PPH Diagnosis

An accurate diagnosis of PPH (Primary Pulmonary Hypertension) may require time for the symptoms to develop. It generally involves the use of chest x-rays, CAT scans, pulmonary function tests, echocardiograms and angiography (inserting a catheter into the pulmonary circulation and injecting dye to demonstrate abnormal structure). Required treatment for the serious medical complications related to PPH (Primary Pulmonary Hypertension) includes intensive medical management with a variety of medications employed in an effort to reduce symptoms. It may involve the need for organ transplantation. The symptoms associated with PPH (Primary Pulmonary Hypertension) may include dyspnea (shortness of breath), feeling lightheaded or dizzy, weakness, fatigue, chest pain, ascites and edema, or death. People who have suffered damages related to the use of fen-phen, including PPH (Primary Pulmonary Hypertension), may proceed with claims to recover damages with the assistance of PPH (Primary Pulmonary Hypertension) attorneys. They can receive compensation for pain and suffering, lost earnings, medical expenses, and punitive damages.

While the FDA approves the initial marketing of a drug and specifies indications (diseases or symptoms for which the drug can be used) it does not regulate prescribing practices. Therefore, drugs may be used by individual physicians at their discretion for symptoms or disorders other than those cited by the FDA (off-label use).

Off-label use is a common and necessary part of medical practice. Waiting for FDA approval for every indication would unnecessarily delay and restrict physicians' efforts to treat their patients. In many cases approval will never come, as it depends upon complex, protracted and expensive efforts on the part of pharmaceutical companies to demonstrate that a drug is both effective and safe for each indication.

If physicians have already discovered that a drug is useful in an off-label application, they will prescribe it in that fashion, regardless of a lack of FDA approval.

Unless they believe that FDA approval will lead to an increase in the prescribing practices of physicians (and higher profits that will at least offset the costs of gaining approval) there is no incentive for drug companies to pursue approval for additional indications.