Summary

  • You can tell the U.S. Food and Drug Administration (FDA) if a doctor prescribed a drug without adequate patient testing, screening or counseling.
  • You can tell the FDA about drug prescribing to high-risk patients (such as females with autism or psychiatric disorders).
  • You can tell about a problem that a drug caused or might have caused.
  • People from the U.S. and other countries can file FDA reports.
  • You can file a report for yourself or your child, even if your child is 18 or older.
  • You do NOT need to give your child’s name to the FDA or to the drug manufacturer.
  • The FDA may require stronger warnings on drug labels, or take other actions, if many people report their problems to the FDA.

Step 1 — Collect Your Information

You need to gather your information so you can fill out the FDA adverse effects form. This information will also help you if you want to file a malpractice lawsuit or a complaint about your doctor with a medical licensing board.

Ask yourself the following questions. Then go to Step 2 to complete the FDA form:

  1. Drug: What drug did the patient (you or your child) get? For a list of drug names, see Testosterone Drugs or GnRHa Drugs. If you don’t know the exact name, then just mention the drug type: Testosterone or Gonadotropin-Releasing Hormone Analog (GnRHa) (“puberty blocker”) or other drug.
  2. Doctor: Who prescribed the drug? (An endocrinologist, psychiatrist, pediatrician, etc.?)
  3. Clinic: What university, gender clinic or other organization was the doctor affiliated with? For example: Brown University or Planned Parenthood of NYC, or XYZ Transgender Health Clinic of Your_Town.
  4. Counseling & Screening: How many counseling, screening or other sessions did the patient attend before getting a prescription for the drug? For example: “My daughter was prescribed testosterone drugs after just one session with a psychologist at XYZ University.” Or: “My daughter was given testosterone one month at starting university–without enough time for adequate counseling and screening.”
  5. Mental Health: Did the patient have any mental health conditions diagnosed before or after the drug was prescribed?
  6. Was the condition: Autism, Social anxiety, Generalized anxiety, Attention deficit disorder (ADHD), Bipolar disorder, Borderline personality disorder, Depression, Dissociative disorder, Eating disorder, Obsessive-compulsive disorder (OCD), Posttraumatic stress disorder (PTSD), Schizophrenia, Learning disability or another condition?
  7. Failure to Diagnose or Treat: Do you think your doctor failed to diagnose or treat a mental health condition?
  8. Did your doctor conduct any tests to determine whether the patient had a mental health condition?
  9. Did the doctor examine information from parents, school records, previous doctors and counselors, etc.?
  10. Physical Health: Did the patient have any physical health conditions diagnosed before or after the drug was prescribed?
  11. Was the diagnosed condition: Polycystic ovary syndrome (PCOS), Hyperandrogenism (high testosterone), Dysmenorrhea (painful menstrual cramps), Endometriosis, Classic congenital adrenal hyperplasia (CAH), Non-classic Congenital adrenal hyperplasia (NC-CAH), chromosomal disorder of sex development (DSD) or another condition?
  12. Do you think your doctor failed to diagnose a physical health condition?
  13. Did the doctor conduct any tests to determine whether the patient had a physical health condition, such as hyperandrogenism (high testosterone) or PCOS?
  14. Doctor’s Failure to Provide Information: Female autism and psychiatric disorders have been linked to high testosterone or low estrogen in medical studies. (Click here for details). Did your doctor “forget” to tell you about that?
  15. Female-to-male treatments have been shown to alter gray and white matter brain structures and brain activity in ways that might be dangerous. (Click here for details). Did your doctor “forget” to tell you about that?
  16. Did the doctor warn you about all of the brain and behavioral effects that might result from testosterone or GnRHa drugs? (Click here for details).
  17. Lack of FDA Approval: Testosterone and GnRHa drugs are not FDA-approved for gender transition. An FDA panel rejected a testosterone drug for females in 2004 on safety grounds, after drug companies pushed testosterone for females (Moynihan 2003, 2004). The Endocrine Society in 2016 commented: “There are no FDA-approved testosterone…therapies for women….There also are concerns about under- or overdosing as well as side effects from these treatments.” Did the doctor warn you about any of this?
  18. Failure to Offer Alternative Treatments: Did the doctor offer any alternatives to gender transition drugs, such as counseling, anti-depressants, coaching for patients with autism, etc.? Many females who experienced gender dysphoria say that such alternatives are helpful, but many doctors fail to offer these alternatives.
  19. New or Worsened Problems: Did any of the following problems begin or get worse after the patient started using the gender transition drug?
  • Addiction or problematic use of cigarettes, alcohol or drugs
  • Aggression or violence
  • Anti-social, criminal or violent behavior
  • Anxiety, social anxiety or panic attacks
  • Arguing excessively or unreasonably
  • Attention deficit disorder (ADHD)
  • Autism symptoms
  • Bipolar disorder symptoms
  • Bulimia or eating disorder
  • Concentration or attention problems
  • Confusion or “brain fog”
  • Crying or sadness
  • Death from physical health problem, accident or suicide
  • Delusions or false beliefs
  • Dementia
  • Depression or feelings of hopelessness
  • Dissociation
  • Eating disorder
  • Employment difficulties, such as conflicts with customers or co-workers, loss of interest in work, frequent mistakes, rule-breaking, memory or learning problems
  • Fatigue
  • Friendship problems, such as increased conflicts or loss of interest in friends
  • Gambling excessively
  • Hallucinations
  • Immune problems or frequent physical illness
  • Impulsive or reckless behavior such as speeding or drinking while driving, or reckless sexual behaviors
  • Internet or Social media—excessive or problematic use
  • Isolating oneself from friends and family
  • Learning disability
  • Memory problems
  • Mitochondrial dysfunction
  • Multiple sclerosis
  • Obsessive-Compulsive disorder (OCD)
  • Out-of-body experiences
  • Paranoia or feelings of persecution
  • Physical health problems involving the heart, liver, kidney, blood, etc.
  • Posttraumatic stress disorder (PTSD)
  • Psychiatric hospitalization
  • Schizophrenia symptoms
  • School difficulties, such as conflicts with teachers or classmates, loss of interest in school, excessive absence, mistakes, rule-breaking, memory or learning problems
  • Self-harm, such as cutting or burning
  • Sensory problems with pain, noise, light, heat, cold, odors, etc.
  • Sexually transmitted disease, HIV/AIDS, etc.
  • Shopping or spending money excessively
  • Suicidality
  • Threatening other people
  • Verbal difficulties
  • Video gaming excessively
  1. Were there any other problems related to the patient’s treatment?
  2. Why do you think the treatment was harmful or inappropriate?

Step 2 — Go to the FDA Site

Go to the FDA’s MedWatch Voluntary Reporting site to file a report online or download a PDF that you can print and mail to the FDA. If you’re getting the PDF, select Form 3500. Click here to get to the FDA site.

FDA Adverse Effects Report 1.jpg

Step 3 — Start Filling in the Form

Begin to fill in the FDA form. Check the box to indicate that the patient had a bad side effect, including new or worsening symptoms of mental or physical health problems. Check the boxes to tell the FDA if the patient had to be hospitalized, had mental or physical health problems after using the drug, or had a life-threatening problem such as attempted or threatened suicide.

If the patient did not yet suffer an adverse drug effect, but you think it was inappropriate for the doctor to prescribe the drug, then just skip this section and go to the next part of the form.

FDA Adverse Effects Report 3B.jpg

Step 4 — Tell What Happened

On the first screen, a box says: Tell us what happened and how it happened:* You must provide information here.

Tell the FDA what happened, truthfully (don’t make things up!) and in your own words. For example: Tell the FDA if the patient did not get enough testing, screening or counseling before getting transition drugs. Tell the FDA if doctors handed out a prescription for transition drugs without trying other alternatives or warning you about possible adverse drug effects.

If the patient already had autism, a psychiatric disorder or a learning disability that might be worsened by high testosterone/low estrogen drug treatments, then tell the FDA.

Tell the FDA if the patient’s depression, anxiety, autism, ADHD, PTSD or other mental health conditions got worse. Mention problems such as aggression, mood swings, delusions, reckless behavior, problems at school or work, new or worsened symptoms of a psychiatric disorder, suicidal behavior, need for hospitalization, unplanned pregnancy, HIV/AIDS or other problems that occurred after the patient started used the testosterone or GnRHa drug.

Here are some examples:

FDA Adverse Effects Report 10.jpg

FDA Adverse Effects Report 6.jpg

FDA Adverse Effects Report 5.jpg

FDA Adverse Effects Report 4.jpg

Step 5— Check the Blue Box

At the bottom of the first screen, check the top blue box to indicate that the problem involved a drug (instead of a medical device):

FDA Adverse Effects Report 9.jpg

Step 6 — Don’t Give Your Name to Drug Company?

Continue to fill out the FDA form. On the fourth screen, the FDA will ask for your contact information. Enter a name. Below that, there is an option to enter your email address and phone number. You are not required to provide your phone or email. The FDA will accept your form without verifying your legal name, phone or address.

FDA Adverse Effects Report 12.jpg

At the bottom of the fourth screen, there will be questions asking if you reported your problem to the drug manufacturer and if you want to identify yourself to the drug manufacturer. This is your choice. If you do NOT want to identify yourself to the drug manufacturer, then check the box to say NO. You can still submit the form to the FDA.

A warning will pop up. You can just close it and continue without agreeing to give your name to the drug manufacturer.

FDA Adverse Effects Report 8.jpg

Step 7 — SAVE or PRINT

Proceed to the final screen where you can review your information. SAVE or PRINT a copy for yourself. Then submit it to the FDA.

Step 8 — Let Us Know (optional)

What problems did you describe to the FDA? What steps are you planning next? Will you encourage other patients and parents to submit an FDA form?

Let us know! Send us an email at editor@transbrainfx.com