Doctor HealthHealth Tips

Postmenopausal women who have lost interest in sex may be able to bring their libidos back to life with a testosterone patch, according to new research published this week in The New England Journal of Medicine.
However, the use of the male hormone to boost sex drive in women may not be risk-free. Out of the 814 women in the study, four women who were taking testosterone developed breast cancer, but none of the women on placebo did. It’s not clear whether this was a statistical blip or a warning sign that excess testosterone could cause or spur the growth of a malignancy. Some women also reported excess hair growth, although none stopped using the hormone for this reason.
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The Food and Drug Administration on Friday warned women not to use or purchase Mommy’s Bliss Nipple Cream, marketed by MOM Enterprises Inc. of San Rafael, Calif.

The cream, promoted to nursing mothers to help soothe dry or cracked nipples, contains ingredients that may cause respiratory distress, vomiting and diarrhea in infants, the agency said.

The potentially harmful ingredients in the cream are chlorphenesin and phenoxyethanol.

“FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects,” said Janet Woodcock, director of the Center for Drug Evaluation and Research. “Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants.”

The company has stopped selling the cream.

The FDA said consumers should stop using the cream and consult a doctor if they experience problems or believe that their infant may have experienced problems due to the product.
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The U.S. Food and Drug Administration (FDA) is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug.

These two studies were not among the six studies that were described in revised labeling approved by FDA Nov. 8, 2007, which strengthened warnings about ESAs in cancer patients.

Taken together, all eight studies show more rapid tumor growth or shortened survival when patients with breast, non-small cell lung, head and neck, lymphoid or cervical cancers received ESAs compared to patients who did not receive this treatment. In all of these recent studies, ESAs were administered in an attempt to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater, although many patients did not reach that level.

FDA plans to discuss this new data and revisit the risks and benefits of using ESAs in patients with chemotherapy-induced anemia at a public advisory committee meeting in the next few months.

“This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer, which FDA addressed in previous communications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research.

“FDA is reviewing these data and may take additional action. In the meantime, FDA recommends that health care providers review the risks and benefits of ESAs outlined in the product label and discuss this information with their patients.”

ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells.

Physicians determine whether a patient is anemic and decide on ESA dosing by measuring how much of the protein known as hemoglobin is present in a patient’s red blood cells, typically expressed in grams per deciliter.

FDA-approved uses of ESAs are for the treatment of anemia in patients with chronic kidney failure; for cancer patients whose anemia is caused by chemotherapy; and for those infected with the human immunodeficiency virus (HIV) whose anemia is caused by the HIV drug AZT (zidovudine). ESAs are also approved to reduce the number of transfusions during and after major surgery.

On Nov. 30, Amgen, manufacturer of the three ESAs — Aranesp, Epogen, and Procrit — provided FDA with information from the 733-patient PREPARE study of women who received chemotherapy before undergoing surgery for breast cancer. After three years, 14 percent of the patients who received Aranesp to treat their anemia had died, compared to 9.8 percent who did not receive the drug. Tumor growth was also faster in patients receiving Aranesp.

On Dec. 4, Amgen informed FDA of the results of a study by the National Cancer Institute’s Gynecologic Oncology Group of patients receiving chemotherapy and radiation for advanced cervical cancer. The patients were administered either Procrit to maintain hemoglobin levels above 12 g/dL or blood transfusions as needed. After three years, 66 percent of the patients who did not take Procrit were alive and free of cancer growth compared to 58 percent who had received the drug.

FDA approved revised boxed warnings and other safety-related product labeling changes for ESAs in November and March 2007. Safety concerns regarding ESAs were discussed during advisory committee meetings in 2004 and 2007 and labeling was revised in 1997, 2004 and 2005 to reflect new safety information

Amgen is based in Thousand Oaks, Calif. Procrit is marketed and distributed by Ortho Biotech LP of Bridgewater, N.J, a subsidiary of Johnson & Johnson.

Source: FDA,

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.

Methicillin is an antibiotic that has been used successfully to treat infections from the Staphylococcus aureus bacterium. Over the years, the staph bacterium mutated and spawned MRSA, a strain of staph bacterium that is resistant to methicillin and which has a higher rate of being fatal.

The BD GeneOhm StaphSR Assay uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin.

“The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, health care personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment,” said Daniel G. Schultz, M.D., director, FDA’s Center for Devices and Radiological Health.

Staph infections occur most frequently among persons in hospitals and health care facilities (such as nursing homes and dialysis centers) who have weakened immune systems. Both types of bacteria also can infect healthy people.

Distinguishing between the two sources of infection is critical to successful treatment.
The more common, less dangerous strain of staph results in infections that are generally mild and affect the skin with pimples or boils that can be swollen, painful and drain pus.

However, the MRSA staph bacterium is difficult to treat with ordinary antibiotics. It can cause potentially life-threatening conditions such as blood stream infections, surgical site infections or pneumonia.

FDA cleared the BD GeneOhm StaphSR assay based on the results of a clinical trial at five locations. The new assay identified 100 percent of the MRSA-positive specimens and more than 98 percent of the more common, less dangerous staph specimens.

In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response to treatment. Test results should not be used as the sole basis for diagnosis as they may reflect the bacteria’s presence in patients who have been successfully treated for staph infections. Also, the test will not rule out other complicating conditions or infections.

The BD GeneOhm StaphSR test is manufactured by BD Diagnostics, a subsidiary of BD of Franklin Lakes, N.J.

The U.S. Food and Drug Administration today approved Amitiza (lubiprostone) for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adult women aged 18 and over. There is currently no prescription drug therapy for IBS-C. With this approval, Amitiza becomes the only FDA-approved medical treatment for IBS-C available in the United States.

Irritable bowel syndrome is a disorder characterized by cramping, abdominal pain, bloating, constipation, and diarrhea. IBS causes a great deal of discomfort and distress to its sufferers. It affects at least twice as many women as men.

“For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. “This drug represents an important step in helping to provide medical relief from their symptoms.”

The safety and efficacy of Amitiza was established in two major studies involving 1,154 patients diagnosed with IBS-C. The majority of the patients studied were women (approximately 8 percent were men). Patients enrolled in the studies were experiencing at least mild abdominal discomfort or pain that was associated with at least two of the following additional symptoms: 1) fewer than 3 spontaneous bowel movements per week (that did not result from laxative use); 2) hard stools; or 3) moderate or severe straining with bowel movements. In the studies some patients received Amitiza and others were given a placebo. More patients treated with Amitiza reported that their IBS symptoms were moderately or significantly relieved over a 12 week treatment period than patients who received placebo. The safety of long term treatment was assessed in a study in which all patients were treated with Amitiza for a duration that ranged 9 to 13 months.

The efficacy of Amitiza in men was not conclusively demonstrated for IBS-C.
Amitiza, like most prescription medications, is accompanied by some side effects. Common side effects of Amitiza include nausea, diarrhea, and abdominal pain. Other rare side effects include urinary tract infections, dry mouth, syncope (fainting), peripheral edema (swelling of the extremities), dyspnea (difficulty breathing), and heart palpitations.

Amitiza should be taken twice-a-day in 8 microgram doses with food and water. Patients and their health care professionals should periodically assess the need for continued therapy.

Amitiza is not approved for use in children and men. It is not to be administered to patients suffering from severe diarrhea or patients with known or suspected bowel obstructions. Its safety and efficacy has not been established in patients with renal or hepatic impairment, pregnant, or nursing mothers.

Amitiza is also approved for the treatment of chronic idiopathic constipation (CIC), but the dose for that indication is higher, 24 micrograms twice a day.

Amitiza is manufactured by Sucampo Pharmaceuticals, Bethesda, MD, and will be jointly marketed by Sucampo and Takeda Pharmaceuticals America, Inc., Deerfield, IL.

Source: FDA,

The wait is over. Women who want silicone breast implants can now have them — thanks to the lifting of a 14-year ban by the U.S. Food and Drug Administration.

The implants were taken off the market in 1992 after some women complained that they leaked silicone into their bodies and caused serious health problems. Several extensive studies have since been conducted in and outside the United States, and some doctors say claims the implants are harmful have not been proven.

“Essentially, they found through fairly exhaustive studies that the new generation silicone implants are safe for people,” said Dr. Peter Butler, a plastic surgeon with Gulf Coast Plastic Surgery in Gulf Breeze. “The main factor is that leaking does not cause tissue problems —— simply put, we don’t want silicone leaking into our systems.”

Butler and his partner, Dr. Jocelyn Leveque, both certified plastic surgeons, have been involved in a four-year U.S. Department of Health and Human Services study, which began in 1997. The agency appointed the Institute of Medicine of the National Academy of Sciences to conduct the study, which was underwritten by two California companies, Allergan Medical and Mentor Medical, manufacturers of the gel-based silicone implants.

Both doctors have enrolled some of their patients in the study, and each patient will be followed for at least 10 years.

“To date, Dr. Leveque has used silicone implants in 99 of her patients; I have used the implants in 73 cases in Pensacola,” Butler said. Before then, Butler practiced in North Carolina. So far, he said none of their patients has experienced any problems.

When the implants were taken off the market, women were concerned that leaking silicon implants were causing a number of diseases. At the time, the doctors said, there was no research to disprove the claims. But new studies have found that the gel implants are much more cohesive and are safe for use.

This is good news for Jan Carlo, one of Butler’s patients, who is also part of the study. Four months ago, Carlo, 50, was fitted with the implants following gastric bypass surgery. But not before doing some personal research.

“When you have surgery, you lose a lot of breast volume,” said Carlo, a registered nurse. “I knew the silicone implants were more natural feeling and looking. I feel comfortable making the decision to have them.”

Still, the FDA will continue to monitor the products and is requiring each company to conduct follow-up studies. Both companies are expected to track about 40,000 women for 10 years after they receive implants. The agency said package labeling should alert women who opt for the silicone implant to consider these factors as well:

· Breast implants are not lifetime devices, and a woman will likely need additional surgeries on her breast at least once over her lifetime.

· Many of the changes to a woman’s breast following implementation are irreversible.

· Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured.

· A woman will need regular screening MRI (magnetic resonance imaging) exams over her lifetime to determine if a rupture has occurred; a woman should have her first MRI three years after the initial implant surgery and every two years thereafter. The cost of MRI screening over a women’s lifetime may exceed the cost of her initial surgery and may not be covered by medical insurance. And if the implant rupture is noted on an MRI, the implant should be removed and replaced, if needed.

“FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information, to determine the benefits and risks of these products,” said Dr. Daniel Schultz, FDA director, Center for Devices and Radiological Health. “The extensive body of scientific evidence provides reasonable assurance of the benefits and risks of these devices. This information is available in the product labeling and will enable women and their physicians to make informed decisions.”

by: Pensacola News Journal

NEW YORK — Pfizer Inc. said Friday that the European Commission has approved anti-smoking pill Champix.Champix will be available with a patient support plan which smokers can customize to address their individual behavioral triggers as they try to quit smoking.Champix is believed to work by reducing the severity of the smoker’s urge to smoke and alleviating many withdrawal symptoms from nicotine. In addition, if a person smokes a cigarette while receiving treatment, the medicine has the potential to diminish the satisfaction associated with smoking.In Europe alone, more than 1.2 million people die each year from smoking-related diseases. By 2010, the World Health Organization predicts the annual global cost of tobacco-related illness will be about $500 billion, with Europe accounting for up to $165 billion of this sum.The medication, varenicline, received Food and Drug Administration approval as an aid to quitting smoking in May, under the tradename Chantix.

F.D.A. Says Bayer Failed to Reveal Drug Risk Study
WASHINGTON, Bayer A.G., the German pharmaceutical giant, failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke, the Food and Drug Administration announced Friday.Bayer scientists even appeared at a public meeting called by the F.D.A. on Sept. 21 to discuss the possibility that the drug, Trasylol, might have serious risks. But they did not mention the study or its worrisome results.In a highly unusual move, the food and drug agency released a public health advisory saying it had learned of the study’s existence only on Wednesday. Preliminary results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes,” the advisory said.Nevertheless, the agency did not change its advice about whether patients should be given the drug. Instead, it restated previous warnings that Trasylol’s use should be limited to patients in whom the risks of blood loss outweighed the drug’s risks.The disclosure comes exactly two years after Merck announced it was withdrawing its arthritis drug, Vioxx, after a study showed that it doubled the risks of heart attacks. Since then, members of Congress and even top scientific advisers have concluded that the F.D.A. lacks the regulatory authority and the money needed to detect and protect against drug dangers.Drug companies have also been sharply criticized for failing to make public the results of some human trials of their drugs that suggest that the drugs are either ineffective or dangerous. Some lawmakers have proposed legislation that would require that nearly all human drug trials must be announced and their results disclosed publicly.A top F.D.A. official said the agency learned of the Trasylol study on Wednesday only after a getting a tip from a researcher involved in it. The official insisted on anonymity because of the sensitive nature of the information.In a written statement, Bayer said “that it mistakenly did not inform” the F.D.A. of the study and added, “This data was not shared immediately with the agency because it was preliminary in nature.”Staci Gouveia, a Bayer spokeswoman, said the company nonetheless stood behind the safety of Trasylol, which has become one of Bayer’s fastest sellers. Sales last year were $200 million and were expected to nearly triple this year.Several members of the advisory committee that met last week said they were shocked that Bayer failed to inform them of the study.“For them not to mention that it was under way, that it was being analyzed or that results were available is appalling and will do significant harm to their reputation for transparency,” said Dr. John Teerlink, an associate professor of medicine at the University of California, San Francisco, and a member of the advisory committee.Steven Findlay, a health care analyst at Consumers Union and another committee member, said the agency needed to investigate whether Bayer knowingly withheld the information from the advisory committee.“The safety of this drug is called into further question now,” Mr. Findlay said.Doctors give Trasylol to patients before surgery to reduce the risks of blood loss. It can also reduce the need for transfusions in patients undergoing heart bypass surgery. Trasylol, also known as aprotinin, has been on the market for 13 years.But two recent studies suggested that the drug might have serious risks. One of the articles, published in January in The New England Journal of Medicine, found that the drug increases the risks of kidney failure, heart attack and stroke. The study concluded that halting the drug’s use would prevent 10,000 to 11,000 cases of kidney failure a year and save more than $1 billion a year in dialysis costs, as well as nearly $250 million spent on the drug itself.There are other, cheaper drugs that can be used in Trasylol’s place.Still, the advisory panel concluded that Trasylol’s risks were worth taking in some patients. Dr. Teerlink said that despite the results of the new study, that might still be true.Bayer’s study was performed by a contract research organization. But Bayer did not inform the F.D.A. that the study was being done, even though that is routine practice.It examined hospital records of 67,000 patients, 30,000 of whom received Trasylol. The rest got other drugs. It concluded that the patients given Trasylol were at greater risk.Such studies, however, are fraught with statistical and other problems. Patients given Trasylol may have been sicker than those given other drugs. Their worse outcomes would be explained not by problems with Trasylol but by their own illness.Susan Bro, an F.D.A. spokeswoman, said it was evaluating the new study and would decide soon whether the results merit changing the agency’s advice about use of the drug.“It is regrettable that the F.D.A. advisory board did not have the benefit of a frank scientific dialogue based on the totality of available data,” she said.Senator Charles E. Grassley, Republican of Iowa and chairman of the Senate Finance Committee and a longtime critic of the F.D.A., said Bayer’s behavior proved that the agency was largely toothless.“The remedy is mandatory reporting of all clinical trials and real teeth for the F.D.A. to do its job in holding drug companies accountable,” Mr. Grassley said.

(Bloomberg) — Consumers can resume buying and eating fresh spinach after an outbreak of E. coli that killed one person and sickened 188 in the U.S. and Canada, the U.S. Food and Drug Administration said.“Spinach on the shelves is as safe as it was before this event,” said David Acheson, chief medical officer for the FDA Center for Food Safety and Applied Nutrition, today on a conference call with reporters. All brands that were affected have been recalled, the agency said.The tainted spinach all came from Natural Selection Foods LLC, a San Juan Bautista, California-based vegetable grower and processor, Acheson said. The company on Sept. 15 recalled all of its spinach products with use-by dates of Aug. 17 to Oct. 1. Four U.S. distributors, all of which said they bought their spinach from Natural Selection, subsequently recalled their products.“The FDA is not preventing other spinach from coming back on the market,” Acheson said, adding that this applies to products from Natural Selection which don’t fall within the recall dates.20th OutbreakSeven bags of Dole-brand spinach — which were included in the Natural Selection recall — tested positive for the outbreak strain of E. coli in Colorado, Indiana, Nevada, New Mexico, Pennsylvania, Utah and Wisconsin, Acheson said. Two more bags of Dole spinach in Pennsylvania and Wisconsin are likely to test positive, he said.Dole Food Co. and Natural Selection didn’t immediately return calls for comment.The FDA and the state of California have called on the industry to come up with a “comprehensive plan” to prevent future E. coli outbreaks in leafy vegetables, Acheson said, noting that this was the 20th outbreak from leafy vegetables in about a decade, and about half of those trace back to central California.“It is not appropriate for FDA to look at this outbreak in isolation,” he said. “It raises concerns about what is going on in that environment. At this stage, it’s very important that industry take the initiative to come up with a plan to address the underlying concerns and problems.”Investigators are still trying to determine how the spinach became contaminated, though Acheson said that they may never know.SymptomsFood contamination from the strain of E. coli blamed in the current cases affects about 73,000 peo