Greg's Pharmacy Blog

FDA Educating Patients Re: Online Accutane

The FDA has recently set up a website warning patients of the dangers of purchasing the drug Accutane, used for the treatment of severe acne, over the Internet. Accutane has been designated as Pregnancy Category X by the FDA, and can cause severe teratogenic and birth defects in pregnant women. It is required that women receiving Accutane have a negative pregnancy test before filling the prescription. The new FDA website advises against ordering the medication online, as online pharmacies may not screen for pregnancy before filling the prescription, or may not require a prescription at all.

It is the responsibility of pharmacists to educate patients about the dangers of Accutane, and ensure compliance with the iPledge program, the program put in place to ensure negative pregnancy tests before filling the prescriptions. Pharmacists should ensure the safety of their patients and their children.

For more information, visit http://www.fda.gov/buyonline/accutane/

FDA Recommends PDUFA Renewal

On March 23, the FDA recommended to Congress that the Prescription Drug User Fee Act, first passed in 1992, be renewed. The Act requires that manufacturers of prescription drugs pay a fee, which supplements the FDA's funding for the review of submitted NDAs and post-marketing safety surveillance. The recommendation for renewal comes with a recommendation to increase the fees by $87.4 million, to a total of $392.8 million. The increase in funding will continue the original mission of the PDUFA, while increasing safety monitoring through, amongst other things, the review of direct-to-consumer advertising.

The increased oversight and review that comes from renewal of the PDUFA may have several consequences for the practice. First of all, it has the potential to expedite review and bring many new medications to the market. Also, the increased safety review may result in more medications being pulled from the market. It is the responsibility of pharmacists to continue to monitor these developments and educate patients accordingly.

For more information, visit http://www.fda.gov/bbs/topics/NEWS/2007/NEW01592.html

Another Withdrawal

New post-marketing safety data have caused the withdrawal of another medication from the market. The FDA, in response to articles in the New England Journal of Medicine, has asked manufacturers of the dopamine agonist medication pergolide, sold both in generic forms and under the brand name Permax, to withdraw their products from the market. The medication, used in the treatment of symptoms of Parkinson's Disease, has been associated with backflow in the valves of the heart since 2002. Since that time, the condition was added to the package inserts of the medications, both as a general adverse event and as a black box warning. However, with this confirmation of the data, the products were withdrawn entirely.

However, this withdrawal is not expected to affect patients that much, as many other medications for Parkinson's symptoms are still on the market. That being said, it is still important for patients to work with their physicians and pharmacists to find the best possible alternative. Even though prescribing of pergolide is not extensive (only 12,000 prescriptions filled in 2006), these patients cannot be ignored, and all health care professionals, including pharmacists, must work to maintain control of their symptoms.

For more information, visit http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html

New Orphan Biologic Approved

The FDA recently approved a new biologic for the treatment of an extremely rare genetic condition which results in increased blood clotting. Severe Congenital Protein C Deficiency, literally a one-in-a-million condition, manifests symptoms shortly after birth and is fatal if left untreated. The new biologic, Ceprotin, is used in conjunction with other anticoagulant medications to help patients deal with potentially life-threatening situations.

This medication is indicative of the benefits of the Orphan Drug Act, passed in 1983. Without the marketing exclusivity and tax benefits given to firms researching orphan drugs, over 200 drugs would not be on the market. This gives pharmacists and other health care professionals more options to benefit all of their patients.

For more information about Ceprotin, visit http://www.fda.gov/bbs/topics/NEWS/2007/NEW01598.html

Zelnorm Pulled From Market

Keeping with their mission to protect the public health by ensuring the safety of medications, the FDA has requested that Novartis Pharmaceuticals 'discontinue marketing' the medication Zelnorm, used for treatment of irritable bowel syndrome and constipation in women. 29 clinical studies involving over 11,000 patients have shown that Zelnorm increased the incidence of serious cardiovascular side effects, including heart attack and stroke.

In increasing Phase 4 monitoring of medications, it is likely that more medications may be removed from the market in response to undesirable safety profiles. It is therefore essential that pharmacists keep track of those medications that have been deemed unsafe, and educate themselves about alternative, safer medications to recommend to patients.

For more information about Zelnorm, visit http://www.fda.gov/cder/drug/advisory/tegaserod.htm

FDA Educating Patients About Online Drugs

As part of its mission to protect the public health through ensuring the safety of the drug supply, the FDA has been educating patients of the risks associated with online pharmacies. The FDA realizes the benefits that an online pharmacy can provide, such as convenience for possibly disabled patients, and the privacy afforded when obtaining medications for potentially embarrassing conditions. However, patients need to be made aware of unlicensed websites selling counterfeit medications, or websites that are not associated with licensed pharmacies. To this end, the FDA has has published materials educating patients about the benefits and risks of using online pharmacies.

However, the responsibility for this should not fall completely on the patient. Online pharmacies may not afford the same patient-pharmacist contact as a traditional retail setting. Even if they occasionally use online pharmacies, community pharmacists must continue to monitor the medication regimens of their patients to ensure the best possible health outcomes, regardless of where their medications are obtained from.

For more information about the FDA's patient education program concerning online pharmacies, visit http://www.fda.gov/usemedicinesafely/Buy_meds_online_text.htm

New HTN Drug Approved

The FDA recently announced approval of a new drug for the treatment of hypertension, manufactured by Novartis Pharmaceuticals. This medication is unique in that it acts on a slightly different pathway than other existing treatments, acting earlier in the hypertensive pathway and on a different compound, renin. This medication was demonstrated to be effective in multiple large-scale, placebo-controlled studies. However, effectiveness relative to existing treatments was not established.

This new medication represents an exciting opportunity for patients who do not respond to the existing treatments. However, because relative efficacy has not been established, it is possible that extensive direct-to-consumer advertising may pressure patients into requesting a switch to the new 'miracle drug,' even if their hypertension is already controlled. It is, therefore, up to patients, physicians, and pharmacists to establish a dialog to determine the most effective treatment, both in terms of health outcomes and finances, for any given patient.

For more information on Tekturna, the drug described, visit http://www.fda.gov/bbs/topics/NEWS/2007/NEW01580.html

FDA Reviewing Pediatric Cold Medicines

According to the Associated Press, the FDA has begun to review safety data for common OTC cold medications, especially when used in children under 2. High doses of these common medications have been linked to increased blood pressure and cardiac arrhythmia. A spokesperson for companies marketing these medications maintain that they are safe when taken in recommended doses, a point conceded by pediatricians. However, overdoses can result when a parent administers multiple medications to a child for the same symptoms. These medications have been on the market for some time, and the regulations under which they were approved have become more stringent.

The questions raised for pharmacy practice to consider in this situation are twofold. First, though it may be questionable ethically, there is a need for increased pediatric safety and efficacy data. While the FDA has been extending marketing exclusivity for firms who provide such data, the practice needs to become more widespread. Also, there is a need for vigilance at the community level. Community pharmacists must be on the watch for parents buying multiple medcations with the same active ingredients to treat both their children and themselves. With increased counseling of patients and further patient education initiatives, these situations can be avoided.

For more information, visit http://www.msnbc.msn.com/id/17417416/

Orlistat approved for OTC

On February 7, the FDA approved Orlistat for OTC sale. Sold under the Rx brand name Xenical, orlistat promotes weight loss by blocking the absorption of fat in the intestine. The medication will be sold in a starter pack containing information about how to safely use the medication.

This approval has the potential to benefit many patients who are at risk for diabetes or other complications due to their weight. However, there is also the potential for misuse by those who would use the medication for cosmetic use. By approving orlistat for OTC use, the FDA has placed an even greater responsibility on the pharmacist, who must begin to counsel patients purchasing this medication, to ensure that it is used safely by those patients who would benefit most from it.

For more information on the approval, visit http://www.fda.gov/cder/drug/infopage/orlistat_otc/index.htm

Ketek Loses Indications

Three days ago, the FDA and sanofi-aventis Pharmaceuticals agreed on a labeling change for the antibiotic Ketek (telithromycin). After reviewing reports through the FDA's MedWatch adverse event reporting system, the FDA chose to drop two of the previously reported indications: treatment of exacerbated bacterial bronchitis, and treatment of acute bacterial sinusitis. In addition, the FDA placed a boxed warning on the label contraindicating the medication in patients with myasthenia gravis, a form of muscle weakness that can be exacerbated by the medication, leading to severe respiratory depression.

While I am pleased with the fact that the MedWatch system has led to greater safety reporting, I am disturbed by the loss of another antibiotic for these two indications. With the continuing rise of drug-resistant pathogens, the health care system needs as many lines of defense as it can get. However, the ultimate solution to this problem, development of new classes of antibiotic agents, is still mostly wishful thinking. For the time being, we must continue to monitor the use of antibiotics, and use them only when necessary, and even then with moderation.

For more information about Ketek, and the change in labeling information, visit:

http://www.fda.gov/cder/drug/infopage/telithromycin/default.htm

FDA!

So...

The powers that be have assigned me the task of reporting on the dealings of the Food and Drug Administration for the term. After some introspection, I have decided to focus the blog on the following aspects of the FDA:

1) New Drug/Generic Drug Approvals
2) MedWatch and Safety Monitoring

So be on the lookout for forthcoming entries into these two aspects. As for the rest of the stuff the FDA does, I'm sure you can find it somewhere else if you really want to read it.

Welcome to my blog!

Welcome to my blog for all pharmacy-related news, to be updated regularly, or at least until the end of this term. Look around, even though there isn't much yet. Enjoy!