a drug and have experienced any adverse side effects consult with one of our attorneys as well as visit our website at www.kerrysteigerwalt.com. (Always seek the medical attention you need first.)

Morphine Sulfate Recall- Voluntarily Recall by Ethex Corp

ETHEX Corporation announced today that it has voluntarily recalled a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008. No other dosage strength, nor any other lot of the 60 mg strength is affected by this recall. The voluntary single-lot recall is due to a report that a tablet with as much as double the appropriate thickness was identified and the possibility therefore that there may be other similar oversized tablets that may have been commercially released in the affected lot. Such tablets may contain as much as twice the labeled level of active morphine ingredient. The product is a white oval tablet with “60″ on one side, and “E” on the reverse.

No report of unexpected side effects or injury has been received. However, opioids such as morphine have life-threatening consequences if overdosed. Those consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness. As such, they may be less likely to be able to determine that a tablet is overweight or oversized than an unimpaired individual.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-321-1705, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8 am to 5 pm CST.

ETHEX Corporation previously initiated the recall notification to wholesalers and retailers who have received any inventory of the recalled lot of this product with instructions for returning the recalled product and, if they have not already done so, they are urged to contact the number above regarding procedures for returning the recalled product. If consumers have any questions about the recall, they should call the number above, their physician, their pharmacist or other health care provider.

This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).
Any adverse reactions experienced with the use of this product, and/or quality problems may also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Chantix Banned by FAA Over Side Effects

Pfizer Inc.’s once promising anti-smoking drug Chantix received another blow Wednesday after a nonprofit group’s report about serious physical side effects prompted the Federal Aviation Administration to ban the drug’s use by pilots and air traffic controllers.The report, from the Institute for Safe Medication Practices, points out hundreds of serious problems reported since the popular drug was approved in May 2006, including dizziness, loss of consciousness, seizures, and abnormal spasms and movements.

“We have immediate safety concerns about the use of varenicline (Chantix) among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury,” the researchers said in the report.

FAA spokesman Les Dorr said the Chantix ban is effective immediately and that the agency was notifying unions representing pilots and controllers. He said the FAA is unaware of any aviation accident caused or contributed to by Chantix. Pfizer, in a statement, reaffirmed its stand on the drug’s safety and said the label already contains safety warnings about driving or operating machinery.

Digitek Recall by FDA

Several Brands of Heart Medication Recalled

Heart problems and heart failure are two of the leading causes of death in the United States every year. As a result, pharmaceutical companies everywhere are placing a high priority on the research and development of medications that will provide relief and the ability to manage these conditions for patients.

Unfortunately, every new drug hits the market with at least some degree of risk, and that appears to have been the case with a drug that’s been known under several names, including Digitek, which was formulated by Actavis Totowa LLC, Bertek, distributed by Mylan Pharmaceuticals, Inc. and UDL, which is put out by UDL Laboratories, Inc. All of these drugs have been recalled, effective immediately, according to an announcement by the companies in conjunction with the FDA on its Web site.

The problem with these drugs is that many of the pills that were manufactured were released with twice the normal thickness in other pills, which means by result that these faulty pills can contain twice the amount of medication necessary to treat these heart conditions. When a patient inadvertently doubles the dose of this drug, he or she can suffer from digitalis toxicity, particularly in this situation when the patients have experienced renal failure. This condition can lead to vomiting, nausea, low blood pressure, dizziness and a dangerously low resting heart rate, known as bradycardia.

If you are taking any form of this medication, you need to contact your doctor immediately to find out how you should proceed. If you’ve been injured by any of these medications, contact a defective drugs attorney as soon as possible to schedule an initial consultation.