FDA May Recall Blood Pressure Drug
The Food and Drug Administration is considering the recall of a blood pressure drug that has not been proven to help patients, according to an article by the Associated Press.
The drug ProAmatine, which is produced by Shire Laboratories, has been on the market for fourteen years. It was designed to help stimulate patients with extremely low blood pressure. The drug was approved in 1996 based on results from a study in which ProAmatine was used by individuals with very low blood pressure.
However, the company has never submitted a subsequent follow-up study, as required. The FDA is giving Shire Laboratories a chance to schedule a hearing on the drug. This will be the first time the FDA has pulled a drug off the market because of missing follow-up studies.
For the past twenty years, the FDA has allowed drugs to be placed on the market quickly based on initial studies that show that the drugs will make significant improvements in patients’ health. However, critics have pointed out that many drugs do not actually live up to the hype. Since 1993, the FDA has requested 144 follow-up studies, and almost one-third are still pending.
Have you taken drugs that have later been recalled due to dangerous side effects? Or have you been regularly taking a drug, such as ProAmatine, for a serious medical problem that the drug has actually not been proven to treat? If so, you may be entitled to compensation for your medical conditions. Contact the experienced New York pharmaceutical injury attorneys at Wingate, Russotti & Shapiro for a free consultation at 212-296-7353.