Posts Tagged ‘Drug Recall’

Accidental Overdose Dextroamphetamine/Amphetamine 20mg Tablets

Friday, September 4th, 2009

Barr Laboratories, Inc., distributor for  Dextroamphetamine/Amphetamine 20mg Tablet bottles Lot number 311756, has announced a recall of the company’s  Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 20mg Tablets  that were distributed beginning June of 2009 for a period of 5 days. It is the potency of the super-therapeutic dose that has caused the alarm. The potency exceeds the approved dosage.

Side Effects from the Overdose Tablets include:

  • Tardive Dysnkensia
  • Tachycardia and heart palpitations
  • High blood pressure
  • Tremors
  • Dizziness
  • Distorted vision
  • Euphoria
  • Mania
  • Anxiety
  • Nausea
  • Irregular Bowel Movements
  • Dry Mouth
  • Lack of appetite

Consumers, pharmacists and medical providers can identify the tablet by its oval shape, peach color and written text on one side indicating b/973 and 2/0 on the other side. People with these tablets are advised to return them to the pharmacy in which they purchased the prescription.

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Ethex Recall: Over-Dose Tablets Pose Risks

Thursday, May 21st, 2009

By Lesley Ranft

Ethex Corporation announced multiple recalls of numerous drugs, including morphine, iron and prenatal vitamins. The string of recalls began to commence last year due to double dose tablets of morphine and other potential concerns. There have been recent reports that the FDA is questioning adequate quality control at the manufacturing facility where the morphine tablets were made. As Richard Schulte, Attorney at Law of Dayton, Ohio explains, “This is a clear case of manufacturer defect. The problem we are faced with now is we do not yet know the extent of defective pills on the market and how great of harm they caused to consumers.”

Signs of Overdose
The long term effects of the prenatal vitamins are unknown. Iron supplement overdose side effects usually occur shortly after intake. Iron poisoning side effects may include, vomiting diarrhea, liver dysfunction, jaundice, internal bleeding, and seizures.-1- The initial signs of overdose in morphine are clear and can be life threatening, but may not be fully apparent to the person using the drug. Opioid overdose includes:
• Rapid Heart Beat
• Hypertension
• Tremors
• Bluish Lips
• Headache
• Insomnia
• Dizziness and Fainting
• Blurred vision
• Upset stomach
• Fainting
• Low Blood Pressure

The List of Ethex Recalls

Isosorbide mononitrate: 30mg and 60mg
Propafenone HCI: 150mg, 225mg, and 300 mg
Dextroamphetamine sulfate tablets: 5mg and 10mg
Morphine sulfate ER: 15mg, 30mg, 60mg, 100mg 200mg
Morphine IR: 15mg and 30mg

Prenatal Vitamin Recalls
Advanced NatalCare® Tablets and Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss, PIC, PIC Forte, Plus, Rx, Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE and MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets

Iron Supplement Recalls
Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules

-1- http://www.merck.com/mmhe/sec24/ch297/ch297h.html

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Denture Cream Dangers Uncovered through Lawsuits

Saturday, May 9th, 2009

Dentures Creams such as Polydent and Fixodent have shaken up the medical community as much as the legal community over the past year. In mid 2008, the results of a study were published in Neurology, a journal for Neurologists, showing a link between denture cream use and neurological health issues. The University of Texas Southwestern Medical Center study authors suggested that excessive zinc exposure was at the core of the problems. The published findings carried a warning: one denture cream tube should last up to 10 weeks, but study participants were using two tubes each week.

Dental Cream Health Problems
By 2009, dental creams health issues were reported by numerous people from across the U.S. to lawyers. High levels of zinc may deplete copper in the body. The simultaneous effects of excess zinc and diminished copper may lead to serious and permanent health issues, including.

• Premature Tooth Loss
• Numbness
• Pain
• Weakness in the arms, legs, hands and feet
• Body sores
• Water retention
• Hair loss
• Anorexia
• Fatigue
• Anemia
• Difficulty breathing
• Paralysis
• Immune disorders
• Cardiovascular disorders
• Bone marrow disorders

Proof is in the Study
The University of Texas Southwestern Medical Center research team found that participants had comprising levels of zinc and copper in their bodies. Study participants were also suffering from health problems.
• Zinc blood levels were over the normal range by .36-3.18
• Copper levels were between 0.1 and .23, normal copper levels range from 0.75 to 1.45

This imbalance is suspected to be the cause of the described symptoms above. In fact, there may be other symptoms that have not been uncovered at this time. Personal injury attorneys are often some of the first people to know about problems such as those caused by denture creams. If you feel you have been injured by your use of dental cream, select personal injury attorneys are available to speak with you.

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Drug Induced Steven’s Johnson Syndrome

Wednesday, May 6th, 2009

By Lesley Ranft

“The seriousness of the injuries and the fact that the types of drugs that can cause Stevens Johnson Syndrome are in frequent use signify the need for all consumers to take a closer look at the labels for side effect warnings in both over-the-counter and prescription drugs that they are taking. ” as Frank Woodson, Shareholder in the law firm of Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, AL explains. Once thought to be an allergic reaction by some, has evolved into a lifelong nightmare for people suffering from severe drug induced Steven’s Johnson Syndrome (SJS).

SJS Symptoms

SJS is toxic, life threatening and may damage the immune system, organs, and neurological function. The underlying skin disorder is so dramatic for people with severe SJS that they may appear to have fourth degree burns, resulting from epidermal rash blisters which may encompass the body. According to legal case reports, the side effects of SJS are, as follows:

• Nausea, vomiting, diarrhea, fever, sore throat, cough, and chills
• Blisters or lesions on the body
• Inability to eat, drink or void
• Burns to the skin and organs such as the esophagus and corneas of the eyes
• Eye conditions such as anterior uveitis, keratitis and panophthalmitis
• Blindness
• Hypotension
• Tachycardia
• Respiratory failure
• Urinary tract impairment or failure
• Gastrointestinal dysfunction or failure
• Kidney impairment or failure
• Vaginal stenosis and penile scarring
• Skin sloughing and necrosis (death) from 10% to 80% of the body
• Seizures
• Coma
• Death

Candidates for SJS

SJS predominantly affects Caucasians, with ratios of two men to one female. Most people contract SJS between their 20’s and 40’s, but children as young as 3 months old have contracted SJS. SJS is commonly misdiagnosed at the onset. SJS is considered idiopathic in 25-50% of all cases. The condition affects people in varying degrees of severity. The risk of death is associated with the extent of skin necrosis (skin death). The mortality rate is 1-5% when necrosis is less than 10%, up to 35% when necrosis is 30% and so on.-1-

SJS Causes: Virus, Disease, Infection and Malignancy

The root associations of SJS may be viral diseases, infections and malignancies including: carcinomas, lymphomas, herpes simplex virus (HSV), AIDS, coxsackie viral infections, influenza, hepatitis, mumps, mycoplasmal infection, lymphogranuloma venereum (LGV), rickettsial infections, and variola. Bacterial associations include: group A beta streptococci, diphtheria, Brucellosis, mycobacteria, Mycoplasma pneumoniae, tularemia, and typhoid. Fungal viruses include: Coccidioidomycosis, dermatophytosis, and histoplasmosis. Malaria and trichomoniasis are also reported causes. Epstein-Barr virus and enteroviruses have been identified as well.

SJS Drug Induced Causes

The medication list of causes that is identified include: Sulfa drugs, Phenytoin, Ciprofloxacin, and Penicillin may trigger SJS. Anticonvulsant drugs such as oxcarbazepine (Trileptal), phenytoin, carbamazepine, valproic acid, and lamotrigine are in the linked category. Non-nucleoside reverse transcriptase inhibitor drugs, Nevirapine, Indinavir, and Modafinil (Provigil) have been identified too. Attorneys have reported an association between SJS and Allopropenol, EFFEXORA, Lemectal, Ibuprofen, Motrin and barbiturates.MRI diagnostic testing equipment using Gado Dye caused an unexpected outbreak of SJS recently.

Check Your Drug Labels

Not all drug labels provide current up-to-date warnings about medical condition risks. For example, Motrin bottles provided a warning label about the risk of Steven’s Johnson Syndrome when it was a prescription drug. However, today’s over-the-counter version of Motrin does not provide a warning for the risk of Steven Johnson’s Syndrome. In addition, it may require a significant amount of time between a reported link between SJS and a drug and the time that the information appears on a drug label. Furthermore, there may be additional time before a drug is recalled for risks of SJS because the foundation of a recall may be based on a high number of reports and the average individual may not know to report the drug or realize the correlation between the drug and the disease.

By the same token, checking your prescription and over-the-counter medications for warnings is important. High incidence ratings may be bumped up on the scale of the label. Severe adverse events and high rates of incidence should appear in the warning or precaution section of label.

Check with Your Doctor

Some people with SJS may only experience fever, sore throat, vomiting and/or diarrhea. In fact, rashes and lesions may never appear. Some doctors may not be familiar with SJS. If you experience any SJS related symptom, contact your doctor and request to stop taking the drugs you are taking. If you suspect SJS, maintain hydration. The diagnosis of Steven’s Johnson Syndrome is conducted through a skin biopsy. The treatment for SJS may consist of medications and treatment for the impairment(s) that you are suffering from.

Check with a Lawyer

A select number of product liability lawyers are accepting SJS legal cases to submit lawsuits against the makers of the drugs who have failed to adequately warn the public about the risk of SJS. It is the culmination of patient reports acquired by lawyers, victims themselves and other interested parties that substantiates the need for public policy makers to take greater action to prevent the public from further harm. Your experience with SJS is important. Check in with a lawyer today.

-1- http://emedicine.medscape.com/article/756523-overview

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Moisture Plus Consequences: Corneal Infection Increases Risks

Tuesday, April 28th, 2009

The number of contact lens users with corneal infections has grown due to risks of injury from select contact lens solutions such as Moisture Plus, manufactured by Advanced Medical Optics. Diagnosis of corneal infection may be particularly problematic because the type of Keratitis associated with contact lens solution is often mistaken for a different type of eye infection or Keratisis. The type of Keratisis that many people using contact lens solution have is Acanthamoeba Keratitis. Eye doctors may not be familiar with this eye condition because it is rare. There have been reports that people suffering from Acanthamoeba Keratitis have been misdiagnosed. This delay in treatment adds to the risk for blindness from Acanthamoeba Keratitis.

Ophthalmologists that are corneal specialists are more likely to be familiar with Acanthamoeba Keratitis than optometrists and general eye doctors. Different classes of Keratitis are caused by bacteria, virus or fungus. Acanthamoeba Keratitis may be contracted though tap water or the use of contact lenses in the shower, bathtub or pool. The risk of Acanthamoeba Keratitis from using contact lens solution is two to one million, according to All about Vision. The risk from MoisturePlus has been seven times that number.

If you are experiencing symptoms from your contact solution, seek out the advice of an ophthalmologist and tell them about your concern over Acanthamoeba Keratitis There are a select number of product liability attorneys that are familiar with Acanthamoeba Keratitis injuries. They can provide information about the legal rights of victims from MoisturePlus injuries.

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