On August 30, 2012, the FDA issued a Safety Announcement that recommended that Revatio, a drug used to treat pulmonary arterial hypertension (PAH) or high pressure in the blood vessels leading to the lungs, not be prescribed for children between the ages of 1 and 17. Revatio may not sound familiar, nor will its chemical name, Sildenafil. However, everyone will recognize Sildenafil when told it is also marketed as VIAGRA. Both Revatio and VIAGRA are prescribed for the FDA approved treatment of erectile dysfunction (inability to get or maintain an erection) in men. As if this reason alone is not reason enough not to prescribe Revatio for children with pulmonary arterial hypertension, it is now known that giving Sildenafil to children significantly increases the potential risk of death.

Now known only because the FDA learned of this increased risk from a 16 week study of 234 patients with PAH who ranged in age from 1 year old to 17 years old. This study was designed to see if Revatio increased the exercise capacity of these young patients. As referenced above, it did not result in a statistically significant improvement in exercise capacity in those patients. Put another way, being absolutely no benefit of this therapy, the risk outweighed the benefit. Further, the higher the dose the more increased the risk, and the lower the dose the less effective the therapy.

Again, the study found absolutely no benefit of this therapy for children 17 years of age and younger. So why prescribe such a dangerous drug to a child? Doctors have been prescribing it as an off label use since its FDA approval on June 3, 2005. Off label means that the use is not approved by the FDA. The prescribing physicians learned of the off label use by the PFIZER drug reps who positioned the drug for that off label use. Positioned is the word used by PFIZER and all other drug companies who encourage doctors to prescribe it for non-approved uses because promoting and marketing for off label use is illegal.

One dares to think what other problems might occur when children 17 years of age and younger are given a drug to treat erectile dysfunction, but it gives a pretty good idea of why Revatio’s use for children under the age of 17 who have pulmonary arterial hypertension is not FDA approved.


Drug Companies Say The Doctor Knew and Did Not Tell You

Product liability cases are filed against drug companies to recover compensation for serious injuries and damages from dangerous prescription drugs. These lawsuits are based on the inadequacy of the written warnings (also referred to as the label or package insert) that come with the drug to warn the patient and prescribing physician of its risks and serious side effects. The lawsuits are premised on the principle that the drug companies have the duty not to injure the patient. Drug companies fulfill that duty when their drug’s warnings disclose all of the drug’s risks and serious side effects. Only then can the patient exercise their absolute right to know all of the risks and serious side effects of a drug before they take a drug. When the drug companies fail to fulfill that duty and serious injuries and harm result, the drug company must be held responsible and accountable.

Notice that I said the drug company must be held responsible and accountable. That litigation may or may not involve the doctor who prescribed the dangerous drug. At Bailey & Galyen, litigation against the drug companies rarely if ever involves the prescribing doctor. Prescribing doctors are not sued because they only know what the drug companies tell them. Fact is that the prescribing doctors know little more about a drugs risks and serious side effects than that, and the information they do have is solely from the drug company’s written warnings. So, if the warnings are inadequate, in all likelihood so is the doctor’s knowledge of the drugs risks and serious side effects. That effectively makes both the doctors as well as their patients the victims when their patients experience serious side effects that the drug company did not adequately warn about. To add insult to injury, when a lawsuit is filed the drug companies deny any responsibility of wrongdoing and blame both the injured patient and the prescribing doctor for the patients’ injuries and damages. Here is an example of that language which drug companies regularly include in their defensive pleadings:

When the drug company takes the prescribing doctor’s deposition with hopes to prove that the doctor would not have done anything differently no matter what was in it’s warnings and not matter what the prescribing doctor knew, it is important to be clearly point out and emphasized to the prescribing doctor that his patient did not sue or make any allegations against him in the case against the drug company. The prescribing doctor must be shown in the drug company’s pleadings filed in the lawsuit the allegations against the prescribing doctor, stating that the prescribing doctor is responsible and at fault for his patient’s injuries and damages.

The drug companies further contend:
1. even if armed with this knowledge, it wouldn’t matter because the prescribing doctor already knew everything that a supposedly adequate warning would have contained;
2. that the prescribing doctor didn t read the warnings and therefore a different warning wouldn’t have changed the doctor’s decision to prescribe that drug for the patient; and
3. that even if at the time the prescribing doctor prescribed this dangerous drug to the patient he knew everything then that he has since learned about this drug, he still would have treated the plaintiff the very same way (by prescribing the drug).

To justify this position, the drug companies use the statistics of how many patients might experience a drug’s serious side effects. Drug companies take the callous position that all drugs have side effects, and it is acceptable if 1 in 10,000 patients experience a serious side effect from their drug because 9,999 people didn t.

Putting the blame on another in a lawsuit is called alleging an affirmative defense. The affirmative defense states that if the drug company did something wrong (which it denies it did), someone else actually caused the patient’s injuries and damages. The drug company’s affirmative defense alleges that its warnings were accurate and complete and the prescribing doctor caused the patient’s injuries because the drug company passed on to the prescribing doctor all of the information that it had about the drug’s risks and serious side effects, and it was the prescribing doctor’s responsibility to then pass that information on to the patient. That works fine if the drug company did make accurate and complete disclosure of all the drug’s risks and serious side effects in its warnings. In that event, the prescribing doctor would have been fully aware of the same and could have passed those warnings on to the patient. Most often however, that is not the case: The prescribing doctor knows only what they read in the drug company’s warnings.

The fact of the matter is that a prescribing doctor’s learning about a drug’s risks and serious side effects does change his prescribing practices accordingly: It does affect which patients he prescribes the drug for, what doses he prescribes, what directions he gives for taking the drug, and the risk/benefit discussion the prescribing doctor has with the patient before prescribing the drug. It does change the patient’s decision whether or not to take the drug when the patient is aware of and weighs all known risks against the touted benefits of the drug.

The problem is multifold:
1. The FDA approves prescription drugs solely on the information it is provided by the drug company. The FDA does no testing; it is understaffed and underfunded. The FDA relies on the drug companies to test drugs for safety or effectiveness. If the drug company does not adequately test for safety or effectiveness and does not disclose all study results to the FDA, and the FDA approves the drug, it has done so on inaccurate and incomplete information.
2. The drug company warnings only include that which the FDA makes it include based on what the drug company tells it about the drug’s safety and effectiveness. If the drug company does not disclose all known risks and side effects to the FDA, the warnings will be inaccurate and incomplete
3. The drug company’s incentive is not to make accurate and complete disclosure of all known risks and serious side effects to the FDA and in its drug’s label. The reason: Doctors will be hesitant to prescribe it and patients will be hesitant to take it, and that reduction in prescriptions being written equates to a drop in the drug company’s revenue.

The solution is having the ability to hold the drug companies responsible and make them accountable for their failing to fulfill their duty to the patient to protect them from known risks and serious injuries.