Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used as pain relievers for inflammatory conditions. These drugs include ibuprofen (Advil, Motrin, Nuprin), naproxen, (Aleve), aspirin, rofecoxib (Vioxx) and celecoxib (Celebrex). The pain relieving effects though come with some potentially dangerous and possibly deadly side effects.
NSAIDs work by inhibiting hormones known as prostaglandins. Prostaglandins serve numerous functions within the body including regulating blood pressure, antidepressant, protecting the stomach from acid, etc. Inflammatory prostaglandins are essential for increasing blood flow to injured areas, which promotes healing by increasing oxygen and nutrient levels to the injured site. Prostaglandins do this by dilating the blood vessels. The inflammation occurs when the blood vessels are dilated, which causes the blood vessels to become permeable. This permeability causes the small blood vessels to leak fluid in to the surrounding tissues, which leads to the swelling. NSAIDs decrease the pain and swelling by countering these inflammatory prostaglandins. This causes the blood vessels to constrict, thereby reducing leakage of capillaries.
By reducing blood flow, NSAIDs actually inhibit the healing process. Although this is one of the more mild side effects of these drugs. Other side effects of NSAIDs include, but are not limited to, liver failure, kidney failure, heart attack, stroke, aseptic meningitis, loss of vision, tinnitus (ringing in the ears), high blood pressure, depression and bleeding ulcers. Contrary to popular belief these side effects do not require long term use or over dose.
The most common side effect is bleeding ulcers, which leads to the majority of the over 16,000 deaths annually from these drugs. These ulcerations occur from the inhibition of another prostaglandin required to form the protective mucous lining of the stomach. This mucous coating protects the stomach wall from stomach acid. By inhibiting the formation of the protective stomach lining the stomach wall is prone to direct attack from the stomach acid leading to ulceration of the stomach wall and internal bleeding.
Constriction of blood flow leads to elevation of blood pressure. Loss of vision and tinnitus occur from reduced blood flow to the eye and in the area of the neck due to the blood vessel constriction. The risk of heart attack and stroke are also increased by the ability of these drugs to decrease or block blood flow to the heart and brain.
Prostaglandins play a major role in mood. By countering prostaglandins, the use of NSAIDs will cause depression.
Kidney and liver failure occur from a lack of blood flow to these organs. In fact, 2 dozen people died from ibuprofen induced hepatitis during clinical trials. People with poor perfusion to the organs such as those with congestive heart failure, diabetes, Raynaud’s, etc. are at a higher risk for the damage or organ failure since blood flow is already reduced in these individuals. Further constriction of the blood vessels by NSAIDs may completely cut off the blood supply to organs and glands leading to damage or complete failure.
Contrary to popular belief it does not take long term use or overdose to cause organ failure. In fact a single recommended, dose can cause sufficient constriction of the blood vessels to cause damage. I know of 4 people that developed kidney failure after taking a single recommended dose of ibuprofen. And the number of cases is most likely heavily underreported since adverse effects of drugs are commonly attributed to other disorders.
The NSAID Bextra, manufactured by the pharmaceutical company Pfizer, was approved by the FDA in November of 2001. Bextra was later recalled after it was revealed that the drug could cause potentially deadly allergic reactions, the disorder Steven’s-Johnson syndrome and toxic epidermal necrolysis.
The new proposals for warning labels on these drugs need to include the risk of adverse effects from recommended use as well. Not only long term use and overdose as is currently being recommended.
A few other recommendations that I feel should be implemented include:
- Pulling NSAIDs off the market as was done with Bextra since the safety studies were either never done, or were suppressed by the drug companies or ignored by the FDA to get approval.
- Requiring more evidence of safety before approving these drugs.
- Charging pharmaceutical drug company executives and FDA officials with manslaughter when it is shown that side effects were hidden to gain approval and it has resulted in deaths. Right now only pharmaceutical companies are held liable. Although only by civil liability, not criminal. Fines are sometimes imposed against pharmaceutical companies although they are hardly punishment. Fines are generally around a million dollars or slightly higher. By the time they are fined though the drug companies have made hundreds of millions or even billions of dollars in profits. This is hardly punishment and encourages the drug companies to hide adverse effects since profits will far outweigh any liabilities.
- Heavier civil penalties against the drug companies to actually punish them for deliberately hiding known side effects and for manipulating research to make their drugs appear safe and effective
- Civil lawsuits should not only include the drug companies but also the FDA officials who receive bribes in the form of gifts, payoffs and jobs to push the drugs through the approval process.
- Cracking down on illegal investments by FDA officials in to the drug companies they regulate. This is a violation of insider trading laws. Despite this, nothing has been done to correct this illegal activity within the FDA despite these illegal investments being reported for nearly 3 decades.
- Faster action on pulling drugs from the market suspected of causing harm until safety of the drugs can be established.
- Testing of drugs by independent testing agencies. Currently the FDA requires the drug companies to provide their own safety data to obtain approval. If the drug company has already invested millions of dollars in to the drug and a safety issue appears the drug company is not going to reveal the safety issue and risk approval being denied. This is a major reason drugs are being approved then being pulled several years later after the drug companies have not only paid for the cost of approval but have also paid stockholders and made millions of dollars or more in profits.
- Drugs requiring a prescription when they are originally approved should remain only available by prescription. They should not be made available over the counter when the drug’s patent expires. The chemistry or dangers, of the drug do not change just because the patent has expired on the drug.