The makers of Raptiva, a once-a-week injection used to treat adults who suffer from moderate to severe cases of plaque psoriasis, have announced a voluntary withdrawal of the drug from the U.S. market. The announcement comes in the wake of reports that long-term use of Raptiva may cause patients to develop progressive multifocal leukoencephalopathy, or PML, a rare but serious neurological disease. PML usually occurs in people with compromised immune systems. Symptoms can included confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems. To date there is no known treatment for PML. In February 2009, the FDA issued a Public Health Advisory after receiving 4 reports of patients with PML. Genentech, the makers of Raptiva, planned to make the drug unavailable in the U.S. by June 2009.
Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are 2 common women’s health problems that are treated with the surgical implantation of a transvaginal mesh. However, the U.S. Food & Drug Administration has received a growing number of reports that the mesh device is causing complications, including urinary problems, erosion of vaginal tissue, pain, and infection. The transvaginal mesh has not been recalled and has continued to be used by health care practitioners, despite the warnings.