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Zyprexa

Zyprexa (Olanzapine)- Oral ZYPREXA, manufactured by Eli Lilly, is indicated for the treatment of schizophrenia. It has also been indicated for the treatment of acute mixed or manic episodes associated with Bipolar I Disorder. On March 29, 2004, Zyprexa for injection was approved by the FDA for the control of acute agitation associated with schizophrenia and bipolar mania.

Since its introduction in 1996, Zyprexa has been prescribed to more than 16 million people worldwide. However, Zyprexa has been linked to hyperglycemia and diabetes mellitus. Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including Zyprexa. This drug has also been linked to Tardive Dyskinesia as well.

In July 2002 Duke University revealed in a press release the link between early onset diabetes and Zyprexa. The study was an analysis of the FDA’s MedWatch adverse event reporting database. This analysis revealed 289 cases of diabetes linked to the use of Zyprexa. Of these 289, 225 cases were newly diagnosed cases. 100 patients developed ketosis, a complication of diabetes and 22 patients developed pancreatitis which is a life-threatening condition. There were 23 deaths, including a 15 year old adolescent who died of necrotizing pancreatitis, a condition where the pancreas breaks down and dies. Seventy-one percent (71%) of these cases occurred within six months of starting the medication. These findings appear in the July 2, 2002 issue of Pharmacotherapy.

Hyperglycemia also called low blood sugar, occurs when your blood glucose (blood sugar) level drops too low to provide enough energy for your body's activities.


Diabetes MellitusDiabetes-accumulating evidence surrounding Zyprexa and other atypical antipsychotic drugs shows a connection between weight gain, elevated glucose and triglyceride levels and the use of these drugs. This family of antipsychotic family of drugs is linked to exacerbation of existing Type1 and 2 diabetes and new onset type 2 diabetes mellitus and the severe often fatal metabolic complications, diabetic ketoacidosis.

Neuroleptic Malignant Syndrome (NMS) this condition refers to the combination of hyperthermia, rigidity, and autonomic dysregulation that can occur as a serious complication of the use of antipsychotic drugs. Delay first used the term in 1960, after observing patients treated with high-potency antipsychotics. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure

Tardive Dyskinesia is a neurological syndrome which can be caused by the long-term use of neuroleptic drugs such as Zyprexal, Tardive dyskinesia is characterized by repetitive, involuntary, purposeless movements. Features of the disorder may include grimacing, tongue protrusion, lip smacking, puckering and pursing, and rapid eye blinking. Rapid movements of the arms, legs, and trunk may also occur. This syndrome can be disabling and disfiguring. When used in higher doses, atypical antipsychotics such as Risperdol can cause this syndrome

 

Zoloft

In the news: Pfizer, the manufacturer of Zoloft will turn over internal research documents on the drug to lawyers defending a 15 year old boy who shot and killed his grandparents while taking Zoloft. A forensic psychiatrist has testified that the Zoloft caused the boy to hear voices which told him to kill. Zoloft is not expressly approved by the FDA for use in children and adolescents but such use "off label" use has been prescribed by physicians. In September 2004, an FDA advisory committee called for all antipressants labels to get a black box warning about the risk of increased suicidal tendancies in young people taking these drugs.


Zoloft, a SSRI antidepressant, has been the focus of several patient and family complaints concerning the drug's side effects. Many of the SSRIs have been reported by patients to induce agitated, suicidal or homicidal behavior. Pfizer does list agitation and hypomania and/or mania activation as possible side effects of taking Zoloft. Agitation is actually listed by Pfizer as a common adverse reaction to Zoloft. This agitation is what some patients are claiming made them engage in various illegal agitated behaviors including murder.

Most disturbing is that many of these types of patients had no prior history of illegal activity or agitation prior to taking Zoloft. The FDA has received many letters from Zoloft patients concerning agitation and other severe adverse effects from taking Zoloft. While the FDA did research the patients' complaints in 1991, no correlation between agitated illegal behavior and Zoloft were found by the FDA.

However, further research and better doctor monitoring of patients taking antidepressant was recommended. Ten years later, the problem still persists, and the FDA has not released any further reports. M

 

Vioxx

Vioxx (rofecoxib) is a prescription drug belonging to a new class of non-steroidal anti-inflammatory drugs called COX-2 inhibitors. Traditional NSAIDs (ibuprofen and aspirin) block both COX-2 and COX-1 enzymes. However, COX-1 enzyme protects the lining of the stomach and blocking it can lead to stomach irritation. Vioxx works by blocking only COX-2 enzymes that cause inflammation characteristic to arthritis.

Vioxx is manufactured by Merck & Co. and is prescribed primarily to relieve symptoms associated with osteoarthritis. It can also be prescribed to relieve acute pain and to treat the pain associated with menstruation. Vioxx comes in 12.5mg and 25mg tablets or in liquid form and is taken orally.

Osteoarthritis

Approximately 15 million Americans suffer from the most common type of arthritis, osteoarthritis. Also known as degenerative arthritis, osteoarthritis occurs when cartilage begins to break down, eventually leading to the loss of cartilage in the joints. This causes joint pain, swelling, and friction between the bones

Osteoarthritis occurs most often in the hips, knees, feet, hands, and spine. There are two types:

Primary osteoarthritis - the most common type of osteoarthritis. Although there is no known cause of primary osteoarthritis, it is related to aging.
Secondary osteoarthritis - is caused by diseases or conditions such as obesity, diabetes, gout, hormone disorders, or repeated trauma to the joints.

Vioxx is prescribed to treat the pain and inflammation associated with osteoarthritis. It blocks the COX-2 enzymes that cause inflammation in the joints.

   

Trovan

Trovan is an antibiotic manufactured by Pfizer Pharmaceuticals and approved by the Food and Drug Administration (FDA) in 1997. The drug, whose generic name is Trovafloxacin, is used to treat many bacterial infections including, but not limited to sinusitis (sinus infection), sexually transmitted disease (STDs), pneumonia, urniary tract infection, severe strep throat, bronchitis, and chronic obstructive pulmonary disease In June 1999 the FDA dramatically reduced the permitted uses of Trovan after numerous reports surfaced regarding the drug's damaging affect on the liver, including its propensity to induce fatal liver failure. Today, Trovan is used as a drug of last resort, given only to those patients who are on the verge of death and have not responded successfully to other antibiotic treatments.

It is estimated that 2.5 million prescriptions have been written for

Trovan, a quinolone antibiotic, since its February 1998 market launch in oral and intravenous formulations. Trovan was initially approved for treating a broad range of infections, from minor skin infections to severe infections in hospitalized patients.

In July 1998, FDA worked with the manufacturer to strengthen the product's labeling concerning liver problems after receiving reports of elevated liver enzymes and symptomatic hepatitis in patients after short- and long-term therapy. Since then, FDA has continued to receive reports of liver toxicity, including reports of a more serious nature.

FDA is now aware of 14 cases of acute liver failure that it has concluded are strongly associated with the drug. Six of these patients died: five due to liver failure and one of four additional patients who received liver transplants. Three patients recovered without requiring liver transplants, and for the remaining two patients the final outcome is still pending.

 

Thimerosal

Thimerosal is a preservative used in vaccines to prevent spoiling, to inactivate bacteria used to make certain vaccines, and to prevent bacterial contamination in the finished vaccine. Several reports have linked the thimerosal in vaccines to mercury poisoning because thimerosal contains a mercury related compound. Since infants receive many vaccines, the reports have pointed to the mercury poisoning from thimerosal containing vaccines as a possible cause of autism. Mercury can cause immune, sensory, neurological, motor, and behavioral dysfunctions. The FDA is working towards eliminating or reducing the amount of thimerosal in vaccines.

Thimerosal is a preservative that has been used in some vaccines since the 1930's, when it was first introduced by Eli Lilly Company. It is 49.6% mercury by weight and is metabolized or degraded into ethyl mercury and thiosalicylate. At concentrations found in vaccines, it meets the requirements for a preservative as set forth by the United States Pharmacopeia; that is, it kills the specified challenge organisms and is able to prevent the growth of the challenge fungi. Prior to its introduction in the 1930's, data were available in several animal species and humans providing evidence for its safety and effectiveness as a preservative. Since then, thimerosal has a long record of safe and effective use preventing bacterial and fungal contamination of vaccines, with no ill effects established other than minor local reactions at the site of injection.

While the use of mercury-containing preservatives has declined in recent years with the development of new products formulated with alternative or no preservatives, thimerosal is still used in certain antivenins, skin test antigens, and ophthalmic and nasal products, in addition to certain vaccines recommended for adults or older children. As a vaccine preservative it is used in concentrations of 0.003% to 0.01%. A vaccine containing 0.01% thimerosal as a preservative contains 50 micrograms of thimerosal per 0.5 ml dose or approximately 25 micrograms of mercury per 0.5 mL dose.

An association that has been noted by some concerned parents of autistic children is that the increase in the prevalence of autism over the last few decades "closely matches the introduction and spread of thimerosal-containing vaccines". This type of comparison is known as an ecological study. Ecological studies alone are generally not accepted as strong evidence of causality, because they do not link individual exposure to individual outcome, and can be subject to confounding by unknown or uncontrollable factors. In addition, it has been noted that some children with autism have high levels of mercury in hair, urine and blood. This observation cannot be interpreted without information on the levels of mercury in individuals without autism (i.e. case-control study). However, such observations do indicate that the hypothesis should be studied further.

   

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FDA Recalls

Food and Drug Administration--Recalls/Safety Alerts
  • Eco-Cuisine Recalls Product Because of Possible Health Risk
    Eco-Cuisine of Boulder, Colorado is recalling all lots of T3314 Basic Brownie Mix, T3333 Betty Brownie Mix with Vanilla, T3388 Ground Beef Style Quick Mix, T3394 Sausage Style Quick Mix, T3416 Chocolate Cookie Mix, T3417 Lemon Muffin Mix, and T3418 English Scone Mix, CM25COOK Basic Cookie Mix 25 lb. bag, CM25MUFF Basic Muffin Mix 25 lb. bag, CM25SCON Basic Scone Mix 25 lb. Bag, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
  • Sandoz US Announces Voluntary Nationwide Recall of two lots of Methotrexate Sodium, USP, Injectable Vials, 25mg/mL, 40mL vials
    Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free.
  • Precautionary Recall Issued For Pre-Packaged Texas Gulf Shrimp
    Galveston Shrimp Company has issued a precautionary voluntary recall of its pre-packaged Texas Gulf Shrimp due to foreign material found in a bag. The pre-packaged bags are shipped to HEB Stores. Customers who recently purchased pre-packaged Gulf Shrimp are encouraged to check their refrigerators and/or freezers.

Disclaimer

Effective 2010, Mr. Feldman is semi-retired and on inactive status, but is consulting or referring many matters to experienced counsel with which he has maintained longstanding relationships.

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