The U.S. Food and Drug Administration (FDA) reported June 18th that it is looking into the deaths of two patients who died following their routine injections of the drug.
Patient overdose was not the cause of death, as legally, this shot can only be administered by physicians in a controlled setting. Patients are required to wait 3 hours in the doctor’s office following their injection to monitor any bad Zyprexa side effects and have access to emergency vehicles if hospitalization is required.
These victims did have very high levels of the drug in their bloodstreams at the time of death.
Zyprexa was originally approved by the FDA in 1996 and built up a long and serious history of adverse side effects and lawsuits against Eli Lily. With its patent expiration date looming in 2011, the company developed the injection form of the drug hoping to cushion the profit loss that would occur when generic forms of Zyprexa hit the market to compete with their product. The FDA obliged by approving Zyrexa Relprevv late in 2009. Eli Lily’s patent on the injection form runs through 2018.
An injected form would be easy to promote to doctors as it solves the problem of patients who forgot (or deliberately) don’t take their meds and the doctors could collect a fee for each injection given.
Of course Zyprexa Relprevv has a couple of dangerous drawbacks that one can see on Eli Lily’s own website page for “Patients, Family and Caregivers”.
After assuring the patient with this statement, “To help you feel better, your doctor has prescribed Zyprexa Relprevv (zy-prex-a rel-prev).” patients, family and friends are assaulted with the following list of side effects:
- Post-injection Delirium Sedation Syndrome (PDSS): Patients are at risk for severe drowsiness (including unconsciousness or coma) and/or confusion and disorientation after each injection and must stay at the doctor’s office or clinic for at least 3 hours after the injection is given. Zyprexa Relprevv is only prescribed by doctors who are enrolled in the Zyprexa Relprevv Patient Care Program to patients who are also enrolled.
- Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis
- High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. This could lead to ketoacidosis (build up of acid in the blood due to ketones), coma, or death.
- High fat levels in your blood (cholesterol and trigylcerides). High fat levels in your blood may happen in people treated with Zyprexa Relprevv, especially in teenagers (13-17 years old).
- Weight gain. Weight gain is very common in people who take Zyprexa Relprevv. Teenagers (13-17 years old) are more likely to gain weight and to gain more weight than adults. Zyprexa Relprevv is not approved in patients less than 18 years old.
- Strokes and “mini-strokes” called transient ischemic attacks (TIAs). These are more common in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). Zyprexa Relprevv is not approved for these patients.
- Suicide. The symptoms of schizophrenia may include thoughts of suicide or of hurting yourself or others.
- Neuroleptic malignant syndrome (NMS). NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including Zyprexa Relprevv. NMS can cause death and must be treated in a hospital. The symptoms include high fever; excessive sweating; rigid muscles; confusion; and changes in breathing, heartbeat, and blood pressure
- Tardive dyskinesia. This condition causes body movements that keep happening and that you cannot control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking Zyprexa Relprevv. It may also start after you stop taking Zyprexa Relprevv.
- Decreased blood pressure when you change position, with symptoms of dizziness, fast or slow heartbeat, or fainting.
- Decreases in white blood cells (infection fighting cells) have been reported in some patients taking antipsychotic agents, including Zyprexa (olanzapine).
- Trouble swallowing, that can cause food or liquid to get into your lungs.
- Problems with control of body temperature. Call your doctor right away if you become severely ill and have some or all of these symptoms of dehydration: sweating too much or not at all, dry mouth, feeling very hot, feeling thirsty, not able to produce urine.
- Increases in prolactin (a naturally occurring hormone in the body) have been reported in some patients taking Zyprexa Relprevv and these increases can continue while taking the medication. Some patients have reported milk production from the breasts, stopping of menstrual periods, enlargement of the breasts in men, and impotence
- Zyprexa Relprevv can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Zyprexa Relprevv affects you. You should not drive or operate heavy machinery for the rest of the day after each injection.
Despite this horror list of Zyprexa side effects, Eli Lily managed to sell over $5 billion dollars worth of this drug in 2010 and, despite competition from generics, $1.7 billion in 2012. Since first being approved, total sales probably top $60 billion.
Lawsuits and fines cannot effect those income numbers.
Eli Lilly pled guilty on January 15, 2009 to illegally marketing Zyprexa for unapproved uses to children and the elderly, a misdemeanor charge, and paid $1.42 billion including $615 million to end the criminal investigation and around $800 million to settle the civil case.
Thanks to 8 ethical employee whistleblowers, some shameless marketing techniques were brought to light.
A former Lilly sales representative Robert Rudolph who testified against the company knows it won’t change due to a few lawsuit payments – he feels jail time for executives is needed to make the point. “You have to remember, with Zyprexa,” said Rudolph, “people lost their lives.”
To get FDA approval in 1995, Lily omitted its own study that showed Zyprexa produced an average weight gain of 24 pounds in a single year (one in six patients gained more than 66 pounds) – the result was elevated blood-sugar levels, metabolic disorders and diabetes. These effects were very pronounced in children.
Yet, knowing this, sales teams illegally pressed doctors to calm down disruptive children with Zyprexa.
Elderly patients got the same marketing treatment as described by Bruce E. Levine in his article “The Case for Giving Eli Lilly the Corporate Death Penalty.” He wrote that the sales team urged geriatricians “to use Zyprexa to sedate unruly nursing home and assisted-living facilities patients. Lilly sales reps distributed a study claiming that elderly patients taking Zyprexa required fewer skilled nursing staff hours than were necessary for patients taking competing medications.”
The slogan used was “Five by Five” – which meant giving 5 mg. of Zyprexa at 5:00 PM would keep the elderly patients quiet. Omitted in the slogan was the the risk of heart failure and life-threatening infections such as pneumonia in these older patients.
In another infamous sales technique doctors were encouraged to prescribe Zyprexa to correct a patients poor fashion sense. “Drab” or “disheveled” clothes meant someone was depressed and in need of an off-label prescription. The sales campaign was named “Viva Zyprexa” Eli Lily reps presented doctors with a profile of an imaginary patient named Donna … “a single mom in her mid-30s, appearing in your office in drab clothing and appearing somewhat ill at ease. Her chief complaint is, ‘I feel so anxious and irritable lately.’ Today, she says she’s been sleeping more than usual and has trouble concentrating at work and at home. However, several appointments earlier, she was talkative, elated, and reported little need for sleep.”
Reps were taught to tell doctors: “I would like you to get a patient like Donna started today. I will be back in a week to follow up.”
An industry report in 2011 stated, “Zyprexa is the most successful product in the history of neuroscience”
Sales wise this might be true. But its effects on patients – death, diabetes, coma and suicide – tell the real truth about this drug and its maker. Hopefully, this time, the FDA will discover that truth and ban use of the drug.