Wyeth-Ayerst Laboratories put itself on the map with the introduction of the first compressed tablet via a rotary press in 1872.
The company has gone through several name changes and mergers over the years. In 1860, the Philadelphia-based John Wyeth and Brother was run by pharmacist brothers who started out manufacturing medications that were commonly ordered, at the request of prescribing doctors. Wyeth sold the business to American Home Products (AHP) in 1931. In 2002, AHP sold off many of its divisions to focus on healthcare and pharmaceuticals, and it was rebranded as Wyeth. In 2009, Wyeth was acquired by the world’s largest drug manufacturer, Pfizer, for close to $70 billion, The New York Times publishes.
Wyeth has developed, manufactured, and distributed a wide range of pharmaceutical products over the years, including the first version of over-the-counter (OTC) ibuprofen with Advil in 1984; many OTC cough and cold medications like Robitussin and Dimetapp; the antidepressant drug Effexor (venlafaxine), which was developed in 1993; the anti-anxiety benzodiazepine drug Ativan (lorazepam); and the “z-drug,” non-benzodiazepine, sleep aid Sonata (zaleplon).
Wyeth had success developing and marketing an international vaccine in 2006. Prevnar 13 (pneumococcal 13-valent conjugate vaccine) protects infants, children, and adults from 13 strains of the deadly pneumonia disease. It remains the only vaccine of its kind for infants and children worldwide.
Now underneath Pfizer, Wyeth is part of a global leader in the biopharmaceutical field with medications in the fields of cardiology, immunology, pain, virology, vaccines, oncology, neurology, and endocrinology, to name a few.
Pfizer Inherits Wyeth’s Legal Troubles
Wyeth has faced many lawsuits and accusations of price fraud; marketing drugs outside of their FDA-approved uses; product liability; downplaying of negative side effects, including addiction; and false advertising of their products. As AHP, Wyeth was involved in a scandal in the 1990s involving the weight loss drug combination of fenfluramine (brand names of Pondimin and Redux) and phentermine when this fen-phen mix was found to cause potentially fatal damage to heart valves. The drugs were pulled from shelves in 1997, and many lawsuits have been settled, ABC News reports.
In 2013, Wyeth Laboratories, Inc., which had since been acquired by Pfizer, agreed to pay close to $500 million to resolve civil and criminal liability for the marketing of the immunosuppressive drug Rapamune (sirolimus) outside of its FDA-approved purpose. Rapamune was approved for use with kidney (renal) transplants; however, the United States Department of Justice (DOJ) published that Wyeth marketed the drug to healthcare providers and consumers for use with other transplants in an attempt to boost sales and increase profits of the drug between 1998 and 2009.
Investors and shareholders to the follow-up drug to Effexor, Pristiq (desvenlafaxine) filed a class action suit against Wyeth Laboratories, Inc. in 2012 after they were misled regarding the drug’s potential approval and undisclosed side effects, Reuters reports.
In 2016, Wyeth was found guilty of submitting false and fraudulent prices to the federal government on two of its proton pump inhibitor (PPI) drugs, often used to treat acid reflux, Protonix (pantoprazol) IV and Protonix Oral. In conjunction with Pfizer, they agreed to pay nearly $785 million to settle the allegations, the DOJ reports. The arrangement worked in the following way: Wyeth would sell the drugs in a bundle and at a discount to healthcare providers who promoted them and then falsely reported Medicaid prices back to the government without disclosing the discounted rate, thus pocketing the difference in profit.
Issues with Ativan
Benzodiazepines have been some of the most successful prescription medications for pharmaceutical companies as they consistently top the charts as some of the most-prescribed drugs. Wyeth helped to diversify the benzodiazepine (benzo) market that had been previously dominated by Librium (chlordiazepoxide) and Valium (diazepam) with the introduction of Ativan (lorazepam) in the mid-1970s.
Benzodiazepines are prescribed for anxiety; however, it came to light in the 1990s that they were also habit-forming and should not be used for longer than a few weeks at a time and certainly not on a long-term basis. Ativan and other benzos are classified as Schedule IV controlled substances by the Drug Enforcement Administration (DEA), meaning that there is a recognizable risk of these substances being abused and for the formation of drug dependence and potentially addiction. Warnings included in the prescribing information provided by the FDA for Ativan state that benzodiazepines can lead to both physical and psychological dependence; therefore, they should not be used for periods longer than 2-4 weeks at a time.
Benzos interfere with normal production of some of the brain’s chemical messengers, including dopamine and GABA (gamma-aminobutyric acid). Dopamine is responsible for mood regulation and happiness, and GABA works to manage anxiety and the stress response, which includes autonomic functions of the central nervous system like heart rate, body temperature, respiration rates, and blood pressure. When Ativan is used long-term, changes are made to brain chemistry and wiring to compensate for the continued presence of the drug. Stopping use can cause a difficult and even possibly dangerous withdrawal syndrome that may include the following negative side effects:
- Rapid heart rate
- Heightened blood pressure
- Sweating and elevated body temperature
- Fast breathing
- Nausea and vomiting
- Tingling in the extremities
- Panic attacks
- Short-term memory loss
- Changes in sensory perceptions
- Sensitivity to light and sound
- Loss of appetite
- Abdominal cramps
The wide range of negative withdrawal side effects that can occur after trying to stop Ativan can lead a person to misuse the drug and take it compulsively. Addiction may follow. Addiction involving Ativan often requires medical detox to help allow the drug to safely process out of the body, often through a slow and controlled tapering schedule followed with a complete addiction treatment program.
Issues with Sonata
As what is often called a “z-drug,” the non-benzodiazepine sleep aid Sonata (zaleplon) has been marketed as a substitution sedative-hypnotic insomnia drug for traditional benzodiazepine medications.
At first, these products seemed to have far fewer negative side effects than benzos; however, it soon came to light that they could cause bizarre and complex “sleep activities,” such as driving, eating, having sex, or talking on the phone while being asleep. In 2006, the FDA requested that changes be made to the labeling of drugs like Sonata to warn people of the possible risks.
As with benzodiazepine drugs, Sonata may have a risk of being misused and also the potential for developing a dependency on and/or addiction involving the drug. Sonata may carry less risk for addiction than traditional benzodiazepines, as the withdrawal syndrome is likely milder, but it may still be abused. As a result, abuse of Sonata requires specialized treatment to sustain long-term abstinence and to develop coping skills and tools to enhance sleep without substance abuse.