HCV Weekend News Ticker;Japan-Telaprevir Improves Chronic Hepatitis C Therapy

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Hepatitis C Therapy Can Cause Mild Depression to Spike
The Hepatitis C Treatment Pipeline Report

Transplant-HCV Reinfection

Major Postoperative Liver Transplant Complications Associated With Hepatitis Reinfection: Presented at ESOT

By Jenny Powers
GLASGOW, Scotland -- September 9, 2011 -- Among patients who received a liver transplant due to hepatitis B virus (HBV) and/or hepatitis C virus (HCV) liver cirrhosis, a significant association was seen between reinfection with either virus and major postoperative complications.

No significant association was seen between major complications and other variables, such as age, comorbidities, or the severity of cirrhotic disease, researchers said here September 6 at the 15th Congress of the European Society for Organ Transplantation (ESOT).
Arzu Oezcelik, MD, Transplantation Surgery, University of Essen, Essen, Germany, and colleagues retrospectively reviewed data from 186 patients who underwent a liver transplantation for HBV and/or HCV liver cirrhosis between 2004 and 2008.
Postoperative complications were graded using the Clavien Classification system, and scored from minor (grade 1) to the most severe (grade 4). Major complications were defined as Clavien grade ≥3b.

Of the patients, 135 (72%) had complications within 4 years post transplant. Less severe complications (grade 1-3a) were seen in 43 (23%) patients. Severe complications (grade >3b) were seen in 92 (49%).

Within the first month after transplantation, 34 (18%) patients died and their data were not included in the analyses; of the remaining 58 patients who experienced major complications, 29 (50%) had a reinfection of hepatitis within a median time of 14 months. Reinfection occurred after a median time of 26 months in 10 (11%) of the 94 patients with no or minor complications.
Reinfection with HBV or HCV was significantly associated with major postoperative complications (P <.0001).

“Reinfection was the only significant association with major postoperative complications and may be seen as a risk factor for poorer outcome,” said Dr. Oezcelik.

[Presentation title: Correlation of Major Surgical Complications After Liver Transplantation for Hepatitis-B and -C and Hepatitis Re-infection Rate. Abstract RO-041]

From HIV and Hepatitis

HALT-C Finds High Rate of Liver-Related Death and Transplants among Interferon Non-Responders
Jules Dienstag and fellow investigators with the Hepatitis C Antiviral Long-term Treatment against Cirrhosis Trial sought to learn more about disease progression among people with chronic hepatitis C virus (HCV) infection who had histologically advanced but compensated liver disease.

PSI-7977 with Standard Therapy Produces 91% Sustained Response
Details
Category: Experimental HCV Drugs
Published on Friday, 09 September 2011
The experimental hepatitis C virus (HCV) nucleotide analog polymerase inhibitor PSI-7977, used in combination with pegylated interferon and ribavirin, demonstrated a 12-week sustained virological response rate of 91% for previously untreated genotype 1 chronic hepatitis C patients in the ongoing PROTON trial.

From NATAP

Telaprevir Alone or With Peginterferon and Ribavirin Reduces HCV RNA in Patients With Chronic Genotype 2 but Not Genotype 3 Infections
"For treatment-naïve patients with genotype 2 HCV, studies to examine a shortened duration of therapy that includes telaprevir should be considered."

From Hepatitis Central

Drug Companies Headed Toward Improving Hep C Therapy
With the recent approval of the direct acting antivirals (DAA) Incivek and Victrelis, Hepatitis C treatment is improving. However, the next crop of DAAs has the potential to make Hepatitis C treatment even better.

Adding Telaprevir Improves Chronic Hepatitis C Therapy
By C. Vidya Shankar MD
NEW YORK (Reuters Health) Sep 07 -
Telaprevir added to standard therapy for chronic hepatitis C virus (HCV) was an improvement over the usual interferon/ribavirin protocol in a recent study in Japan.

Patients who received the first-generation HCV protease inhibitor telaprevir had a shorter duration of treatment, more rapid responses, and a higher rate of sustained virological response (SVR), the research team reports.

The telaprevir/interferon/ribavirin combination will "set the stage for a new standard of care for HCV," predicted Dr. Michael Manns from Medical School of Hanover, Germany. Dr. Mann, who sent his comments to Reuters Health by email, was not involved in the new study.

Pegylated interferon plus ribavirin -- the current standard of care -- achieves SVR only about half the time, lead author Dr. Hiromitsu Kumada from Toranomon University, Tokyo and colleagues pointed out in an August 8th online paper in the Journal of Hepatology.
For a randomized multicenter trial, the researchers enrolled 189 treatment-naive and otherwise healthy adults with HCV genotype-1. Each patient entered the study with a viral load of at least 5.0 log 10 IU/ml.

Two-thirds of the patients received telaprevir, interferon, and ribavirin for 12 weeks, followed by another 12 weeks of interferon and ribavirin. The remaining third received interferon and ribavirin for 48 weeks.

Patients in both groups received interferon 1.5 mcg/kg subcutaneously once a week, and everyone took ribavirin 200-600 mg twice a day. Patients in the telaprevir group took 750 mg three times a day.

Ribavirin and interferon doses were adjusted based on hemoglobin levels (ribavirin) or leukocyte, neutrophil, or platelet counts (interferon). Telaprevir dosing couldn't be changed; if hemoglobin fell below 8.5 mg/dL, triple therapy was stopped. If hemoglobin returned to at least 8.5 mg/dL within two weeks, treatment resumed but just with interferon and ribavirin.
Follow-up continued for 24 weeks after the end of therapy.

The patterns of HCV change in the two groups were very different, the research team said.
In the telaprevir group, the virus disappeared more often (98.4% vs. 79.4%, p<0.001) and more quickly (within 8 vs. 38 weeks).

With telaprevir, "the loss of HCV RNA increased constantly, sharply and swiftly," the authors wrote. Without telaprevir, "it gradually increased during the first 24 weeks on treatment."
The rates of rapid virological response (i.e., undetectable HCV RNA after four weeks of treatment) with and without telaprevir were 84% vs. 4.8% (p<0.0001). Rates of sustained virological response were 73% vs. 49.2% with and without telaprevir (p=0.002).
In the telaprevir group, however, the total ribavirin dose was only 47.0% of the target, while it was 77.7% in the control group.

The triple therapy group also had more adverse reactions, including severe anemia (11.1% vs. 0%) and skin rashes of severity grade 3-4 (11.9% vs. 4.8%) -- although rates of treatment discontinuation for adverse reactions were similar between the groups.
"Although the triple therapy with telaprevir-based regimen for 24 weeks resulted in more adverse events and less total ribavirin dose than pegylated-interferon and ribavirin for 48 weeks, it was able to achieve higher (rates of) sustained viral response within (a) shorter duration" with careful monitoring of adverse events and modifying the ribavirin dose as required, the researchers concluded.

Dr. Manns told Reuters Health in his email that he expects the telaprevir combination to have a role in treatment-naive hepatitis C, relapsed patients, and partial responders.
"Alternatives are boceprevir and the drugs under development, so called second wave HCV protease inhibitors, HCV polymerase inhibitors and maybe cyclophilin A inhibitors," he added.
The U.S. Food and Drug Administration approved telaprevir (Incivek; Vertex Pharmaceuticals) this past May. In July, a European Medicines Agency statement said its Committee for Medicinal Products for Human Use had recommended the granting of a marketing authorization for telaprevir (Incivo; Janssen-Cilag International).
SOURCE: http://bit.ly/ofORGg
J Hepatol 2011.

Diabetes

Nature
New twist in diabetes drugs could reduce life-threatening side effects
Researchers from Dana-Farber and the Scripps Research Institute in Jupiter, Fla., have created prototype drugs that have powerful anti-diabetic effects and are free of dangerous side effects plaguing some current diabetes medications. National Institutes of Health...

Cancer

Many liver cancer patients survive using SIR-Spheres microspheres
By: Theresa S. Samaniego
HONG KONG—It is alarming to know that 80 percent of liver cancer cases occur in the Asia-Pacific region and that this particular type is the third cause of cancer-related deaths in this side of the world.

But what is disturbing to note is that at present there is still no efficient mechanism that will allow the early detection of liver cancer. What’s more, the number of cases continues to grow every single year.

In fact, some 750,000 new cases of hepatocellular carcinoma, more commonly known as liver cancer, are reported worldwide every year, said Dr. Bruno Sangro of Clinica Universitaria, in a recent briefing here conducted by oncology treatment company Sirtex Medical.
Sangro added that hepatocellular carcinoma is usually more common in countries where Hepatitis B virus carriers are prevalent.

Cause of liver damage
In the Philippines, it was earlier reported that Hepatitis B was the leading cause of liver damage resulting in liver cirrhosis and liver cancer. At least one out of 10 people is a carrier of Hepatitis B. It is estimated that more than 7.7-million people are chronically infected with Hepatitis B, of whom between 1.1 and 1.9 million are expected to die prematurely of cirrhosis or liver cancer, according to a previous Inquirer news report.

The good news, however, is that the medical community continues to find ways to cure, or at least improve the quality of life of patients diagnosed with liver cancer.
A case in point is the publication of Sirtex Medical’s six-year retrospective analysis of 325 patients treated with its targeted radioactive SIR-Spheres microspheres therapy for inoperable primary liver cancer.

The study, according to Sirtex chief executive officer Gilman Wong, is the largest multicenter evaluation of radioembolisation (also known as Selective Internal Radiation Therapy or SIRT) using SIR-Spheres that showed results confirming that the treatment was safe and effective in a range of patients with early to advanced stages of the disease.
“These positive results build on the growing body of robust clinical evidence that demonstrates SIR-Spheres microspheres deliver very encouraging clinical outcomes across the different stages of liver cancer,” Wong shared.

To date, independent researchers from eight European treatment centers reported robust evidence of the survival achieved using SIR-Spheres microspheres, including patients with advanced diseases and few treatment options.

“The new data will further support the expanding use of SIR-Spheres microspheres in a wider patient population and bolster our efforts to support medical professionals treating liver cancer patients at over 400 treatment centers worldwide,” Wong added.
In the same briefing, Dr. Vanessa H. de Villa, director of Center for Liver Disease Management and Transplantation at the Medical City, said that although the procedure is still very new in the Philippines, it has already benefited a number of patients.
“We are one among the first to do it. We started in 2008 and we have done 15 to 20 procedures already,” De Villa said.
At present, De Villa said there are three hospitals in the Philippines where the procedure can be done.

Admittedly though, the procedure can be very expensive, De Villa believes that cost should not be the only thing highlighted when it comes to improving the quality of life of patients.

Factor in 3 things

“Cost varies from country to country and in the Philippines, you have to factor in three things: hospital cost, doctors’ fee and cost of the procedure itself, which is actually expensive at about P500,000 already,” De Villa explained.

Roughly, the treatment may run up to as much as P1 million.
“But if you do the other treatments like taking drugs such as Sorafenib, that is also quite expensive … At the recommended dose, you spend something like P300,000 a month and that (is something) you take for life. So if you compare that with SIRT—which is a single or one-shot deal or at most you can have two or three treatments—then the costs are comparable,” she further noted.

SIRT, according to De Villa, requires two admissions. First is for mapping and geography, which is done to assess and see if the patient will qualify for the treatment or not. Second would be the actual procedure, which would normally take one or two hours at most.
“First option is surgery but if for some reason the patient can’t go through surgery we have other alternatives to offer and one of them is SIRT,” De Villa said.
She further stressed that patients who cannot be operated are those with tumors or those with portal vein thrombosis. Patients with advance disease will greatly benefit from this procedure, she added.

“If only it can be widely applied, it will really help improve outcomes,” De Villa concluded

A*STAR scientists make headway for cancer treatment and cancer prevention with landmark discovery
Scientists at A*STAR's Institute of Molecular and Cell Biology have made a landmark discovery in the battle against the rapid spread of aggressive cancers. Contrary to the current theory that antibodies can only bind to cancer proteins found on the cancer cell surface, the A*STAR team is the first to discover that antibodies can in fact directly target oncoproteins that reside within the cancer cells to suppress aggressive cancer growth. Agency for Science, Technology and Research

Pharmaceuticals

From Reuters

Three US lawmakers urge close look at Medco deal

The lawmakers also expressed concern about the merged company's dominance of the market for expensive specialty drugs, such as those used to treat Crohn's Disease, hepatitis C, infertility and many cancers.

Fri Sep 9, 2011 2:55pm EDT
* Lawmakers fear merged company would dominate
* Express Scripts confident of approval, working with FTC
WASHINGTON, Sept 9 (Reuters) - Three lawmakers asked U.S. antitrust enforcers to give Express Scripts' (ESRX.O) plan to buy rival Medco Health Solutions (MHS.N) "close scrutiny" because it would create a company twice as large as its nearest competitor.
Representatives Henry Waxman, Frank Pallone and Diana DeGette, all Democrats, asked the Federal Trade Commission on Friday to take a hard look at the deal, saying they were concerned that the merged company would dominate the pharmacy benefits manager business.
Pharmacy benefit managers, or PBMs, oversee drug benefit programs for health insurers and employers.

Medco agreed to the cash and stock deal in July, worth about $26.6 billion based on Friday afternoon trading.

The lawmakers also expressed concern about the merged company's dominance of the market for expensive specialty drugs, such as those used to treat Crohn's Disease, hepatitis C, infertility and many cancers.

"The market for prescription drugs, which involves often opaque interactions between insurance companies, pharmaceutical manufacturers, pharmacies, and PBMs, is complex and rapidly changing, and the impacts of this merger could be significant," the lawmakers wrote in the letter to FTC Chairman Jon Leibowitz.

"We are therefore asking that you carefully examine the impacts on healthcare cost and access as a result of the proposed Express Scripts-Medco merger," they said.
The deal would combine two of the three largest U.S. drug benefit managers and create an industry leader that holds about one-third of the market, leading some investors to remain skeptical that U.S. antitrust regulators will approve it.

A spokesman for Express Scripts said that the company remained confident that the deal would be approved and would close in the first half of 2012. "We have been and we continue to work collaboratively with the FTC staff," said spokesman Brian Henry.

The FTC has already asked for additional information on the deal. [ID:nN1E7811PG]
The lawmakers said Medco was losing large contracts with Blue Cross Blue Shield and United Health Care next year, which could resolve some concerns.

Share prices of Express Scripts were down 5 percent on Friday afternoon to $43.53 while Medco was down 4.3 percent at $51.13, underperforming the broader market where the S&P 500 index was down 3 percent. (Reporting by Diane Bartz; Editing by Tim Dobbyn)

From Pharmalot

FDA Panel On Bone Drugs And Conflicted Members
The controversy over conflicts of interest among FDA advisory committee members shows no sign of abating. Three years after enacting tougher standards over concerns that financial ties to drugmakers were potentially corrosive, the agency is now considering loosening its rules because some officials say it has become harder to find qualified experts who are not conflicted...

Media

From Miami Herald

Veterans
VA board recommends discipline for Miami VA director, ex-chief of staff
By Fred Tasker

Miami Veterans Administration hospital director Mary Berrocal and her former chief of staff, Dr. John Vara, should be disciplined for “lack of oversight” that led to long delays in notifying 79 local veterans that they might have been infected with HIV or hepatitis through improperly performed colonoscopies at the hospital, a VA board has concluded....

From Kevin MD

The dual tragedy of suffering catastrophic illness and being uninsured
by John Maa, MD

An estimated 60% of American bankruptcies result from overwhelming medical costs. My uncle’s tale illuminates the dual tragedy of suffering catastrophic illness and being uninsured.
The 2008 recession claimed my uncle’s job, health benefits, and assets, except for a small inheritance. By 2009 he found work (but not health coverage) as a consultant.

One day he noticed that his eyes were yellow. He emailed a photograph, and I immediately recognized jaundice. I calmed him by suggesting benign causes such as hepatitis, gallstones, or liver cirrhosis. But I secretly dreaded a liver or pancreas cancer, given his recent weight loss and itching.

Laboratory and x‐ray tests, which he charged to his credit card, all suggested cancer. His doctor in New Jersey indicated urgent surgery was necessary. An appointment was unavailable for weeks at the county hospital, and private surgeons wouldn’t see him without a cash deposit. Time was ticking. Cure was already unlikely, and delays were allowing the tumor to grow. He decided to travel to the West Coast to expedite surgery.

My uncle arrived around midnight, glowing yellow; he had worn sunglasses to avoid frightening other airline passengers. He was immediately admitted to undergo a procedure to identify the site of blockage and insert a plastic stent to drain bile externally. While awaiting the outcome, I had a premonition that the worst was yet to come. The doctors brought dreadful news that a massive tumor, too large to remove surgically, lay centrally in the liver. The remote possibility existed of a benign condition masquerading as cancer. The aggressive option was upfront chemotherapy and radiation to shrink the tumor, for possible surgery afterwards. But several surgeons deemed the case hopeless, and estimated my uncle had only 6 months to live. They recommended hospice, and a more comfortable internal metal stent. My family chose not to share these findings with my uncle until he recovered from anesthesia.

The crushing blows continued. Within 36 hours, my uncle lapsed into a coma from kidney failure induced by bile toxins. Knowing the costs, we refused transfer to the ICU. Dialysis was necessary, but the nephrologists regarded the situation futile and refused treatment, comforting us that dying from kidney failure was painless. Miraculously, he rallied. Seeing improvement, the nephrologists started dialysis. We could finally share with my uncle the difficult choices ahead.
He responded “It’s hopeless. Why risk money that could provide my daughters’ education?” He asked to be made “do not resuscitate”, and declined surgery. Two weeks of recuperation made transfer to less expensive skilled nursing care possible, but here I learned it takes money to save money. Ambulance transport was mandatory, costing $1700. As I read the dispatcher my credit card information, I wondered if I could have driven him myself.

In the following days, we tried everything to minimize costs. My uncle had a fever, but refused evaluation in the ER, and was treated with blankets and oral antibiotics. His fever broke, as did the stitches on his stent, which I re‐sutured at the bedside.

In the end, my uncle made the ultimate sacrifice for his daughters by rationing his care. Death came swiftly, only 72 days after he became jaundiced. He never received metal stents, or saw New Jersey again.

His final medical bills totaled over $250,000. Charity care was denied, and MediCal unavailable since he was from out of state. After receiving a 20% discount for paying in a lump sum and in cash, we negotiated a final 40% discount.

The costs of his care can be translated as follows. Each session of dialysis equaled a month of private college tuition. Each day’s blood work would have provided a year of textbooks. The daily hospital room charge would pay for a half‐year in the dormitory. The anesthesia fee would have purchased a full year’s meal plan.

My uncle’s cause of death remains unknown. Weeks into treatment, his tumor markers came back normal. Surgery might have been curative, or confirmed a hopeless situation. The cost to know with certainty would have consumed his inheritance. The World Health Organization recognizes this universal tragedy worldwide: “The poor are treated with less respect and given less choice of providers. In trying to buy health from their own pockets, they pay and become poorer.”

Whenever someone faults the medical system for the epidemic of bankruptcies, I ask instead: My uncle was 59, and for decades had contributed to the system by paying health insurance premiums while employed. Did the system treat him fairly when he needed care?
John Maa is Assistant Professor of Surgery, University of California, San Francisco.

Costs of Care has launched its annual 2011 healthcare essay contest, with the goal of expanding the national discourse on the role of doctors, nurses, and other care providers in controlling healthcare costs. The contest will solicit stories from care providers and patients across the nation that illustrate everyday opportunities to curb unnecessary and even harmful health care spending on a grassroots level.

From The Las Vegas Sun

Court won’t stop health district workers from testifying at hepatitis C trials
By Cy Ryan (contact)
Friday, Sept. 9, 2011 4:37 p.m.
Sun Coverage
Hepatitis scare
CARSON CITY – The Nevada Supreme Court has refused to issue an emergency order to stop employees of the Southern Nevada Health District from being called as witnesses at multiple trials involving the 2008 hepatitis C outbreak in Las Vegas.
The health district said it would result in a hardship if its employees were required to appear in person at each of the possibly hundreds of trials. It suggested that the depositions taken earlier of the district workers would be satisfactory for introduction at the trials.....

From The The Associated Press

3 charged in alleged chemotherapy fraud in Miss.
HOLBROOK MOHR, Associated Press

JACKSON, Miss. (AP) — A clinic in south Mississippi gave cancer patients less chemotherapy or cheaper drugs than they were told and reused the same needles on multiple people as part of a multimillion-dollar Medicare and Medicaid fraud, a 15-count indictment alleges.
Three women, including Dr. Meera Sachdeva, the 50-year-old founder of Rose Cancer Center in Summit, were charged in the indictment Thursday. The clinic had already been shut down by the state Health Department for "unsafe infection control practices."
Sachdeva has been ordered held without bond.
The others charged in the case are employees, 24-year-old Brittany McCoskey of Monticello and 43-year-old Monica Weeks of Madison.

The defendants "knew that the liquid solutions that were infused into the patients treated at Rose Cancer Center contained a smaller amount of the chemotherapy drugs than the defendants had billed to various health care benefit programs, or contained different, less expensive drugs," the indictment says.

The clinic also allegedly billed the agencies for new syringes for each patient, even though it reused some syringes on multiple people.
Prosecutors say Medicaid and Medicare paid the clinic $15.1 million during the alleged scheme. Authorities have seized $6 million.

Sachdeva's attorney, Rob McDuff, said "she'll enter a plea of not guilty and we'll go from there."
When contacted Friday, McCoskey said she did not know she was indicted and wanted to read the indictment before commenting.
It wasn't clear if Weeks had an attorney. A phone call to a listing for Weeks was not immediately returned.

Prosecutor Scott Gilbert said Sachdeva was arrested in August and ordered held without bond. She appealed that ruling, but it was upheld Friday by a different judge.
Prosecutors argued that Sachdeva should remain in jail until trial because she's a naturalized U.S. citizen from India, routinely travels to her native country and is a flight risk.
"Moreover, the defendant has substantial financial resources available to her, in spite of the seizure of almost $6,000,000 by the government," court records said.

Rose Cancer Center came under scrutiny earlier this year when 11 patients went to hospitals with bacterial infections, according to the Mississippi Department of Health.
Liz Sharlot, a Health Department spokeswoman, said Friday that the clinic was closed July 20. The Health Department advised patients to get screened for Hepatitis B and C and HIV, though officials have not found anyone who got a viral infection as a direct result of treatment at the cancer center.

Sharlot said 150 to 200 patients have been screened and the department will conduct additional testing.

Federal authorities began investigating the clinic after a confidential informant told them the suspects were "altering, forging and destroying patient records in anticipation of a Medicare audit," court records said. Authorities said they found shredded documents when the clinic was raided the next day.

Sachdeva faces up to 165 years in prison and more than $3.2 million in fines if convicted.
McCoskey was a receptionist and later the office manager at Rose Cancer Center. Weeks submitted the claims for Rose Cancer Center to Medicare, Medicaid and private insurance companies.

McCoskey and Weeks are both charged with 11 counts and, if convicted, face 125 years in prison and $2.25 million in fines.

"My office will remain vigilant as health care fraud investigations continue to ensure that patients receiving treatment are being provided the appropriate and adequate treatment," U.S. Attorney John Dowdy told The Associated Press on Friday.

"The patients in the case are truly as much as victims as the government," he said. "There was over $15 million in claims that she made through Medicaid and Medicare. It's disturbing to see this kind of fraud continuing when the federal government is looking for ways to cut costs."

From MyHealth News Daily

How Safe Is the Nation's Blood Supply?
Sep 9, 2011 2:06 PM ET By Rachael Rettner, MyHealthNewsDaily Staff Writer
Researchers announced this week that the parasite that causes babesiosis, a malarialike illness transmitted by ticks, is passing undetected through the nation's blood supply.
The study found 162 cases of babesiosis acquired through blood transfusions over the last three decades

The risk of becoming infected with HIV or hepatitis C is around one in a million. On the other hand, some 50,000 to 70,000 people per year ― around one to three in a hundred ― will experience a significant reaction from a transfusion, he said....

FDA

From WebMD Health News

Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

By Rita Rubin
Reviewed by Laura J. Martin, MD
But the panel backed off giving any specific time limits.
Bisphosphonates include Aclasta, Actonel, Altevia, Boniva, Fosamax, and Reclast. Four million to 5 million Americans fill prescriptions for the drugs every year, according to the FDA
The FDA convened the meeting because of emerging safety concerns related to long-term use -- generally considered more than three to five years -- of bisphosphonates.
In particular, the agency has received reports of osteonecrosis, or bone death, of the jaw and unusual fractures of the femur, or thigh bone, in women who had taken the drugs for several years or more.

Meanwhile, some research suggests that because bisphosphonates remain in bone for years, women could still benefit after they stop taking them.
Sept. 9, 2011 -- Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

But the panel backed off giving any specific time limits.
Bisphosphonates include Aclasta, Actonel, Altevia, Boniva, Fosamax, and Reclast. Four million to 5 million Americans fill prescriptions for the drugs every year, according to the FDA
The FDA convened the meeting because of emerging safety concerns related to long-term use -- generally considered more than three to five years -- of bisphosphonates.
In particular, the agency has received reports of osteonecrosis, or bone death, of the jaw and unusual fractures of the femur, or thigh bone, in women who had taken the drugs for several years or more.

Meanwhile, some research suggests that because bisphosphonates remain in bone for years, women could still benefit after they stop taking them....

FDA Blasts Brazilian Blowouts
Huffington
At the root of the problem is the dangerously high level of liquid formaldehyde in the product, known to cause nervous system disorders, chest pain, vomiting and rashes (to name a few). The FDA confirmed that some Brazilian Blowout samples contained up to 10.7% of the offending chemical. Time notes that the Cosmetics Ingredient Review Expert Panel considers 0.2% to be a safe level.

The FDA also determined that Brazilian Blowouts are "mislabeled" because the bottles incorrectly state "No Formaldehyde" or 'Formaldehyde Free."....