Why this news story is relevant to you and what you need to know to be your own health advocate.
As a pharmacist, I am very aware of the adverse effects, risks, and warnings that come along with pharmaceutical therapy. There are limitations to that knowledge, however. Some risks and effects of pharmaceuticals are either not transparently disclosed by drug manufacturers, or not yet discovered as the cause of a problem.
A recent news headline about damages caused by one of the Top 200 Drugs (the 200 most prescribed drugs in the United States) has served as a reminder that when consumers do not have the information about risk and adverse effects of their treatment, they are vulnerable to serious harm. As a result, I am using this headline as an example of the consequences of not having the full available information in order to make choices about your health. I will go over risks that are disclosed about the drug in question, as well as outlining how to get the information you need to be your own health advocate in general.
News headlines lit up October 8th with reports of corporate giant Johnson & Johnson being ordered to pay $8 billion in punitive damages to 26-year-old Nicholas Murray. Johnson & Johnson has a subsidiary (Janssen Pharmaceuticals) that manufactures the antipsychotic drug Risperdal. Back in 2003, Nicholas (at the age of 9) was prescribed Risperdal after being diagnosed with an Autism Spectrum Disorder. As a consequence of taking the drug, Nicholas developed a condition called gynecomastia (the growth of female breast tissue in a male). News Story Below:
Johnson & Johnson, Risperdal Maker Hit With $8B Verdict
Breast development in boys from Risperdal is most likely caused by the drug increasing prolactin levels. Prolactin is a pituitary hormone that is present in low levels in both men and women. It affects the reproductive system, immune system, and fluid regulation. When a woman is pregnant or breastfeeding, prolactin goes up to stimulate milk production. When prolactin goes too high in a male, he can develop breasts. He may also experience erectile dysfunction and loss of body and facial hair. In some cases, gynecomastia can only be treated by surgical removal.
Mayo Clinic Laboratories Endocrinology Catalog: Prolactin, Serum
Gynecomastia is not the only consequence of taking Risperdal; however, it is a very visible and undeniable adverse effect. There are other, more subtle and harder to directly correlate effects.
Below is a screenshot of some of the adverse reactions of Risperdal taken from the prescribing information:
Here are definitions of the some of the technical terms on that list:
- Parkinsonism: Symptoms of Parkinson disease (such as slow movements and tremors) that are caused by another condition (in this case, antipsychotics)
- Akathisia: A feeling of muscle quivering, restlessness, and inability to sit still, sometimes a side effect of antipsychotic or antidepressant medication
- Dystonia: A disorder characterized by involuntary muscle contractions that cause slow repetitive motions or abnormal postures. The movements may be painful and some individuals with dystonia may have a tremor or other neurologic features.
The following is a screenshot of Warnings and Precautions from the prescribing information of Risperdal.
Here is a link to the full prescribing information of Risperdal from the manufacturer’s website. This is the information supplied to doctors and pharmacists. Package Insert on Risperdal
There are many known and dangerous side effects of Risperdal. The main issue Johnson & Johnson is getting called out for is the failure to accurately disclose the risk involved, especially in children. There is also the allegation that Johnson & Johnson marketed the use of the drug in children in ways that are not FDA approved.
This judgment for 8 billion dollars in damages is eye-opening. It is a message that disregard for the public safety for profit will not be tolerated. This judgment opens the door for thousands of other pending lawsuits against Risperdal to also be awarded punitive damages and a wakeup call to Americans to question our healthcare system.
Unfortunately, severe side effects are not isolated to Risperdal. Most prescription medications have their tradeoffs. The following is a table of drugs that can cause gynecomastia taken from an endocrinology journal.
Gynecomastia: Clinical Evaluation and Management
When it comes to medical treatment, most consumers are not trained health experts. The medical system speaks a complex language. Many of the conditions are Latin (and Greek) words, so even simple terms sound very concerning. For example, I’ve had many patients say that they were diagnosed with tonsillitis and were worried and felt pressure to take treatment based upon this diagnosis. I explain to them that although it sounds scary, it is just a combination of the word tonsil and the Latin (from Greek) suffix -itis which means inflammation. They went to the doctor because their throat hurt so learning that their tonsils were inflamed was not actually a surprising revelation. If you don’t have any background in Latin or Greek, tonsillitis sounds quite ominous.
So how do people navigate the complex and somewhat esoteric system which is conventional medicine? Often individuals trust their doctor to make these decisions for them since a doctor is trained to interpret medical data and knows the language. I implore you to look at the data I shared above on Risperdal. Seeing those warnings and adverse effects, is that really a decision you would want someone else to make for you or your child? I certainly wouldn’t, regardless of how competent they may be.
The solution to this dilemma is to arm yourself with education. Make sure you read any information provided with a medication you are about to take. Don’t throw that paperwork in the trash. The information with a prescription is there for a reason – a legal reason.
You can also gain access to the full prescribing information of any prescription drug. This information is referred to as the “Package Insert” (PI). There is also a Patient Package Insert, which contains less information, but the regular PI intended for the doctor has it all. Drug companies are legally mandated to provide information on the studied use of their drugs and also risks associated with them but are not necessarily required to provide this to individual patients. The intention is that the prescriber reads the PI and then has the information to make treatment decisions and share it with the patient. You can have access to the same information as the doctors have. Most PIs are available from the following link. Click the link, type the drug name into the search bar and click the entry that applies to the specific form of the medication you are searching for. DailyMed Drug Search
For more information on PIs, read this link: U.S. Pharmacist: The Package Insert
However, before you even get to the pharmacy or opt to do any treatment you should ASK QUESTIONS. It is your legal right and obligation to receive Informed Consent from your doctor. The Oxford Dictionary defines Informed Consent as “permission granted in the knowledge of the possible consequences, typically that which is given by a patient to a doctor for treatment with full knowledge of the possible risks and benefits.”
Below is a link description of Informed Consent from the American Medical Association. Read this information to make sure you can get the information you need from your doctors. It is your LEGAL RIGHT.
American Medical Association Informed Consent
Even if your doctor is amazing, they may not have knowledge of alternative therapies that are outside of their expertise. This is where you need to be your own health advocate and do some research on alternative treatment options to surgery or prescriptions. Holistic doctors and Naturopaths can be great resources to consult as they take a different viewpoint on healthcare.
I see many patients who have taken medications and had serious reactions to them. If this describes you, you can and SHOULD help yourself and others by reporting any reaction to the FDA MedWatch program. Reporting to this program can help with information gathering to make others aware of potential risks and may play a role in future warnings or even drugs being pulled from the market.
FDA MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Medications have effects that extend beyond what’s intended for the treatment of a given condition.
When possible (when it’s not an emergency) it is good to look at other, simpler solutions first such as diet, exercise, and natural supplements. Many conditions, even severe, can be alleviated in a risk-free manner. With autism as an example, I have good results with patients in applying principles of the GAPS diet (Gut and Psychology Syndrome by Dr. Natasha Campbell-McBride, MD). The foundation of this diet is healing the gut with the use of bone broth. GAPS Diet
Although it is tragic to hear about the damages individuals have suffered from Risperdal, the good news is that these headlines are bringing awareness about concerns with medications and healthcare at large. I recommend you use the resources I have provided so you have the data you need to make more informed choices. The problems of living are great, but there are solutions to explore that are safe options. It is time to be your own advocate and get the information you deserve.
Dr. Amanda Childress, PharmD