FDA Panel Advises Strict Limits on Testosterone Prescriptions

FDA Warning sign

Assuming the FDA adopts the advice of the panel, the drug companies will be forced to severely alter marketing strategies and the number of men prescribed these drugs will be significantly reduced. The recommendations might also impact insurance coverage of testosterone prescriptions.

On June 19, 2014 the FDA announced that labels for these drugs are now required to include warnings pertaining to the risk of blood clots.

Questions remain concerning the long-term risks of testosterone and prior studies have linked the medication to increased rates of heart disease. The same panel  voted 20 – 1 for the FDA  to require further studies be conducted related to cardiovascular risk and testosterone use. On Thursday, September 18th, the panel voted 18 – 3 against the approval of the oral testosterone drug Rextoro; the panel concluded that the risk-benefit ratio fails to support FDA approval.

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Lawsuits Allege Link Between Pancreatic Cancer and Diabetes Drug Byetta

byetta packagingApproved in 2005, Byetta is an injectable medication used to help lower blood sugar levels of people suffering from Type 2 Diabetes. In 2007 the FDA issued a public warning that there were concerns over a possible link between pancreatitis, a condition associated with the development of pancreatic cancer, and the use of Byetta and other incretin mimetic drugs.  A 2011 study from UCLA suggested that Byetta might increase the risk  of developing pancreatic cancer and thyroid cancer. According to a report published by The Institute for Safe Medication Practices, 612 of the 1,069 cases of pancreatitis, pancreatic cancer, thyroid cancer or hypersensitivity reaction reported to the FDA in 2012 were linked to Byetta.

These concerns escalated in March of 2013 when a study suggested a connection between the use of Byetta and the development of a precancerous condition called pancreatic duct metaplasia. Although the FDA as yet to confirm that patients taking incretin mimetics such as Byetta are in fact at risk of this disease, research on this concern is ongoing.  Both the FDA and the American Diabetes Association have requested more testing of drugs like Byetta to determine additional risks. A recent report in the British Medical Journal suggests that risks associated with incretin memtics have been minimized by drug manufacturers.

Over 60 lawsuits involving the use of Byetta and other incretin mimetic drugs such as Januvia and Victoza are underway in U.S. District Court, Southern District of California. On August 26, 2013 the Judicial Panel on Multidistrict Litigation consolidated these cases (Incretins Products Liability, Sales and Marketing Litigation, MDL 252, United States Judicial Panel on Multidistrict  Litigation). The first trial conference is scheduled for October 17, 2013.

Recall of Children’s Tylenol, Motrin, Zyrtec & Benadryl

children's medications recalledMcNeil Consumer Healthcare, together with the U.S. Food & Drug Association, has implemented the voluntary recall of infant and children’s liquid  Tylenol, Motrin, Zyrtec and Benadryl due to concerns over manufacturing deficiencies. According to the announcement published on the FDA website, some of the products might a have higher concentration of the active ingredient than is specified on the label; others might contain inactive ingredients that have not satisfied testing requirements; and others possibly contain small particles that could be harmful to infants and children.

Although the likelihood of serious medical problems is believed to be remote, the FDA is advising consumers to discontinue using the above products. Consumers are being asked to report any adverse reactions to these products to: FDA’s MedWatch Program by fax 1-800-FDA-0178, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

Supreme Court Considers the Liability of Generic Drug Companies

In 2008 a New Hampshire federal jury awarded Karen Bartlett $21 million for injuries she sustained after using a medication called sulindac. She was prescribed Clinoril for shoulder pain and received the generic version — sulindac. The drug was directly responsible for Bartlett developing Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), conditions that led to severe skin deterioration. Bartlett eventually suffered additional permanent injuries, including near-blindness, lung damage and burns in her esophagus.

The jury award relied on a New Hampshire products liability law allowing for damages based on defective design. The defendant in the case, Mutual Pharmaceutical Company, appealed to the U.S. Court of Appeals for the 1st Circuit arguing that the federal law regulating generic drugs preempts state design-defect laws. The 1st Circuit upheld the lower court decision and Mutual Pharmaceutical then appealed to the U.S. Supreme Court. The Supreme Court agreed to hear the case and oral arguments were held on March 19, 2013.

Mutual Pharmaceutical claims no liability since they are required, pursuant to the Food & Drug Cosmetic Act (FDCA) to use the same ingredients and warning labels as those used by the original manufacturer. In other words, they claim they are legally required to keep a generic drug identical to the brand name drug. Brand name manufactures maintain that they are not responsible for injuries caused by drugs that were not purchased from them.

Ultimately, this case well help clarify how federal law applies to generic pharmaceutical companies as well as determine the extent to which state product liability laws pertain to the generic drug industry.

For a thorough analysis of the legal issues involved in this case see  Cornell’s Legal Information Institute.

Judge’s Order Nullifies $6.5 Million Verdict in Diabetes Drug Trial

In a May 1, 2013 press release Takeda Pharmaceuticals announced that the trial court judge granted the defendant’s motion for non-suit. The ruling nullifies the April 26th jury verdict.

A Los Angeles Superior Court jury awarded $6.5 million to the plaintiff Jack Cooper in the first trial involving the diabetes drug Actos (Cooper v. Takeda Pharmaceuticals America, Inc., CGC-12-518535). The jury found Takeda Pharmaceuticals liable for the failure to warn patients that Actos could cause bladder cancer. The verdict awarded $5 million in compensatory damages to Jack Cooper and $1.5 million to his wife. As many as 3000 similar lawsuits are pending in the United States.

According to the attorney representing Cooper, the Japanese drug company was aware of possible links between Actos and bladder cancer as early as 2004. However, the company waited 7 years before reporting these findings to U.S. regulators. In 2011 Actos was removed from the market in both France and Germany after studies revealed that some patients using Actos have increased risk of developing heart problems and bladder cancer.

In 2012 the British Medical Journal reported that patients who use Actos for 2 years are twice as likely to develop bladder cancer. In the same year  the Canadian Medical Association Journal published the results of a study showing that users of Actos have a 20 percent increased risk of developing bladder cancer. Canada has since removed Actos from the list of approved medications.

A “black box” warning, the strongest of the FDA warnings, informing users that Actos is linked to congestive heart failure was added to the label in 2007. In 2011 an FDA Safety Announcement informed the public that the use of Actos for more than one year might result in “increased risk of bladder cancer”. The announcement required the drug manufacturer to add this warning to the drug label.

In response to FDA demands, Takeda launched a ten year study addressing the long term risk of bladder cancer associated with Actos. Data from the first five years of the study showed that patients taking the drug for over a year have a 40 percent higher risk of developing bladder cancer. The study was completed in 2012 and the full results should be available sometime in 2013.

Dozens of Lawsuits Allege Serious Risks Associated with Mirena IUD

Mirena birth control device Manufactured by Bayer Healthcare Pharmaceuticals, the Mirena IUD was approved by the FDA in 2000 as a contraceptive and later as treatment for heavy bleeding after childbirth. The device is used by more than 2 million women in the U.S. and 15 million women worldwide. Although considered a safe form of birth control, the FDA has received thousands of reports from women claiming they have suffered serious complications from the device. Recent lawsuits allege that women who use the contraceptive are susceptible to the following risks:

  • Perforation of the uterine or cervix wall
  • Embedment in vaginal tissue
  • Pelvic inflammatory disease
  • Ovarian Cysts
  • Migration out of the uterus which can result in infection or other injuries

Of the nearly 3 dozen lawsuits filed, the primary allegation is perforation of surrounding tissue.  According to the lawsuits, Bayer Healthcare Pharmaceuticals knew or should have known about the risks and neglected to provide adequate warnings to the medical community. Plaintiffs allege that the company withheld information about the risks and made false and deceptive representations concerning the safety  of the device. Although the FDA has not yet recommended a recall of the Mirena IUD, it appears likely that the manufacturer will be required to alter the warning label to include more comprehensive information about potential risks.

Click here to access the FDA’s description of the Mirena IUD, including side affects and risks.

Death Toll for Meningitis Outbreak Reaches 23

NECC injection bottlesOn Monday, October 22nd, the CDC announced that 3 more people have died from the national meningitis tragedy, bringing the total deaths to 23. There have now been 297 non-fatal cases, and of the approximately 14,000 people who received the contaminated steroid, 12,000 have been contacted.

The FDA is currently investing two additional drugs made by the New England Compounding Center (NECC) that appear to be linked to the fungal meningitis outbreak. They have received reports of two heart transplant patients who developed fungal infections after being given one of these drugs during surgery. The NECC has recalled all of the drugs produced at the facility and has surrendered its state license.

According to recent press reports, a 2006 investigation of the NECC revealed inadequate contamination controls along with other insufficiencies related to operation procedures. The House Committee on Energy and Commerce has requested up to 10 years of records from the drug company. Furthermore, two members of the House Oversight Committee appealed to the Government Accountability Office to investigate the pharmacy compounding industry with a goal to reforming state and federal rules so as to prevent this type of tragedy in the future.

On Tuesday, October 23rd, Massachusetts launched a criminal investigation into the specialty pharmacy. The Massachusetts Office of Health and Human Services started investigating the pharmacy on September 26 and the “Preliminary Investigation Report of NECC” is now available online.

Contaminated Steroid Linked to Fungal Meningitis Outbreak

aspergillus fumigatus fungasAs many as 119 patients who received epidural steroid injections have developed fungal meningitis. As of October 9, 2012, 11 people have died from the outbreak. According to the Food and Drug Administration, a vial of the steroid called methylprednisolone acetate was found to be contaminated with a fungus. In several of the patients, the meningitis was caused by the fungus aspergillus. New England Compounding Center (NECC) in Framingham, Massachusetts is believed to be the source of the contaminated steroid. NECC has recalled three lots of the drug and is no longer in operation.

The Centers for Disease Control & Prevention along with the Food and Drug Administration are conducting and a multi-state investigation focusing on cases of meningitis where the patient was given an epidural spinal injection. The injections are given to help relieve back pain. Up to 75 clinics in 23 states received the recalled lots of the steroid.The potentially contaminated injections were given staring May 21, 2012.

The States that received the NECC steroid include: California, Connecticut, Florida, Giorgia, Idaho, Illinois, Indiana, Maryland, Michigan, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, Texas, and West Virginia. A complete list of the Healthcare facilities which received lots of the recalled drug is available on the CDC website.

The CDC is advising patients to find out if they received a potentially contaminated medication by contacting the health care provider who performed the procedure.

“If you have received a potentially contaminated medication, seek medical attention if you have symptoms. It is important to note that infected patients have had very mild symptoms that are only slightly worse than usual. For example, many infected patients have had slight weakness, slightly worsened back pain, or even a mild headache. Patients have had symptoms generally starting from 1 to 4 weeks after their injection.”

People who received an epidural steroid injection since May 21, 2012 should seek medical attention should they have any of the symptoms listed below:
New or worsening headache
Fever
Sensitivity to light
Stiff neck
New weakness or numbness in any part of your body
Slurred speech
Increased pain, redness or swelling at your injection site”

Updates about the investigation as well as patient guidelines and answers to frequently asked questions are available at the CDC website.

Durezol / Durasal: FDA Warning About Name Confusion

Durezol, DurasalDurazol is an eye medication sometimes prescribed for patients after eye surgery and Durasal, consisting of 26% salicylic acid, is an unapproved topical solution used for wart removal. Although the FDA usually reviews drugs to protect against confusion due to similar names, the safety check did not occur in the case of Durasal because the medication did not go through the FDA approval process. The name confusion has resulted in one incident where a pharmacist dispensed the wart remover instead of Durazol eye drops. The patient suffered a serious eye injury and has filed a $1 million lawsuit against a pharmacy chain. There have been other instances where the two drugs were confused but the error was discovered before the patient received the medication. Although a warning that Durasal is not to be used in the eyes is included on the box, no such warning appears on the medication bottle. The FDA has asked Elorac, Inc., the manufacturer of Durasal, to remove the medication from the market. According to the FDA, several health care professionals have complained about the similar names and expressed concern about possible injuries due to medical errors. The FDA has released an alert to pharmacists and health care professionals warning of the “potential for injury when dispensing” these two medications.

Propecia – Increased Concern Over Permanent Sexual Side Effects

Propecia is one of several prescription drugs called “5-alpha reductase inhibitors (5-ARI)” used to treat hair loss and pattern baldness in men. Pending lawsuits allege that Merck, the drug company that makes Propecia, failed to warn consumers of permanent sexual side effects. The cases claim that the drug was not thoroughly researched and Merck withheld information from health care providers and consumers. Although Merck acknowledged potential sexual side effects, they maintained these problems would go away when the drug was discontinued. However, in April 2011 Merck changed the label to include information about “reports of erectile dysfunction that continued after discontinuation of Propecia.” The label also includes a warning that in “rare cases” users of propecia have developed breast cancer.

In June 2011 the FDA required the warning labels on Propencia and several other 5-ARI drugs to include information on the increased risk of high-grade prostate cancer. The FDA has yet to take action in response to rising concerns over reports linking Propecia to permanent sexual side effects. Information about these potential side effects have been well publicized in Europe for several years. As far back as 2008 Sweden demanded that Merck add reports of “persistent erectile dysfunction” to the label.

The recent removal of the Merck-sponsored website, Propecia.com, has sparked speculation about a possible recall. The promotional website has been replaced with prescription information, refund request procedures related to the Propecia Promise Program, and information on how to report adverse side effects to the FDA.