The New Jersey State government unveiled its registry of drug prices for the 150 most prescribed medications last week
October 30, 2007
The New Jersey State government unveiled its registry of drug prices for the 150 most prescribed medications last week. Users can search by drug name, town, or zip code to find how the prices compare at pharmacies. Users can access the information by telephone or at www.njconsumeraffairs.gov/njpdr. Similar registries already exist in New York and Michigan. Compliance has not been a problem for state pharmacists since the prices are taken from the usual-and-customary prices that pharmacies are already reporting to the state Medicaid board.
Popularity: 30% [?]
FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil)
October 30, 2007
FDA and Cephalon notified healthcare professionals of updates to the WARNINGS section of the prescribing information for Provigil (modafinil). Provigil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work sleep disorder. The revised labeling updates safety information to include warnings regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms. Rare cases of serious or life-threatening rash, including Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms have been reported in adults and children in worldwide postmarketing experience. Angioedema and multi-organ hypersensitivity reactions have also been reported in postmarketing experience.
Popularity: 44% [?]
The FDA has ordered a black box warning on the use of mycophenolate mofetil (CellCept) during pregnancy
October 30, 2007
The FDA has ordered a black box warning on the use of mycophenolate mofetil (CellCept) during pregnancy.
In announcing the label change, the agency cited an increased risk of spontaneous abortion or congenital malformation for transplant patients who become pregnant while using the immunosuppressant.
Post-marketing data from the National Transplantation Pregnancy Registry (NTPR) and worldwide adverse event reporting found an increased risk of cleft lip and palate, malformation of the external ear, and anomalies of distal limbs, heart, esophagus, and kidney.
Roche, the drug’s maker, said that in December 2006 NTPR published data from prospective cases where 24 female transplant patients reported 33 pregnancies exposed to mycophenolate mofetil-containing regimens.
Popularity: 48% [?]
Drugs used for Erectile Dysfunction Linked to Hearing Loss
October 22, 2007
The U.S. Food and Drug Administration has approved labeling changes for erectile dysfunction (ED) drugs in the class that includes Cialis, Levitra, and Viagra, to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.
In addition, the FDA plans to require the same changes in labeling for the drug Revatio, also a member of this drug class known as phosphodiesterase type 5 (PDE5) inhibitors. Revatio is used to treat pulmonary arterial hypertension (PAH). PAH is a serious medical condition in which continuous high blood pressure in arteries of the lungs weakens the heart muscle and often leads to right heart failure and death.
The FDA asked manufacturers of these drugs to revise product labeling after a very small number of patients taking the PDE5 inhibitors reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.
Patients taking Cialis, Levitra, or Viagra who experience sudden hearing loss should immediately stop taking the drug and seek prompt medical attention. Those using Revatio should continue taking their medication but should contact their health care provider for further evaluation. Because Revatio is used to treat a potentially life-threatening condition, the FDA does not recommend patients abruptly stop taking this medication but should consult their physician if they experience sudden problems with their hearing.
A case report in the April 2007 issue of the Journal of Laryngology & Otology involving sudden hearing loss in a man taking Viagra prompted the FDA to search the FDA’s Adverse Events Reporting System for instances of hearing loss and PDE5 inhibitors. The FDA found a total of 29 postmarketing reports of sudden hearing loss, both with and without accompanying ringing in the ears, vertigo, or dizziness. In most of the cases, the hearing loss involved one ear. The hearing loss was either a partial or complete loss of usual hearing. In approximately one third of cases, the event was temporary. In the remainder, the hearing loss was ongoing at the time of the report or the final outcome was not described.
Although no causal relationship has been demonstrated, the strong relationship between the use of these drugs and sudden hearing loss in these cases warrants revisions to the product labeling for this drug class.
Popularity: 85% [?]
Pharmaceutical Company Influence on our Teaching Centers
October 18, 2007
About 60% of department heads at medical schools and teaching hospitals in the U.S. have personal financial relationships with pharmaceutical or medical device companies, according to a study published on Wednesday in the Journal of the American Medical Association. Researchers sent a survey to department heads at all 125 accredited medical schools and the 15 largest teaching hospitals in the U.S. About two-thirds of department heads responded to the survey.
Popularity: 53% [?]
State Controls Pharmaceutical Influence
October 18, 2007
Click here to read the entire New York Times article
Two years after Minnesota officials forbade drug makers to give doctors more than $50 worth of food or other gifts per year, drug company sales representatives there are having a far harder time marketing to doctors. The rule change was small and almost accidental — a state official decided to interpret a 1993 law differently from his predecessor. But the effect on drug makers has been profound.
The year after the change, the number of visits that Minnesota primary care doctors accepted from drug sales representatives decreased at about twice the rate of the decline reported by primary care doctors nationwide, according to a survey by ImpactRx, a New Jersey firm that tracks pharmaceutical marketing. A growing number of Minnesota hospitals and clinics have banned routine visits from them.
Popularity: 33% [?]
Medical Device Disaster
October 18, 2007
Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic’s action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.
Medtronic first notified physicians in March about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted today’s action.
Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. ICDs and CRT-Ds shock the heart back into normal rhythm by sending a pulse of energy through an electronic wire or lead that is connected to the heart.
When a defibrillator lead is slightly more prone to fracture, it doesn’t mean that every lead will break. Most leads will function well, as is the case with Sprint Fidelis. In the infrequent circumstance where a lead actually breaks, or “fractures,” the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
Current adverse event information indicates that fractures have occurred in less than 1 percent of the approximately 268,000 of these leads implanted worldwide. We don’t know if this rate of adverse events will remain constant or increase over the life of these leads.
FDA considers Medtronic’s action to be a product recall, as defined by FDA regulations, and we will soon be issuing a recall classification for this action. We recognize that some patients and health care professionals might inappropriately interpret the word “recall” to mean that the devices must be surgically removed and returned to the manufacturer. Although the leads should no longer be implanted in patients, we do not mean to imply that these leads should be surgically removed.
The leads continue to function properly in the vast proportion of patients. Although there is no test to predict which lead will fracture, FDA agrees with Medtronic’s recommendation that defibrillator settings be adjusted at the patient’s next scheduled follow-up visit with their doctor. Doing so may increase the likelihood that a fracture will be detected before a patient is harmed.
Neither FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer useable and implanting a different model.
Read the full statement from the FDA
Popularity: 73% [?]
States take a Stand Against Overinflated Drug Prices
October 10, 2007
The state of Iowa joined a number of other states in taking a stand against overly inflated drug prices. Pharmaceutical companies have been very successful convincing the public that the high cost of prescriptions is the result of trial lawyers and frivolous lawsuits. The fact is that pharmaceutical companies over inflate the price of their drugs by setting arbitrary price points that capitalize on the limited monopoly a patent gives a company.
It is a simple case of supply and demand. As consumers demand the product the insurance companies are forced to pay the huge increase because the product is not available from any other source. This type of abuse will not stop until there is a change in the way the U.S. patents pharmaceuticals. The U.S. is one of the only places in the word where a company can patent a drug without a cap on the price.
Think about it.
Popularity: 33% [?]
FDA Takes Next Step in Transformation of its Center for Drug Evaluation and Research
October 9, 2007
The FDA has taken the scathing criticism by the Institute of Medicine to heart and is now taking action to reform the Center for Drug Evaluation and Research (CDER). The first step in the hopefully multi-step process was to award a $1.5 million two year contract to the Center for Professional Development to help the FDA improve workplace leadership, empower staff, and establish more effective business practices. This is a step in the right direction for the FDA. Kudos to the FDA.
Popularity: 31% [?]
