Permax is one of the commercial forms of pergolide mesylate. Pergolide mesylate is a dopamine precursor that promotes the body’s production of the dopamine neurotransmitter. The FDA approved it in 1982 as a treatment for the signs and symptoms of Parkinson’s disease. Dopamine is a neurochemical involved in controlling body movement.
Permax was a potent and effective drug for patients with motor function problems caused by Parkinson’s disease. Unfortunately, Permax had significant negative side effects.
The drug was withdrawn from the U.S. market in March 2007 and from the Canadian market in August 2007 because it created the risk of serious damage to patients’ heart valves. While the use of pergolide in humans is still approved in some countries, pergolide is mainly used for veterinary purposes. Again, it is not legally available in the U.S.
What Are the Adverse Effects of Permax?
The FDA ordered a recall of pergolide products, including Permax, produced by Valeant Pharmaceuticals, Par, and Teva.
Permax is an oral prescription medication that Eli Lilly Pharmaceuticals originally manufactured. As noted above, Permax was used to treat the symptoms of Parkinson’s disease affecting movements, such as tremors and slow movement.
Parkinson’s disease is a progressive disease that affects the central nervous system. It causes a person to have tremors, rigidity, slow movement, and impaired balance and coordination. The secondary symptoms of Parkinson’s disease can include speech problems, loss of control of facial muscles, trouble swallowing, confusion, memory problems, loss of energy, and more.
Permax and related pergolide products were originally approved in 1989 as an additional therapy for other Parkinson’s treatments. About 12,000 American patients took Permax or other pergolide products in 2006, just before it was taken off the market.
Permax and pergolide were taken off the market and recalled because of the risk of damage to the heart valve caused by Permax. The medical term for this condition is “cardiac valvulopathy,” which means an abnormality of the heart valves.
Research studies in reputable medical journals confirmed that Permax could increase the risk of heart valve regurgitation. Valve regurgitation is when the blood in the heart valve leaks backward into the valves instead of flowing normally through them. This is a serious condition with symptoms including heart palpitations, an awareness of a more forceful or irregular heartbeat, breathing difficulties, swelling of the legs, and fatigue.
Valve regurgitation is a potentially life-threatening condition. It can lead to several other health problems, such as stroke, heart failure, and fibrosis. Stopping the use of Permax can improve the symptoms of valve regurgitation and other symptoms of heart valve damage.
What Other Side Effects Are There for Permax?
In addition, Permax warnings stated that the use of pergolide products caused the following conditions:
- Pleuritis: This is an inflammation of the lining of the lungs;
- Pleural effusion: This is an accumulation of fluid between the membrane layers of lung tissue and other issues in the chest cavity;
- Pleuris: This is a thickening of the lung’s lining;
- Pericarditis: Pericarditis is an inflammation of the pericardium, the membrane surrounding the heart;
- Retroperitoneal fibrosis: This disorder causes the tubes that carry urine from the kidneys to the bladder to be blocked.
These are all serious health conditions. Numerous other adverse effects were reported for the use of Permax. In one study, twenty-seven percent of approximately 1,200 patients administered Permax for treating Parkinson’s disease in clinical trials in the U.S. and Canada had to discontinue treatment because of adverse reactions.
The reactions that most commonly caused discontinuation was related to the nervous system. The most common event was hallucinations, and the next most common was confusion.
Still, other side effects reported by users of Permax included falling asleep at random times during daily activity. Some of these episodes of falling asleep occurred while the person taking Permax was operating a motor vehicle. This had predictable consequences.
What Is the Current Status of Permax?
As noted above, Permax has been taken off the market in the U.S., and the products that three manufacturers produced were recalled. This means that U.S. doctors should not prescribe Permax to patients, and any Permax in circulation in pharmacies or elsewhere should be disposed of somehow.
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Some, but not all, recalls are announced on the website FDA.gov or in the news media. A public notification is generally made by the FDA when a product that has been distributed or poses a serious health hazard is recalled.
Or a pharmaceutical company that manufactures a recalled drug may issue a public notification of a recall. If the company does not do it, the FDA may do so if it determines that it is necessary to protect patients. Patients may also learn about a recall from the manufacturer, healthcare professional, or pharmacist.
If a person has a medicine that has been recalled, such as Permax, the FDA recommends that they talk to their doctor about the best course of action for their health. If the person is taking the medication at the time of a recall, they may want to plan to stop the medication. Sometimes this should not be done abruptly. They may also want to return any unused product to the store or pharmacy where they bought it.
Stores and pharmacies will usually accept returns and give refunds when a company has announced a recall of its products. Generally, Class I recall notifications give instructions to patients with specific instructions. The FDA recommends that patients follow the instructions given in a Class I recall given by the recalling company.
What Can I Do Now If I Have Taken Permax?
Permax was taken off the market many years ago, in 2007, so presumably, a person would no longer be using the medication. However, if they are, they want to talk to their physician about getting off the drug.
If a person believes that they were injured by taking Permax, they may be able to file a lawsuit to recover damages against the manufacturer for failure to warn of the known dangers of taking Permax. Or, they might be able to file a lawsuit against the physician who prescribed the medication for medical malpractice.
A person’s course of action would depend on when they took the medication, whether before or after it was removed from the market or recalled.
One issue that might have to be addressed and could make filing a lawsuit difficult would be the statute of limitations. The statute of limitations is a time limit the law imposes on people for filing a lawsuit. The statute of limitations varies depending on the kind of claim a person has and the statute of limitations law of the state where the person files their lawsuit.
For example, in several states, the statute of limitations for medical malpractice is only 1 year from the date on which a person learns of the malpractice. It is 2 years in some other states. But a person would not want to delay deciding whether to file a lawsuit for medical malpractice.
Do I Need the Help of a Lawyer for a Permax Issue?
Again, given that Permax is no longer available in the U.S. and has been recalled, any legal action in connection with Permax is likely to be challenging at best. If you think you have been injured by taking Permax, you should contact a class action attorney as soon as possible. Your attorney will be able to analyze the facts of your situation and tell you whether legal action is still an option.
