Video originally created by FDA -- posted by Lawsuit.com on December 10, 2009
Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Hypersensitivity reactions have also been reported, sometimes leading to organ dysfunction, including liver failure.
New labeling for Intelence warns that the drug must be discontinued immediately if severe skin or hypersensitivity reactions develop. Signs include severe rash, malaise, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial edema, hepatitis and eosinophilia. The labeling cautions practitioners that a delay in stopping treatment after the onset of a severe rash may result in a life-threatening reaction.
The tissue transplant industry is under legal fire. Dating back to at least five years ago, bone skin and ligament from cadavers used in transplantation has been an area of concern for the public at large. It has been estimated that hundreds of body parts used for surgeries like knee surgery, back fusion and neurosurgery may not be sterile and inadequately processed. Companies such as Allosource, Biomedical Tissue Services, and Medtronic are under scrutiny for their suspected role in the ill-prepared and un-screened tissue. As R. Helm, Attorney at Law, of Anchorage Alaska explains, “The greatest concern is that no one knows if the people receiving the cadavers have been exposed to medical conditions nor do we know what occurs in the body should the cadaver dissolve.”
Tissue Transplant Watchdogs
Tissue is procured and sent on to manufacturers such as LifeCell Corporation, Blood and Tissue Center of Central Texas, and Regeneration Technologies. However, tissue banks are not required to obtain membership in organizations such as the American Association of Tissue Banks (AATB) which serve to guard against the infiltration of defective tissue to the public. The AATB has set standards for operation and an accreditation process which includes inspections of facilities that procure and process human tissue from cadavers. The inspectors’ analysis includes record-keeping, quality control, quality assurance, donor screening, testing and suitability determinations. The process of tissue procurement is comprised of donor and tissue suitability determination, tissue retrieval, decontamination techniques, quality control, product testing, and clinical application of allografts. The FDA has issued recalls over the years and some companies have come forward to issue their own recalls over the years. Yet, the check and balance system is not refined, placing hundreds of people requiring tissue transplantation at risk.
The tissue transplant scare could have been sparked by the New Jersey case involving stolen body parts that were sent to Medtronic for processing. Or perhaps, the funeral director in North Carolina that conducted tissue recovery in the embalming room of the funeral home has been more provoking. Assuredly, the tissue transplantation industry is under scrutiny now. Select personal injury attorneys are accepting cases involving people that have been injured by questionable tissue transplantation.
Video originally created by FDA -- posted by Lawsuit.com on March 10, 2009
FDA is cautioning healthcare professionals against using skin patch testing to immunologically confirm suspected cases of hypersensitivity reaction in patients treated with the antiretroviral drug abacavir. Abacavir is sold under the trade name Ziagen and is part of the combination products Epzicom and Trizivir.
Abacavir is associated with serious and potentially fatal hypersensitivity reactions. Patients with a particular HLA allele, HLA-B*5701, have a higher risk of developing these reactions if they are treated with abacavir, and so abacavir is not recommended for these patients. Because of this, a boxed warning recommends that all patients be screened for the HLA-B*5701 allele before starting or restarting abacavir therapy. If a hypersensitivity reaction is suspected in any patient, even those without the allele, the drug should be stopped immediately and permanently, because rechallenging the patient with abacavir could be fatal.
Abacavir hypersensitivity reactions can be difficult to diagnose because they can be confused with adverse events from the patient’s other HIV medications, or they may mimic the infections that frequently occur in HIV patients.
Several research reports have described using skin patch testing to confirm suspected cases of abacavir hypersensitivity immunologically. However, data suggest that skin patch testing may miss cases of true hypersensitivity reaction or provide false positive results. FDA points out that the accuracy of skin patch testing is unknown, and that using skin patch testing to confirm cases of abacavir hypersensitivity has not been validated clinically. Given that rechallenging a patient with a suspected hypersensitivity reaction could be fatal, these reactions must continue to be diagnosed clinically.
Video originally created by FDA -- posted by Lawsuit.com on August 13, 2008
The Food and Drug Administration wants to be sure that consumers know about new warnings on over-the-counter vaginal contraceptive products that contain the spermicide ingredient nonoxynol 9 (N9). These products include spermicidal gels, foams, films and inserts.These warnings emphasize that nonoxynol 9 does not protect against infection from HIV, the virus that causes AIDS, or other sexually transmitted diseases. The warnings are intended to correct a mistaken impression that nonoxynol 9 protects against STD infection, including HIV/AIDS. In fact, using it may actually increase the risk of contracting HIV/AIDS from an infected partner, because nonoxynol 9 can irritate the vagina and rectum.The new labeling makes several other points:• Nonoxynol 9 contraceptive products are for vaginal use only, not rectal use. If you or your partner experience burning, itching, a rash or irritation of the vagina or penis, stop using it and talk to your doctor.• You can use nonoxynol 9 for birth control if you are not at risk for getting HIV/AIDS i.e., you have sex with only one partner who is not infected with HIV and who has no other sexual partners or HIV risk factors.• Don’t use nonoxynol 9 spermicides if you or your partner have HIV/AIDS, or if you don’t know whether you or your partner are infected, or if either of you has multiple sex partners or other HIV risk factors. Instead, use a condom that doesn’t contain nonoxynol 9. Remember, when used correctly every time you have sex, latex condoms can greatly reduce, but don’t eliminate the risk of catching or spreading HIV.• And finally, talk to your doctor, pharmacist or other health care provider if you have questions about your options for birth control or about how to prevent infection with sexually transmitted diseases.
Video originally created by FDA -- posted by Lawsuit.com on July 14, 2008
Roche Pharmaceuticals has notified health care professionals about new information that reinforces a contraindication when prescribing combination antiretroviral therapy for treating HIV infection..Rifampin has been contraindicated with saquinavir, because the rifampin will reduce plasma levels of saquinavir. A study was recently performed to see whether boosting saquinavir with ritonavir would overcome this problem. But when healthy volunteers in the study were given rifampin along with the combination of saquinavir and ritonavir, 39 percent developed significant hepatocellular toxicity.As a result, Roche Pharmaceuticals is cautioning that rifampin should not be given to patients who are also receiving a combination of saquinavir and ritonavir.
