Drug & Device News

New Warnings Required for Some Immunosuppressant Drugs

Although it may have seemed an obvious concern, certain immunosuppressant drugs were not, until July, required to carry warnings that their use could increase a patient's risk for developing opportunistic infections, such as latent viral infections. Of primary concern is BK virus-associated nephropathy, a kidney disease that is being seen in renal transplant patients. Most healthy adults have at one time contracted the BK virus, which remains in their kidneys and urinary tracts indefinitely, generally causing no harm. However, when the immune system is suppressed or otherwise compromised, the virus can replicate. On July 17, based on what the FDA termed new safety information, the agency announced that, from now on, the manufacturers of the following immunosuppressants must update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy:

• Sirolimus, marketed as Rapamune;
• Cyclosporine, marketed as Sandimmune and generics;
• Cyclosporine, modified marketed as Neoral and generics;
• Mycophenolate mofetil, marketed as Cellcept and generics; and
• Mycophenolic acid, marketed as Myfortic.

The FDA advises that BK virus-associated nephropathy can progress to renal allograft loss, so medical professionals should monitor patients carefully and consider adjusting their immunosuppression therapies if BK virus-associated nephropathy develops.

Criminal Charges Brought Against Scrub Tech Who Tampered with Syringes

A former Colorado scrub surgery tech has been charged with product tampering and other drug charges after she allegedly stole syringes containing the painkiller Fentanyl Citrate while at her workplace. According to the indictment, the accused, who has hepatitis C, took 21 syringes containing Fentanyl from the operating room between the months of October 2008 and April 2009. She then injected herself with them and refilled them with saline solution, replacing the used syringes in the operating room. The accused, Kristen Diane Parker, was terminated from her position at Denver's Rose Medical Center in April 2009.

After the Medical Center was informed by the State Health Department in June that there was a risk that its patients contracted Hepatitis C due to Parker's actions, it set up a program offering free Hepatitis C testing to patients who underwent procedures during the months that Parker was employed there.

Judge Dismisses Seroquel Claim Against AstraZeneca

A federal judge in Florida has granted AstraZeneca Pharmaceuticals L.P.'s motion to dismiss claims by the Pennsylvania Employees Benefit Trust Fund that charged the drug company with fraudulently marketed its antipsychotic drug Seroquel. The trust fund claimed unjust enrichment and a breach of express warranty, arguing that AstraZeneca improperly marketed the drug for unapproved uses and improperly told doctors the drug was better and safer than similar alternatives. U.S. District Judge Anne C. Conway ruled that the fund, which provides health insurance and prescription drug coverage for Pennsylvania employees, did not expressly receive the marketing pitches on Seroquel and was therefore too remote from the alleged harm to have a viable claim.

Boxed Warnings Ordered For Chantix and Zyban

The FDA is requiring the manufacturers of smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) to put a Boxed Warning on their prescribing information highlighting the serious mental health risks associated with taking the drugs. Users of the products have reported marked changes in behavior, including depression, suicidal thoughts and increased hostility. In announcing the new requirements, Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research, noted that the risks of experiencing these side effects should be weighed against the advantage of quitting smoking. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit,” Woodcock said in a release. Health care providers are being advised to watch for symptoms of mood change in their patients taking Chantix or Zyban, and to tell their patients to report any such changes to them as soon as possible.

FDA Issues Final Regulation on Dental Amalgam

The FDA has issued a final regulation classifying dental amalgam and its component parts (elemental mercury and a powder alloy), used in dental fillings, as a Class II (moderate risk) substance. Noting that elemental mercury can be dangerous at high levels, the agency's release reassures dental care providers and their patients that the levels of mercury released by dental amalgam fillings are not high enough to pose a health hazard. The FDA is, however, imposing certain controls on the use of dental amalgam and warning dental care providers not to use dental amalgam in patients with mercury allergy and not to work with the substance unless there is adequate ventilation. To view the final regulation, go to: http://www.fda.gov/MedicalDevices/ProductsandedicalProcedures/DentalProducts/DentalAmalgam/default.htm.

Businessman Caught Up in Sting Accused of Brokering Human Organ Sale

The sensational July arrests of more than 40 individuals ' including five rabbis and three New Jersey mayors ' following a Federal Bureau of Investigation (FBI) inquiry into alleged political corruption and money-laundering schemes netted one more unusual suspect: a Brooklyn businessman accused of brokering the sale of human organs, a practice prohibited in the United States. The complaint filed against Levy Izhak Rosenbaum charges him with agreeing to obtain a kidney for the fictitious uncle of an undercover FBI officer who was posing as the secretary of what the charges termed the FBI's “cooperating witness” ' a man who is currently facing federal bank fraud charges. According to the complaint, the cooperating witness contacted Rosenbaum in February 2008 expressing an interest in obtaining a kidney for someone. At a meeting soon after that initial discussion, Rosenbaum allegedly explained that the donor would come from Israel, and said, “Let me explain to you one thing. It's illegal to buy or sell organs ' . So you cannot buy it. What you do is, you're giving a compensation for the time ' whatever ' he's not working.” The ultimate price requested for the kidney was $160,000, according to the complaint.

Lawsuits Claim Failure to Warn of Birth Control Pill Risks

The first four of what are expected to be a large number of lawsuits concerning the birth control pills Yaz and Yasmin were filed in the first days of July, in federal courts in Wisconsin and Ohio. The claims are being brought against Bayer HealthCare Pharmaceuticals, which recently entered into an agreement with the FDA to run “clarification” advertisements pointing out the risks of the pills' use that were downplayed in earlier commercials. In fact, the FDA's warning letter to Bayer ' which emphasized that Yaz poses particular risks because it contains progestin drospirenone, which can increase potassium levels ' is being touted by plaintiff attorneys as strong evidence of the company's failure to warn. “That's going to be important evidence ' overpromotion and downplaying the risks,” said attorney Janet G. Abaray, who is representing several claimants. In response, Bayer spokesperson Rose Talarico said, “All oral contraceptives contain clear labeling indicating the benefits and risks. Bayer stands behind the safety and efficacy of Yaz and Yasmin when used as directed. A woman and her health care professional should always discuss the benefits and potential risks of adverse health effects associated with all oral contraceptives.”

New Warnings Required for Some Immunosuppressant Drugs

Although it may have seemed an obvious concern, certain immunosuppressant drugs were not, until July, required to carry warnings that their use could increase a patient's risk for developing opportunistic infections, such as latent viral infections. Of primary concern is BK virus-associated nephropathy, a kidney disease that is being seen in renal transplant patients. Most healthy adults have at one time contracted the BK virus, which remains in their kidneys and urinary tracts indefinitely, generally causing no harm. However, when the immune system is suppressed or otherwise compromised, the virus can replicate. On July 17, based on what the FDA termed new safety information, the agency announced that, from now on, the manufacturers of the following immunosuppressants must update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy:

• Sirolimus, marketed as Rapamune;
• Cyclosporine, marketed as Sandimmune and generics;
• Cyclosporine, modified marketed as Neoral and generics;
• Mycophenolate mofetil, marketed as Cellcept and generics; and
• Mycophenolic acid, marketed as Myfortic.

The FDA advises that BK virus-associated nephropathy can progress to renal allograft loss, so medical professionals should monitor patients carefully and consider adjusting their immunosuppression therapies if BK virus-associated nephropathy develops.

Criminal Charges Brought Against Scrub Tech Who Tampered with Syringes

A former Colorado scrub surgery tech has been charged with product tampering and other drug charges after she allegedly stole syringes containing the painkiller Fentanyl Citrate while at her workplace. According to the indictment, the accused, who has hepatitis C, took 21 syringes containing Fentanyl from the operating room between the months of October 2008 and April 2009. She then injected herself with them and refilled them with saline solution, replacing the used syringes in the operating room. The accused, Kristen Diane Parker, was terminated from her position at Denver's Rose Medical Center in April 2009.

After the Medical Center was informed by the State Health Department in June that there was a risk that its patients contracted Hepatitis C due to Parker's actions, it set up a program offering free Hepatitis C testing to patients who underwent procedures during the months that Parker was employed there.

Judge Dismisses Seroquel Claim Against AstraZeneca

A federal judge in Florida has granted AstraZeneca Pharmaceuticals L.P.'s motion to dismiss claims by the Pennsylvania Employees Benefit Trust Fund that charged the drug company with fraudulently marketed its antipsychotic drug Seroquel. The trust fund claimed unjust enrichment and a breach of express warranty, arguing that AstraZeneca improperly marketed the drug for unapproved uses and improperly told doctors the drug was better and safer than similar alternatives. U.S. District Judge Anne C. Conway ruled that the fund, which provides health insurance and prescription drug coverage for Pennsylvania employees, did not expressly receive the marketing pitches on Seroquel and was therefore too remote from the alleged harm to have a viable claim.

Boxed Warnings Ordered For Chantix and Zyban

The FDA is requiring the manufacturers of smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) to put a Boxed Warning on their prescribing information highlighting the serious mental health risks associated with taking the drugs. Users of the products have reported marked changes in behavior, including depression, suicidal thoughts and increased hostility. In announcing the new requirements, Janet Woodcock, M.D., director, the FDA's Center for Drug Evaluation and Research, noted that the risks of experiencing these side effects should be weighed against the advantage of quitting smoking. “Smoking is the leading cause of preventable disease, disability, and death in the United States and we know these products are effective aids in helping people quit,” Woodcock said in a release. Health care providers are being advised to watch for symptoms of mood change in their patients taking Chantix or Zyban, and to tell their patients to report any such changes to them as soon as possible.

FDA Issues Final Regulation on Dental Amalgam

The FDA has issued a final regulation classifying dental amalgam and its component parts (elemental mercury and a powder alloy), used in dental fillings, as a Class II (moderate risk) substance. Noting that elemental mercury can be dangerous at high levels, the agency's release reassures dental care providers and their patients that the levels of mercury released by dental amalgam fillings are not high enough to pose a health hazard. The FDA is, however, imposing certain controls on the use of dental amalgam and warning dental care providers not to use dental amalgam in patients with mercury allergy and not to work with the substance unless there is adequate ventilation. To view the final regulation, go to: http://www.fda.gov/MedicalDevices/ProductsandedicalProcedures/DentalProducts/DentalAmalgam/default.htm.

Businessman Caught Up in Sting Accused of Brokering Human Organ Sale

The sensational July arrests of more than 40 individuals ' including five rabbis and three New Jersey mayors ' following a Federal Bureau of Investigation (FBI) inquiry into alleged political corruption and money-laundering schemes netted one more unusual suspect: a Brooklyn businessman accused of brokering the sale of human organs, a practice prohibited in the United States. The complaint filed against Levy Izhak Rosenbaum charges him with agreeing to obtain a kidney for the fictitious uncle of an undercover FBI officer who was posing as the secretary of what the charges termed the FBI's “cooperating witness” ' a man who is currently facing federal bank fraud charges. According to the complaint, the cooperating witness contacted Rosenbaum in February 2008 expressing an interest in obtaining a kidney for someone. At a meeting soon after that initial discussion, Rosenbaum allegedly explained that the donor would come from Israel, and said, “Let me explain to you one thing. It's illegal to buy or sell organs ' . So you cannot buy it. What you do is, you're giving a compensation for the time ' whatever ' he's not working.” The ultimate price requested for the kidney was $160,000, according to the complaint.

Lawsuits Claim Failure to Warn of Birth Control Pill Risks

The first four of what are expected to be a large number of lawsuits concerning the birth control pills Yaz and Yasmin were filed in the first days of July, in federal courts in Wisconsin and Ohio. The claims are being brought against Bayer HealthCare Pharmaceuticals, which recently entered into an agreement with the FDA to run “clarification” advertisements pointing out the risks of the pills' use that were downplayed in earlier commercials. In fact, the FDA's warning letter to Bayer ' which emphasized that Yaz poses particular risks because it contains progestin drospirenone, which can increase potassium levels ' is being touted by plaintiff attorneys as strong evidence of the company's failure to warn. “That's going to be important evidence ' overpromotion and downplaying the risks,” said attorney Janet G. Abaray, who is representing several claimants. In response, Bayer spokesperson Rose Talarico said, “All oral contraceptives contain clear labeling indicating the benefits and risks. Bayer stands behind the safety and efficacy of Yaz and Yasmin when used as directed. A woman and her health care professional should always discuss the benefits and potential risks of adverse health effects associated with all oral contraceptives.”