Orlistat (Alli, Xenical) linked to liver damage

The Food and Drug Administration has announced it is reviewing adverse reports of liver injury in patients taking the weight loss drug orlistat, also known as Xenical or Alli.

Over a 9 year period starting in 1999, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those reports, 27 reported hospitalization and six resulted in liver failure. The most commonly reported side effects included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is performing an analysis of data from clinical trials and the manufacturer these data. To date no definite association between liver injury and orlistat has been established. The FDA will release its findings on orlistat as soon as the review is completed and is not recommending to stop taking the medication at this time.

If you have used or continue to use orlistat you should consult a health care professional if you experience symptoms possibly associated with development of liver injury: weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

Why is there a shortage of desiccated thyroid (e.g. Armour thyroid, Thyroid (dessicated), Nature-Throid)

There is a lot of speculation about the reasons for the shortages of desiccated thyroid preparations. Typically drug shortages exist due to the discontinuation of a product by a manufacturer, raw ingredient shortage, manufacturing problems, or regulatory action by the FDA. In the case of the current desiccated thyroid shortage, it may be a combination of factors. The only manufacturer to provide information about the shortage is Forest who stated their shortage is due to a manufacturing change.

The shortage has required patients to switch to levothyroxine (T4), Cytomel (T3), or alternative desiccated thyroid preparations (if they can find them). Coordination of these switches should occur under the supervision of a physician to ensure appropriate monitoring. There is a small subset of patients unable able to use levothyroxine as they lack the ability to covert T4 to T3. A combination synthetic T4/T3 combination product is marketed but is also currently on backorder (Thyrolar, Forrest).

At the beginning of August the following preparations were experiencing shortages:

Thyroid (desiccated) 30 mg tablets (Major)
Thyroid (desiccated) 30 mg tablets, (Major)
Thyroid (desiccated) 60 mg tablets, (Major)
Thyroid (desiccated) 180 mg tablets, (Major)

Armour Thyroid 15 mg tablets, (Forest)
Armour Thyroid 30 mg tablets, (Forest)
Armour Thyroid 30 mg tablets, (Forest)
Armour Thyroid 30 mg tablets, (Forest)
Armour Thyroid 60 mg tablets, (Forest)
Armour Thyroid 60 mg tablets, (Forest)
Armour Thyroid 60 mg tablets, (Forest)
Armour Thyroid 90 mg tablets, (Forest)
Armour Thyroid 180 mg tablets, (Forest)
Armour Thyroid 180 mg tablets, (Forest)

Nature-Throid NT-3 194.4 mg (3 grain) tablets, (RLC)

The following products have been discontinued:

Thyroid (desiccated) 120 mg tablets, (Major)

Thyroid (desiccated) capsules (Bio-Tech Pharm)
Thyroid (desiccated) tablets (Qualitest)
Thyroid (desiccated) tablets (Time-Cap)

Is the pharmacist shortage over?

Over the last decade or so, the U.S. has experienced a pharmacist shortage. This has resulted in a high job vacancy rate, higher salaries, and increased workload. It appears that the pharmacist shortage may be coming to an end. This is due in part to the opening of dozens of new pharmacy schools increasing the graduation rate and the increased use of automation. In addition, healthcare reform will have an impact. With finite healthcare resources, pharmacists will need to continue to become more operationally efficient. Also, as quality becomes a more important metric, the provision of high-quality pharmacy services will be required of pharmacists.

The next decade is likely to see changes to the profession and a shift to more clinical activities and less dispensing related functions. Although the demand/need for medication experts is likely to continue to expand, it appears that their will be the supply to meet this demand.

New Creon dose - why was there a change?

The Food and Drug Administration (FDA) regulates the efficacy and safety of medications. Drugs marketed prior to 1938 were "grandfathered" in and did not require submission for FDA approval. One example of these types of drug include pancreatic enzymes (Creon, Ultrase, Pancrease, Pancrecarb) commonly used for patients with diseases of the pancreas, cystic fibrosis, and pancreatic enzyme deficiency.

In May of 2009 the FDA approved a new Creon formulation, the first and only FDA approved pancreatic enzyme. The new Creon formulation was available from the manufacturer in July of 2009.

Although the ingredients on the label differ on the old and new formulations, the amount of pancreatic enzymes in each corresponding capsule are the same and no change in dosing is necessary when converting from old to new formulation. The old formulation had "extra enzymes in the capsule that were not included in the label. The new formulation has been labeled with the actual amount of enzymes.

Creon 5 = Creon 6,000

Creon 10 = Creon 12,000

Creon 20 = Creon 24,000

The new formulation does require a new prescription for filling at your pharmacy.

Are prescriptions from Canada or internet pharmacies safe?

As the price of prescription drugs continue to rise, consumers are always looking for ways to save money on their medications. One such method that has become increasingly popular is to obtain medications from Internet pharmacies or prescriptions from Canada.

The problem with obtaining prescriptions in this fashion is that the medications you receive could contain the wrong medication, contain no active ingredients, or be contaminated with lead/other toxic agents.

Although many of the Internet pharmacy sites look authentic and reputable, there is no regulation at a state or federal level of these entities. So the prescription you think is coming from Canada may be coming from China, Russia, etc. The prescription does not need to be filled by a pharmacist and their is no recourse for the consumer if the wrong/counterfeit medication is dispensed.

Audits by the state of Minnesota and Wisconsin of a Canadian internet pharmacy pointed out significant safety problems, such as:

• several pharmacies used unsupervised technicians to enter medication orders and to try to clarify prescriptions
• one pharmacy had its pharmacists review 100 new prescriptions or 300 refill prescriptions per hour (a typical safe number is around 10-20 prescriptions per hour);
• one pharmacy failed to label its products, instead it shipped the labels unattached in the same shipping container, even to patients who received multiple medications
• drugs requiring refrigeration were being shipped un-refrigerated;
• dispensing medications that had been recalled or removed from the market by the FDA;
• dispensing expired medications

The bottom line is that the potential cost savings of using these pharmacies does not outweigh the significant risks to consumers.

Recommendations for drug disposal

There has been a lot of publicity over the last decade about ground water contamination and drinking water contamination with prescription drugs. The short-term and long-term effects of this contamination on the environment and humans in unknown. One step that can help to minimize the potential for ground water contamination is proper drug disposal.

1. Do not flush prescription drugs down the toilet or dump down a sink drain unless the label or accompanying patient information specifically instructs you to do so.

2. To dispose of prescription drugs not labeled to be flushed, you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events, that collect drugs at a central location for proper disposal. Call your city or county government’s household trash and recycling service and ask if a drug

take-back program is available in your community.

3. If a drug take-back or collection program is not available:

• Take your prescription drugs out of their original containers.
• Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.
• Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag.
• Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or by scratching it off.
• Place the sealed container with the mixture, and the empty drug containers, in the trash.

Federal Guidelines

FDA recommendations

Why should I keep a medication list?

I commonly hear from patients that they do not need to keep a medication list because that information is in their "medical record". Unfortunately, this is not the case as most patients see multiple providers that do not share common medical records. For example, you cardiologist may have a different chart than your internist. In addition, patients take a variety of non-prescription (over-the-counter) products, herbals, and dietary supplements. Even when providers have a medication, this list is often what is prescribed vs. what the patient is actually taking.

One of the best things you can do as a patient is to keep an updated list of your medications in your wallet/purse.

The list should include the name, dose, how you take it, why you take it, and who told you to take it. Your list should be updated every time there is a change in your medications.

There are a number of websites that have templates you can use.

Safe Care Wisconsin

Safe Medication

Institute for Safe Medication Practices

UW Health

When I interview patients admitted to the hospital where I work, I find that on average there are 2-10 errors found between what the doctor orders and what the patient is actually taking at home when admission orders are written. The main source of this error is that patient's do not have an accurate list of medications with them and the doctor must rely on what information they have which is often out of date and incomplete.

These errors can include but are not limited to:

• ordering a drug that has stopped
• not ordering a drug that is being taken
• ordering the wrong dose
• ordering a drug that has already been taken today
• ordering a medication that has caused allergic reactions in the past

Any of these errors can complicate your admission and in some cases lead to death. Taking the time to create and update your list of medications is one of the best things you can do for your health.