Labeling for Chantix and Zyban will be updated to include a Black Box Warning regarding their link to mental health events, including changes in behavior, depressed mood, hostility, and suicidal thoughts. A Black Box Warning is the Food & Drug Administration’s (FDA) most serious safety notice.

It should be of no surprise to readers of this blog that Chantix is getting such a serious safety warning, as its problems are well-documented. The FDA actually began investigating its link to psychiatric side effects in late 2007. In 2008, Chantix maker Pfizer elevated the prominence of safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. However, many consumer advocates, including the group Public Citizen, want the FDA to go further and highlight the Chantix suicide risk with a Black Box warning. (more…)

Arthritis and other autoimmune medications have made recent headlines over a variety of issues including links to serious opportunistic fungal infections and cancer. Now, as part of President Barack Obama’s health care overhaul, a review of arthritis medications manufactured by Wyeth, Abbott Laboratories, and Johnson & Johnson (J&J) might warrant some additional scrutiny, reports Bloomberg.com.

Recently, we reported that federal regulators ordered the makers of Humira, Cimzia, Enbrel, and Remicade to strengthen the existing warnings about opportunistic fungal infections linked to the drugs. At least 45 people are known to have died from such infections. The U.S. Food & Drug Administration (FDA) ordered the new labeling under authority it was granted with the passage of its Amendments Act of 2007. (more…)

A government panel voted that two popular prescription painkillers be taken off of the market because of their alleged impact in dangerous, sometimes fatal, overdoses. The Associated Press reported that Vicodin and Percocet, which are combined with the popular medication acetaminophen, should be removed because of issues linked with acetaminophen, a component in a variety of other common medications.

Acetaminophen is, said Dow Jones previously, the most “widely used drug in America” and is found in over-the-counter (OTC) painkillers, fever reducers, and cough medications such as Excedrin, Tylenol, NyQuil, and Theraflu, to name just some. Acetaminophen is also used in combination with powerful prescription medications such as Vicodin and Percocet. (more…)

We recently wrote that Bausch & Lomb, maker of ReNu with MoistureLoc, settled around 600 lawsuits involving the recalled contact lens solution. Now, Bausch & Lomb is focusing on ReNu marketing. According to a prior report in the Associated Press (AP), the settled ReNu with MoistureLoc claims have cost the company about $250 million, to date.

WXXI Center for Public Affairs reports that Bausch & Lomb announced a massive marketing and re-branding campaign that is expected to cost several million dollars and is geared to helping consumers understand its ReNu products. (more…)

Another Tysabri patient has developed progressive multifocal leukoencephalopathy or PML. Ten cases of the often-fatal brain infection have now been associated with Tysabri since it was reintroduced in 2006. Of those patients, at least 3 have died. According to a report in the Boston Business Journal, Biogen Idec disclosed the latest case on Friday, and a total of three have been reported this month alone.

In the U.S. Tysabri was taken off the market in 2005 after three patients in clinical trials developed PML. But the drug was reapproved in 2006, although it was subject to restrictions. Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections. (more…)

Accutane is being pulled from the market by its maker, Roche AG. According to the Associated Press, Roche said the decision to withdraw Accutane was made for economic rather than safety reasons. But as anyone who reads this blog known, over the past couple of years, Roche has lost several Accutane lawsuits, and been ordered to pay more than $33 million to people who claim they were injured by the drug.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems. (more…)

Federal regulators have decided to wait on approving Botox as a treatment for upper limb spasticity in stroke victims. According to a Reuters report, the Food & Drug Administration (FDA) wants to review a bit more information before deciding to expand the approved use of Botox to include treatment of the movement disorder.

Allergan markets two Botox products. Botox Cosmetic is made from botulinum toxin type A, and is approved for temporary improvement in the appearance of moderate to severe facial frown lines. It is different from Botox, another Allergan botulinum toxin product, which is approved to treat conditions such as blepharospasm (spasm of the eyelids), cervical dystonia (severe neck muscle spasms), and severe primary axillary hyperhydrosis (excess sweating).

(more…)

Government regulators will be taking an even closer look next week at painkillers such as Tylenol and how these medications affect the liver. Dow Jones reported that acetaminophen, an ingredient found in a vast array of over-the-counter drugs is at the center of the issue.

Acetaminophen is, said Dow Jones, the most “widely used drug in America” and is found in OTC painkillers, fever reducers, and cough medications such as Excedrin, Tylenol, NyQuil, and Theraflu, to name some. (more…)

Drug companies may be using employees known as medical science liaisons (MSLs) to get around rules that prohibit the promotion of unapproved drug uses, The Wall Street Journal reported today. Because MSLs are considered medical - not sales staff - they are allowed to discuss off-label uses of medications with doctors and other health professionals.

According to the Journal, MSLs are often doctors or pharmacists. They call on doctors to discuss the science behind a medicine, including unapproved uses. (more…)

U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized drug products manufactured by Caraco Pharmaceutical Laboratories Limited. The products were seized at Caraco’s Michigan facilities in Detroit, Farmington Hills, and Wixom and also include ingredients held at these facilities.

“The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Compliance with these standards prevents harm to the public,” she added, said the FDA. (more…)