FDA Public Health Advisory - Permax Withdrawn From The Market
3/29/07 - The FDA reported today that the companies that manufacture pergolide, marketed as Permax, have agreed to withdraw this drug from the market. Permax has been linked to increased risk of heart valve injuries.
Two studies published in the New England Journal of Medicine on January 3, 2007 confirm that Permax increases the risk of heart valve injury, similar to the damage caused by the weight loss drug fen-phen. Permax is prescribed throughout the United States to treat the effects of Parkinson's disease, but many doctors also use it to treat a condition called Restless Leg Syndrome.
The first of the two studies followed the medical records of 11,417 Britons that took the highest recommended dose of Permax. Researchers discovered these patients suffered a 37-fold increase in developing potentially fatal heart valve damage. The second study involved the monitoring of 245 Italian patients, including 155 people undergoing Permax treatment for Parkinson's. This study concluded that 23.4% of the Permax patients suffered heart valve damage rather than the 5.6% of people in the control group.
The side effects of Permax were also observed at the Mayo Clinic. In three female patients with no prior history of heart disease, long-term Permax usage allegedly lead to serious valve complications that required two of the patients to undergo valve replacement surgery.
These studies confirm the long-standing fears that Permax was far more dangerous than cheaper generic forms of the drug. The Food and Drug Administration mandated in 2003 that the packaging of Permax must carry a black-box warning to alert doctors to the potential risks of the drug. Doctors have known the potential risks of Permax since it was launched in 1989, and since that time almost 500,000 prescriptions for the drug have been filed.
Other common side effects of Permax generally affect three areas; the nervous system, the respiratory system, and the digestive system. They tend to include:
- Nervous system:
- Insomnia
- Hallucinations
- Spasms
- Dizziness
- Sleepiness
- Respiratory system:
- Runny noses
- Difficulty breathing
- Digestive system:
- Constipation
- Diarrhea
- Nausea
- Indigestion
If you or someone you love was affected by the serious and potentially fatal side effects of Permax, you must take action immediately. You could be entitled to financial compensation for your pain and suffering, but if you hesitate the statute of limitations time restrictions in your state could run out, leaving you with no way to take legal action. We can work together on your case to ensure you will get the justice you deserve. Contact us today.
Images portrayed in this site are not actual clients. It is not implied that images of
people on this site are real or have had their health harmed or affected from using Permax.
