FDA Notifications: HIV/AIDS patients should avoid raw oysters from Pacific NW
HIV/AIDS patients should avoid raw oysters from Pacific NW
The Food and Drug Administration is advising consumers to avoid eating raw oysters harvested in the Pacific Northwest as a result of increased reports of illnesses associated with the naturally occurring bacteria Vibrio parahaemolyticus (Vp) in oysters harvested from the area.
Oysters harvested from this region have been reported to cause gastrointestinal illness. The threat is particularly important for people who have compromised immune function, including those living with HIV/AIDS.
Until the threat of Vp from oysters harvested in the Pacific Northwest has passed, consumers are advised to thoroughly cook oysters harvested from that area before eating. They also should thoroughly cook oysters if they are not certain of the oysters' origin, or if they wish to further reduce their risk of infection from bacteria that may be found in raw oysters.
In recent months, there has been an unusual increase in bacterial illness associated with eating raw oysters from the Pacific Northwest. The illnesses are associated with the naturally occurring bacterium Vp, which is most prevalent during summer months when water temperatures in the Pacific Northwest are most favorable for its growth. While Vp can cause mild gastrointestinal disorders in healthy individuals, those with weak immune systems and older persons are at greater risk for serious more illness, such as septicemia (infection of the blood system).
Pacific Northwest oysters are distributed nationally. Although to date most of the illnesses reported have occurred in the Pacific Northwest, some have been reported in New York state as well.
In Washington state, shellfish control authorities are identifying and closing areas where people have become sick from eating oysters. Washington state has initiated a recall of all shell stock oysters (oysters in the shell) harvested from areas closed within the state. Because of the potential for nationwide distribution, consumers are advised to follow recall instructions and return associated shell stock oysters to the retailer from which they were purchased.
Cooking destroys the bacteria, eliminating the risk of illness for both healthy and immunocompromised individuals. The majority of illnesses that occur from the consumption of raw oysters are not life-threatening to the general population and commonly range from mild intestinal disorders of short duration to acute gastroenteritis. The symptoms are watery diarrhea, often with abdominal cramping, nausea, vomiting, fever and chills. Usually these symptoms occur within 24 hours of ingestion and last no more than three days. Severe disease is rare and occurs most commonly in persons with weakened immune systems.
Persons with weakened immune systems, including those affected by AIDS; and persons with chronic alcohol abuse, liver, stomach or blood disorders, cancer; diabetes, or kidney disease should avoid raw oyster consumption altogether, regardless of where the oysters are harvested.
Consumers can continue to enjoy oysters in many cooked preparations by following this advice.
At Restaurants and other Foodservice Establishments:
- Order oysters fully cooked.
In the shell:
- Purchase oysters with the shells closed. Throw away any oysters with shells already opened.
- Boil oysters until the shells open. Once open boil for an additional 3-5 minutes.
- Steamer - add oysters to water that is already steaming and cook live oysters until the shells open, once open steam for another 4-9 minutes.
- Use smaller pots to boil or steam oysters. Using larger pots, or cooking too many oysters at one time, may cause uneven heat distribution, which may cause the oysters in the middle to not get fully cooked.
- Discard any oysters that do not open during cooking.
Shucked Oysters:
- Boil or simmer shucked oysters for at least 3 minutes or until the edges curl.
- Fry at 375 degrees for at least 3 minutes.
- Broil 3 inches from heat for 3 minutes.
- Bake at 450 degrees for 10 minutes.
For further information contact: FDA Food Safety Hotline: 1-888-SAFEFOOD
Tentative approval given for generic lamivudine/zidovudine
The FDA granted tentative approval on July 26, 2006 for lamivudine/zidovudine tablets co-packaged with abacavir sulfate tablets for treatment of HIV, manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India.
The lamivudine/zidovudine combination is a generic formulation of the approved combination product, Combivir, manufactured by GlaxoSmithKline, which combines the two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in a single tablet. Abacavir sulfate, which is also an NRTI, is a generic formulation of the approved product, Ziagen, also manufactured by GlaxoSmithKline.
The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).
"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, though it may not be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.
Check Vironostika HIV-1 test kit for problems
The FDA has issued an important notification regarding the Vironostika HIV-1 test kit: bioMerieux, Inc. has become aware of five HIV-1 finished kit lots in the field which have been reported to contain EnzAbody reagent that appears noticeably cloudy and/or flocculent, instead of clear and non-turbid as expected 30 minutes after reconstitution.
Kit lot numbers identified are 121566, 121567, 121568, 160342, and 160339 with EnzAbody Lot Numbers of 1008926, 1008926, 1008926, 1011220 and 1011021 respectively.
bioMerieux is asking all customers to verify the appearance of the EnzAbody reagent prior to using it in an assay as a general practice for all lots, whether or not they appear in this list.
If the EnzAbody reagent appears to be noticeably cloudy and/or flocculent 30 minutes after reconstitution, as a precaution, the reagent should not be used to perform the assay. Use of cloudy EnzAbody could possibly increase your risk of inaccurate HIV test results in patients and therefore should be avoided.
FDA approves Atripla as single pill once daily
The FDA has approved Atripla Tablets, a new fixed-dose combination of three widely used antiretroviral drugs, to be taken in a single tablet once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults.
Atripla is the first fixed dose combination available in the United States to combine two different classes of antiviral drugs in a single pill. This "one-pill-once-a-day" product to treat HIV/AIDS combines the active ingredients of Sustiva (efavirenz) a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), with Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate), two Nucleoside Reverse Transcriptase Inhibitors (NRTIs). Emtriva and Viread are also available in a fixed dose combination known as Truvada.
Atripla is the result of an unprecedented inter-company cooperative effort between Gilead Sciences, the manufacturer of Emtriva and Viread, with Bristol-Myers Squibb, the manufacturer of Sustiva. Merck controls the marketing of Sustiva outside the United States. The approval of Atripla will not only make the new fixed dose combination available in the U.S., but also permit its purchase under the President's Emergency Plan for AIDS Relief program.
Atripla was approved in less than 3 months under FDA's fast track program. The approval is the result of an expedited review process outlined in guidance for industry from the FDA in May 2004 (www.fda.gov/oc/initiatives/hiv/hivguidance.html). The guidance encourages manufacturers to develop fixed dose combination and co-packaged products consisting of previously approved antiretroviral therapies for the treatment of HIV infection.
The drug combination represented by this product is a recommended first line regimen for treatment naive patients (except during first trimester of pregnancy or in women with high pregnancy potential) in the national Guidelines for the Use of Antiretroviral agents in HIV-1-Infected Adults and Adolescents (http://aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf).
Atripla can significantly simplify a drug treatment regimen by reducing the pill burden, helping to increase adherence and thus reducing potential development of viral resistance to the drugs. This may result in longer term effectiveness of the drug regimen.
Since the three components of Atripla have been in use for some time, their characteristics and effects are well known. In addition, the safety and effectiveness of the combination of these three drugs were shown in a 48 week-long clinical study with 244 HIV-1 infected adults receiving the drugs contained in Atripla. In this trial, 80 percent of the participants achieved a marked reduction of the human immunodeficiency virus and a substantial increase in the number of healthy CD4 cells.
The labeling of Atripla includes a boxed warning that the drug's use can cause lactic acidosis (buildup of an acid in the blood). In patients with chronic Hepatitis B infection, the discontinuation of the treatment with Atripla (which is not indicated for this use) can result in severe flare-ups of Hepatitis B infection. Other potential serious adverse events reported for the use of Atripla's ingredients include serious liver toxicity, renal impairment and severe depression. The most common adverse events experienced by participants in the combination trial included headache, dizziness, abdominal pain, nausea, vomiting, and rash.
The FDA approved Sustiva in 1998, Viread in 2001 and Emtriva in 2003. Truvada, which combined Viread and Emtriva in a fixed dose combination, was approved in 2004.
Guidelines for pregnant women infected with HIV-1 are updated
The Public Health Service Task Force Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV-1 Transmission in the United States has been revised to include an update of the "Antiretroviral Drug Resistance and Resistance Testing in Pregnancy" section to reflect new recommendations for resistance testing for HIV-infected pregnant women. You can download the guidelines or can request to receive them by e-mail or regular mail on the AIDSinfo Web site (www.AIDSinfo.nih.gov).
The Perinatal Working Group now recommends resistance testing for 1) all pregnant women not currently receiving antiretrovirals, before starting treatment or Mother-To-Child Transmission prophylaxis and 2) all pregnant women receiving antenatal antiretroviral therapy who have virologic failure or who have sub-optimal viral suppression after initiation of antiretroviral therapy.
The Food and Drug Administration is advising consumers to avoid eating raw oysters harvested in the Pacific Northwest as a result of increased reports of illnesses associated with the naturally occurring bacteria Vibrio parahaemolyticus (Vp) in oysters harvested from the area.Subscribe Now for Access
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