Medications for Scleroderma, Arthritis,
Autoimmune and Rheumatic Diseases |
| This page was written by Janey Willis, and has not yet been medically edited. See Disclaimer. |
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| FDA Warnings and Voluntary Recalls on Medications and Treatments |
| FDA Puts Black-Box Warning on Bowel-Cleansing Drugs. The FDA said it would now require a black-box warning on the oral sodium phosphate products Visicol and OsmoPrep, alerting consumers about the risk of acute phosphate nephropathy -- a type of severe kidney injury. Washington Post. 12/11/08. (Also see: Bowel Dysfunction) |
| Govt pays for deadly, unapproved drugs. Dozens of deaths have been linked to medications that have never been reviewed by the government for safety and effectiveness but are still covered under Medicaid. Comcast.net News. 11/24/08. (Also see: Colchicine) |
| Psoriasis Drug Raptiva Gets FDA Warning. The psoriasis drug Raptiva is getting a "black box" warning, the FDA's sternest warning, about the risk of life-threatening infections including a rare brain infection and meningitis. WebMD. 10/16/08. (Also see: Psoriasis) |
| Cases of progressive multifocal leukoencephalopathy (PML), sometimes fatal, have been reported in patients treated with mycophenolate mofetil (MMF). PML is a rare, progressive, demyelinating disease of the central nervous system (CNS) that usually leads to death or severe disability. Novartis global safety database has no cases of PML. Roche has reported ten confirmed and seven possible cases of PML with MMF. The ten confirmed cases were six solid organ transplant patients and four systemic lupus erythematosus (SLE) patients. The seven possible cases were four solid organ transplant patients and two SLE patients. The seventh possible case was an HIV positive patient. U.S. Food and Drug Administration. 07/01/08. (Also see: Cellcept) |
| FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now . The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008. FDA. 05/30/08. (Also see: Asthma) |
| Mercury teeth fillings may harm some: U.S. FDA. Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses. Reuters. 06/04/08. (Also see: Causes of Scleroderma) |
| Bisphosphonates Linked To Incapacitating Bone, Joint, and Muscle Pain - FDA Alerts The Food and Drug Administration (FDA) is reminding doctors of the link between taking bisphosphonates and a raised risk of experiencing often incapacitating bone, joint, and/or musculoskeletal pain. Medical News Today. 07 Jan 2008. (Also see: Osteoporosis) |
| Fentanyl Pain Patch Recalled. Voluntary Recall of Duragesic and Generic Fentanyl Patch Due to Overdose Risk. WebMD. 02/13/08. |
| Botox Linked To Respiratory Failure And Death, FDA Advises. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. ScienceDaily. 02/10/08. |
| FDA Alert for CellCept (mycophenolate mofetil). Roche and FDA notified healthcare providers that use of CellCept (mycophenolate mofetil) is associated with increased risk of first trimester pregnancy loss and increased risk of congenital malformations. In addition, CellCept reduces blood levels of the hormones in an oral contraceptive pill and could theoretically reduce its effectiveness. FDA Medwatch. October 2007. (Also see: Medications) |
| Viagra (sildenafil citrate) Information, FDA Warning. FDA received reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors, Viagra, Levitra, Cialis for the treatment of erectile dysfunction and Revatio for the treatment of pulmonary arterial hypertension. U.S. FDA. 10/22/07. (Also see: Ear Involvement, Raynaud's and Pulmonary Hypertension) |
| FDA: Don't Use Quinine for Leg Cramps. FDA Cracks Down on Unapproved Quinine Drugs, Cites Problems Including Deaths. WebMD Medical News. 12/12/06. |
| FDA Public Health Advisory: Life-threatening Brain Infection in Patients with Systemic Lupus Erythematosus After Rituxan (Rituximab) Treatment. FDA has received reports of the death of two patients who were treated with Rituxan for systemic lupus erythematosus (SLE). Both patients developed a life-threatening viral infection of the brain. U.S. Food and Drug Administratoin 12/18/06. (Also see: Lupus) |
| COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Manufacturers of non-prescription (over-the-counter) NSAIDs are being asked to revise their labeling to provide more specific information about the potential cardiovascular and gastrointestinal risks of their individual products and remind patients of the limited dose and duration of treatment of these products in accordance with the package instructions. FDA. July, 2005. |
| FDA Issues Public Health Advisory on the Fentanyl (Duragesic) Patch in response to reports of deaths in patients using this potent narcotic medication for pain management. Medical News Today 07/18/05. |
| FDA Alert: Alemtuzumab (marketed as Campath) Information. Three patients in a clinical study of the drug Campath for the treatment of Multiple Sclerosis (MS) developed severe idiopathic thrombocytopenic purpura (ITP). One of the patients died. U.S. Food and Drug Administration. 11/05. |
| Thalidomide - Important Patient Information. Thalidomide is not approved for general sale in the United States. However, the Food and Drug Administration allows it to be used in studies. FDA. July 7, 2005. |
| FDA Alert: Detention without Physical Examination of Domperidone, brands names Motilium, Euciton, Cilroton, Praxis, Seronex, Emiken. Domperidone is not approved for any use in the U.S. There have been several published reports and case studies of cardiac arrhythmias, cardiac arrest and sudden death in patients receiving an intravenous form of domperidone. U.S. Food and Drug Administration (FDA). 2004. |
| Scleroderma Clinical Trials and Open Enrollments Includes proven treatments, unproven, open enrollments, pending results, and research registries. ISN. |
